"A phase 3, randomised, placebo-controlled study of erenumab for the prevention of chronic migraine in patients from Asia: the DRAGON study"

作者全名:"Yu, Shengyuan; Kim, Byung-Kun; Wang, Hebo; Zhou, Jiying; Wan, Qi; Yu, Tingmin; Lian, Yajun; Arkuszewski, Michal; Ecochard, Laurent; Wen, Shihua; Yin, Fangfang; Li, Zheng; Su, Wendy; Wang, Shuu-Jiun"

作者地址:"[Yu, Shengyuan] Chinese Peoples Liberat Army Gen Hosp, Beijing, Peoples R China; [Kim, Byung-Kun] Eulji Univ, Nowon Eulji Med Ctr, Sch Med, Seoul, South Korea; [Wang, Hebo] Hebei Gen Hosp, Shijiazhuang, Hebei, Peoples R China; [Zhou, Jiying] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China; [Wan, Qi] Jiangsu Prov Hosp, Nanjing, Peoples R China; [Yu, Tingmin] Second Hosp Jilin Univ, Changchun, Peoples R China; [Lian, Yajun] Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou, Peoples R China; [Arkuszewski, Michal; Ecochard, Laurent] Novartis Pharma AG, Basel, Switzerland; [Wen, Shihua; Su, Wendy] Novartis Pharmaceut, E Hanover, NJ USA; [Yin, Fangfang; Li, Zheng] China Novartis Inst Biomed Res Co Ltd, Shanghai, Peoples R China; [Wang, Shuu-Jiun] Taipei Vet Gen Hosp, Neurol Inst, Taipei, Taiwan; [Wang, Shuu-Jiun] Natl Yang Ming Chiao Tung Univ, Brain Res Ctr, Taipei, Taiwan; [Wang, Shuu-Jiun] Natl Yang Ming Chiao Tung Univ, Coll Med, Taipei, Taiwan"

通信作者:"Yu, SY (通讯作者),Chinese Peoples Liberat Army Gen Hosp, Beijing, Peoples R China.; Wang, SJ (通讯作者),Taipei Vet Gen Hosp, Neurol Inst, Taipei, Taiwan.; Wang, SJ (通讯作者),Natl Yang Ming Chiao Tung Univ, Brain Res Ctr, Taipei, Taiwan.; Wang, SJ (通讯作者),Natl Yang Ming Chiao Tung Univ, Coll Med, Taipei, Taiwan."












关键词:Asian; Calcitonin gene-related peptide; Chronic migraine; Efficacy; Erenumab; Monoclonal antibodies; Clinical trial; Safety

摘要:"Background: DRAGON was a phase 3, randomised, double-blind, placebo-controlled study which evaluated the efficacy and safety of erenumab in patients with chronic migraine (CM) from Asia not adequately represented in the global pivotal CM study. Methods: DRAGON study was conducted across 9 Asian countries or regions including mainland China, India, the Republic of Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam. Patients (N=557) with CM (aged 18-65 years) were randomised (1:1) to receive once-monthly subcutaneous erenumab 70 mg or matching placebo for 12 weeks. The primary endpoint was the change in monthly migraine days (MMD) from baseline to the last 4 weeks of the 12-week double-blind treatment phase (DBTP). Secondary endpoints included achievement of >= 50% reduction in MMD, change in monthly acute headache medication days, modified migraine disability assessment (mMIDAS), and safety. Study was powered for the primary endpoint of change from baseline in MMD. Results: At baseline, the mean (SD) age was 41.7 (+/- 10.9) years, and 81.5% (n =454) patients were women. The mean migraine duration was 18.0 (+/- 11.6) years, and the mean MMD was 19.2 (+/- 5.4). 97.8% (n =545) randomised patients completed the DBTP. Overall, demographics and baseline characteristics were balanced between the erenumab and placebo groups except for a slightly higher proportion of women in the placebo group. At Week 12, the adjusted mean change from baseline in MMD was - 8.2 days for erenumab and - 6.6 days for placebo, with a statistically significant difference for erenumab versus placebo (adjusted mean difference vs placebo: - 1.57 [95%CI:- 2.83,- 0.30]; P= 0.015). A greater proportion of patients treated with erenumab achieved >= 50% reduction in MMD versus placebo (47.0% vs 36.7%, P= 0.014). At Week 12, greater reductions in monthly acute headache medication days (-5.34 vs - 4.66) and mMIDAS scores (- 14.67 vs - 12.93) were observed in patients treated with erenumab versus placebo. Safety and tolerability profile of erenumab was comparable to placebo, except the incidence of constipation (8.6% for erenumab vs 3.2% for placebo). Conclusion: DRAGON study demonstrated the efficacy and safety of erenumab 70 mg in patients with CM from Asia. No new safety signals were observed during the DBTP compared with the previous trials."

基金机构:Novartis Pharma AG

基金资助正文:This study was fully funded by Novartis Pharma AG. Erenumab is co-developed in partnership with Amgen and Novartis.