11 research outputs found
Π Π°ΡΡΠ΅Ρ Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠΈ ΠΏΠΎΡΠΎΠΊΠ° Π² ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π΅
To analyze the elektrocyclone flow hydrodynamic computer calculation using the finite element method (FEM) is applied. The geometry of the model corresponds to the laboratoryΒ Β elektrocyclone. k-Ξ΅-turbulence model is used for the computation. The system of equations is solved by SIMPLE algorithm. The calculation results give a pattern of the flow velocity distribution and flow lines in different sections. There is conclusion based on the results about elektrocyclone flow hydrodynamic.ΠΠ»Ρ Π°Π½Π°Π»ΠΈΠ·Π° Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠΈ ΠΏΠΎΡΠΎΠΊΠ° Π² ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π΅ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ ΠΊΠΎΠΌΠΏΡΡΡΠ΅ΡΠ½ΡΠΉ ΡΠ°ΡΡΠ΅Ρ Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΠΌΠ΅ΡΠΎΠ΄Π° ΠΊΠΎΠ½Π΅ΡΠ½ΡΡ
ΡΠ»Π΅ΠΌΠ΅Π½ΡΠΎΠ² (ΠΠΠ). ΠΠ΅ΠΎΠΌΠ΅ΡΡΠΈΡ ΠΌΠΎΠ΄Π΅Π»ΠΈ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΠ΅Ρ Π»Π°Π±ΠΎΡΠ°ΡΠΎΡΠ½ΠΎΠΌΡ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Ρ. ΠΠ»Ρ ΡΠ°ΡΡΠ΅ΡΠΎΠ² ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½Π° k-Ξ΅-ΠΌΠΎΠ΄Π΅Π»Ρ ΡΡΡΠ±ΡΠ»Π΅Π½ΡΠ½ΠΎΡΡΠΈ. Π‘ΠΈΡΡΠ΅ΠΌΠ° ΡΡΠ°Π²Π½Π΅Π½ΠΈΠΉ ΡΠ΅ΡΠ°Π΅ΡΡΡ Ρ ΠΏΠΎΠΌΠΎΡΡΡ Π°Π»Π³ΠΎΡΠΈΡΠΌΠ° SIMPLE. Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ ΡΠ°ΡΡΠ΅ΡΠ° Π΄Π°ΡΡ ΠΊΠ°ΡΡΠΈΠ½Ρ ΡΠ°ΡΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΡΠΊΠΎΡΠΎΡΡΠ΅ΠΉ ΠΏΠΎΡΠΎΠΊΠ° ΠΈ Π»ΠΈΠ½ΠΈΠΉ ΡΠΎΠΊΠ° Π² ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
ΡΠ΅ΡΠ΅Π½ΠΈΡΡ
. ΠΠ° ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΠΈ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² Π΄Π΅Π»Π°Π΅ΡΡΡ Π²ΡΠ²ΠΎΠ΄ ΠΎ Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠ΅ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π°. ΠΡΡΠ²Π»Π΅Π½ ΡΠ°ΠΊΡ, ΡΡΠΎ Π² Π±ΡΠ½ΠΊΠ΅ΡΠ΅ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π° ΠΎΡΡΡΡΡΡΠ²ΡΠ΅Ρ Π²ΠΈΡ
ΡΠ΅Π²ΠΎΠ΅ Π΄Π²ΠΈΠΆΠ΅Π½ΠΈΠ΅, ΡΠ°ΠΊΠΆΠ΅ Π½Π΅Ρ ΡΠ°Π·Π²ΠΈΡΠΎΠ³ΠΎ ΡΠ΅ΡΠ΅Π½ΠΈΡ Π² ΠΎΠ±Π»Π°ΡΡΠΈ ΡΡΠ΅Π½ΠΎΠΊ, Π° Π½ΠΈΠΆΠ΅ Π²ΡΡ
Π»ΠΎΠΏΠ½ΠΎΠ³ΠΎ ΠΎΡΠ²Π΅ΡΡΡΠΈΡ ΡΠΊΠΎΡΠΎΡΡΡ ΠΏΠΎΡΠΎΠΊΠ° Π±Π»ΠΈΠ·ΠΊΠ° ΠΊ 0. ΠΡΠΎ Π±Π»Π°Π³ΠΎΠΏΡΠΈΡΡΠ½ΠΎ ΡΠΊΠ°Π·ΡΠ²Π°Π΅ΡΡΡ Π½Π° ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΎΡΠΈΡΡΠΊΠΈ, Ρ. ΠΊ. Π²ΡΡ
