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- Title
Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials.
- Authors
Smith, Timothy R.; Spierings, Egilius L. H.; Cady, Roger; Hirman, Joe; Schaeffler, Barbara; Shen, Vivienne; Sperling, Bjørn; Brevig, Thomas; Josiassen, Mette Krog; Brunner, Elizabeth; Honeywell, Loan; Mehta, Lahar
- Abstract
Background: The humanized anti-CGRP monoclonal antibody eptinezumab has been evaluated in five large-scale clinical trials conducted in patients with migraine. This integrated analysis was conducted to evaluate the comprehensive safety and tolerability of eptinezumab in patients with migraine across these studies. Methods: Data were pooled from four randomized, double-blind, placebo-controlled studies and the first year of one open-label study. Results: The pooled population comprised 2867 adults with migraine: eptinezumab, n = 2076 (4797 infusions); placebo, n = 791 (1675 infusions). A total of 1137/2076 (54.8%) patients who received eptinezumab and 414/791 (52.3%) patients who received placebo experienced ≥1 treatment-emergent adverse event (TEAE); rates were similar across eptinezumab dose groups (10–1000 mg). For most patients with TEAEs, the events were mild or moderate in severity and considered unrelated to study drug by the investigators. Thirty infusion-site AEs occurred in 27/2076 (1.3%) patients who received eptinezumab and 7 in 7/791 (0.9%) patients who received placebo. Infusion-site AEs led to infusion interruption in 19/2076 (0.9%) and 5/791 (0.6%) patients in the eptinezumab and placebo groups, respectively. Nasopharyngitis occurred in ≥2% of patients in the eptinezumab 300-mg group and with an incidence of at least 2 percentage points greater than in the placebo group; however, in most patients (eptinezumab, 139/140; placebo 40/41), its occurrence was considered not related to study treatment. Adverse events coded to hypersensitivity occurred for 23/2076 (1.1%) patients treated with eptinezumab and no patients in the placebo group. If additional TEAE terms that could indicate hypersensitivity are considered (e.g., urticaria, flushing/hot flush, rash, and pruritus), hypersensitivity reactions in the two pivotal placebo-controlled phase 3 studies occurred in ≥2% of patients in the eptinezumab 100-mg and 300-mg groups, and the incidence was at least 2 percentage points greater in either of these groups than in the placebo group. Most hypersensitivity reactions were not serious and resolved with standard medical treatment or observation without treatment, usually within 1 day. Conclusions: In adults with migraine, the intravenous administration of eptinezumab every 12 weeks demonstrated a favorable safety and tolerability profile. Trial registration: ClinicalTrials.gov (Identifiers: NCT01772524, NCT02275117, NCT02559895, NCT02974153, NCT02985398).
- Subjects
THERAPEUTIC use of monoclonal antibodies; NASOPHARYNX diseases; DRUG tolerance; CLINICAL trials; INTRAVENOUS therapy; MIGRAINE; MONOCLONAL antibodies; ADVERSE health care events; DRUG allergy
- Publication
Journal of Headache & Pain, 2021, Vol 22, Issue 1, p1
- ISSN
1129-2369
- Publication type
Article
- DOI
10.1186/s10194-021-01227-5