28 research outputs found
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
REVIEW OF IMPLEMENTATION OF GOVERNMENT AUTHORITIES IN POLICY-MAKING IN THE "RELIGIOUS AFFAIRS"
Government absolute authorities in the religion affairs is the authority of the central government. In the dynamic development of political, many district that produce regional policy with respect to religion or to follow religious aspirations of local people. Some districts in Riau Province, a county division during the reform, including the district are very concerned about the development in the field of religion. In addition to physical development, the county authority also extend its authority in the religion affairs. Regional policy is embodied in the form of local laws, regulations regent, or Medium Term Development Plan (Plan) Government District in Riau Province. This is possible because there are no clear boundaries of understanding in the rule of religion affairs formulated by the law on local government. The central government, based on this study, it gives tacit consent when local governments do just that, because the rate it is going to add a lot of partners in the central government district. There is no struggle for power between central government and local governments, but the expansion of the district authority in religious issues involved in managing the government's response is a manifestation of the district in the religious aspirations of the people of the are
Comparative analysis of fingolimod versus teriflunomide in relapsing-remitting multiple sclerosis
Boz, Cavit/0000-0003-0956-3304; Altintas, Ayse/0000-0002-8524-5087; YUCEYAR, NUR/0000-0003-4590-6423; Sevim, Serhan/0000-0002-0518-3374; Efendi, Husnu/0000-0002-9143-3893WOS: 000502098900008PubMed: 31473488Background: Fingolimod and teriflunomide are commonly used in the treatment of relapsing-remitting multiple sclerosis (RRMS). These have not been compared in controlled trials, but only in observational studies, with inconclusive results. Comparison of their effect on relapse and disability in a real-world setting is therefore needed. Objectives: the objective of this study was to compare the efficacy of fingolimod and teriflunomide in reducing disease activity in RRMS. Methods: This multicenter, retrospective observational study was carried out with prospectively collected data from 15 centers. All consecutive RRMS patients treated with teriflunomide or fingolimod were included. Data for relapses, Expanded Disability Status Scale (EDSS) scores and brain magnetic resonance imaging (MRI) scans were collected. Patients were matched using propensity scores. Annualized relapse rates (ARR), disability accumulation, percentage of patients with active MRI and treatment discontinuation over a median 2.5-year follow-up period were compared. Results: Propensity score matching retained 349 out of 1388 patients in the fingolimod group and 349 out 678 in the teriflunomide group for final analyses. Mean ARR decreased markedly from baseline after 1 and 2 years of treatment in both the fingolimod (0.58-0.17 after 1 year and 0.11 after 2 years, p < 0.001) and teriflunomide (0.56-0.29 after 1 year and 0.31 after 2 years, p < 0.001) groups. Mean ARR was lower in fingolimod-treated patients than in those treated with teriflunomide at years 1 (p = 0.02) and 2 (p = 0.004). Compared to teriflunomide, the fingolimod group exhibited a higher percentage of relapse-free patients and a lower percentage of MRI-active patients after 2.5-year follow-up. Disability worsening was similar between the two groups. Patients were less likely to discontinue fingolimod than teriflunomide (p < 0.001). Conclusion: Fingolimod was associated with a better relapse control and lower discontinuation rate than teriflunomide. the two oral therapies exhibited similar effects on disability outcomes
Differences Between General Neurologists And Multiple Sclerosis Specialists In The Management Of Multiple Sclerosis Patients: A National Survey
Introduction: The management of multiple sclerosis (MS) has become more complicated after the introduction of new diagnostic and treatment options. Despite the abundance of guidelines, the experience of physicians still plays a major role in the management of patients. This study aimed to define differences in behavior patterns between general neurologists (GNs) and MS specialists (MSSs). Methods: We conducted a survey of 36 questions to 318 neurologists, including 33 MSSs. The survey covered topics including laboratory investigations, pregnancy, and treatment. Results: Our study found many differences between GNs and MSSs in terms of management, the most important being treatment initiation and switching. GNs had a tendency to initiate treatment later than MSSs however, they tended to switch treatment faster. Our study also showed that GNs ordered magnetic resonance imaging (MRI) more frequently than MSSs, even if patients were clinically stable. Moreover, although GNs more frequently relied on MRI, they did not consider brain atrophy as an important measure in the follow-up of their patients. Furthermore, GNs considered replacement therapy less often than MSSs, even in patients with vitamin D deficiency. Discussion: Our study revealed important discrepancies between the management patterns of GNs and MSSs in MS patients. These findings suggest the need for a national education program for GNs on MSSs.Wo