Erenumab Immunogenicity: a Pooled Analysis of Phase 2 and Phase 3 Migraine Prevention Clinical Trials (P4.098)
Abstract
Objective: To determine the frequency of occurrence and potential clinical impact of anti-erenumab antibodies. Background: Anti-drug antibodies, commonly reported with biologics, may impact the efficacy, safety, and pharmacokinetics of the drug. Erenumab is a fully human anti-CGRP receptor antibody in development for migraine prevention. Here we report a pooled analysis of erenumab immunogenicity. Design/Methods: Data were obtained from all phase 2/phase 3 placebo-controlled clinical trials (NCT01952574, NCT02066415 [and open-label extension study, NCT02174861], NCT02456740, NCT02483585) that evaluated erenumab for migraine prevention. Serum was tested for anti-erenumab binding antibodies (BAbs); BAb-positive samples were tested for neutralizing antibodies (NAbs). Pooled data were used to determine the impact of anti-erenumab antibodies on efficacy, safety, and pharmacokinetics. Results: Subject incidence of BAbs during the double-blind phase of the four placebo-controlled trials was 6.3% (56/884) with 70 mg (of 3 NAb-positive subjects, 2 were NAb-negative by end of study [EOS]), and 2.6% (13/504) with 140 mg (0 NAb-positive). With continued treatment, more than 50% of BAb-positive subjects reverted to BAb-negative status by EOS. Mean (SE) change in monthly migraine days from baseline to month 3 with the 70-mg/140-mg dose was −3.2 (0.2)/−3.6 (0.2) in BAb-negative subjects and −3.2 (0.7)/−4.1 (0.8) in BAb-positive subjects. Mean change in monthly migraine days from baseline…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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