Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

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

Food & Society : Principles and Paradoxes

By: Amy E. Guptil (College at Brockport faculty member), Denise A. Copelton (College at Brockport faculty member), and Betsy Lucal. This timely and engaging text offers students a social perspective on food, food practices, and the modern food system. It engages readers’ curiosity by highlighting several paradoxes: how food is both mundane and sacred, reveals both distinction and conformity, and, in the contemporary global era, comes from everywhere but nowhere in particular. With a social constructionist framework, the book provides an empirically rich, multi-faceted, and coherent introduction to this fascinating field. Each chapter begins with a vivid case study, proceeds through a rich discussion of research insights, and ends with discussion questions and suggested resources. Chapter topics include food’s role in socialization, identity, work, health and social change, as well as food marketing and the changing global food system. In synthesizing insights from diverse fields of social inquiry, the book addresses issues of culture, structure, and social inequality throughout. Written in a lively style, this book will be both accessible and revealing to beginning and intermediate students alike.https://digitalcommons.brockport.edu/bookshelf/1302/thumbnail.jp