Assessment of the relative effectiveness of erenumab compared with onabotulinumtoxinA for the prevention of chronic migraine

Abstract

Objective

To assess the available clinical and economic evidence of erenumab vs onabotulinumtoxinA for chronic migraine (CM) and present de-novo indirect treatment comparisons (ITCs) based on available clinical trial data.

Methods

We conducted ITCs based on results from the pivotal 295 trial (NCT02066415) of erenumab vs placebo and published aggregate data from the PREEMPT 1 (NCT00156910) and PREEMPT 2 (NCT00168428) trials of onabotulinumtoxinA vs placebo. ITCs were conducted for CM patients with and without prior administration of onabotulinumtoxinA and among CM patients with ≥3 prior preventive treatment failures. Efficacy was assessed based on responder rates of ≥50% reductions in monthly headache days (MHDs) and monthly migraine days (MMDs) as well as change from baseline in both MHDs and MMDs.

Results

Among patients with CM, 140 mg erenumab was associated with a reduction of 1.2 MHD (p = .092) and a reduction of 1.0 MMD (p = .174) compared to onabotulinumtoxinA at Week 12. Among onabotulinumtoxinA-naïve patients, erenumab was associated with a reduction of 1.8 MHD (p = .026) and 1.4 MMD (p = .080) at Week 12. Among patients that had received ≥3 prior preventive treatments, the odds ratios comparing erenumab vs onabotulinumtoxinA were 1.7 for ≥50% responder rates based on reductions in MHD (p = .155) and 1.7 for ≥50% responder rates based on reductions in MMD (p = .140).

Conclusion

These findings suggest directional benefits (although not reaching the threshold of statistical significance) associated with erenumab vs onabotulinumtoxinA for the preventive treatment of CM. Evidence from this study may inform healthcare stakeholders in treatment selection and optimization for patients with CM.

Keywords:

• Chronic migraine
• erenumab
• indirect treatment comparison
• onabotulinumtoxinA

Transparency

Declaration of funding

This study was funded by Novartis. The study sponsor was involved in several aspects of the research, including the study design, interpretation of data, and preparation of the manuscript for publication.

Declaration of financial/other relationships

Katharina Pannagl, Santosh Tiwari, and Harald Heemstra are full-time employees of Novartis. Ronan Mahon, Pamela Vo, and Matias Ferraris are full-time employees of Novartis and hold shares of Novartis. Keith A. Betts is an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Novartis. Jing Zhao was an employee of Analysis Group, Inc. at the time of study conduct. Pascal Proot receives fees for educational lectures from Lilly, Novartis, and Abbvie, and receives support from Natus for lectures about neurophysiology. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors have made substantial contributions to the conception or design of the study, or the acquisition, analysis, or interpretation of data, drafting the manuscript and revising it critically for important intellectual content, and have provided final approval of this version to be published and agree to be accountable for all aspects of the work.

Acknowledgements

Medical writing assistance was provided by Loraine Georgy, PhD, an employee of Analysis Group, Inc., which provided paid consulting services to Novartis for the development and conduct of this study and manuscript, and Gloria DeWalt, PhD, who was an employee of Analysis Group, Inc, during the time of the study.

Data availability statement

Data are available upon reasonable request. The data sharing policy of Novartis is available at https://www.novartis.com/clinicaltrials/transparency. De-identified and anonymized datasets of clinical trial information, including patient-level data, will be shared with qualified external researchers based on review by an external scientific review panel. All data provided is anonymized to respect the privacy of patients who have participated in the trials in line with applicable laws and regulations.