13 research outputs found
Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension
- Author
- Acary Souza Bulle Oliveira
- Adam Hart
- Adife Veske
- Aditya Kumar
- Aikaterini Dimitriou
- Akihiro Mukaino
- Akiko Kanzaki
- Akiyuki Uzawa
- Akshay Shah
- Alan Ross Berger
- Albert Hietala
- Alberta Locatelli
- Alejandra Dalila Garcia
- Alejandro Tobon Gonzalez
- Alessandro Filla
- Alex Fondaw
- Alexandre Guerreiro
- Alexandre Guerreiro
- Ali Malekniazi
- Aline de Cassia Santos
- Alzira Alves de Siqueira Carvalho
- Amaiak Chilingaryan
- Amanda Anderson
- Amelia Evoli
- Amna Shah
- Amy Saklad
- Amy Woodall
- Ana Carolina Amaral de Andrade
- Ana Lazaro
- Ana Paula Macagnan
- Ana Paula Melo
- Andrea Corse
- Andrea Kelley
- Andrea Swenson
- Angela Ardoin
- Angela Campanella
- Angela Marsili
- Angela Micheels
- Angiola Fasanaro
- Anh Tran
- Anita Mogensen
- Ann D'Hont
- Anna Gonzalez
- Anne Cooley
- Anne Mette Ostergaard Autzen
- Anneke van der Kooi
- Annelies Depreitere
- Annelies Vanhee
- Anthony Amato
- Antonella Di Pasquale
- Antonella Di Pasquale
- April McVey
- Arshira Seddigh
- Arzu Meherremova
- Ashley Mallon
- Aya Mizugami
- Ayse Kutlu
- Baki Dogan
- Barbara Lokaitis
- Barbora Kurkova
- Bengu Balkan
- Benison Keung
- Benjamin Brooks
- Beth DiSanzo
- Betsy Mosmiller
- Booth H. D. E.
- Brajesh Agrawal
- Brian Droker
- Brian Minton
- Brigitta Szabadosne
- Brittany Harvey
- Bruno Bezerra Rosa
- Bryan Kim
- Byoung Joon Kim
- Byung-Jo Kim
- Can Ebru Bekircan-Kurt
- Cansu Semiz
- Carlo Antozzi
- Carlos Casasnovas
- Carol Herbert
- Carolina Miranda
- Caroline Schotte
- Cecile Phan
- Celal Tuga
- Chae Won Shin
- Chafic Karam
- Chafic Karam
- Chang Nyoung Lee
- Charlene Hafer-Macko
- Charlotte Smetcoren
- Christian Homedes-Pedret
- Christopher Nance
- Claire Brown
- Clara Schommer
- Claudio Gabriel Mazia
- Colleen Pineda
- Craig Donahue
- Cristiani Fernanda Butinhao
- Csilla Rozsa
- Cynthia Bodkin
- Cynthia Carter
- Da Yoon Koh
- Dae Lim Koo
- Dai Matsuse
- Daiane da Cruz Pacheco
- Daisuke Yamamoto
- Dallas Forshew
- Daniel Ambrosio
- Daniel Dicapua
- Danielle Sheldon
- Dave Watling
- David Feder
- Debbie Davies
- Debora Dada Martineli Torres
- Dennis Jeffery
- Derrick Blackmore
- Diana Dimitrova
- Diego Lopergolo
- Donna Carnes
- Doreen Ho
- Délphine Mahieu
- Edina Varga
- Elaine Weiner
- Elena Bravver
- Elena Cortes Vicente
- Elena Giacomelli
- Eliana Reyes
- Elisabet Arribas-Ibar
- Elizabeth Watt
- Emanuela Onesti
- Emiko Tsuda
- Enrico Marano
- Eri Kobayashi
- Erica Nogueira Coelho
- Eriko Higuchi
- Eriko Miyawaki
- Eun Bi Hwang
- Eun Bin Cho
- Eun Haw Choi
- Exuperio Diez Tejedor
- Ezgi Yilmaz
- Fabio Barroso
- Faisal Sohail
- Fatima Maqsood
- Fernanda Carrara
- Fernanda Troili
- Filiz Muharrem
- Fiona Norwood
- Floyd Jones
- Francesco Saccà
- Francisco Javier Rodriguez de Rivera
- Frank Lin
- Fredrik Piehl
- Fujita K. P.
- Fumie Meguro
- Gabor Lovas
- Gabor Lovasamela César
- Gabriel Paiva
- Gabrielle Rico
- Gal Maier
- Gedeonne Jakab
- Gedeonne Jakab
- Giannis Sokratous
- Giorgia Camera
- Giorgia Puorro
- Giovanni Antonini
- Girija Sadalage
- Gisela Gili
- Gonzalo Mazuela
- Gonzalo Vidal
- Graziela Pinto
- Gulmohor Roy
- Gulsah Becerikli
- Gulsah Orsel
- Gustavo Duran
- Guy Van den Abeele
- Gyorgyi Szabo
- H James Jones
- Ha Young Shin
- Ha-Neul Jeong
- Hakan Cavus
- Harpreet Kaur
- Heena Olalde
- Heike Arndt
- Henning Andersen
- Henrique Mohr
- Hidekazu Suzuki
- Hirokazu Shiraishi
- Hiroyuki Murai
- Hisako Kobayashi
- Hong Vu
- Hoo Nam Kang
- Howard J. F.
- Hui Gong
- Huned Patwa
- Hung Youl Seok
- Husnu Efendi
- HyeJin Ra
- HyeLim Lee
- Hyung Seok Lee
- Iandra Souza
- Igor Dias Brockhausen
- Ihsan Sengun
- Ikuko Kamegamori
- Ikuko Yasuda
- Irene Yang
- Isabel Illa
- Ivana Jurajdova
- Iveta Novakova
- Jaana Eriksson
- Jae-Sung Lim
- Jaimin Shah
- Jakit Gollogly
- James Gilchrist
- Jan De Bleecker
- Jan Vynckier
- Jana Junkerova
- Jane Distad
- Jane Pedersen
- Janice Massey
- Jasmine Hewlett
- Jaya Trivedi
- Jayashri Srinivasan
- Jeffery Statland
- Jeffrey Guptill
- Jeffrey Narayan
- Jeffrey Rosenfeld
- Jenna Seelbach
- Jeri Sieren
- Jerry Locheke
- Ji Ye Hwang
- JiEun Lee
- Jinmyoung Seok
- JinWoo Jung
- Jiri Pitha
- Joan Højgaard
- Joan Nye
- Joanne Nemeth
- John Kincaid
- John Kissel
- John Loor
- John Vissing
- Jonathan Katz
- Jonathan McKinnon
- Jordan Jara
- Jordana Gonçalves Geraldo
- Jordi Diaz-Manera
- Josef Bednarik
- Josep Gamez Carbonell
- Joseph Chad Hoyle
- Ju-Hong Min
- Judit Matolcsi
- Juha-Pekka Erälinna
- Julie Agriesti
- Julie Khoury
- Julie Steele
- Juliet Saba
- Jun Kawamata
- Justin Kwan
- JuYoung Kwon
- Kaitlyn McKenna
- Kaori Osakada
- Kaori Uwasa
- Kara Patrick
- Karan Alcon
- Karen Callison
- Karen Zakalik
- Katarina Reguliova
- Kate Beck
- Katherine Amato
- Kathryn Johns
- Kathy de Koning
- Katrien De Mey
- Katsuhisa Masaki
- Kazumi Futono
- Kazumi Takada
- Keiko Kikutake
- Kelley Emmons
- Kendrick Henderson
- Kenichi Tsukita
- Kenkichi Nozaki
- Kerry Naunton
- Kevin Daniels
- Khema Sharma
- Kimberly Robeson
- Kimiaki Utsugisawa
- Koichi Narikawa
- Krishna Polaka
- Kristen Roe
- Kristin Huynh
- Lara Katzin
- Laszlo Vecsei
- Laura Diez Porras
- Laura Echevarria
- Laura Fionda
- Laura Fionda
- Laura Golden
- Laura Haar
- Laura Herbelin
- Lauren Wheeler
- Laurie Gutmann
- Lena Bjarbo
- Lesly Welsh
- Liang Lu
- Liene Duarte Silva
- Linda Wagemaekers
- Lindsay Zilliox
- Lisa Hobson-Webb
- Lisa Smith
- Livia Dezsi
- Lorenzo Maggi
- Lorraine Dishman
- Lotte Vinge
- Louisa Mezache
- Lucas Eduardo Pazetto
- Luciana Ferreira
- Luciana Renata Cubas Volpe
- Luciana Souza Duca
- Ludwig Gutmann
- Luis Antonio Querol Gutiérrez
- Luiz Augusto da Silva
- Luiz Otavio Maia Gonçalves
- Maeda Yasuko
- Magda Chmelikova
- Maki Jingu
- Makoto Samukawa
- Mamatha Pasnoor
- Manisha Chopra
- Mantegazza R.
- Marcela Silva
- Marcela Wolfova
- Marcelo Annes
- Marcelo Chaves
- Marcelo Rugiero
- Marek Cierny
- Marguerite Engel
- Maria Antonia Alberti Aguilo
- Maria da Penha Ananias Morita
- Maria Gabriele
- Maria Gori
- Maria Pasanisi
- Maria Salvado Figueras
- Maria Sastre
- Marianne de Visser
- Mariela Bettini
- Marina Pozo
- Martin Bilsker
- Mary Varghese
- Maryanne Burdette
- Masahiro Mori
- Masakatsu Motomura
- Masaki Saitoh
- Masako Tsurumaru
- Masanori Takahashi
- Masayuki Nakamori
- Matteo Garibaldi
- Maureen Walsh
- Maurer Pereira Martins
- Maurizio Inghilleri
- Maurício AndréGheller Friedrich
- Mayuko Noshiro
- Mazen Dimachkie
- Megan Kramer
- Megumi Koga
- Meinoshin Okumura
- Melanie Glenn
- Melinda Horvath
- Michael Benatar
- Michael Hehir
- Michael Pulley
- Michael Weiss
- Michaela Tyblova
- Michal Vytopil
- Miguel Wilken
- Mihoko Takada
- Miju Shin
- Mikko Laaksonen
- Mireya Fernandez-Fournier
- Mireya Fernandez-Fournier
- Miri Kim
- Miriam Freimer
- Misa Shimpo
- MiSong Choi
- Miwako Sato
- Miyuki Morikawa
- Mohamed Kazamel
- Mohamed Mahdi-Rogers
- Mohammad Alsharabati
- Mohammed Salajegheh
- Mohammed Sanjak
- Mollie Vanderhook
- Mona Elsayed
- Monika Konyane
- Muppidi S.
- Murat Terzi
- Murilo Santos Engel
- Musa Kazim Onar
- Muzeyyen Ugur
- Nadia Sattar
- Namie Taichi
- Namita Goyal
- Nanna Witting
- Naoki Kawaguchi
- Naoko Ishiyama
- Natalia Julia Palacios
- Natalia Prando
- Natália Assis
- Naya McKinnon
- Nazire Pinar Acar
- Neelam Goyal
- Nicholas Silvestri
- Nicholas Ventura
- Nicolas Vandenbussche
- Nicole Jenci
- Nicole Kressin
- Nivedita Jerath
- Nuria Vidal
- O'Brien F. L.
- Ohito Tano
- Olga Zapletalova
- Olivier Stevens
- Olli Oksaranta
- Ozlem Tun
- Paolo Emilio Alboini
- Patricia Padilla
- Patrícia Fernandes
- Pedro Lopez Ruiz
- Petra Tilkin
- Philip Van Damme
- Pilar Gomez Salcedo
- Pilar Sune
- Pinar Ozcelik
- Pravin Torane
- Pravin Torane
- Raffaele Iorio
- Ratna Bhavaraju-Sanka
- Rebecca Traub
- Rebekah Garcia
- Rekha Pillai
- Renata Martins Ribeiro
- Ricardo Rojas Garcia
- Richard Barohn
- Richard Nowak
- Rikako Kurihara
- Rikki Roderus
- Riley Snook
- Robert Miller
- Robert Pascuzzi
- Rosana Rocha
- Rudy Mercelis
- Rumi Takeyama
- Rup Tandan
- Sabrina Pol
- Sachiko Kamakura
- Said Beydoun
- Saiju Jacob
- Salma Akhter
- Sanaz Karimi
- Sandi Mumfrey-Thomas
- Sandra Guingrich
- SangAe Park
- Sara-Claude Michon
- Sarada Sakamuri
- Sarah Plevka
- Sarah Verjans
- Scott Cunningham
- Seda Aydinlik
- Sedat Sen
- Seiko Yoshida
- Seung Min Kim
- Sevim Erdem-Ozdamar
- Shachie Aranke
- Shannon Lucy
- Sharmeen Alam
- Sharon Chelnick
- Sharon Downing
- Sharon Nations
- Shin Hisahara
- Shirley Paulose
- Shirli Toska
- Shizuka Asada
- Shoko Amamoto
- Shuichiro Suzuki
- Shun Shimohama
- Shun Shimohama
- Shunsuke Yoshimura
- Sien Van Daele
- Silvia Bonanno
- Sivakumar Sathasivam
- So-Hyun Ahn
- Soichiro Funaka
- Sonia Garcia
- Stanislav Vohanka
- Stanislava Toncrova
- Stefania Morino
- Stephanie Kohlrus
- Stephanie Scala
- Steve Hopkins
- Susan Strom
- Susanne Krogh
- Tahseen Mozaffar
- Taira Uehara
- Takashi Hayashi
- Takashi Murahara
- Takuya Matsushita
- Tamar Gibson
- Tamires Cristina Gomes da Silva
- Taylor Darnell
- Teiichiro Miyazaki
- Teresa Costabile
- Terry McClain
- Terry McClain
- Tessa Marburger
- Tetsuya Akiyama
- Tetsuya Kanai
- Thabata Veiga
- Thomas Arnold
- Thomas Cochrane
- Thomas Harbo
- Tierney Scott
- Tina Liu
- Tiyonnoh Cash
- Tomihiro Imai
- Tomihiro Imai
- Tomohiro Kawamura
- Tomoko Tsuda
- Tomomi Kobashikawa
- Tomoya Hasuike
- Tomás Augusto Suriane Fialho
- Tuan Vu
- Tugce Kirbas Cavdar
- Tulio Bertorini
- Tuula Harrison
- Valentina D'Amato
- Valentina Velez Santamaria
- Valeria Cavalcante Lino
- Valerie Young
- Veena Mathew
- Vern Juel
- Victor Doan
- Vinay Chaudhry
- Vittorio Frasca
- Vittorio Frasca
- Waqar Waheed
- Wiendl H.
