Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials

The Journal of Headache and Pain

Loan Honeywell¹  Mette Krog Josiassen¹  Thomas Brevig¹  Bjørn Sperling¹  Elizabeth Brunner²  Vivienne Shen²  Roger Cady³  Lahar Mehta⁴  Barbara Schaeffler⁴  Egilius L. H. Spierings⁵  Joe Hirman⁶  Timothy R. Smith⁷ 

[1] H. Lundbeck A/S, Copenhagen, Denmark;Lundbeck LLC, Deerfield, IL, USA;Lundbeck La Jolla Research Center, San Diego, CA, USA;Lundbeck Seattle BioPharmaceuticals, Inc., Seattle, WA, USA;Medvadis Research Corporation, Boston PainCare, Waltham, MA, USA;Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA;StudyMetrix Research, LLC, 3862 Mexico Road, 63303, St. Peters, MO, USA;

关键词: Eptinezumab;    Episodic migraine;    Chronic migraine;    Safety;    Tolerability;   

DOI  :  10.1186/s10194-021-01227-5

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsData were pooled from four randomized, double-blind, placebo-controlled studies and the first year of one open-label study.ResultsThe 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.ConclusionsIn adults with migraine, the intravenous administration of eptinezumab every 12 weeks demonstrated a favorable safety and tolerability profile.Trial registrationClinicalTrials.gov (Identifiers: NCT01772524, NCT02275117, NCT02559895, NCT02974153, NCT02985398).

【 授权许可】

CC BY