ΠΎΠ΄ΡΡΠΈΠΉ ΡΠΈΡΡΡΠΉ Π³Π°Π· Π½Π΅ ΡΠ²Π»Π΅ΠΊΠ°Π΅Ρ Ρ ΡΠΎΠ±ΠΎΠΉ ΠΎΡΠ΅Π²ΡΠΈΠ΅ ΡΠ°ΡΡΠΈΡΡ. ΠΡΠ²ΠΎΠ΄Ρ: 1) Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠ° ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π° ΠΌΠΎΠΆΠ΅Ρ Π±ΡΡΡ ΠΎΠΏΠΈΡΠ°Π½Π° Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΌΠ°ΡΠ΅ΠΌΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠΉ ΠΌΠΎΠ΄Π΅Π»ΠΈ ΠΈ ΡΠ°ΡΡΡΠΈΡΠ°Π½Π° Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΠΠ; 2) ΠΏΠΎΡΠΎΠΊ Π² ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π΅, ΠΊΠ°ΠΊ ΠΈ ΠΎΠΆΠΈΠ΄Π°Π»ΠΎΡΡ, ΠΈΠΌΠ΅Π΅Ρ Π·Π°ΠΊΡΡΡΠ΅Π½Π½ΡΡ ΡΡΡΡΠΊΡΡΡΡ, ΡΠ³ΠΎΠ» Π·Π°ΠΊΡΡΡΠΊΠΈ Π·Π°Π²ΠΈΡΠΈΡ ΠΎΡ Π΄Π»ΠΈΠ½Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΠΉ Π·ΠΎΠ½Ρ; 3) ΠΊΠΎΠ½ΡΡΡΡΠΊΡΠΈΡ Π±ΡΠ½ΠΊΠ΅ΡΠ° ΠΎΠ±Π΅ΡΠΏΠ΅ΡΠΈΠ²Π°Π΅Ρ Π²ΡΡ
ΠΎΠ΄ ΠΎΡΠΈΡΠ΅Π½Π½ΠΎΠ³ΠΎ Π³Π°Π·Π° Π±Π΅Π· Π²ΠΎΠ²Π»Π΅ΡΠ΅Π½ΠΈΡ Π² Π½Π΅Π³ΠΎ ΡΠ»ΠΎΠ²Π»Π΅Π½Π½ΡΡ
ΡΠ°ΡΡΠΈΡ
THE RESEARCH RESULTS OF DEHYDRATION PROCESS OF GOSSYPOL RESIN
This article is focused on the results of dehydration process of the oil and fat waste products- gossypol. The research was held in the temperature interval from room temperature until 160 degrees Celsius while constant shufflin
RESEARCHES OF PROCESS OF RECEPTION OF ANTICORROSIVE MATERIALS AND BUILDING BITUMENS ON THE BASIS OF GOSSIPOL RESIN
The article presents the results of research of technological processes of anticorrosive coatings and substitute petroleum bitumen based on gossipol resin from waste oil and fat plant
Elektrocyclone hydrodynamic flow computation
ΠΠ»Ρ Π°Π½Π°Π»ΠΈΠ·Π° Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠΈ ΠΏΠΎΡΠΎΠΊΠ° Π² ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π΅ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ ΠΊΠΎΠΌΠΏΡΡΡΠ΅ΡΠ½ΡΠΉ ΡΠ°ΡΡΠ΅Ρ Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΠΌΠ΅ΡΠΎΠ΄Π° ΠΊΠΎΠ½Π΅ΡΠ½ΡΡ
ΡΠ»Π΅ΠΌΠ΅Π½ΡΠΎΠ² (ΠΠΠ). ΠΠ΅ΠΎΠΌΠ΅ΡΡΠΈΡ ΠΌΠΎΠ΄Π΅Π»ΠΈ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΠ΅Ρ Π»Π°Π±ΠΎΡΠ°ΡΠΎΡΠ½ΠΎΠΌΡ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Ρ. ΠΠ»Ρ ΡΠ°ΡΡΠ΅ΡΠΎΠ² ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½Π° k-Ξ΅-ΠΌΠΎΠ΄Π΅Π»Ρ ΡΡΡΠ±ΡΠ»Π΅Π½ΡΠ½ΠΎΡΡΠΈ. Π‘ΠΈΡΡΠ΅ΠΌΠ° ΡΡΠ°Π²Π½Π΅Π½ΠΈΠΉ ΡΠ΅ΡΠ°Π΅ΡΡΡ Ρ ΠΏΠΎΠΌΠΎΡΡΡ Π°Π»Π³ΠΎΡΠΈΡΠΌΠ° SIMPLE. Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ ΡΠ°ΡΡΠ΅ΡΠ° Π΄Π°ΡΡ ΠΊΠ°ΡΡΠΈΠ½Ρ ΡΠ°ΡΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΡΠΊΠΎΡΠΎΡΡΠ΅ΠΉ ΠΏΠΎΡΠΎΠΊΠ° ΠΈ Π»ΠΈΠ½ΠΈΠΉ ΡΠΎΠΊΠ° Π² ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
ΡΠ΅ΡΠ΅Π½ΠΈΡΡ
. ΠΠ° ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΠΈ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² Π΄Π΅Π»Π°Π΅ΡΡΡ Π²ΡΠ²ΠΎΠ΄ ΠΎ Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠ΅ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π°. ΠΡΡΠ²Π»Π΅Π½ ΡΠ°ΠΊΡ, ΡΡΠΎ Π² Π±ΡΠ½ΠΊΠ΅ΡΠ΅ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π° ΠΎΡΡΡΡΡΡΠ²ΡΠ΅Ρ Π²ΠΈΡ
ΡΠ΅Π²ΠΎΠ΅ Π΄Π²ΠΈΠΆΠ΅Π½ΠΈΠ΅, ΡΠ°ΠΊΠΆΠ΅ Π½Π΅Ρ ΡΠ°Π·Π²ΠΈΡΠΎΠ³ΠΎ ΡΠ΅ΡΠ΅Π½ΠΈΡ Π² ΠΎΠ±Π»Π°ΡΡΠΈ ΡΡΠ΅Π½ΠΎΠΊ, Π° Π½ΠΈΠΆΠ΅ Π²ΡΡ