- Wladimir Pinto
- Wolfe G. I.
- Yagmur Caliskan
- Yasmeen Shabbir
- Yasmeen Shabbir
- Yasushi Suzuki
- Ye Liu
- Yoko Ishiyama
- Yoko Kaneko
- Yong Seo Koo
- Yool-Hee Kim
- Yoon-Ho Hong
- Yoshiko Sano
- Yuen T So
- Yuka Saito
- Yukiko Ozawa
- Yuko Fujii
- Yumi Yamashita
- Yumiko Nakamura
- Yunxia Wang
- Yuriko Nagane
- Yusuke Fukuda
- Zaeem Siddiqi
- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 01/01/2021
- Field of study
OBJECTIVE: To evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension. METHODS: Patients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study. RESULTS: A total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected. CONCLUSION: Eculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population. CLINICALTRIALSGOV IDENTIFIER: REGAIN, NCT01997229; REGAIN open-label extension, NCT02301624. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo
Minimal Symptom Expression' in Patients With Acetylcholine Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis Treated With Eculizumab
- Author
- Agrawal Brajesh
- Agriesti Julie
- Ahn So-Hyun
- Akhter Salma
- Akiyama Tetsuya
- Alam Sharmeen
- Alcon Karan
- Alsharabati Mohammad
- Alves de Siqueira Carvalho Alzira
- Amamoto Shoko
- Amato Anthony
- Amato Katherine
- Ambrosio Daniel
- Andersen Henning
- Anderson Amanda
- Andoin Angela
- André Gheller Friedrich Maurício
- Annes Marcelo
- Antonia Alberti Aguilo Maria
- Antonini Giovanni
- Antonio Querol Gutiérrez Luis
- Antozzi Carlo
- Aranke Shachie
- Arndt Heike
- Arnold Thomas
- Arribas-Ibar Elisabet
- Asada Shizuka
- Assis Natália
- Augusto da Silva Luiz
- Augusto Suriane Fialho Tomás
- Aydinlik Seda
- Balkan Bengu
- Barohn Richard
- Barroso Fabio
- Becerikli Gulsah
- Beck Kate
- Bednarik Josef
- Benatar Michael
- Bertorini Tulio
- Bettini Mariela
- Beydoun Said
- Bezerra Rosa Bruno
- Bhavaraju-Sanka Ratna
- Bi Hwang Eun
- Bilsker Martin
- Bin Cho Eun
- Bjarbo Lena
- Blackmore Derrick
- Bodkin Cynthia
- Bonanno Silvia
- Bravver Elena
- Brooks Benjamin
- Brown Claire
- Burdette Maryanne
- Caliskan Yagmur
- Callison Karen
- Camera Giorgia
- Campanella Angela
- Carnes Donna
- Carolina Amaral de Andrade Ana
- Carrara Fernanda
- Carter Cynthia
- Casasnovas Carlos
- Cash Tiyonnoh
- Cavalcante Lino Valeria
- Cavus Hakan
- Chad Hoyle Joseph
- Chaudhry Vinay
- Chaves Marcelo
- Chelnick Sharon
- Chilingaryan Amaiak
- Chmelikova Magda
- Choi MiSong
- Chopra Manisha
- Cierny Marek
- Cochrane Thomas
- Cooley Anne
- Corse Andrea
- Cortes Vicente Elena
- Costabile Teresa
- Cristina Gomes da Silva Tamires
- Cunningham Scott
- César Pamela
- D'Amato Valentina
- D'Hont Ann
- da Cruz Pacheco Daiane
- da Penha Ananias Morita Maria
- Dada Martineli Torres Debora
- Dalila Garcia Alejandra
- Daniels Kevin
- Darnell Taylor
- Davies Debbie
- De Bleecker Jan
- de Cassia Santos Aline
- de Koning Kathy
- De Mey Katrien
- de Visser Marianne
- Depreitere Annelies
- Dezsi Livia
- Di Pasquale Antonella
- Dias Brockhausen Igor
- Diaz-Manera Jordi
- Dicapua Daniel
- Diez Porras Laura
- Diez Tejedor Exuperio
- Dimachkie Mazen
- Dimitriou Aikaterini
- Dimitrova Diana
- DiSanzo Beth
- Dishman Lorraine
- Distad Jane
- Doan Victor
- Dogan Baki
- Donahue Craig
- Downing Sharon
- Droker Brian
- Duarte Silva Liene
- Duran Gustavo
- Ebru Bekircan-Kurt Can
- Echevarria Laura
- Eduardo Pazetto Lucas
- Efendi Husnu
- Elsayed Mona
- Emilio Alboini Paolo
- Emmons Kelley
- Engel Marguerite
- Erdem-Ozdamar Sevim
- Eriksson Jaana
- Erälinna Juha-Pekka
- Evoli Amelia
- Fasanaro Angiola
- Feder David
- Fernanda Butinhao Cristiani
- Fernandes Patrícia
- Fernandez-Fournier Mireya
- Fernandez-Fournier Mireya
- Ferreira Luciana
- Filla Alessandro
- Fionda Laura
- Fionda Laura
- Fondaw Alex
- Forshew Dallas
- Frasca Vittorio
- Frasca Vittorio
- Freimer Miriam
- Fujii Yuko
- Fukuda Yusuke
- Funaka Soichiro
- Futono Kazumi
- Gabriel Mazia Claudio
- Gabriele Maria
- Gamez Carbonell Josep
- Garcia Rebekah
- Garcia Sonia
- Garibaldi Matteo
- Giacomelli Elena
- Gibson Tamar
- Gilchrist James
- Gili Gisela
- Glenn Melanie
- Golden Laura
- Gollogly Jakit
- Gomez Salcedo Pilar
- Gong Hui
- Gonzalez Anna
- Gonçalves Geraldo Jordana
- Gori Maria Cristina
- Goyal Namita
- Goyal Neelam
- Guerreiro Alexandre
- Guinrich Sandra
- Guptill Jeffrey
- Gutmann Laurie
- Gutmann Ludwig
- Haar Laura
- Hafer-Macko Charlene
- Harbo Thomas
- Harrison Tuula
- Hart Adam
- Harvey Brittany
- Hasuike Tomoya
- Haw Choi Eun
- Hayashi Takashi
- Hehir Michael
- Henderson Kendrick
- Herbelin Laura
- Herbert Carol
- Hewlett Jasmine
- Hietala Albert
- Higuchi Eriko
- Hisahara Shin
- Ho Doreen
- Hobson-Webb Lisa
- Homedes-Pedret Christian
- Hong Yoon-Ho
- Hopkins Steve
- Horvath Melinda
- Howard Jr James
- Huynh Kristin
- Højgaard Joan
- Illa Isabel
- Imai Tomihiro
- Imai Tomihiro
- Inghilleri Maurizio
- Iorio Raffaele
- Ishiyama Naoko
- Ishiyama Yoko
- Jacob Saiju
- Jakab Gedeonne
- James Jones H
- Jara Jordan
- Javier Rodriguez de Rivera Francisco
- Jeffery Dennis
- Jenci Nicole
- Jeong Ha-Neul
- Jerath Nivedita
- Jingu Maki
- Johns Kathryn
- Jones Floyd
- Joon Kim Byoung
- Juel Vern
- Julia Palacios Natalia
- Jung JinWoo
- Junkerova Barbora Kurkova Jana
- Jurajdova Ivana
- Kamakura Sachiko
- Kamegamori Ikuko
- Kanai Tetsuya
- Kaneko Yoko
- Kanzaki Akiko
- Karam Chafic
- Karam Chafic
- Karimi Sanaz
- Katz Jonathan
- Katzin Lara
- Kaur Harpreet
- Kawaguchi Naoki
- Kawamata Jun
- Kawamura Tomohiro
- Kazamel Mohamed
- Kazim Onar Musa
- Kelley Andrea
- Keung Benison
- Khoury Julie
- Kikutake Keiko
- Kim Bryan
- Kim Byung-Jo
- Kim Miri
- Kim Yool-Hee
- Kincaid John
- Kirbas Cavdar Tugce
- Kissel John
- Kobashikawa Tomomi
- Kobayashi Eri
- Kobayashi Hisako
- Koga Megumi
- Kohlrus Stephanie
- Konyane Monika
- Kramer Megan
- Kressin Nicole
- Krogh Susanne
- Kumar Aditya
- Kurihara Rikako
- Kutlu Ayse
- Kwan Justin
- Kwon JuYoung
- Laaksonen Mikko
- Lazaro Ana
- Lee HyeLim
- Lee JiEun
- Lim Koo Dae
- Lim Jae-Sung
- Lin Frank
- Liu Tina
- Liu Ye
- Locatelli Alberta
- Locheke Jerry
- Lokaitis Barbara
- Loor John
- Lopergolo Diego
- Lopez Ruiz Pedro
- Lovas Gabor
- Lu Liang
- Lucy Shannon
- Maeda Yasuko
- Maggi Lorenzo
- Mahdi-Rogers Mohamed
- Mahieu Délphine
- Maier Gal
- Makamori Masayuki
- Malekniazi Ali
- Mallon Ashley
- Mantegazza Renato
- Maqsood Fatima
- Marano Enrico
- Marburger Tessa
- Marsili Angela
- Martins Ribeiro Renata
- Masaki Katsuhisa
- Massey Janice
- Mathew Veena
- Matolcsi Judit
- Matsuse Dai
- Matsushita Takuya
- Mazuela Gonzalo
- McClain Terry
- McClain Terry
- McKenna Kaitlyn
- McKinnon Jonathan
- McKinnon Naya
- McVey April
- Meguro Fumie
- Meherremova Arzu
- Mercelis Rudy
- Mette Ostergaard Autzen Anne
- Mezache Louisa
- Micheels Angela
- Michon Sara-Claude
- Miller Robert
- Min Kim Seung
- Min Ju-Hong
- Minton Brian
- Miranda Carolina
- Mitazaki Teiichiro
- Miyawaki Eriko
- Mizugami Aya
- Mogensen Anita
- Mohr Henrique
- Mori Masahiro
- Morikawa Miyuki
- Morino Stefania
- Mosmiller Betsy
- Motomura Masakatsu
- Mozaffar Tahseen
- Muharrem Filiz
- Mukaino Akihiro
- Mumfrey-Thomas Sandi
- Muppidi Srikanth
- Murahara Takashi
- Murai Hiroyuki
- Nagane Yuriko
- Nakamura Yumiko
- Nam Kang Hoo
- Nance Christopher
- Narayan Jeffrey
- Narikawa Koichi
- Nations Sharon
- Naunton Kerry
- Nemeth Joanne
- Nogueira Coelho Erica
- Norwood Fiona
- Noshiro Mayuko
- Novakova Iveta
- Nowak Richard
- Nozaki Kenkichi
- Nye Joan
- Nyoung Lee Chang
- Oksaranta Olli
- Okumura Meinoshin
- Olalde Heena
- Onesti Emanuela
- Orsel Gulsah
- Osakada Kaori
- Otavio Maia Gonçalves Luiz
- Ozawa Yukiko
- Ozcelik Pinar
- Padilla Patricia
- Paiva Gabriel
- Park SangAe
- Pasanisi Maria
- Pascuzzi Robert
- Pasnoor Mamatha
- Patrick Kara
- Patwa Huned
- Paula Macagnan Ana
- Paula Melo Ana
- Paulose Shirley
- Pedersen Jane
- Pereira Martins Maurer
- Phan Cecile
- Piehl Fredrik
- Pillai Rekha
- Pinar Acar Nazire
- Pineda Colleen
- Pinto Graziela
- Pinto Wladimir
- Pitha Jiri
- Plevka Sarah
- Pol Sabrina
- Polaka Krishna
- Pozo Marina
- Prando Natalia
- Previous
- Previous
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- Pulley Michael
- Puorro Giorgia
- Ra HyeJin
- Reguliova Katarina
- Renata Cubas Volpe Luciana
- Reyes Eliana
- Rico Gabrielle
- Robeson Kimberly
- Rocha Rosana
- Roderus Rikki
- Roe Kristen
- Rojas Garcia Ricardo
- Rosenfeld Jeffrey
- Ross Berger Alan
- Roy Gulmohor
- Rozsa Csilla
- Rugiero Marcelo
- Saba Juliet
- Saccà Francesco
- Sadalage Girija
- Saito Yuka
- Saitoh Masaki
- Sakamuri Sarada
- Saklad Amy
- Salajegheh Mohammed
- Salvado Figueras Maria
- Samukawa Makoto
- Sanjak Mohammad
- Sanjak Mohammed
- Sano Yoshiko
- Santos Engel Murilo
- Sastre Maria
- Sathasivam Sivakumar
- Sato Miwako
- Sattar Nadia
- Scala Stephanie
- Schommer Clara
- Schotte Caroline
- Seddigh Arshira
- Seelbach Jenna
- Semiz Cansu
- Sen Sedat
- Sengun Ihsan
- Seo Koo Yong
- Seok Lee Hyung
- Seok Jinmyoung
- Shabbir Yasmeen
- Shabbir Yasmeen
- Shah Akshay
- Shah Amna
- Shah Jaimin
- Sharma Khema
- Sheldon Danielle
- Shimohama Shun
- Shimohama Shun
- Shimpo Misa
- Shin Miju
- Shiraishi Hirokazu
- Siddiqi Zaeem
- Sieren Jeri
- Silva Marcela
- Silvestri Nicholas
- Smetcoren Charlotte
- Smith Lisa
- Snook Riley
- Sohail Faisal
- Sokratous Giannis
- Souza Bulle Oliveira Acary
- Souza Duca Luciana
- Souza Iandra
- Srinivasan Jayashri
- Statland Jeffery
- Steele Julie
- Stevens Olivier
- Strom Susan
