Background and Importance Migraine is characterised by repeated headache attacks lasting hours or days and usually accompanied by other associated symptoms. According to the International Headache Society, it can be classified into migraine with aura, without aura and chronic migraine. A target pathway to treat or prevent migraine is the calcitonin gene-related peptide. Available treatments in our country that act interfering that pathway are erenumab, fremanezumab, galcanezumab, iptenezumab and rimegepant.
Aim and Objectives To analyse whether the different therapeutic options are equivalent alternatives through an adjusted indirect comparison.
Material and Methods The therapies included were found after a systematic search performed in PubMed. The analysis included randomised, double-blind, phase 2 and 3, controlled trials, prophylaxis therapies and number of migraine days reduced measurement after 12 weeks of treatment. The analysis was performed using the R® software to estimate Bayesian statistics, with rimegepant taken as a reference for the comparison. A delta value of 1 day, as provided by the regulatory agencies FDA and EMA, was used to determine the margin (maximum acceptable difference as a non-inferiority criteria) and the average number of migraine days reduced. To establish the therapeutic positioning, the National Equivalent Therapeutic Alternatives Positioning Guide criteria were applied.
Results As shown in Figure 1, the difference in the mean number of migraine days reduced per month versus placebo was favourable in all cases. Each treatment reduced migraine by between one to two days per month, showing statistically significant differences. The most outstanding being fremanezumab (-1,73 [-2.33;-1.12]). Based on the results obtained, a subsequent analysis was carried out comparing fremanezumab with the other alternatives. In this case, erenumab 140 mg showed the most similar efficacy result (0.13 [-1.14; 1.39]). Nevertheless, it did not show a statistically significant difference against any treatment, exclusively against placebo. No differences were found in terms of safety.
Conclusion and Relevance No statistically significant differences were found between rimegepant and monoclonal antibodies against the CGRP/CGRP receptor except for fremanezumab. Fremanezumab presented a statistically significant more pronounced response in the decrease of migraine days per month at 12 weeks of treatment.
Conflict of Interest No conflict of interest
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