Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine

Abstract

Introduction Acute medication overuse is prevalent in patients with migraine. Methods In three phase 3, double-blind, randomized, placebo-controlled studies, patients with episodic migraine (EVOLVE-1 and EVOLVE-2) or chronic migraine (REGAIN) were randomized 2:1:1 to monthly subcutaneous injections of placebo or galcanezumab 120 or 240 mg for 3 or 6 months. This subgroup analysis evaluated mean changes in the number of monthly migraine headache days in each treatment among patients with versus without baseline acute medication overuse via mixing modelling with repeated measures. Results The percentages of patients with baseline medication overuse in placebo, galcanezumab 120-mg and 240-mg groups, respectively, were 19.4%, 17.3%, and 19.3% for EVOLVE-1/-2 (pooled; post hoc), and 63.4%, 64.3%, and 64.1% for REGAIN ( a priori). Both galcanezumab doses demonstrated significant improvement compared with placebo for overall least squares mean change in monthly migraine headache days in patients with baseline medication overuse in both the episodic and chronic migraine studies ( p ≤ 0.001). Furthermore, both galcanezumab doses reduced average monthly medication overuse rates compared to placebo ( p < 0.001) in both patient populations with medication overuse at baseline. Conclusions Galcanezumab appears to be effective for the preventive treatment of episodic and chronic migraine in patients who overuse acute medications. Trial registration: ClinicalTrials.gov Identifiers: NCT02614183, NCT02614196, and NCT02614261

Anti-CGRP monoclonal antibodies in chronic migraine with medication overuse: real-life effectiveness and predictors of response at 6 months

“…In our real-life cohort of chronic migraine patients with MO, demographic data and baseline headache characteristics were similar to clinical trials [8][9][10], with the exception of longer disease duration and more refractoriness to preventive medication, in line with other real-world studies [4][5][6][7].…”

“…Clinical trials with anti-CGRP MAbs included a small proportion of patients who were overusing acute medication, although they were not designed to evaluate this population. However, post-hoc subgroup analyses have observed efficacy in reducing headache frequency and acute medication intake [8][9][10] in those overusing.…”

Medication overuse and drug addiction: a narrative review from addiction perspective

“…Preventive medication such as monoclonal antibodies acting on the CGRP pathway [108][109][110][111] or Onabotulinum-toxin A [61,112] can be prescribed prior to the withdrawal treatment [113,114]. Interdisciplinary approaches with psychological counselling and behavioral interventions are beneficial [61,115] for complex cases [22,61,105].…”

Galcanezumab (Emgality)

“…Ailani et al� (2020) 44 Ailani et al� (2020) 45 Ament et al� (2021) 46 Dodick et al� (2021) 47 Förderreuther et al� (2018) 48 Pozo-Rosich et al� (2021) 49 Stauffer et al� (2020…”