- Sub-Investigators
- Sune Pilar
- Suzuki Hidekazu
- Suzuki Shuichiro
- Suzuki Yasushi
- Swenson Andrea
- Szabadosne Brigitta
- Szabo Gyorgyi
- T So Yuen
- Taichi Namie
- Takada Kazumi
- Takada Mihoko
- Takahashi Masanori
- Takeyama Rumi
- Tandan Rup
- Tano Ohito
- Terzi Murat
- Tilkin Petra
- Tinerney Scott
- Tobon Gonzalez Alejandro
- Toncrova Stanislava
- Torane Pravin
- Toska Shirli
- Tran Anh
- Traub Rebecca
- Trivedi Jaya
- Troili Fernanda
- Tsuda Emiko
- Tsuda Tomoko
- Tsukita Kenichi
- Tsurumaru Masako
- Tuga Celal
- Tun Ozlem
- Tyblova Michaela
- Uehara Taira
- Ugur Muzeyyen
- Utsugisawa Kimiaki
- Uwasa Kaori
- Uzawa Akiyuki
- Van Daele Sien
- Van Damme Philip
- Van den Abeele Guy
- van der Kooi Anneke
- Vandenbussche Nicolas
- Vanderhook Mollie
- Vanhee Annelies
- Varga Edina
- Varghese Mary
- Vecsei Laszlo
- Veiga Thabata
- Velez Santamaria Valentina
- Ventura Nicholas
- Verjans Sarah
- Veske Adife
- Vidal Gonzalo
- Vidal Nuria
- Vinge Lotte
- Vissing John
- Vohanka Stanislav
- Vu Hong
- Vu Tuan
- Vynckier Jan
- Vytopil Michael
- Wagemaekers Linda
- Waheed Waqar
- Walsh Maureen
- Wang Yunxia
- Watling Dave
- Watt Elizabeth
- Weiner Elaine
- Weiss Michael
- Welsh Lesly
- Wheeler Lauren
- Wilken Miguel
- Witting Nanna
- Wolfe Gil
- Wolfova Marcela
- Won Shin Chae
- Woodall Amy
- Yamamoto Daisuke
- Yamashita Yumi
- Yang Irene
- Yasuda Ikuko
- Ye Hwang Ji
- Yilmaz Ezgi
- Yoon Koh Da
- Yoshida Seiko
- Yoshida Seiko
- Yoshimura Shunsuke
- Youl Seok Hung
- Young Shin Ha
- Young Valerie
- Zakalik Karen
- Zapletalova Olga
- Zilliox Lindsay
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 01/01/2020
- Field of study
The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension
Supplemental_Material_Study_Sites - Efficacy and Safety of a Biosimilar Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery: A Randomized, Prospective, Single-Blinded, Multicenter Clinical Trial
- Author
- Agenor José Vasconcelos Costa (5535674)
- Alessandro Bersch Osvaldt (5535665)
- Daniela Garcia de Souza (5535695)
- Debora Garcia Rodrigues (5535680)
- Debora Yuri Sato (5535707)
- Eduardo Ramacciotti (5535704)
- Eliane Yumii Fugii (5535677)
- Eloá Maria da Silva Colnago (5535671)
- Flávia Magalhães Magella (5535668)
- Gilson Roberto Araujo (5535629)
- Giuliano Giova Volpiani (5535644)
- Gleison Juliano da Silva Russeff (5535698)
- Jorge Barros Afiune (5535692)
- João Antônio Correa (5535647)
- Juliana Sekeres Mussalem (177303)
- Leandro Agati (5535686)
- Lucas Eduardo Pazetto (5535650)
- Lucas Zeponi DalAcqua (5535689)
- Odaly Toffoletto (5535662)
- Roberto Augusto Caffaro (5535641)
- Ronaldo Davila (5535656)
- Salvador Gullo Neto (5535635)
- Selma Regina O. Raymundo (5535683)
- Tania Benevenuto Caltabiano (5535653)
- Tiago Aparecido Maschio de Lima (5535638)
- Ubirajara Ferreira (2839004)
- Valter Castelli (5535659)
- Valéria Cristina Resende Aguiar (5535701)
- Vanessa Therumi Assao (5535632)
- Wagner Eduardo Matheus (5535626)
- Publication venue
- Publication date
- Field of study
<p>Supplemental_Material_Study_Sites for Efficacy and Safety of a Biosimilar Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery: A Randomized, Prospective, Single-Blinded, Multicenter Clinical Trial by Eduardo Ramacciotti, Ubirajara Ferreira, Agenor José Vasconcelos Costa, Selma Regina O. Raymundo, João Antônio Correa, Salvador Gullo Neto, Alessandro Bersch Osvaldt, Leandro Agati, Valéria Cristina Resende Aguiar, Ronaldo Davila, Tania Benevenuto Caltabiano, Flávia Magalhães Magella, Giuliano Giova Volpiani, Valter Castelli, Roberto Augusto Caffaro, Lucas Zeponi DalAcqua, Wagner Eduardo Matheus, Debora Yuri Sato, Gleison Juliano da Silva Russeff, Daniela Garcia de Souza, Lucas Eduardo Pazetto, Tiago Aparecido Maschio de Lima, Eloá Maria da Silva Colnago, Eliane Yumii Fugii, Juliana Sekeres Mussalem, Vanessa Therumi Assao, Odaly Toffoletto, Debora Garcia Rodrigues, Jorge Barros Afiune, and Gilson Roberto Araujo in Clinical and Applied Thrombosis/Hemostasis</p
Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study
- Author
- Abramov Vladislav
- Acar Nazire Pinar
- Agopian Eliz
- Agriesti Julie
- Akhter Salma
- Akiyama Tetsuya
- Alberti Aguilo Maria
- Alboini Paolo Emilio
- Alcon Karan
- Alsharabati Mohammad
- Altiparmak Didem
- Alvermann Sascha
- Alves de Siqueira Carvalho Alzira
- Amaral de Andrade Ana Carolina
- Amato Anthony
- Amato Katherine
- Ambrosio Daniel
- Andersen Henning
- Anderson Amanda
- Andersson Blanka
- Andoin Angela
- Angelini Corrado
- Annes Marcelo
- Antonini Giovanni
- Antozzi Carlo
- Appel Stanley H
- Aranke Shachie
- Arima Hideki
- Arndt Heike
- Arnold Thomas
- Arribas-Ibar Elisabet
- Asada Shizuka
- Atula Sari
- Augusto da Silva Luiz
- Autzen Anne Mette
- Aydinlik Seda
- Azrilin Olga
- Babenko Larisa
- Bali Kuperman Hila
- Balyazin Victor
- Bandukwala Ibrez
- Barohn Richard J
- Beck Kate
- Bednarik Josef
- Bekircan-Kurt Can Ebru
- Benatar Michael
- Berger Alan Ross
- Bernitsas Evanthia
- Bertorini Tulio
- Bettini Mariela
- Bevilacqua Francesca
- Beydoun Said
- Bhavaraju-Sanka Ratna
- Bilsker Martin
- Bird Shawn
- Bjarbo Lena
- Blackmore Derrick
- Blount Ira
- Bodkin Cynthia
- Bonanno Silvia
- Bonifati Domenico Marco
- Bostantzopoulou Sevasti
- Boterhoven Heidi
- Bouhour Franç
- Boz Cavit
- Bratton Joan
- Bravver Elena
- Bril Vera
- Brooks Benjamin
- Brown Gavin
- Brown Morris
- Bulle Oliveira Acary Souza
- Burdette Maryanne
- Burns Ted M
- Butters Janelle
- Caliskan Yagmur
- Callison Karen
- Campanella Angela
- Campbell Natasha
- Carnes Donna
- Carrara Fernanda
- Carter Cynthia
- Casasnovas Pons Carlos
- Caserta Cinzia
- Cash Tiyonnoh
- Cavalcante Lino Valeria
- Cavdar Tugce Kirbas
- Cavus Hakan
- Charalambous Despoina
- Chaudhry Vinay
- Chilingaryan Amaiak
- Chmelikova Magda
- Cho Eun Bin
- Chopra Manisha
- Cierny Marek
- Cochrane Thomas
- Coelho Erica
- Cooley Anne
- Corse Andrea
- Cortes Vicente Elena
- Costabile Teresa
- Crabtree Brigid
- Cudia Paola
- D&apos
- D&apos
- da Cruz Pacheco Daiane
- da Penha Morita Ananias Maria
- Dada Martineli Torres Debora
- Daniels Kevin
- Darnell Taylor
- David William
- Davies Debbie
- de Baets Marc
- De Bleecker Jan
- de Cassia Santos Aline
- de Koning Kathy
- De Mey Katrien
- De Rosa Anna
- de Visser Marianne
- Decressac Sonia
- Deneve Michel
- Deruelle Fabienne
- Desnuelle Claude
- Dezsi Livia
- Dheel Christina
- Di Pasquale Antonella
- Dias Brockhausen Igor
- Diaz-Manera Jordi
- Dicapua Daniel
- Diez Tejedor Exuperio
- Dimitriou Aikaterini
- Dimitrova Diana
- DiSanzo Beth
- Distad Jane
- Dogan Baki
- Donahue Craig
- Doreen Ho
- Downing Sharon
- Droker Brian
- Duran Gustavo
- Echevarria Laura
- Eduardo Ng
- Efendi Husnu
- Engel Marguerite
- Erä
- Erdem-Ozdamar Sevim
- Eriksson Jaana
- Evoli Amelia (ORCID:0000-0003-0282-8787)
- Fä
- Faber Catherine
- Faigle Casey
- Feder David
- Fernanda Butinhao Cristiani
- Fernandez-Fournier Mireya
- Filla Alessandro
- Fionda Laura
- Frasca Vittorio
- Freimer Miriam
- Fricke Karin
- Fujii Yuko
- Fukuda Yusuke
- Fukudome Takayasu
- Fukui Sachie
- Funaka Soichiro
- Futono Kazumi
- Fyfe Beverly
- Gaboreau Morgane
- Gabriele Maria
- Gallatti Nichole
- Gamez Josep
- Garcia Alejandra Dalila
- Garcia Rebekah
- Garcia Sonia
- Garibaldi Matteo
- Gazioglu Sibel
- Genge Angela
- Gervais-Bernard Helene
- Gheller Friedrich Maurí
- Giacomelli Elena
- Gibson Tamar
- Gilchrist James
- Gingele Stefan
- Goldstein Jonathan
- Gollogly Jakit
- Gomes da Silva Tamires Cristina
- Gonç
- Gondo Yuichiro
- Gori Maria
- Goyal Namita
- Goyal Neelam
- Greenbereg Nelly
- Gross Bella
- Guerreiro Alexandre
- Guidon Amanda
- Guinrich Sandra
- Guptill Jeffrey
- Gutmann Laurie
- Gutmann Ludwig
- Hø
- Haar Laura
- Hafer-Macko Charlene
- Halton Sharon
- Harbo Thomas
- Harrison Tuula
- Hart Adam
- Hartmann J. Edward
- Harvey Brittany
- Hasan Rosa
- Hasuike Tomoya
- Hayashi Takashi
- Hehir Michael
- Henderson Kendrick
- Herbert Carol
- Hewlett Jasmine
- Hietala Albert
- Higuchi Eriko
- Hisahara Shin
- Hobson-Webb Lisa
- Holzberg Shara
- Homedes-Pedret Christian
- Hong Vu
- Hong Yoon-Ho
- Hopkins Steve
- Horvath Melinda
- Hourquin Caroline
- Howard James F
- Hoyle J. Chad
- Huynh Kristin
- Hwang Eun Bi
- HyeJin Ra
- Ikeda Yasuko
- Illa Isabel
- Imai Tomihiro
- Imamura Tomomi
- Inghilleri Maurizio
- Inoue Masashi
- Iorio Raffaele
- Jacob Saiju
- Jacobs Daniel
- Jasinarachchi Mahi
- Jeffery Dennis
- Jia Kelly
- Jingu Maki
- Jones Floyd
- Jones H. James
- Jons Daniel
- Juel Vern
- Junkerova Jana
- Jurajdova Ivana
- Kamakura Sachiko
- Kamegamori Ikuko
- Kaminska Anna
- Kanai Tetsuya
- Kanda Takashi
- Kane Jennifer
- Kaneko Yoko
- Kang Hoo Nam
- Kanzaki Akiko
- Kaplan Lindsay
- Karam Chafic Karam
- Kasioti Eleni
- Kassebaum Nicole
- Katz Jonathan
- Katzberg Hans
- Katzin Lara
- Kaufman Jacob
- Kaur Harpreet
- Kawai Motoharu
- Kawamata Jun
- Kawamura Tomohiro
- Kazamel Mohamed
- Keijzers Maria Johanna
- Keo Roseann
- Keung Benison
- Khan Omar
- Khoury Julie
- Kikutake Keiko
- Kim Byoung Joon
- Kim Byung-Jo
- Kim MiRi
- Kim Seung Min
- Kim Yool-hee
- Kincaid John
- Kissel John T
- Kobashikawa Tomomi
- Kobayashi Eri
- Kobayashi Hisako
- Koga Megumi
- Koga Michiaki
- Koh Da Yoon
- Konno Shingo
- Konyane Monika
- Koo Yong Seo
- Korobko Denis
- Kostera-Pruszczyk Anna
- Kosykh Evgeniya
- Kramer Megan
- Kumar Sriwastava Shitiz
- Kumar Aditya
- Kurkova Barbora
- Kwan Justin
