Efficacy and Safety of Erenumab, Galcanezumab, and Fremanezumab in the Treatment of Drug-Resistant Chronic Migraine: Experience in Real Clinical Practice

Abstract

Background: Due to the recent introduction of new biologic drugs for chronic migraine, a global evaluation in real clinical practice is necessary. Objective: The objective was to evaluate the effectiveness and safety in real clinical practice of drugs targeting the calcitonin gene-related peptide receptor (CGRPr) in patients with chronic migraine. Methods: Single-center, restrospective study (2019-2022), including patients with chronic migraine treated with erenumab, galcanezumab, or fremanezumab. Effectiveness variables were recorded, namely, number of migraine headache days per month (MHD), Migraine Disability Assessment Scale (MIDAS) score, and Headache Impact Test–6 (HIT-6) score, assessing changes at week 12, 24 from baseline. Toxicity was recorded following the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. Results: In all, 104 patients were included (46.2% erenumab, 41.3% galcanezumab, 12.5% fremanezumab). A reduction in MHD, MIDAS, and HIT-6 was achieved at weeks 12 and 24 with erenumab (p75% at week 24 than those intensified; P = 0.041). There was no difference in efficacy ( P = 0.154) or improvement in quality of life ( P = 0.783, P = 0.150), but there was greater toxicity ( P < 0.001) among nonresponders with erenumab 70 mg versus erenumab 140 mg. Conclusions: The results confirm the effectiveness and safety of anticalcitonin gene-related peptide (CGRP) drugs in real clinical practice. However, the study shows little benefit from erenumab intensification, with similar effectiveness and worse tolerability than the standard dose.

Evaluation of the change in efficacy of erenumab when used long‐term for migraine prevention after initial established benefit in a veteran population

“…These findings suggest that erenumab may still be a reasonable and potentially effective option even for patients with multiple other prophylactic medication failures. This is also consistent with recently published literature that found significant benefits with erenumab after multiple other preventative treatments failed 21,22 . The second most common reason for exclusion from our study was the initial prescription of erenumab at the higher 140 mg monthly dose ( n = 75, 19.5%).…”

“…21 Interestingly, one recent analysis did not find that intensification with erenumab 140 mg offered significant improvement in those categorized as partial responders on erenumab 70 mg but did find that tolerability was significantly lower with the higher dose. 22 In our analysis 31% of patients continued erenumab 70 mg monthly without the need for further dose titration until the end of the study period, which was a minimum of 6 months of duration for all patients. This suggests that some patients may respond well to a lower erenumab dose, potentially limiting unnecessary exposure to greater amounts of erenumab that could pose a greater risk of side effects, though further research would be needed to investigate this hypothesis.…”

“…This is also consistent with recently published literature that found significant benefits with erenumab after multiple other preventative treatments failed. 21,22 The second most common reason for exclusion from our study was the initial prescription of erenumab at the higher 140 mg monthly dose (n = 75, 19.5%). Package labeling for erenumab does not specify any preference for a starting dose, and head-to-head comparisons of erenumab 70 and 140 mg regimens have not yet been studied.…”

“…Clinical trials and post hoc analyses have reported a numerically greater reduction in MMDs, but inferences about statistical or clinical significance cannot be made 21 . Interestingly, one recent analysis did not find that intensification with erenumab 140 mg offered significant improvement in those categorized as partial responders on erenumab 70 mg but did find that tolerability was significantly lower with the higher dose 22 . In our analysis 31% of patients continued erenumab 70 mg monthly without the need for further dose titration until the end of the study period, which was a minimum of 6 months of duration for all patients.…”

Fremanezumab in real-life clinical practice: specialized headache center experience

“…В нашем исследовании получены значимые результаты при лечении сложных пациентов с ХМ, ЛИГБ, с предыдущим неуспехом приема двух и более классов препаратов для профилактики мигрени, а также с сопутствующей депрессией. В других открытых исследованиях также показа-на эффективность фреманезумаба у труднокурабельных пациентов [13,14,31,32]. В наше исследование вошли пациенты с предыдущим неуспехом использования эренумаба.…”