[Correction added on 9 April 2014 after first online publication: article was made Open Access and copyright line was amended.]
Pooled analysis of the safety and tolerability of onabotulinumtoxinA in the treatment of chronic migraine
Article first published online: 15 MAR 2014
© The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of EAN.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
European Journal of Neurology
Volume 21, Issue 6, pages 851–859, June 2014
How to Cite
Diener, H.-C., Dodick, D. W., Turkel, C. C., Demos, G., DeGryse, R. E., Earl, N. L. and Brin, M. F. (2014), Pooled analysis of the safety and tolerability of onabotulinumtoxinA in the treatment of chronic migraine. European Journal of Neurology, 21: 851–859. doi: 10.1111/ene.12393
- Issue published online: 8 MAY 2014
- Article first published online: 15 MAR 2014
- Manuscript Accepted: 28 JAN 2014
- Manuscript Received: 15 OCT 2013
- Allergan Inc.
- Imprint Publication Science, New York, NY
- BOTOX ;
- chronic migraine;
Background and purpose
OnabotulinumtoxinA was effective and well tolerated for prophylaxis of headache in patients with chronic migraine (CM) in two randomized, double-blind, placebo-controlled, phase 3 trials. To further assess the safety and tolerability of onabotulinumtoxinA in CM prophylaxis in adults, the pooled safety data from four double-blind, placebo-controlled trials were analyzed.
The pooled analysis included two phase 2 and two phase 3 double-blind, placebo-controlled trials. The safety population was 2436 patients, 1997 of whom received ≥1 dose of onabotulinumtoxinA. The studies shared similar dosing intervals (approximately 12 weeks) with doses between 75 and 260 U. Safety assessments included adverse events (AEs), physical examination and clinical laboratory tests.
OnabotulinumtoxinA was safe and well tolerated, with a low discontinuation rate (3.4%) due to AEs. The majority of patients in this pooled analysis received doses between 150 and 200 U, with an average of 163 U per treatment cycle. Of the 1997 patients who received any onabotulinumtoxinA injections, 1455 patients (72.9%) reported at least one AE. Neck pain (12.6%) was the most common onabotulinumtoxinA-associated AE, followed by muscle weakness (8.0%), musculoskeletal stiffness (6.1%) and eyelid ptosis (4.6%). Serious AEs were infrequent, occurring in 5.4% of patients who received any onabotulinumtoxinA treatment and 3.0% of patients receiving placebo. AEs were consistent with the known tolerability profile of onabotulinumtoxinA.
Multiple treatments with onabotulinumtoxinA at doses of 75–260 U administered every 12 weeks, and up to five treatment cycles, were well tolerated for the prophylaxis of headache in adults with CM.