- Kwon JuYoung
- Lö
- Laaksonen Mikko
- Lacour Arnaud
- Lahaut Pauline
- Lai Eugene
- Lamont Phillipa
- Lange Dale
- Lay Luis
- Lazaro Ana
- Le Masson Gwendal
- Lee Chang Nyoung
- Lee HyeLim
- Lee Hyung Seok
- Lee JiEun
- Leong Wai-Kuen
- Levine-Weinberg Mark
- Liang Lu
- Lim Jae-Sung
- Lin Frank
- Lindberg Christopher
- Lindsay Molly
- Lisak Robert
- Liu Ye
- Loor John
- Lopergolo Diego
- Lopez Ruiz Pedro
- Lovas Gabor
- Lucy Shannon
- Macagnan Ana Paula
- Maeda Yasuhiro
- Maeda Yasuko
- Maessen Jos
- Maestri Tassoni Michelangelo
- Maggi Lorenzo
- Mahdi-Rogers Mohamed
- Mahieu Delphine
- Maier Gal
- Makamori Masayuki
- Malekniazi Ali
- Malkova Nadezhda
- Manning Erin
- Mantegazza Renato
- Maqsood Fatima
- Marano Enrico
- Marburger Tessa
- Marsil Angela
- Masaki Katsuhisa
- Massie Rami
- Mathew Veena
- Matolcsi Judit
- Matsuo Hidenori
- Matsuse Dai
- Matsushita Takuya
- Mazia Claudio Gabriel
- McClain Terry
- McKenna Kaitlyn
- McKinnon Jonathan
- McKinnon Naya
- Meguro Fumie
- Mellion Michelle
- Melnikova Anna
- Melo Ana Paula
- Mercelis Rudy
- Merle Hé
- Messina Silvia
- Micheels Angela
- Michon Sara-Claude
- Miesen Monique
- Miller Robert
- Millois Edouard
- Min Ju-Hong
- Minton Brian
- Miranda Carolina
- Mitazaki Teiichiro
- Mitropoulou Efstathia
- Mitsikostas Dimos-Dimitrios
- Mogensen Anita
- Mohr Henrique
- Moreau Caroline
- Mori Masahiro
- Morikawa Miyuki
- Morino Stefania
- Mosmiller Betsy
- Motomura Masakatsu
- Moutarde Julie
- Mozaffar Tahseen
- Mukaino Akihiro
- Mumfrey-Thomas Sandi
- Muppidi Srikanth
- Murahara Takashi
- Murai Hiroyuki
- Murata Mayumi
- Nagaishi Akiko
- Nagane Yuriko
- Nakamura Yumiko
- Nakane Shunya
- Nakayama Ritsu
- Nakazora Hiroshi
- Narikawa Koichi
- Nations Sharon
- Naunton Kerry
- Nemeth Joanne
- Nesterova Yulia
- Nigro Catherine
- Nogueira Coelho Erica
- Norwood Fiona
- Novakova Iveta
- Nowak Richard J
- Nye Joan
- Nyrhinen Anne
- O&apos
- Ogasawara Junichi
- Ogawa Miki
- Oksaranta Olli
- Okubo Yoshinori
- Okumura Meinoshin
- Olalde Heena
- Omoto Masatoshi
- Onar Musa Kazim
- Onesti Emanuela
- Orrico Daniele
- Ortea Carolina
- Osakada Kaori
- Otavio Maia Gonç
- Outteryck Olivier
- Ozcelik Pinar
- Ozen Aydin Cigdem
- Paiva Gabriel
- Palacios Natalia Julia
- Papadopoulou Nikoletta
- Papagiannopoulos Sotirios
- Park SangAe
- Pascuzzi Robert
- Patrick Kara
- Patti Francesco
- Patwa Huned
- Pazetto Lucas Eduardo
- Pedersen Jane
- Pegoraro Valentina
- Pereira Martins Maurer
- Perez Ele Kim
- Phan Celile
- Piehl Fredrik
- Pillai Rekha
- Pinto Wladimir
- Pinzan Elena
- Pitha Jiri
- Pleitez Milvia
- Plevka Sarah
- Pokhabov Dmitry
- Pozo Marina
- Prando Natalia
- Pulley Michael
- Puorro Giorgia
- Quarles Brandy
- Querol Gutierrez Luis
- Reggio Ester
- Reguliova Katarina
- Renata Cubas Volpe Luciana
- Reyes Eliana
- Richman David
- Rivner Michael
- Roberts Leslie
- Robeson Kimberly
- Rocha Rosana
- Rodriguez de Rivera Francisco Javier
- Roe Kristen
- Rojas Garcia Ricardo
- Rosa Bruno
- Rosenfeld Jeffrey
- Roy Gulmohor
- Rozsa Csilla
- Rugiero Marcelo
- Saba Juliet
- Sacca Francesco
- Sacconi Sabrina
- Sachs George
- Saito Yuka
- Saitoh Masaki
- Sakamuri Sarada
- Saklad Amy
- Salajegheh Mohammed
- Salvado Figueras Maria
- Salvado Maria
- Salvatore Caramma Andrea
- Samukawa Makoto
- Sanjak Mohammad
- Sano Yasuteru
- Sano Yoshiko
- Sathasivam Sivakumar
- Sato Miwako
- Sattar Nadia
- Sazonov Denis
- Scala Stephanie
- Schommer Clara
- Schoser Benedikt
- Seddigh Arshira
- Semiz Cansu
- Sen Sedat
- Sengun Ihsan
- Seok Hung Youl
- Seok Jinmyoung
- Shabbir Yasmeen
- Shah Akshay
- Shah Jaimin
- Sharma Khema
- Shimohama Shun
- Shimose Shigemi
- Shimpo Misa
- Shin Ha Young
- Shin MiJu
- Shin Susan
- Shinozaki Hirokazu
- Shiraishi Hirokazu
- Shirane Maoko
- Siddiqi Zaeem
- Silvestri Nicholas
- Simpson Ericka
- Sivak Mark
- Skripuletz Thomas
- Smalley Nicole
- Smetcoren Charlotte
- Smith Lisa
- Snook Riley
- Sohail Faisal
- Solé
- Soltani Mehran
- Soriani Marie-Hé
- Souza Duca Luciana
- Souza Iandra
- Srinivasan Jayashri
- Stangel Martin
- Steele Julie
- Stevens Olivier
- Strom Susan
- Suehs Kurt-Wolfram
- Suriane Fialho Tomá
- Suzuki Hidekazu
- Suzuki Shuichiro
- Suzuki Yasushi
- Swenson Andrea
- Szabadosne Brigitta
- Szabo Gyorgyi
- Taber Sandra
- Taichi Namie
- Takada Kazumi
- Takada Mihoko Takada
- Takahashi Masanori
- Tandan Rup
- Terzi Murat
- Thompson Lisa
- Tilkin Petra
- Tobon Gonzalez Alejandro
- Toncrova Stanislava
- Toska Shirli
- Tran Anh
- Trebst Corinna
- Trivedi Jaya
- Troili Fernanda
- Tselis Alexandros
- Tsuda Emiko
- Tsuda Tomoko
- Tsukita Kenichi
- Tuan Vu
- Tuga Celal
- Tun Ozlem
- Tyblova Michaela
- Uehara Taira
- Ugur Muzeyyen
- Utsugisawa Kimiaki
- Uzawa Akiyuki
- Van Damme Philip
- Van den Abeele Guy
- van der Kooi Anneke
- Vanderhook Mollie
- Varga Edina
- Varghese Mary
- Vecsei Laszlo
- Veiga Thabata
- Ventura Nicholas
- Verjans Sarah
- Vermersch Patrick
- Vial Christophe
- Vidal Gonzalo
- Vidal Nuria
- Vinge Lotte
- Vissing John
- Vlaikidis Nicholas
- Vohanka Stanislav
- Vytopil Michael
- Wagemaekers Linda
- Waheed Waqar
- Wang Jing-Jing
- Wanschitz Julia
- Watanabe Masanori
- Watling Dave
- Weiner Elaine
- Weiss Michael
- Welsh Lesly Welsh
- Wenninger Stephan
- Wheeler Lauren
- Wielanek-Bachelet Anne-Cé
- Wilken Miguel
- Willlems Natasha
- Wilson Amy
- Witting Nanna
- Wolfe Gil
- Wolfova Marcela
- Woodall Amy
- Yamamoto Daisuke
- Yamashita Yumi
- Yarmoschuk Asya
- Yilmaz Ezgi
- Yoshida Seiko
- Yoshikawa Chieko
- Yoshimura Shunsuke
- Yuen T So
- Zakalik Karen
- Zampaki Martha
- Zapletalova Olga
- Zephir Hé
- Zilliox Lindsay
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2017
- Field of study
Background Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial. Methods We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76 hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II\ue2\u80\u93IV disease, vaccination against Neisseria meningitides, and previous treatment with at least two immunosuppressive therapies or one immunosuppressive therapy and chronic intravenous immunoglobulin or plasma exchange for 12 months without symptom control. Patients with a history of thymoma or thymic neoplasms, thymectomy within 12 months before screening, or use of intravenous immunoglobulin or plasma exchange within 4 weeks before randomisation, or rituximab within 6 months before screening, were excluded. We randomly assigned participants (1:1) to either intravenous eculizumab or intravenous matched placebo for 26 weeks. Dosing for eculizumab was 900 mg on day 1 and at weeks 1, 2, and 3; 1200 mg at week 4; and 1200 mg given every second week thereafter as maintenance dosing. Randomisation was done centrally with an interactive voice or web-response system with patients stratified to one of four groups based on MGFA disease classification. Where possible, patients were maintained on existing myasthenia gravis therapies and rescue medication was allowed at the study physician's discretion. Patients, investigators, staff, and outcome assessors were masked to treatment assignment. The primary efficacy endpoint was the change from baseline to week 26 in MG-ADL total score measured by worst-rank ANCOVA. The efficacy population set was defined as all patients randomly assigned to treatment groups who received at least one dose of study drug, had a valid baseline MG-ADL assessment, and at least one post-baseline MG-ADL assessment. The safety analyses included all randomly assigned patients who received eculizumab or placebo. This trial is registered with ClinicalTrials.gov, number NCT01997229. Findings Between April 30, 2014, and Feb 19, 2016, we randomly assigned and treated 125 patients, 62 with eculizumab and 63 with placebo. The primary analysis showed no significant difference between eculizumab and placebo (least-squares mean rank 56\uc2\ub76 [SEM 4\uc2\ub75] vs 68\uc2\ub73 [4\uc2\ub75]; rank-based treatment difference \ue2\u88\u9211\uc2\ub77, 95% CI \ue2\u88\u9224\uc2\ub73 to 0\uc2\ub796; p=0\uc2\ub70698). No deaths or cases of meningococcal infection occurred during the study. The most common adverse events in both groups were headache and upper respiratory tract infection (ten [16%] for both events in the eculizumab group and 12 [19%] for both in the placebo group). Myasthenia gravis exacerbations were reported by six (10%) patients in the eculizumab group and 15 (24%) in the placebo group. Six (10%) patients in the eculizumab group and 12 (19%) in the placebo group required rescue therapy. Interpretation The change in the MG-ADL score was not statistically significant between eculizumab and placebo, as measured by the worst-rank analysis. Eculizumab was well tolerated. The use of a worst-rank analytical approach proved to be an important limitation of this study since the secondary and sensitivity analyses results were inconsistent with the primary endpoint result; further research into the role of complement is needed. Funding Alexion Pharmaceuticals
Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study
- Author
- Acary Souza Bulle Oliveira
- Adam Hart
- Adife Veske
- Aditya Kumar
- Aikaterini Dimitriou
- Akihiro Mukaino
- Akiko Kanzaki
- Akiyuki Uzawa
- Akshay Shah
- Alan Ross Berger
- Albert Hietala
- Alberta Locatelli
- Alejandra Dalila Garcia
- Alejandro Tobon Gonzales
- Alex Fondaw
- Ali Malekniazi
- Allessandro Filla
- Alzira Alves de Siqueira Carvalho