Π»ΠΎΠΏΠ½ΠΎΠ³ΠΎ ΠΎΡΠ²Π΅ΡΡΡΠΈΡ ΡΠΊΠΎΡΠΎΡΡΡ ΠΏΠΎΡΠΎΠΊΠ° Π±Π»ΠΈΠ·ΠΊΠ° ΠΊ 0. ΠΡΠΎ Π±Π»Π°Π³ΠΎΠΏΡΠΈΡΡΠ½ΠΎ ΡΠΊΠ°Π·ΡΠ²Π°Π΅ΡΡΡ Π½Π° ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΎΡΠΈΡΡΠΊΠΈ, Ρ. ΠΊ. Π²ΡΡ
ΠΎΠ΄ΡΡΠΈΠΉ ΡΠΈΡΡΡΠΉ Π³Π°Π· Π½Π΅ ΡΠ²Π»Π΅ΠΊΠ°Π΅Ρ Ρ ΡΠΎΠ±ΠΎΠΉ ΠΎΡΠ΅Π²ΡΠΈΠ΅ ΡΠ°ΡΡΠΈΡΡ. ΠΡΠ²ΠΎΠ΄Ρ: 1) Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠ° ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π° ΠΌΠΎΠΆΠ΅Ρ Π±ΡΡΡ ΠΎΠΏΠΈΡΠ°Π½Π° Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΌΠ°ΡΠ΅ΠΌΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠΉ ΠΌΠΎΠ΄Π΅Π»ΠΈ ΠΈ ΡΠ°ΡΡΡΠΈΡΠ°Π½Π° Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΠΠ; 2) ΠΏΠΎΡΠΎΠΊ Π² ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π΅, ΠΊΠ°ΠΊ ΠΈ ΠΎΠΆΠΈΠ΄Π°Π»ΠΎΡΡ, ΠΈΠΌΠ΅Π΅Ρ Π·Π°ΠΊΡΡΡΠ΅Π½Π½ΡΡ ΡΡΡΡΠΊΡΡΡΡ, ΡΠ³ΠΎΠ» Π·Π°ΠΊΡΡΡΠΊΠΈ Π·Π°Π²ΠΈΡΠΈΡ ΠΎΡ Π΄Π»ΠΈΠ½Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΠΉ Π·ΠΎΠ½Ρ; 3) ΠΊΠΎΠ½ΡΡΡΡΠΊΡΠΈΡ Π±ΡΠ½ΠΊΠ΅ΡΠ° ΠΎΠ±Π΅ΡΠΏΠ΅ΡΠΈΠ²Π°Π΅Ρ Π²ΡΡ
ΠΎΠ΄ ΠΎΡΠΈΡΠ΅Π½Π½ΠΎΠ³ΠΎ Π³Π°Π·Π° Π±Π΅Π· Π²ΠΎΠ²Π»Π΅ΡΠ΅Π½ΠΈΡ Π² Π½Π΅Π³ΠΎ ΡΠ»ΠΎΠ²Π»Π΅Π½Π½ΡΡ
ΡΠ°ΡΡΠΈΡ.To analyze the elektrocyclone flow hydrodynamic computer calculation using the finite element method (FEM) is applied. The geometry of the model corresponds to the laboratory elektrocyclone. The k-Ξ΅-turbulence model is used for the computation. The system of equations is solved by the SIMPLE algorithm. The calculation results give a pattern of the flow velocity distribution and the flow lines in the different sections. There is conclusion based on the results about the elektrocyclone flow hydrodynamic. Is elicited the fact that in the bunker of an electrocyclone there is no whirl, also there is no developed current in the field of walls, and below an exhaust opening the speed of a stream is close to 0.ΠΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΎ ΠΏΡΠΈ ΡΠΈΠ½Π°Π½ΡΠΎΠ²ΠΎΠΉ ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΠ΅ ΠΌΠΎΠ»ΠΎΠ΄ΡΡ
ΡΡΠ΅Π½ΡΡ
Π£ΡΠ€Π£ Π² ΡΠ°ΠΌΠΊΠ°Ρ
ΡΠ΅Π°Π»ΠΈΠ·Π°ΡΠΈΠΈ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΡ ΡΠ°Π·Π²ΠΈΡΠΈΡ Π£ΡΠ€Π£
Clinicopathological Features and Outcomes of T- and NK-Cell Lymphomas in European Russia
With the introduction of the revised World Health Organization Classification of Tumors of Hematopoietic and Lymphoid Tissues in 2001, many patients had to be re-evaluated for the correct diagnosis of T- and NK-cell lymphomas. Because some T-cell malignancies are associated with poor outcome, it is important to identify subsets of patients that may benefit from novel or more intensive therapies. The purpose of this study was to determine, for the first time, the relative frequencies, pathological features and outcomes of patients with