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

Minimal Symptom Expression' in Patients With Acetylcholine Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis Treated With Eculizumab

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

Control and enhancement of the oxygen storage capacity of ceria films by variation of the deposition gas atmosphere during pulsed DC magnetron sputtering

In this study, nanostructured ceria (CeO2) films are deposited on Si(100) and ITO coated glass substrates by pulsed DC magnetron sputtering using a CeO2 target. The influence on the films of using various gas ambients, such as a high purity Ar and a gas mixture of high purity Ar and O-2, in the sputtering chamber during deposition are studied. The film compositions are studied using XPS and SIMS. These spectra show a phase transition from cubic CeO2 to hexagonal Ce2O3 due to the sputtering process. This is related to the transformation of Ce4+ to Ce3+ and indicates a chemically reduced state of CeO2 due to the formation of oxygen vacancies. TGA and electrochemical cyclic voltammetry (CV) studies show that films deposited in an Ar atmosphere have a higher oxygen storage capacity (OSC) compared to films deposited in the presence of O-2. CV results specifically show a linear variation with scan rate of the anodic peak currents for both films and the double layer capacitance values for films deposited in Ar/O-2 mixed and Ar atmosphere are (1.6 +/- 0.2) x 10(-4) F and (4.3 +/- 0.5) x 10(-4) F, respectively. Also, TGA data shows that Ar sputtered samples have a tendency to greater oxygen losses upon reduction compared to the films sputtered in an Ar/O-2 mixed atmosphere. (C) 2015 Elsevier B.V. All rights reserved