- Amaiak Chilingaryan
- Amanda Anderson
- Amelia Evoli
- Amna Shah
- Amy Saklad
- Amy Woodall
- Ana Carolina Amaral Andrade
- Ana Lazaro
- Ana Paula Melo
- Andrea Corse
- Andrea Kelley
- Andrea Swenson
- Angela Andoin
- Angela Campanella
- Angela Marsili
- Angela Micheels
- Angiola Fasanaro
- Anh Tran
- Anita Mogensen
- Ann D'Hondt
- Anna Gonzalez
- Anne Cooley
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- Tamar Gibson
- Tamires Cristina Gomes da Silva
- Taylor Darnell
- Teiichiro Mitazaki
- Teresa Costabile
- Terry McClain
- Terry McClain
- Tessa Marburger
- Tetsuya Akiyama
- Tetsuya Kanai
- Thabata Veiga
- Thomas Cochrane
- Thomas Harbo
- Tina Liu
- Tiyonnoh Cash
- Tomihiro Imai
- Tomohiro Kawamura
- Tomoko Tsuda
- Tomomi Kobashikawa
- Tomoya Hasuike
- Tomás Augusto Suriane Fialho
- Tuan Vu
- Tugce Kirbas Cavdar
- Tuula Harrison
- Tuzun
- Utsugisawa
- Utsugisawa
- Valentina D'Amato
- Valentina Velez Santamaria
- Valeria Cavalcante Lino
- Valerie Young
- Veena Mathew
- Vern Juel
- Victor Doan
- Vinay Chaudhry
- Waqar Waheed
- Wladimir Pinto
- Yagmur Caliskan
- Yasmeen Shabbir
- Yasuko Maeda
- Yasushi Suzuki
- Yoko Ishiyama
- Yoko Kaneko
- Yoshiko Sano
- Yuen T. So
- Yuka Saito
- Yukiko Ozawa
- Yuko Fujii
- Yumi Yamashita
- Yumiko Nakamura
- Yunxia Wang
- Yuriko Nagane
- Yusuke Fukuda
- Zaeem Siddiqi
- Zhang
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2019
- Field of study
The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with open-label eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (−2.4 [1.34] and − 3.3 [0.65]); Quantitative Myasthenia Gravis (−2.9 [1.98] and − 4.3 [0.79]); Myasthenia Gravis Composite (−4.5 [2.63] and − 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (−8.6 [5.68] and − 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population
Consistent improvement with eculizumab across muscle groups in myasthenia gravis
- Author
- Agrawal Brajesh
- Agriesti Julie
- Ahn So-Hyun
- Akhter Salma
- Akiyama Tetsuya
- Alam Sharmeen
- Alcon Karan
- Alsharabati Mohammad
- Alves de Siqueira Carvalho Alzira
- Amamoto Shoko
- Amaral de Andrade Ana Carolina
- Amato Anthony
- Amato Katherine
- Ambrosio Daniel
- Andersen Henning
- Anderson Amanda
- Annes Marcelo
- Antonia Alberti Aguilo Maria
- Antonini Giovanni
- Antonio Querol Gutiérrez Luis
- Antozzi Carlo
- Aranke Shachie
- Ardoin Angela
- Arndt Heike
- Arnold Thomas
- Arribas-Ibar Elisabet
- Asada Shizuka
- Assis Natália
- Augusto da Silva Luiz
- Augusto Suriane Fialho Tomás
- Aydinlik Seda
- Balkan Bengu
- Barohn Richard
- Barroso Fabio
- Becerikli Gulsah
- Beck Kate
- Bednarik Josef
- Bekircan-Kurt Can Ebru
- Benatar Michael
- Bertorini Tulio
- Bettini Mariela
- Beydoun Said
- Bezerra Rosa Bruno
- Bhavaraju-Sanka Ratna
- Bi Hwang Eun
- Bilsker Martin
- Bin Cho Eun
- Bjarbo Lena
- Blackmore Derrick
- Bodkin Cynthia
- Bonanno Silvia
- Bravver Elena
- Brooks Benjamin
- Brown Claire
- Burdette Maryanne
- Caliskan Yagmur
- Callison Karen
- Camera Giorgia
- Campanella Angela
- Carnes Donna
- Carrara Fernanda
- Carter Cynthia
- Casasnovas Carlos
- Cash Tiyonnoh
- Cavalcante Lino Valeria
- Cavus Hakan
- Chad Hoyle Joseph
- Chaudhry Vinay
- Chaves Marcelo
- Chelnick Sharon
- Chilingaryan Amaiak
- Chmelikova Magda
- Choi MiSong
- Chopra Manisha
- Cierny Marek
- Cochrane Thomas
- Cooley Anne
- Corse Andrea
- Cortes Vicente Elena
- Costabile Teresa
- Cunningham Scott
- César Pamela
- da Cruz Pacheco Daiane
- da Penha Ananias Morita Maria
- Dalila Garcia Alejandra
- Daniels Kevin
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- Illa Isabel
- Imai Tomihiro
- Imai Tomihiro
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- Watt Elizabeth
- Weiner Elaine
- Weiss Michael
- Welsh Lesly
- Wheeler Lauren
- Wilken Miguel
- Witting Nanna
- Wolfe Gil
- Wolfova Marcela
- Won Shin Chae
- Woodall Amy
- Yamamoto Daisuke
- Yamashita Yumi
- Yang Irene
- Yasuda Ikuko
- Ye Hwang Ji
- Yilmaz Ezgi
- Yoshida Seiko
- Yoshimura Shunsuke
- Youl Seok Hung
- Young Shin Ha
- Young Valerie
- Yountz Marcus
- Zakalik Karen
- Zapletalova Olga
- Zilliox Lindsay
- Publication venue
- 'Wiley'
- Publication date
- 01/08/2020
- Field of study
Objective: To assess whether eculizumab, a terminal complement inhibitor, improves patient- and physician-reported outcomes (evaluated using the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale, respectively) in patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis across four domains, representing ocular, bulbar, respiratory, and limb/gross motor muscle groups. Methods: Patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis were randomized 1:1 to receive either placebo or eculizumab during the REGAIN study (NCT01997229). Patients who completed REGAIN were eligible to continue into the open-label extension trial (NCT02301624) for up to 4 years. The four domain scores of each of the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale recorded throughout REGAIN and through 130 weeks of the open-label extension were analyzed. Results: Of the 125 patients who participated in REGAIN, 117 enrolled in the open-label extension; 61 had received placebo and 56 had received eculizumab during REGAIN. Patients experienced rapid improvements in total scores and all four domain scores of both the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale with eculizumab treatment. These improvements were sustained through 130 weeks of the open-label extension. Interpretation: Eculizumab treatment elicits rapid and sustained improvements in muscle strength across ocular, bulbar, respiratory, and limb/gross motor muscle groups and in associated daily activities in patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis
Long-term safety and efficacy of eculizumab in generalized myasthenia gravis
- Author
- Acar Nazire Pinar
- Agrawal Brajesh
- Agriesti Julie
- Ahn So-Hyun
- Akhter Salma
- Akiyama Tetsuya
- Alam Sharmeen
- Alberti Aguilo Maria Antonia
- Alboini Paolo Emilio
- Alcon Karan
- Alsharabati Mohammad
- Alves de Siqueira Carvalho Alzira
- Amamoto Shoko
- Amaral Andrade Ana Carolina
- Amato Anthony
- Amato Katherine
- Ambrosio Daniel
- Ananias Morita Maria da Penha
- Andersen Henning
- Anderson Amanda
- Andoin Angela
- Annes Marcelo
- Antonini Giovanni
- Antozzi Carlo
- Aranke Shachie
- Arndt Heike
- Arnold Thomas
- Arribas-Ibar Elisabet
- Asada Shizuka
- Assis Natália
- Aydinlik Seda
- Balkan Bengu
- Barohn Richard J.
- Barroso Fabio
- Becerikli Gulsar
- Beck Kate
- Bednarik Josef
- Bekircan-Kurt Can Ebru
- Benatar Michael
- Berger Alan Ross
- Bertorini Tulio
- Bettini Mariela
- Beydoun Said
- Bezerra Rosa Bruno
- Bhavaraju-Sanka Ratna
- Bilsker Martin
- Bjarbo Lena
- Blackmore Derrick
- Bodkin Cynthia
- Bonanno Silvia
- Bravver Elena
- Brooks Benjamin
- Brown Claire
- Burdette Maryanne
- Burns Ted M.
- Butinhao Cristiani Fernanda
- Caliskan Yagmur
- Callison Karen
- Camera Giorgia
- Campanella Angela
- Carnes Donna
- Carrara Fernanda
- Carter Cynthia
- Casasnovas Carlos
- Cash Tiyonnoh
- Cavalcante Lino Valeria
- Cavus Hakan
- Chaudhry Vinay
- Chaves Marcelo
- Chelnick Sharon
- Chilingaryan Amaiak
- Chmelikova Magda
- Cho Eun Bin
- Choi Eun Hwa
- Choi MiSong
- Chopra Manisha
- Cierny Marek
- Cochrane Thomas
- Cooley Anne
- Corse Andrea
- Cortes Vicente Elena
- Costabile Teresa
- Cunningham Scott
- César Pamela
- D'Amato Valentina
- D'Hondt Ann
- da Cruz Pacheco Daiane
- da Silva Luiz Augusto
- Daniels Kevin
- Darnell Taylor
- Davies Debbie
- de Bleecker Jan L.
- de Cassia Santos Aline
- de Koning Kathy
- de Mey Katrien
- de Visser Marianne
- Depreitere Annelies
- Dezsi Livia
- di Pasquale Antonella
- Dias Brockhausen Igor
- Diaz-Manera Jordi
- Dicapua Daniel
- Diez Porras Laura
- Diez Tejedor Exuperio
- Dimachkie Mazen
- Dimitriou Aikaterini
- Dimitrova Diana
- DiSanzo Beth
- Dishman Lorraine
- Distad Jane
- Doan Victor
- Dogan Baki
- Donahue Craig
- Downing Sharon
- Droker Brian
- Duarte Silva Liene
- Duran Gustavo
- Echevarria Laura
- Efendi Husnu
- Elsayed Mona
- Emmons Kelley
- Engel Marguerite
- Eralinna Juha-Pekka
- Erdem-Ozdamar Sevim
- Eriksson Jaana
- Evoli Amelia
- Fasanaro Angiola
- Feder David
- Fernandes Patricia
- Fernandez-Fournier Mireya
- Ferreira Luciana
- Fialho Tomás Augusto Suriane
- Filla Allessandro
- Fionda Laura
- Fionda Laura
- Fondaw Alex
- Forshew Dallas
- Frasca Vittorio
- Frasca Vittorio
- Freimer Miriam
- Fujii Yuko
- Fujita Kenji P.
- Fukuda Yusuke
- Funaka Soichiro
- Futono Kazumi
- Gabriele Maria
- Gamez Josep
- Garcia Alejandra Dalila
- Garcia Rebekah
- Garcia Sonia
- Garibaldi Matteo
- Gheller Friedrich Maurício André
- Giacomelli Elena
- Gibson Tamar
- Gilchrist James
- Gili Gisela
- Glenn Melanie
- Golden Laura
- Gollogly Jakit
- Gomes da Silva Tamires Cristina
- Gomez Salcedo Pilar
- Gong Hui
- Gonzalez Anna
- Gonçalves Geraldo Jordana
- Gori Maria
- Goyal Namita
- Goyal Neelam
- Guerreiro Alexandre
- Guingrich Sandra
- Guptill Jeffrey
- Gutmann Laurie
- Gutmann Ludwig
- Haar Laura
- Hafer-Macko Charlene
- Harbo Thomas
- Harrison Tuula
- Hart Adam
- Harvey Brittany
- Hasuike Tomoya
- Hayashi Takashi
- Hehir Michael
- Hendersen Kendrick
- Herbelin Laura
- Herbert Carol
- Hewlett Jasmine
- Hietala Albert
- Higuchi Eriko
- Hisahara Shin
- Ho Doreen
- Hobson-Webb Lisa
- Homedes-Pedret Christian
- Hong Yoon-Ho
- Hopkins Steve
- Horvath Melinda
- Howard James F.