T- and NK-cell lymphomas in a predominantly Russian Slavic population. We identified 291 patients with a diagnosis of T- and NK-cell malignancies treated at our Center between 2000-2008. In applying the revised WHO classification, we confirmed the diagnosis and had complete clinical follow up and pathological information on 264 cases that were included in the analysis. We found some differences in frequency of several subsets as compared with previously published reports, including younger age of onset and relatively higher incidence of T-LGL in our patients. We also confirm that intensive treatment regimens of advanced stage PTCL and ALKβALCL led to considerable improvement in response rates, but not in the overall survival
Elektrocyclone hydrodynamic flow computation
To analyze the elektrocyclone flow hydrodynamic computer calculation using the finite element method (FEM) is applied. The geometry of the model corresponds to the laboratory elektrocyclone. k-Ξ΅-turbulence model is used for the computation. The system of equations is solved by SIMPLE algorithm. The calculation results give a pattern of the flow velocity distribution and flow lines in different sections. There is conclusion based on the results about elektrocyclone flow hydrodynamic.ΠΠ»Ρ Π°Π½Π°Π»ΠΈΠ·Π° Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠΈ ΠΏΠΎΡΠΎΠΊΠ° Π² ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π΅ ΠΏΡΠΈΠΌΠ΅Π½ΡΠ½ ΠΊΠΎΠΌΠΏΡΡΡΠ΅ΡΠ½ΡΠΉ ΡΠ°ΡΡΠ΅Ρ Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΠΌΠ΅ΡΠΎΠ΄Π° ΠΊΠΎΠ½Π΅ΡΠ½ΡΡ
ΡΠ»Π΅ΠΌΠ΅Π½ΡΠΎΠ² (ΠΠΠ). ΠΠ΅ΠΎΠΌΠ΅ΡΡΠΈΡ ΠΌΠΎΠ΄Π΅Π»ΠΈ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΠ΅Ρ Π»Π°Π±ΠΎΡΠ°ΡΠΎΡΠ½ΠΎΠΌΡ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Ρ. ΠΠ»Ρ ΡΠ°ΡΡΡΡΠΎΠ² ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½Π° k-Ξ΅-ΠΌΠΎΠ΄Π΅Π»Ρ ΡΡΡΠ±ΡΠ»Π΅Π½ΡΠ½ΠΎΡΡΠΈ. Π‘ΠΈΡΡΠ΅ΠΌΠ° ΡΡΠ°Π²Π½Π΅Π½ΠΈΠΉ ΡΠ΅ΡΠ°Π΅ΡΡΡ Ρ ΠΏΠΎΠΌΠΎΡΡΡ Π°Π»Π³ΠΎΡΠΈΡΠΌΠ° SIMPLE. Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ ΡΠ°ΡΡΡΡΠ° Π΄Π°ΡΡ ΠΊΠ°ΡΡΠΈΠ½Ρ ΡΠ°ΡΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΡΠΊΠΎΡΠΎΡΡΠ΅ΠΉ ΠΏΠΎΡΠΎΠΊΠ° ΠΈ Π»ΠΈΠ½ΠΈΠΉ ΡΠΎΠΊΠ° Π² ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
ΡΠ΅ΡΠ΅Π½ΠΈΡΡ
. ΠΠ° ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΠΈ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² Π΄Π΅Π»Π°Π΅ΡΡΡ Π²ΡΠ²ΠΎΠ΄ ΠΎ Π³ΠΈΠ΄ΡΠΎΠ΄ΠΈΠ½Π°ΠΌΠΈΠΊΠ΅ ΡΠ»Π΅ΠΊΡΡΠΎΡΠΈΠΊΠ»ΠΎΠ½Π°
Effects of Pregnane Glycosides on Food Intake Depend on Stimulation of the Melanocortin Pathway and BDNF in an Animal Model
Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial
