| Popis: |
Background and importance Erenumab, fremanezumab, galcanezumab and eptinezumab are monoclonal antibodies targeting the calcitonin gene related peptide pathway (anti-CGRP), used as preventive treatment in chronic migraine (CM). Aim and objectives To evaluate whether anti-CGRP drugs are equivalent therapeutic alternatives (ETA) in CM through an adjusted indirect treatment comparison (ITC). Material and methods A bibliographic search of randomised clinical trials (RCTs) in Pubmed was performed (20 May 2019). Inclusion criteria: phase II/III RCTs of anti-CGPR with similar populations, follow-up duration and comparator treatments. CM was defined as ≥15 headache days/month, of which ≥8 were migraine days (event duration ≥4 hours). Exclusion criteria: RCTs with different clinical CM context and other CM definitions. Efficacy end point was ≥50% reduction in migraine days/month (measured from the beginning of treatment to 12 weeks). An ITC was developed using Bucher’s method. Delta value (Δ, maximum difference as a clinical criterion of equivalence) was calculated according to the ETA guide1: use was made of half of the absolute risk reduction (ARR) obtained in the meta-analysis of RCTs included in the ITC (pooled ARR=20%; Δ=10%). Results Six clinical trials were found erenumab (n=3), fremanezumab (n=2), glacanezumab (n=1) and eptinezumab (n=0). One study of erenumab2 and another of fremanezumab3 were selected. The rest were not included in the ITC (non-compliance with the inclusion criteria). Trials included were three arm (control and two different drug regimens), double blind, placebo controlled RCTs. Results of the ITC are shown in table 1. In all cases, there were no statistically significant differences; most 95% CI values were within the calculated delta margins. Conclusion and relevance ITC showed no statistically significant differences in ≥50% reduction in migraine days/month between erenumab and fremanezumab. Probable clinical equivalence was found between erenumab and fremanezumab. These drugs could be considered ETA in CM. Further studies are necessary to include galcanezumab and eptinezumab in the ITC. References and/or acknowledgements 1. Alegre-del-Rey EJ, et al. Evaluacion y posicionamiento de medicamentos como alternativas terapeuticas equivalentes. Med Clin 2014;143:85–90. 2. Tepper S, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 2017;16:425–434. 3. Silberstein SD, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 2017;377:2113–2122. No conflict of interest. |