- Hoyle Joseph Chad
- Huynh Kristin
- Hwang Eun Bi
- Hwang Ji Ye
- Højgaard Joan
- Illa Isabel
- Imai Tomihiro
- Inghilleri Maurizio
- Iorio Raffaele
- Ishiyama Naoko
- Ishiyama Yoko
- Jacob Saiju
- Jakab Gedeonne
- Jara Jordan
- Jeffery Dennis
- Jenci Nicole
- Jeong Ha-Neul
- Jerath Nivedita
- Jingu Maki
- Johns Kathryn
- Jones Floyd
- Jones H. James
- Juel Vern
- Julia Palacios Natalia
- Jung JinWoo
- Junkerova Jana
- Jurajdova Ivana
- Kamakura Sachiko
- Kamegamori Ikuko
- Kanai Tetsuya
- Kaneko Yoko
- Kang Hoo Nam
- Kanzaki Akiko
- Karam Chafic
- Karam Chafic
- Karimi Sanaz
- Katz Jonathan
- Katzin Lara
- Kaur Harpreet
- Kawaguchi Naoki
- Kawamata Jun
- Kawamura Tomohiro
- Kazamel Mohamed
- Kelley Andrea
- Keung Benison
- Khoury Julie
- Kikutake Keiko
- Kim Bryan
- Kim Byoung Joon
- Kim Byung-Jo
- Kim Miri
- Kim Seung Min
- Kim Yool-hee
- Kincaid John
- Kirbas Cavdar Tugce
- Kissel John T.
- Kobashikawa Tomomi
- Kobayashi Eri
- Kobayashi Hisako
- Koga Megumi
- Koh Da Yoon
- Kohlrus Stephanie
- Konyane Monika
- Koo Dae Lim
- Koo Yong Seo
- Kramer Megan
- Kressin Nicole
- Krogh Susanne
- Kumar Aditya
- Kurihara Rikako
- Kurkova Barbora
- Kutlu Ayse
- Kwan Justin
- Kwon JuYoung
- Laaksonen Mikko
- Lazaro Ana
- Lee Chang Nyoung
- Lee HyeLim
- Lee Hyung Seok
- Lee JiEun
- Lim Jae-Sung
- Lin Frank
- Liu Tina
- Liu Ye
- Locatelli Alberta
- Locheke Jerry
- Lokaitis Barbara
- Loor John
- Lopergolo Diego
- Lopez Ruiz Pedro
- Lovas Gabor
- Lu Liang
- Lucy Shannon
- Macagnan Ana Paula
- Maeda Yasuko
- Maggi Lorenzo
- Mahdi-Rogers Mohamed
- Mahieu D. lphine
- Maier Gal
- Makamori Masayuki
- Malekniazi Ali
- Mallon Ashley
- Mantegazza Renato
- Maqsood Fatima
- Marano Enrico
- Marburger Tessa
- Marsili Angela
- Martineli Torres Debora Dada
- Martins Ribeiro Renata
- Masaki Katsuhisa
- Massey Janice
- Mathew Veena
- Matolcsi Judit
- Matsuse Dai
- Matsushita Takuya
- Mazia Claudio Gabriel
- Mazuela Gonzalo
- McClain Terry
- McClain Terry
- McKenna Kaitlyn
- McKinnon Jonathan
- McKinnon Naya
- McVey April
- Meguro Fumie
- Meherremova Arzu
- Melo Ana Paula
- Mercelis Rudy
- Mezache Louisa
- Micheels Angela
- Michon Sara-Claude
- Miller Robert
- Min Ju-Hong
- Minton Brian
- Miranda Carolina
- Mitazaki Teiichiro
- Miyawaki Eriko
- Mizugami Aya
- Mogensen Anita
- Mohr Henrique
- Mori Masahiro
- Morikawa Miyuki
- Morino Stefania
- Mosmiller Betsy
- Motomura Masakatsu
- Mozaffar Tahseen
- Muharrem Filiz
- Mukaino Akihiro
- Mumfrey-Thomas Sandi
- Muppidi Srikanth
- Murahara Takashi
- Murai Hiroyuki
- Nagane Yuriko
- Nakamura Yumiko
- Nance Christopher
- Narayan Jeffrey
- Narikawa Koichi
- Nations Sharon
- Naunton Kerry
- Nemeth Joanne
- Nogueira Coelho Erica
- Norwood Fiona
- Noshiro Mayuko
- Novakova Iveta
- Nowak Richard J.
- Nozaki Kenkichi
- Nye Joan
- O'Brien Fanny L.
- Oksaranta Olli
- Okumura Meinoshin
- Olalde Heena
- Onar Musa Kazim
- Onesti Emanuela
- Orsel Gulsah
- Osakada Kaori
- Ostergaard Autzen Anne
- Otavio Maia Gonçalves Luiz
- Ozawa Yukiko
- Ozcelik Pinar
- Padilla Patricia
- Paiva Gabriel
- Park SangAe
- Pasanisi Maria
- Pascuzzi Robert
- Pasnoor Mamatha
- Patrick Kara
- Patwa Huned
- Paulose Shirley
- Pazetto Lucas Eduardo
- Pedersen Jane
- Pereira Martins Maurer
- Phan Cecile
- Piehl Fredrik
- Pillai Rekha
- Pineda Colleen
- Pinto Graziela
- Pinto Wladimir
- Pitha Jiri
- Plevka Sarah
- Pokala Krishna
- Pol Sabrina
- Pozo Marina
- Prando Natalia
- Pulley Michael
- Puorro Giorgia
- Querol Gutierrez Luis Antonio
- Ra HyeJin
- Reguliova Katarina
- Renata Cubas Volpe Luciana
- Reyes Eliana
- Rico Gabrielle
- Robeson Kimberly
- Rocha Rosana
- Roderus Rikki
- Rodriguez de Rivera Francisco Javier
- Roe Kristen
- Rojas Garcia Ricardo
- Rosenfeld Jeffrey
- Roy Gulmohor
- Rozsa Csilla
- Rugiero Marcelo
- Saba Juliet
- Saccà Francesco
- Sadalage Girija
- Saito Yuka
- Saitoh Masaki
- Sakamuri Sarada
- Saklad Amy
- Salajegheh Mohammed
- Salvado Maria
- Samukawa Makoto
- Sanjak Mohammad
- Sano Yoshiko
- Santos Engel Murilo
- Sastre Maria
- Sathasivam Sivakumar
- Sato Miwako
- Sattar Nadia
- Scala Stephanie
- Schommer Clara
- Schotte Caroline
- Seddigh Arshira
- Seelback Jenna
- Semiz Cansu
- Sen Sedat
- Sengun Ihsan
- Seok Hung Youl
- Seok Jinmyoung
- Shabbir Yasmeen
- Shah Akshay
- Shah Amna
- Shah Jaimin
- Sharma Khema
- Sheldon Danielle
- Shimohama Shun
- Shimpo Misa
- Shin Chae Won
- Shin Ha Young
- Shin Miju
- Shiraishi Hirokazu
- Siddiqi Zaeem
- Sieren Jeri
- Silva Marcela
- Silvestri Nicholas
- Smetcoren Charlotte
- Smith Lisa
- Snook Riley
- So Yuen T.
- Sohail Faisal
- Sokratous Giannis
- Souza Bulle Oliveira Acary
- Souza Duca Luciana
- Souza Iandra
- Srinivasan Jayashri
- Statland Jeffery
- Steele Julie
- Stevens Olivier
- Strom Susan
- Sune Pilar
- Suzuki Hidekazu
- Suzuki Shuichiro
- Suzuki Yasushi
- Swenson Andrea
- Szabadosne Brigitta
- Szabo Gyorgyi
- Taichi Namie
- Takada Kazumi
- Takada Mihoko
- Takahashi Masanori
- Takeyama Rumi
- Tandan Rup
- Tano Ohito
- Terzi Murat
- Tierney Scott
- Tilkin Petra
- Tobon Gonzales Alejandro
- Toncrova Stanislava
- Torane Pravin
- Toska Shirli
- Tran Anh
- Traub Rebecca
- Trivedi Jaya
- Troili Fernanda
- Tsuda Emiko
- Tsuda Tomoko
- Tsukita Kenichi
- Tsurumaru Masako
- Tuga Celal
- Tun Ozlem
- Tyblova Michaela
- Uehara Taira
- Ugur Muzeyyen
- Utsugisawa Kimiaki
- Uwasa Kaori
- Uzawa Akiyuki
- van Daele Sien
- van Damme Philip
- van den Abeele Guy
- van der Kooi Anneke
- Vandenbussche Nicolas
- Vanderhook Mollie
- Vanhee Annelies
- Varga Edina
- Varghese Mary
- Vecsei Laszlo
- Veiga Thabata
- Velez Santamaria Valentina
- Ventura Nicholas
- Verjans Sarah
- Veske Adife
- Vidal Gonzalo
- Vidal Nuria
- Vinge Lotte
- Vissing John
- Vohanka Stanislav
- Vu Hong
- Vu Tuan H.
- Vynckier Jan
- Vytopil Michal
- Wagemaekers Linda
- Waheed Waqar
- Walsh Maureen
- Wang Jing Jing
- Wang Yunxia
- Watling Dave
- Watt Elizabeth
- Weiner Elaine
- Weiss Michael
- Welsh Lesly
- Wheeler Lauren
- Wilken Miguel
- Witting Nanna
- Wolfe Gil
- Wolfova Marcela
- Woodall Amy
- Yamamoto Daisuke
- Yamashita Yumi
- Yang Irene
- Yasuda Ikuko
- Yilmaz Ezgi
- Yoshida Seiko
- Yoshimura Shunsuke
- Young Valerie
- Zakalik Karen
- Zapletalova Olga
- Zilliox Lindsay
- Publication venue
- 'Wiley'
- Publication date
- 01/07/2019
- Field of study
Introduction: Eculizumab is effective and well tolerated in patients with antiacetylcholine receptor antibody-positive refractory generalized myasthenia gravis (gMG; REGAIN; NCT01997229). We report an interim analysis of an open-label extension of REGAIN, evaluating eculizumab's long-term safety and efficacy. Methods: Eculizumab (1,200 mg every 2 weeks for 22.7 months [median]) was administered to 117 patients. Results: The safety profile of eculizumab was consistent with REGAIN; no cases of meningococcal infection were reported during the interim analysis period. Myasthenia gravis exacerbation rate was reduced by 75% from the year before REGAIN (P < 0.0001). Improvements with eculizumab in activities of daily living, muscle strength, functional ability, and quality of life in REGAIN were maintained through 3 years; 56% of patients achieved minimal manifestations or pharmacological remission. Patients who had received placebo during REGAIN experienced rapid and sustained improvements during open-label eculizumab (P < 0.0001). Discussion: These findings provide evidence for the long-term safety and sustained efficacy of eculizumab for refractory gMG. Muscle Nerve 2019
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Eculizumab in refractory generalized myasthenia gravis previously treated with rituximab: subgroup analysis of REGAIN and its extension study
- Author
- Acar Nazire Pinar
- Agrawal Brajesh
- Agriesti Julie
- Aguilo Maria Antonia Alberti
- Ahn So‐Hyun
- Akhter Salma
- Akiyama Tetsuya
- Alam Sharmeen
- Alboini Paolo Emilio
- Alcon Karan
- Alsharabati Mohammad
- Amamoto Shoko
- Amato Anthony
- Amato Katherine
- Ambrosio Daniel
- Andersen Henning
- Anderson Amanda
- Andrade Ana Carolina Amaral
- Annes Marcelo
- Antonini Giovanni
- Antozzi Carlo
- Aranke Shachie
- Ardoin Angela
- Arndt Heike
- Arnold Thomas
- Arribas‐Ibar Elisabet
- Asada Shizuka
- Assis Natália
- Autzen Anne Mette Ostergaard
- Aydinlik Seda
- Balkan Bengu
- Barohn Richard
- Barroso Fabio
- Becerikli Gulsah
- Beck Kate
- Bednarik Josef
- Bekircan‐Kurt Can Ebru
- Benatar Michael
- Berger Alan Ross
- Bertorini Tulio
- Bettini Mariela
- Beydoun Said
- Bhavaraju‐Sanka Ratna
- Bilsker Martin
- Bjarbo Lena
- Blackmore Derrick
- Bodkin Cynthia
- Bonanno Silvia
- Bravver Elena
- Brockhausen Igor Dias
- Brooks Benjamin
- Brown Claire
- Burdette Maryanne
- Butinhao Cristiani Fernanda
- Caliskan Yagmur
- Callison Karen
- Camera Giorgia
- Campanella Angela
- Carbonell Josep Gamez
- Carnes Donna
- Carrara Fernanda
- Carter Cynthia
- Casasnovas Carlos
- Cash Tiyonnoh
- Cassia Santos Aline
- Cavdar Tugce Kirbas
- Cavus Hakan
- Chaudhry Vinay
- Chaves Marcelo
- Chelnick Sharon
- Chilingaryan Amaiak
- Chmelikova Magda
- Cho Eun Bin
- Choi Eun Haw
- Choi Mi Song
- Chopra Manisha
- Cierny Marek
- Cochrane Thomas
- Coelho Erica Nogueira
- Cooley Anne
- Corse Andrea
- Costabile Teresa
- Cruz Pacheco Daiane
- Cunningham Scott
- César Pamela
- D'Amato Valentina
- D'Hont Ann
- Daniels Kevin
- Darnell Taylor
