4CPS-132 Indirect treatment comparison of anti-calcitonin gene related peptide pathway antibodies in chronic migraine

• Published in: European journal of hospital pharmacy. Science and practice Vol. 27; no. Suppl 1; pp. A109 - A110
• Main Authors: Briceño Casado, MDP, Fenix-Caballero, S, Gil-Sierra, MD, Dominguez Cantero, M, Alegre-Del Rey, EJ
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.03.2020
• Subjects: Clinical trials; Migraine; Peptides
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2020-eahpconf.233

Background and importanceErenumab, 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 objectivesTo evaluate whether anti-CGRP drugs are equivalent therapeutic alternatives (ETA) in CM through an adjusted indirect treatment comparison (ITC).Material and methodsA 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%).ResultsSix clinical trials were founderenumab (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. Abstract 4CPS-132 Table 1 Reduction of ≥ 50% migraine days/month (ARR (95% CI)) Erenumab 70 mg Erenumab 140 mg Fremanezumab quarterly 3 (−7.56 to 13.56) 2 (−8.64 to 12.64) Fremanezumab monthly 6 (−4.59 to 16.59) 5 (−5.66 to 15.66) In all cases, there were no statistically significant differences; most 95% CI values were within the calculated delta margins.Conclusion and relevanceITC 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 acknowledgements1. Alegre-del-Rey EJ, et al. Evaluación y posicionamiento de medicamentos como alternativas terapéuticas 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.