The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response
Language English Country England, Great Britain Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
- Keywords
- Erenumab, chronic migraine, monthly migraine days, responder rates,
- MeSH
- Calcitonin Gene-Related Peptide Receptor Antagonists administration & dosage MeSH
- Chronic Disease MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Antibodies, Monoclonal, Humanized administration & dosage MeSH
- Internationality * MeSH
- Middle Aged MeSH
- Humans MeSH
- Migraine Disorders diagnosis drug therapy epidemiology MeSH
- Adolescent MeSH
- Young Adult MeSH
- Drug Administration Schedule MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Calcitonin Gene-Related Peptide Receptor Antagonists MeSH
- erenumab MeSH Browser
- Antibodies, Monoclonal, Humanized MeSH
OBJECTIVE: To assess the efficacy of erenumab across the spectrum of response thresholds (≥50%, ≥75%, 100%) based on monthly migraine days (MMD) reduction in patients with chronic migraine from a 12-week, randomized study (NCT02066415). METHODS: Patients (n = 667) received (3:2:2) placebo or erenumab 70/140 mg once-monthly. The proportion of patients achieving a given response threshold was assessed. A post-hoc analysis was conducted to contextualize the actual treatment benefit in subgroups of patients achieving (or not) specified response thresholds. Outcome measures included MMD, acute migraine-specific medication treatment days (MSMD) and disability. RESULTS: The proportion of patients responding to erenumab exceeded that of placebo at the ≥50% and ≥75% response thresholds. At month 3, 39.9% and 41.2% of patients on erenumab 70 and 140 mg, respectively, achieved ≥50% response versus placebo (23.5%). Similarly, at month 3, 17.0% and 20.9% of patients on erenumab 70 and 140 mg, respectively, achieved ≥75% response versus placebo (7.8%). Compared with the overall erenumab-treated population (change in MMD: -6.6 [both 70 and 140 mg]), ≥50% responders showed MMD reductions of -12.2/-12.5 for 70 mg/140 mg versus -2.6/-2.2 for those not achieving ≥50% response. ≥75% responders showed MMD reductions of -13.9/-14.8 for 70 mg/140 mg versus -5.0/-4.3 for those not achieving ≥75% response. Relative improvements in MSMD and disability were observed in responders versus overall erenumab-treated population. CONCLUSION: For erenumab-treated patients achieving ≥50% response, the actual reduction in MMD was almost twice that of the overall population. These findings provide context for setting realistic expectations regarding actual treatment benefit experienced by patients responding to treatment.
Amgen Inc Thousand Oaks CA USA
Faculty of Medicine University Duisburg Essen Essen Germany
Headache Wellness Center Greensboro NC USA
Nashville Neuroscience Group NUMC Vanderbilt University Department of Neurology Nashville TN USA
New England Institute for Neurology and Headache Stamford CT USA
Novartis Pharma AG Basel Switzerland
Novartis Pharmaceuticals Corporation East Hanover NJ USA
Palm Beach Headache Center West Palm Beach FL USA
Prague Headache Center DADO MEDICAL s r o Prague Czech Republic
References provided by Crossref.org
ClinicalTrials.gov
NCT02066415