- Davies Debbie
- De Bleecker Jan
- De Mey Katrien
- Depreitere Annelies
- Dezsi Livia
- Di Pasquale Antonella
- Di Pasquale Antonella
- Diaz‐Manera Jordi
- Dicapua Daniel
- Dimachkie Mazen
- Dimitriou Aikaterini
- Dimitrova Diana
- DiSanzo Beth
- Dishman Lorraine
- Distad Jane
- Doan Victor
- Dogan Baki
- Donahue Craig
- Downing Sharon
- Droker Brian
- Duca Luciana Souza
- Duran Gustavo
- Echevarria Laura
- Efendi Husnu
- Elsayed Mona
- Emmons Kelley
- Engel Marguerite
- Engel Murilo Santos
- Erdem‐Ozdamar Sevim
- Eriksson Jaana
- Erälinna Juha‐Pekka
- Evoli Amelia
- Fasanaro Angiola
- Feder David
- Fernandes Patrícia
- Fernandez‐Fournier Mireya
- Fernandez‐Fournier Mireya
- Ferreira Luciana
- Fialho Tomás Augusto Suriane
- Figueras Maria Salvado
- Filla Alessandro
- Fionda Laura
- Fionda Laura
- Fondaw Alex
- Forshew Dallas
- Frasca Vittorio
- Frasca Vittorio
- Freimer Miriam
- Friedrich Maurício André Gheller
- Fujii Yuko
- Fukuda Yusuke
- Funaka Soichiro
- Futono Kazumi
- Gabriele Maria
- Garcia Alejandra Dalila
- Garcia Rebekah
- Garcia Ricardo Rojas
- Garcia Sonia
- Garibaldi Matteo
- Garibaldi Matteo
- Geraldo Jordana Gonçalves
- Giacomelli Elena
- Gibson Tamar
- Gilchrist James
- Gili Gisela
- Glenn Melanie
- Golden Laura
- Gollogly Jakit
- Gong Hui
- Gonzalez Alejandro Tobon
- Gonzalez Anna
- Gonçalves Luiz Otavio Maia
- Gori Maria
- Goyal Namita
- Goyal Neelam
- Guerreiro Alexandre
- Guingrich Sandra
- Guptill Jeffrey
- Gutiérrez Luis Antonio Querol
- Gutmann Laurie
- Gutmann Ludwig
- Haar Laura
- Hafer‐Macko Charlene
- Harbo Thomas
- Harrison Tuula
- Hart Adam
- Harvey Brittany
- Hasuike Tomoya
- Hayashi Takashi
- Hehir Michael
- Henderson Kendrick
- Herbelin Laura
- Herbert Carol
- Hewlett Jasmine
- Hietala Albert
- Higuchi Eriko
- Hisahara Shin
- Ho Doreen
- Hobson‐Webb Lisa
- Homedes‐Pedret Christian
- Hong Yoon‐Ho
- Hopkins Steve
- Horvath Melinda
- Howard James
- Hoyle Joseph Chad
- Huynh Kristin
- Hwang Eun Bi
- Hwang Ji Ye
- Højgaard Joan
- Illa Isabel
- Imai Tomihiro
- Imai Tomihiro
- Inghilleri Maurizio
- Iorio Raffaele
- Ishiyama Naoko
- Ishiyama Yoko
- Jacob Saiju
- Jakab Gedeonne
- Jara Jordan
- Jeffery Dennis
- Jenci Nicole
- Jeong Ha‐Neul
- Jerath Nivedita
- Jingu Maki
- Johns Kathryn
- Jones Floyd
- Jones H. James
- Juel Vern
- Jung Jin Woo
- Junkerova Jana
- Jurajdova Ivana
- Kamakura Sachiko
- Kamegamori Ikuko
- Kanai Tetsuya
- Kaneko Yoko
- Kang Hoo Nam
- Kanzaki Akiko
- Karam Chafic
- Karam Chafic
- Karimi Sanaz
- Katz Jonathan
- Katzin Lara
- Kaur Harpreet
- Kawaguchi Naoki
- Kawamata Jun
- Kawamura Tomohiro
- Kazamel Mohamed
- Kelley Andrea
- Keung Benison
- Khoury Julie
- Kikutake Keiko
- Kim Bryan
- Kim Byoung Joon
- Kim Byung‐Jo
- Kim Miri
- Kim Seung Min
- Kim Yool‐hee
- Kincaid John
- Kissel John
- Kobashikawa Tomomi
- Kobayashi Eri
- Kobayashi Hisako
- Koga Megumi
- Koh Da Yoon
- Kohlrus Stephanie
- Koning Kathy
- Konyane Monika
- Koo Dae Lim
- Koo Yong Seo
- Kooi Anneke
- Kramer Megan
- Kressin Nicole
- Krogh Susanne
- Kumar Aditya
- Kurihara Rikako
- Kurkova Barbora
- Kutlu Ayse
- Kwan Justin
- Kwon Ju Young
- Laaksonen Mikko
- Lazaro Ana
- Lee Chang Nyoung
- Lee Hye Lim
- Lee Hyung Seok
- Lee Ji Eun
- Lim Jae‐Sung
- Lin Frank
- Lino Valeria Cavalcante
- Liu Tina
- Liu Ye
- Locatelli Alberta
- Locheke Jerry
- Lokaitis Barbara
- Loor John
- Lopergolo Diego
- Lovas Gabor
- Lu Liang
- Lucy Shannon
- Macagnan Ana Paula
- Maeda Yasuko
- Maggi Lorenzo
- Mahdi‐Rogers Mohamed
- Mahieu Délphine
- Maier Gal
- Malekniazi Ali
- Mallon Ashley
- Mantegazza Renato
- Maqsood Fatima
- Marano Enrico
- Marburger Tessa
- Marsili Angela
- Martins Maurer Pereira
- Masaki Katsuhisa
- Massey Janice
- Mathew Veena
- Matolcsi Judit
- Matsuse Dai
- Matsushita Takuya
- Mazia Claudio Gabriel
- Mazuela Gonzalo
- McClain Terry
- McClain Terry
- McKenna Kaitlyn
- McKinnon Jonathan
- McKinnon Naya
- McVey April
- Meguro Fumie
- Meherremova Arzu
- Melo Ana Paula
- Mercelis Rudy
- Mezache Louisa
- Micheels Angela
- Michon Sara‐Claude
- Miller Robert
- Min Ju‐Hong
- Minton Brian
- Miranda Carolina
- Miyawaki Eriko
- Miyazaki Teiichiro
- Mizugami Aya
- Mogensen Anita
- Mohr Henrique
- Mori Masahiro
- Morikawa Miyuki
- Morino Stefania
- Mosmiller Betsy
- Motomura Masakatsu
- Mozaffar Tahseen
- Muharrem Filiz
- Mukaino Akihiro
- Mumfrey‐Thomas Sandi
- Muppidi Srikanth
- Murahara Takashi
- Murai Hiroyuki
- Nagane Yuriko
- Nakamori Masayuki
- Nakamura Yumiko
- Nance Christopher
- Narayan Jeffrey
- Narikawa Koichi
- Nations Sharon
- Naunton Kerry
- Nemeth Joanne
- Norwood Fiona
- Noshiro Mayuko
- Novakova Iveta
- Nowak Richard J
- Nozaki Kenkichi
- Nye Joan
- O'Brien Fanny
- Oksaranta Olli
- Okumura Meinoshin
- Olalde Heena
- Oliveira Acary Souza Bulle
- Onar Musa Kazim
- Onesti Emanuela
- Orsel Gulsah
- Osakada Kaori
- Ozawa Yukiko
- Ozcelik Pinar
- Padilla Patricia
- Paiva Gabriel
- Palacios Natalia Julia
- Park Sang Ae
- Pasanisi Maria
- Pascuzzi Robert
- Pasnoor Mamatha
- Patrick Kara
- Patti Francesco
- Patwa Huned
- Paulose Shirley
- Pazetto Lucas Eduardo
- Pedersen Jane
- Penha Ananias Morita Maria
- Phan Cecile
- Piehl Fredrik
- Pillai Rekha
- Pineda Colleen
- Pinto Graziela
- Pinto Wladimir
- Pitha Jiri
- Plevka Sarah
- Pol Sabrina
- Polaka Krishna
- Porras Laura Diez
- Pozo Marina
- Prando Natalia
- Pulley Michael
- Puorro Giorgia
- Ra Hye Jin
- Reguliova Katarina
- Reyes Eliana
- Ribeiro Renata Martins
- Rico Gabrielle
- Rivera Francisco Javier Rodriguez
- Robeson Kimberly
- Rocha Rosana
- Roderus Rikki
- Roe Kristen
- Rosa Bruno Bezerra
- Rosenfeld Jeffrey
- Roy Gulmohor
- Rozsa Csilla
- Rugiero Marcelo
- Ruiz Pedro Lopez
- Saba Juliet
- Saccà Francesco
- Sadalage Girija
- Saito Yuka
- Saitoh Masaki
- Sakamuri Sarada
- Saklad Amy
- Salajegheh Mohammed
- Salcedo Pilar Gomez
- Samukawa Makoto
- Sanjak Mohammad
- Sanjak Mohammed
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- Santamaria Valentina Velez
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- Sathasivam Sivakumar
- Sato Miwako
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- Scala Stephanie
- Schommer Clara
- Schotte Caroline
- Scott Tierney
- Seddigh Arshira
- Seelbach Jenna
- Semiz Cansu
- Sen Sedat
- Sengun Ihsan
- Seok Hung Youl
- Seok Jinmyoung
- Shabbir Yasmeen
- Shabbir Yasmeen
- Shah Akshay
- Shah Amna
- Shah Jaimin
- Sharma Khema
- Sheldon Danielle
- Shimohama Shun
- Shimohama Shun
- Shimpo Misa
- Shin Chae Won
- Shin Ha Young
- Shin Miju
- Shiraishi Hirokazu
- Siddiqi Zaeem A
- Sieren Jeri
- Silva Liene Duarte
- Silva Luiz Augusto
- Silva Marcela
- Silva Tamires Cristina Gomes
- Silvestri Nicholas
- Siqueira Carvalho Alzira Alves
- Smetcoren Charlotte
- Smith Lisa
- Snook Riley
- So Yuen T
- Sohail Faisal
- Sokratous Giannis
- Souza Iandra
- Srinivasan Jayashri
- Statland Jeffery
- Steele Julie
- Stevens Olivier
- Strom Susan
- Sune Pilar
- Suzuki Hidekazu
- Suzuki Shuichiro
- Suzuki Yasushi
- Swenson Andrea
- Szabadosne Brigitta
- Szabo Gyorgyi
- Taichi Namie
- Takada Kazumi
- Takada Mihoko
- Takahashi Masanori
- Takeyama Rumi
- Tandan Rup
- Tano Ohito
- Tejedor Exuperio Diez
- Terzi Murat
- the REGAIN Study Grp
- Tilkin Petra
- Toncrova Stanislava
- Torane Pravin
- Torres Debora Dada Martineli
- Toska Shirli
- Tran Anh
- Traub Rebecca
- Trivedi Jaya
- Troili Fernanda
- Tsuda Emiko
- Tsuda Tomoko
- Tsukita Kenichi
- Tsurumaru Masako
- Tuga Celal
- Tun Ozlem
- Tyblova Michaela
- Uehara Taira
- Ugur Muzeyyen
- Utsugisawa Kimiaki
- Uwasa Kaori
- Uzawa Akiyuki
- Van Daele Sien
- Van Damme Philip
- Van den Abeele Guy
- Vandenbussche Nicolas
- Vanderhook Mollie
- Vanhee Annelies
- Varga Edina
- Varghese Mary
- Vecsei Laszlo
- Veiga Thabata
- Ventura Nicholas
- Verjans Sarah
- Veske Adife
- Vicente Elena Cortes
- Vidal Gonzalo
- Vidal Nuria
- Vinge Lotte
- Visser Marianne
- Vissing John
- Vohanka Stanislav
- Volpe Luciana Renata Cubas
- Vu Hong
- Vu Tuan
- Vynckier Jan
- Vytopil Michal
- Wagemaekers Linda
- Waheed Waqar
- Walsh Maureen
- Wang Yunxia
- Watling Dave
- Watt Elizabeth
- Weiner Elaine
- Weiss Michael
- Welsh Lesly
- Wheeler Lauren
- Wilken Miguel
- Wilken Miguel
- Witting Nanna
- Wolfe Gil
- Wolfova Marcela
- Woodall Amy
- Yamamoto Daisuke
- Yamashita Yumi
- Yang Irene
- Yasuda Ikuko
- Yilmaz Ezgi
- Yoshida Seiko
- Yoshida Seiko
- Yoshimura Shunsuke
- Young Valerie
- Yountz Marcus
- Zakalik Karen
- Zapletalova Olga
- Zilliox Lindsay
- Publication venue
- John Wiley & Sons, Inc
- Publication date
- 01/12/2021
- Field of study
Introduction/Aims
Individuals with refractory generalized myasthenia gravis (gMG) who have a history of rituximab use and experience persistent symptoms represent a population with unmet treatment needs. The aim of this analysis was to evaluate the efficacy and safety of eculizumab in patients with refractory anti‐acetylcholine receptor antibody‐positive (AChR+) gMG previously treated with rituximab.
Methods
This post hoc subgroup analysis of the phase 3 REGAIN study (NCT01997229) and its open‐label extension (OLE; NCT02301624) compared baseline characteristics, safety, and response to eculizumab in participants who had previously received rituximab with those who had not. Rituximab use was not permitted within the 6 months before screening or during REGAIN/OLE.