Background: Active-comparator trials are important to inform patient and physician choice. We aimed to evaluate the efficacy and safety of monotherapy with either ustekinumab or adalimumab in biologic-naive patients with moderately to severely active Crohn's disease. Methods: We conducted a randomised, double-blind, parallel-group, active-comparator, phase 3b trial (SEAVUE) at 121 hospitals or private practices in 18 countries. We included biologic-naive patients aged 18 years or older with moderately to severely active Crohn's disease and a Crohn's Disease Activity Index (CDAI) score of 220β450, who had not responded to or were intolerant to conventional therapy (or were corticosteroid dependent) and had at least one ulcer of any size at baseline endoscopic evaluation. Eligible patients were randomly assigned (1:1; via an interactive web response system) to receive ustekinumab (approximately 6 mg/kg intravenously on day 0, then 90 mg subcutaneously once every 8 weeks) or adalimumab (160 mg on day 0, 80 mg at 2 weeks, then 40 mg once every 2 weeks, subcutaneously) through week 56. Study treatments were administered as monotherapy and without dose modifications. Patients, investigators, and study site personnel were masked to treatment group assignment. The primary endpoint was the proportion of patients who were in clinical remission (CDAI score <150) at week 52 in the intention-to-treat population (ie, all patients who were randomly assigned to a treatment group). This trial is registered with ClinicalTrials.gov, NCT03464136, and EudraCT, 2017-004209-41. Findings: Between June 28, 2018, and Dec 12, 2019, 633 patients were assessed for eligibility and 386 were enrolled and randomly assigned to receive ustekinumab (n=191) or adalimumab (n=195). 29 (15%) of 191 patients in the ustekinumab group and 46 (24%) of 195 in the adalimumab group discontinued study treatment before week 52. There was no significant difference between the ustekinumab and adalimumab groups in the occurrence of the primary endpoint; at week 52, 124 (65%) of 191 patients in the ustekinumab group versus 119 (61%) of 195 in the adalimumab group were in clinical remission (between-group difference 4%, 95% CI β6 to 14; p=0Β·42). Safety for both groups was consistent with previous reports. Serious infections were reported in four (2%) of 191 patients in the ustekinumab group and five (3%) of 195 in the adalimumab group. No deaths occurred through week 52 of the study. Interpretation: Both ustekinumab and adalimumab monotherapies were highly effective in this population of biologic-naive patients, with no difference in the primary outcome between the drugs. Funding: Janssen Scientific Affairs