Back to Search
Start Over
Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response.
- Source :
-
Cephalalgia . Sep2021, Vol. 41 Issue 10, p1075-1088. 14p. - Publication Year :
- 2021
-
Abstract
- <bold>Objective: </bold>To evaluate the efficacy of monthly or quarterly fremanezumab in patients with chronic migraine or episodic migraine and documented inadequate response to 2, 3, or 4 classes of prior migraine preventive medications.<bold>Methods: </bold>This is an exploratory analysis of a randomized, double-blind, placebo-controlled, phase 3b trial for patients with chronic migraine or episodic migraine and inadequate response to 2 to 4 prior migraine preventive medication classes randomized (1:1:1) to fremanezumab (quarterly or monthly) or placebo. In this exploratory analysis, changes from baseline in the monthly average number of migraine days during 12 weeks of double-blind treatment and adverse events were evaluated for predefined subgroups of patients by number of prior preventive medication classes with inadequate response.<bold>Results: </bold>Overall, 414, 265, and 153 patients had inadequate response to 2, 3, and 4 preventive medication classes, respectively. Changes from baseline in monthly average migraine days during 12 weeks were significantly greater with fremanezumab compared with placebo for patients with documented inadequate response to 2 classes (least-squares mean difference vs placebo [95% confidence interval]: quarterly, -2.9 [-3.83, -1.98]; monthly, -3.7 [-4.63, -2.75]), 3 classes (quarterly, -3.3 [-4.65, -1.95]; monthly, -3.0 [-4.25, -1.66]), and 4 classes (quarterly, -5.3 [-7.38, -3.22]; monthly, -5.4 [-7.35, -3.48]) of migraine preventive medications (all pā<ā0.001). No significant treatment-by-subgroup interactions were observed for any outcome (p interaction > 0.20 for all). Adverse events were comparable for placebo and fremanezumab.<bold>Conclusion: </bold>Significant improvements in efficacy were observed with fremanezumab compared with placebo, even in patients who had previously experienced inadequate response to 4 different classes of migraine preventive medications.ClinicalTrials.gov identifier: NCT03308968. [ABSTRACT FROM AUTHOR]
- Subjects :
- *MIGRAINE
*SUBGROUP analysis (Experimental design)
*DRUGS
*TREATMENT failure
*CONFIDENCE intervals
*MIGRAINE prevention
*THERAPEUTIC use of monoclonal antibodies
*RESEARCH
*RESEARCH methodology
*MONOCLONAL antibodies
*MEDICAL cooperation
*EVALUATION research
*TREATMENT effectiveness
*COMPARATIVE studies
*RANDOMIZED controlled trials
*BLIND experiment
Subjects
Details
- Language :
- English
- ISSN :
- 03331024
- Volume :
- 41
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- Cephalalgia
- Publication Type :
- Academic Journal
- Accession number :
- 152227456
- Full Text :
- https://doi.org/10.1177/03331024211008401