Results
Of 125 REGAIN participants, 14 had received rituximab previously (7 received placebo and 7 received eculizumab). In the previous‐rituximab group, 57% had used at least four other immunosuppressants compared with 16% in the no‐previous‐rituximab group. Myasthenia Gravis Activities of Daily Living total scores from eculizumab baseline to week 130 of eculizumab treatment improved in both the previous‐rituximab and no‐previous‐rituximab groups (least‐squares mean −4.4, standard error of the mean [SEM] 1.0 [n = 9] and least‐squares mean −4.6, SEM 0.3 [n = 67], respectively; difference = 0.2, 95% confidence interval −1.88 to 2.22). In addition, in both groups, most patients who were treated with eculizumab for 130 weeks achieved a Myasthenia Gravis Foundation of America post‐intervention status of minimal manifestations (66.7% and 65.0%, respectively). The eculizumab safety profile was similar between groups and consistent with its established profile.
Discussion
Eculizumab is an effective therapy for patients with refractory AChR+ gMG, irrespective of whether they had received rituximab treatment previously
Correction to: Eculizumab improves fatigue in refractory generalized myasthenia gravis (Quality of Life Research, (2019), 28, 8, (2247-2254), 10.1007/s11136-019-02148-2)
- Author
- Acar Nazire Pinar
- Agrawal Brajesh
- Agriesti Julie
- Ahn So-Hyun
- Akhter Salma
- Akiyama Tetsuya
- Alam Sharmeen
- Alberti Aguilo Maria Antonia
- Alboini Paolo Emilio
- Alcon Karan
- Alsharabati Mohammad
- Alves de Siqueira Carvalho Alzira
- Amamoto Shoko
- Amaral Andrade Ana Carolina
- Amato Anthony
- Amato Katherine
- Ambrosio Daniel
- Andersen Henning
- Anderson Amanda
- Andoin Angela
- Annes Marcelo
- Antonini Giovanni
- Antozzi Carlo
- Aranke Shachie
- Arndt Heike
- Arnold Thomas
- Arribas-Ibar Elisabet
- Asada Shizuka
- Assis Natália
- Aydinlik Seda
- Balkan Bengu
- Barohn Richard
- Barroso Fabio
- Becerikli Gulsar
- Beck Kate
- Bednarik Josef
- Bekircan-Kurt Can Ebru
- Benatar Michael
- Berger Alan Ross
- Bertorini Tulio
- Bettini Mariela
- Beydoun Said
- Bezerra Rosa Bruno
- Bhavaraju-Sanka Ratna
- Bilsker Martin
- Bjarbo Lena
- Blackmore Derrick
- Bodkin Cynthia
- Bonanno Silvia
- Bravver Elena
- Brooks Benjamin
- Brown Claire
- Burdette Maryanne
- Butinhao Cristiani Fernanda
- Caliskan Yagmur
- Callison Karen
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- Campanella Angela
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- Carter Cynthia
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- Chelnick Sharon
- Chilingaryan Amaiak
- Chmelikova Magda
- Cho Eun Bin
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- Cierny Marek
- Cochrane Thomas
- Cooley Anne
- Corse Andrea
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- da Cruz Pacheco Daiane
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- da Silva Luiz Augusto
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- Piehl Fredrik
- Pillai Rekha
- Pineda Colleen
- Pinto Graziela
- Pinto Wladimir
- Pitha Jiri
- Plevka Sarah
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- Roy Gulmohor
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- Rugiero Marcelo
- Saba Juliet
- Saccà Francesco
- Sadalage Girija
- Saito Yuka
- Saitoh Masaki
- Sakamuri Sarada
- Saklad Amy
- Salajegheh Mohammed
- Salvado Maria
- Samukawa Makoto
- Sanjak Mohammad
- Sano Yoshiko
- Santos Engel Murilo
- Sastre Maria
- Sathasivam Sivakumar
- Sato Miwako
- Sattar Nadia
- Scala Stephanie
- Schommer Clara
- Schotte Caroline
- Seddigh Arshira
- Seelback Jenna
- Semiz Cansu
- Sen Sedat
- Sengun Ihsan
- Seok Hung Youl
- Seok Jinmyoung
- Shabbir Yasmeen
- Shah Akshay
- Shah Amna
- Shah Jaimin
- Sharma Khema
- Sheldon Danielle
- Shimohama Shun
- Shimpo Misa
- Shin ChaeWon
- Shin Ha Young
- Shin Miju
- Shiraishi Hirokazu
- Siddiqi Zaeem
- Sieren Jeri
- Silva Marcela
- Silvestri Nicholas
- Smetcoren Charlotte
- Smith Lisa
- Snook Riley
- So Yuen T.
- Sohail Faisal
- Sokratous Giannis
- Souza Bulle Oliveira Acary
- Souza Iandra
- Souza Duca Luciana
- Srinivasan Jayashri
- Statland Jeffery
- Steele Julie
- Stevens Olivier
- Strom Susan
- Sune Pilar
- Suzuki Hidekazu
- Suzuki Shuichiro
- Suzuki Yasushi
- Swenson Andrea
- Szabadosne Brigitta
- Szabo Gyorgyi
- Taichi Namie
- Takada Kazumi
- Takada Mihoko
- Takahashi Masanori
- Takeyama Rumi
- Tandan Rup
- Tano Ohito
- Terzi Murat
- Tierney Scott
- Tilkin Petra
- Tobon Gonzales Alejandro
- Toncrova Stanislava
- Torane Pravin
- Toska Shirli
- Tran Anh
- Traub Rebecca
- Trivedi Jaya
- Troili Fernanda
- Tsuda Emiko
- Tsuda Tomoko
- Tsukita Kenichi
- Tsurumaru Masako
- Tuga Celal
- Tun Ozlem
- Tyblova Michaela
- Uehara Taira
- Ugur Muzeyyen
- Utsugisawa Kimiaki
- Uwasa Kaori
- Uzawa Akiyuki
- van den Abeele Guy
- van der Kooi Anneke
- Vandenbussche Nicolas
- Vanderhook Mollie
- Vanhee Annelies
- van Daele Sien
- van Damme Philip
- Varga Edina
- Varghese Mary
- Vecsei Laszlo
- Veiga Thabata
- Velez Santamaria Valentina
- Ventura Nicholas
- Verjans Sarah
- Veske Adife
- Vidal Gonzalo
- Vidal Nuria
- Vinge Lotte
- Vissing John
- Vohanka Stanislav
- Vu Hong
- Vu Tuan
- Vynckier Jan
- Vytopil Michal
- Wagemaekers Linda
- Waheed Waqar
- Walsh Maureen
- Wang Jing Jing
- Wang Junxia
- Watling Dave
- Watt Elizabeth
- Weiner Elaine
- Weiss Michael
- Welsh Lesly
- Wheeler Lauren
- Wilken Miguel
- Witting Nanna
- Wolfe Gil
- Wolfova Marcela
- Woodall Amy
- Yamamoto Daisuke
- Yamashita Yumi
- Yang Irene
- Yasuda Ikuko
- Yilmaz Ezgi
- Yoshida Seiko
- Yoshimura Shunsuke
- Young Valerie
- Zakalik Karen
- Zapletalova Olga
- Zilliox Lindsay
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 15/08/2019
- Field of study
The article “Eculizumab improves fatigue in refractory generalized myasthenia gravis”, written by “Henning Andersen, Renato Mantegazza, Jing Jing Wang, Fanny O’Brien, Kaushik Patra, James F. Howard Jr. and The REGAIN Study Group” was originally published electronically on the publisher’s internet portal (currently SpringerLink) on 23 March 2019 without open access
Prospective observational cohort study on grading the severity of postoperative complications in global surgery research
- Author
- Abayasinghe Chamika
- Abbas Muntadhar
- Abbott T. E. F.
- Abbott Tom
- Abdullah Noor Hairiza
- Abdur-Rahman Lukman
- Abeloos Jacques
- Abernethy Caroline
- Abidin Ucu Nurhadiat
- Abrunhosa Alexandra
- Absar Mohammed
- Adam Suwayba
- Adams George
- Adamson Michael
- Adekola Oyebola
- Adelaja Yemi
- Ademola Adeyinka
- Adenekan Anthony
- Adenike Odewabi
- Adeolu Augustine A
- Adetoye Adedapo
- Adewale Badru
- Adigun Tinuola
- Adolfsson Anne
- Aflori Laura
- Africander Cucu
- Afshari Arash
- Agarwal Vandana
- Agodirin Olayide
- Aguzzoli Crisitiano
- Ahmad Abdurrahman
- Ahmad Norfaizan
- Ahmad T.
- Ahmad Tahania
- Ahmad Yousra
- Ahmed Ahmed
- Ahmed Jamil
- Ahmed Tahania
- Ai Yanqiu
- Aignatoaie Mariana
- Aimoniotou-Georgiou Eleni
- Akanmu Olanrewaju
- Akerman Nik
- Akinwale Mukaila
- Al Amri Khalid
- Al Hussaini Sabah
- Al-Soudaine Yassr
- Aladin Hafiz
- Alagbe-Briggs Olubusola
- Albaj Safauldeensalem
- Alcock David
- Alcock Liam
- Aldecoa Cesar
- Aldecoa Cesar
- Aleixo Fábia Berganton
- Alexander Hazel
- Alexander Maini
- Alexander-Sefre Farhad
- Alherz Fadhel
- Ali Hani
- Ali Marlynn
- Ali Sarah
- Alias Abdul Hafiz
- Alias Anita
- Alias Raja Liza Raja
- Allen Samantha
- Allen Sara Jane
- Allison Joanna
- Alloj Chiara
- Allorto Nikki Leigh
- Allsop Joanne
- Almeida William
- Alonso Eduardo
- Alonso José Ignacio
- Alphonsus Christella
- Alvares Danielle
- Alves Maria Joao
- Amador Juan Carlos Bravo
- Ameer Yusuf
- Amendola Cristina Prata
- Ami Noam
- Amstrup-Hansen Louise
- Anagnou Athina
- Andersen Cheme
- Anderson Charlotte
- Anderson Colette
- Anderson Frank
- Anderson Philip
- Andreadaki Evangelia
- Andreou Alexandros
- Andreou Prematie
- Andrew Alyson
- Andrews Emma
- Angel Miguel Paludi
- Angermair Stefan
- Angus Kirsty
- Anillo Victor
- Anizi Mashel Al
- Antal Oana
- Antill Philip
- Antoniadou Eleni
- Apagaki Eymorfia
- Apostolou Konstantinos
- Applewhaite Christopher
- Applewhaite Christopher
- Aquino Laura Patricia González
- Ar Praburaj
- Araujo Daniela Marques
- Arawwawala Dilshan
- Ardern Diane
- Argue Ruth
- Aribawa Mahaalit Alit
- Arkalaki Eleni
- Armaganidis Apostolos
- Armstrong John
- Armstrong Richard
- Arnaoutoglou Christina
- Arnaoutoglou Elena
- Arnold Glenn
- Arrandale Lindsay
- Arrich James
- Arrigo Mario
- Arshad Homa
- Arshad Mohammed Asif
- Artiles Tania Socorro
- Arumugam Swarna
- Arustei Mirela
- Arvaniti Kostoula
- Arvaniti Kostoula
- Arya Aryabiantara
- Arya Shobhit
- Asimakos Andreas
- Aslam M
- Asudo Felicia
- Athanasakis Elias
- Atiku Mamuda
- Attrill Elizabeth
- Attwood Clare
- Auer Patrick
- Avidan Michael
- Avila Erendira Jocelin Dominguez
- Avis Joanne
- Awad Hadi
- Axioti Elena
- Azam Ummi Azmira Ahmad
- Azambuja Pedro
- Azevedo Caroline
- Aziz Faizal Zuhri
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- Bandeira Maria Expedito
- Banerjee Robin
- Bankewitz Carla
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- Barcraft-Barnes Helena
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- Barnett Andrew
- Barraclough James
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- Del Valle Santiago Garcia
- Delgado García David R
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- Ganter Michael T
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- Goebel Ulrich
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- Greaves Rosanna
- Green Garyth M
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- Haddow James
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- Harrichandparsad R
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- Hobrok Maria
- Hodgkiss Tracey
- Hodgson Richard E
- Hodzovic Emil
- Hoedt Marielle
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- Jardim Jaquelline
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- Jeffery Holly
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- Weatherill J
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- Zhao Weilu
- Zhao Xiaoying
- Zhen Jungang
- Zheng Kang
- Zheng Lina
- Zheng Tianzhao
- Zhong Yi
- Zhou Ce
- Zhou Dachun
- Zhou Haidong
- Zhou Haiyan
- Zhou Jiali
- Zhou Jialong
- Zhou Jing
- Zhou Xian-jin
- Zhu Xiaomao
- Zhu Yi
- Zhu Zhipeng
- Zhuang Xiuxiu
- Zilis Georgios
- Zin Nor Hafizah Mohd
- Zingerle Nicolette
- Zingg Urs
- Zoerner Frank
- Zonneveldt Harry
- Zou Xiaohua
- Zoulamoglou Menelaos
- Zsisku Lajos
- Zundert Tom
- Zyl Rebekka
- åkring Irene
- Ögren Katrin
- Publication venue
- 'Wiley'
- Publication date
- 22/10/2018
- Field of study
Background
The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs).
Methods
This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs.
Results
A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59).
Conclusion
Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally