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. 2022 May-Jun;25(3):433-440.
doi: 10.4103/aian.aian_199_22. Epub 2022 Jun 9.

Efficacy and Tolerability of Erenumab for Prevention of Episodic Migraine in India

Debashish Chowdhury  1 , Jaydip R Chaudhuri  2 , Pahari Ghosh  3 , Rahul Kulkarni  4 , Sumit Singh  5 , Sneha Thakur  6 , Anup V Thorat  6
Affiliations

Efficacy and Tolerability of Erenumab for Prevention of Episodic Migraine in India

Debashish Chowdhury et al. Ann Indian Acad Neurol. 2022 May-Jun.

Abstract

Background: EMPOwER, a 12-week, double-blind (DB), randomized, placebo-controlled study evaluated the efficacy and safety of erenumab in adult patients with episodic migraine (EM) from Asia, the Middle East, and Latin America. This study analyzes the Indian experience for the use of erunumab for prevention of episodic migraine.

Objective: The study aimed to evaluate the efficacy and tolerability of erenumab (70 mg and 140 mg) in EM patients from India.

Methods: Randomized patients received monthly subcutaneous injections of placebo and erenumab 70 mg or 140 mg for 3 months. The primary endpoint was a change from the baseline in monthly migraine days (MMDs) at month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in MMD; a change in monthly acute migraine-specific medication treatment days; a change in patient-reported outcomes; and safety assessment.

Results: Of the 539 patients screened, 351 patients were randomized (erenumab, 70 mg: n = 133 and 140 mg: n = 94; placebo: n = 124). The mean (±SD) age, disease duration, and MMD were 35.1 (±8.6) years, 6.77 (±6.01) years, and 7.82 (±2.89) days, respectively. The placebo-adjusted difference in mean MMD for erenumab 70 mg was -0.88 (95% CI, -2.16, 0.39; P = 0.174) days, and that for erenumab 140 mg was -1.01 (-2.42, 0.41; P = 0.164) days versus placebo. Secondary and exploratory endpoints demonstrated consistently better results in both erenumab dosage groups versus placebo. Treatment-emergent adverse events were comparable across groups (erenumab, 70 mg: 22.7% and 140 mg: 24.5%; placebo: 25.2%).

Conclusion: Both doses of erenumab showed numerical improvement for efficacy endpoints and were well-tolerated in the Indian population. No new safety signals were reported.

Keywords: Efficacy; Indian population; erenumab; headache; tolerability episodic migraine.

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Conflict of interest statement

Debashish Chowdhury, Jaydip Ray Chaudhuri, Pahari Ghosh, Rahul Kulkarni are the principal investigators for Novartis sponsored trials. Sumit Singh has attended advisory boards and is a speaker in Novartis sponsored meetings. Sneha Thakur and Anup Thorat are full time employees of Novartis, India.

Figures

Figure 1
Figure 1
Study design and patient disposition (randomized analysis set)
Figure 2
Figure 2
Change from the baseline in MMD in the Indian sub-population (full analysis set)
See this image and copyright information in PMC

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