Background and Importance Several monoclonal antibodies for preventive treatment of chronic migraine have been approved in recent years. However, there are no studies that directly compare these treatments.
Aim and Objectives To establish, through an indirect comparison (IC) against placebo, whether eptinezumab (Ep), galcanezumab (Ga), fremanezumab (Fre) and erenumab (Ere) could be considered equivalent alternatives in efficacy for the preventive treatment of chronic migraine.
Material and Methods A PubMed search was performed for pivotal clinical trials (CTs) of eptinetumab (300 mg/12 weeks), galcanezumab (240 mg/4 weeks), fremanezumab (675 mg/12 weeks) and erenumab (140 mg/4 weeks) for the preventive treatment of chronic migraine. The variable for comparison was the percentage of patients with ≥75% response (% of patients with a 75% reduction in migraine days per month) at week 12 after the start of treatment. With the results of ≥75% response, relative risk (RR) compared to placebo was calculated. Finally, with these values, an IC of these drugs was performed using the Bucher method (ITC calculator, Indirect Treatment Comparisons, of the Canadian Agency for Health Technology Assessment). The results were analysed, seeing if there were statistically significant differences between these four drugs.
Results Four CTs were found, one with each drug, all of them compared to placebo as a common comparator. All the studies presented a similar methodology. However, CT of erenumab was a phase 2 CT, while the others were phase 3. Moreover, in the erenumab CT the sample size (667 patients) was smaller than in the other CTs (between 1072 and 1130 patients). These limitations for IC were eventually accepted. After applying the Bucher method, the following results were obtained:
OR (Ep 300 mg vs Gal2 40 mg) 0,89 [IC 95% 0,48–1,65]; p=0,70
OR (Ep 300 mg vs Fre 675 mg) 0,95 [IC 95% 0,56–1,61]; p=0,85
OR (Ep 300 mg vs Ere 140 mg) 1,21 [IC 95% 0,69–2,13]; p=0,50
OR (Fre 675 mg vs Gal 240 mg) 0,93 [IC 95% 0,46–1,89]; p=0,85
OR(Ere 140 mg vs Gal 240 mg ) 0,73 [IC 95% 0,35–1,52]; p=0,40
OR(Fre 675 mg vs Ere140 mg ) 1,28 [IC 95% 0,66–2,46]; p=0,47
Conclusion and Relevance According to the results obtained, given that no statistically significant differences have been established between the different drugs in terms of efficacy, the choice of one or the other should be based on safety and efficiency criteria. Nevertheless, it would be of special interest to have a direct comparison of these drugs to confirm the equivalence.
Conflict of Interest No conflict of interest
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