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

Factors Associated with Dietary Change since the Outbreak of COVID-19 in Japan

In Japan, dietary habits have greatly changed since the coronavirus disease (COVID-19) outbreak; we examined factors related to dietary changes. An online cross-sectional questionnaire survey was conducted in November 2020 among 6000 Japanese adults (aged 20–64 years) registered with a research company and gathered data on demographics, socioeconomic factors, medical history, COVID-19 status of the respondent’s family and neighbors, fear of COVID-19, and changes in lifestyle and dietary habits since the COVID-19 outbreak. To the question “Have you made healthier changes to your dietary habits compared with the dietary habits before the spread of COVID-19 (1 year ago, November 2019)?”, 1215 (20.3%), 491 (8.2%), and 4294 (71.6%) participants answered that their dietary habits were healthier, unhealthier, and unchanged, respectively. Healthier and unhealthier dietary habits were associated with greater fear of COVID-19, altered exercise and sleep times, and smoking. Unhealthy habits were positively associated with living alone, decreasing household income, colleagues with COVID-19, stress, and weight loss/gain. Annual household income, changing household income, COVID-19 in friends, health literacy, exercise frequency, weight loss, and starting smoking were positively associated with healthier dietary changes. The generalizability of these results and strategies to inculcate healthy diets in this “new normal” should be investigated

Development of an Educational Material Called “Best Adviser for Diet” for Weight Control and its Evaluations by Healthcare Professionals

【目的】成人を対象とした体重管理の誘惑場面における対策について，ゲームを通して学習できるカード教材「ベストアドバイザーFORダイエット」を開発した。本稿では，カード教材の解説を行うとともに，保健医療従事者によるカード教材の評価を報告する。 【方法】２０１１年７月～１０月に開催された市町村の保健医療従事者向けの研修会に参加した６６名を対象にカード教材のゲーム式の使い方を実施した。ゲーム終了後に，質問紙を用いてゲームの感想や遊び方，体重管理の教材としての評価，属性をたずねた。また，質問紙 の最後に意見や感想を自由記述で記載する欄を設けた。 【結果】解析対象者は６２名（女性：５７名，９１．９％）だった。「ゲームは楽しかったですか」，「体重管理の教材として役立つと思いますか」という問いに対してそれぞれ５７名（９１．９％），４９名（７９．０％）が「とてもそう思う／そう思う」と回答した。自由記述では，指導者向けの 教材として利用したいという意見があがった。一方で，教材や遊び方について，ルールや内容が難しいなどの改善すべき点もあがった。 【結論】体重管理の誘惑場面における対策に関する学習教材として，肯定的な意見が得られた。あげられた改善点をもとに，教材の見直しを行い，今後は一般成人を対象に実行可能性および教育効果について，検討をする必要がある。Objective:　We developed the cards as educational materials called “Best Adviser for Diet” designed to teach coping strategies in resisting situational temptations in weight control.　In this paper, we introduce this educational material and report its evaluations by healthcare professionals. Methods:　A game was played using the cards by 66 participants in workshops for healthcare professionals in the period July-October 2011.　After the game, a self-administered questionnaire that requested for feedback, evaluations about how the game is played, the effectiveness of the cards for weight control, demographics and any additional comments and opinions was distributed to participants.　 Results:　Data from 62 subjects (57 women, 91.9%) were analyzed.　Fifty-seven participants (91.9%) gave responses of “completely agree/agree” to the question “Did you have fun during the card game?” and 49 participants (79.0%) answered “completely agree/agree” to the question “Do you think that these cards are useful for weight control?” The respondents also added that they would like to use the cards as educational materials for healthcare professionals.　They also offered some suggestions for improving the contents of the cards and the way the game is played. Conclusion:　Respondents had positive opinions about the cards as educational materials for imparting coping strategies in resisting temptations and promoting weight control.　The cards will be revised on the basis of the results of this study, and further research to test the feasibility and educational effects of the cards for the public is needed

Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension 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