Abstract text (incl. figure legends and references)

Objectives: DRAGON (CAMG334A2304),12-week, double-blind randomized study evaluated efficacy & safety of erenumab (70 mg) in adult Chronic migraine (CM) patients from China, Taiwan, Korea, Southeast Asia & India. This is India sub-set analysis of the global DRAGON study.

Methods: Patients (N=30) were randomized to placebo or erenumab 70 mg (1:1). Primary endpoint was change from baseline in monthly migraine days (MMD). Secondary endpoints were ≥50% reduction in MMD, changes in modified Migraine Disability Assessment (mMIDAS), changes in monthly acute headache medication days (MHMD), & safety/tolerability.

Results: Mean (SD) age was 34.5 (10.8) years, 73.3 % were women; mean MMD was 15.14 (4.93) & only 53.3% had prior preventive treatment failure. Similar change in MMD from baseline at week 12 was observed in erenumab 70 mg group & placebo [-8.37 and -8.62 respectively) (p=0.913)]. Patients achieving ≥50% reduction in MMD was higher in erenumab 70 mg vs placebo (82.4% vs 69.2%; p=0.379) Change in mMIDAS was -11.13 with placebo & -11.92 with erenumab 70 mg (p=0.496). Change in MHMD was -3.90 with placebo & –3.48 for erenumab 70 mg (p=0.556). No AEs leading to discontinuation nor SAEs or deaths were reported in either group. Safety & tolerability of erenumab was comparable to placebo with no new safety signals.

Conclusion: While Indian subset study was not powered to detect statistically significant differences, Erenumab (70mg) s.c QM Vs placebo showed numerical superiority for achieving ≥50% reduction in MMDs. Clinically meaningful reduction in mMIDAS, & MHMD at 12 weeks with favourable safety profile in Indian CM patients & no new safety signals were detected

Key words: India; Chronic Migraine; erenumab; anti-CGRP