Erenumab and galcanezumab in chronic migraine prevention: effects after treatment termination

Abstract

BackgroundMonoclonal antibodies (mAbs) targeting the CGRP pathway are safe and efficacious therapies for the prevention of migraine. In this study we assessed the effects of discontinuation of preventive erenumab and galcanezumab treatment in patients with chronic migraine.MethodsThis retrospective pooled analysis included completers of the open-label extension study phase for the preventive treatment of chronic migraine with galcanezumab (NCT02614261; 9 months) and erenumab (NCT02174861; 12 months) in a single headache center. We compare migraine data until week 12 after open-label treatment completion, when patients did not have any pharmacological preventive medication, to study baseline values of the double-blind trial period, and to the last 4 weeks of the open-label extension. The assessment included changes in monthly migraine days, headache hours, days with severe headache and acute headache medication use.ResultsData from 16 patients after galcanezumab (n = 9) and erenumab (n = 7) open-label treatment completion were analyzed. The mean number of monthly migraine days was 18.38 ± 3.74 at baseline, and 12.19 ± 4.53 in the last 4 weeks of the open-label extension (p < 0.001). Monthly migraine days remained significantly reduced compared to baseline during the entire 12-week observation period after open-label termination (p = 0.002), with a reduction of 5.38 ± 4.92 in weeks 1–4 (p = 0.001), 4.75 ± 4.15 in weeks 5–8 (p = 0.001), and 3.93 ± 5.45 in weeks 9–12 (p = 0.014). There was no significant difference in monthly migraine days between the 12 weeks after open-label termination and the last 4 weeks of the open-label phase (p = 0.228). All other analyses revealed numerical improvement through week 12 in comparison to baseline.ConclusionsIn this small, self-selected cohort, the results indicate a therapeutic effect of monoclonal antibodies targeting the CRGP pathway in chronic migraine prevention after treatment termination up to 12 weeks.

A long-term open-label safety study of galcanezumab in Japanese patients with migraine

“…The efficacy of galcanezumab continued post-treatment, with patients not experiencing any apparent change in the mean number of migraine headache days during the 4-month off-treatment follow-up period. This is consistent with data from previous studies, where reductions in migraine headache days compared with baseline continued for up to 4 months after termination of galcanezumab treatment [32,33]. The clinical meaningfulness of these improvements in migraine headache days in patients with EM and CM is supported by the sustained effect on HRQoL, assessed by MSQ-RFR, and PGI-S.…”

Efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibodies for the preventive treatment of episodic migraine – an updated systematic review and meta-analysis

“…A retrospective pooled analysis in chronic migraineurs was conducted to assess the effects of discontinuation of preventive erenumab and galcanezumab treatment. The results showed continuous efficacy of mAbs against CGRP/ CGRP receptor in the prevention of chronic migraine up to 12 weeks after treatment discontinuation [40]. As for the differences in efficacy among the four mAbs, no direct comparison has ever been made, which requires a large RCT in the future.…”

Upregulation of IL-1 Receptor Antagonist in a Mouse Model of Migraine

“…Recently, monoclonal antibodies targeting the CGRP pathway (i.e. fremanezumab, eptinezumab, and galcanezumab) have also been tested in both chronic and episodic migraine, and were shown to improve migraine-associated symptoms, quality of life, and disability, and to reduce monthly migraine days [78,79,80,81].…”