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Antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor have shown efficacy in the prevention of migraine attacks. We investigated the efficacy and tolerability of fremanezumab, a fully humanised CGRP antibody, in patients with migraine who had previously not responded to two to four classes of migraine preventive medications.

IL-5, a mediator of eosinophil activity, is an important potential treatment target in patients with uncontrolled asthma. The efficacy of reslizumab, a humanized anti-human IL-5 monoclonal antibody, has been characterized in patients with blood eosinophils ≥ 400 cells/μL. This study further characterizes the efficacy and safety of reslizumab in patients with poorly-controlled asthma, particularly those with eosinophils < 400 cells/μL.

The Phase 3b FOCUS study demonstrated the efficacy and tolerability of fremanezumab, a humanised IgG2Δa monoclonal antibody that selectively targets the calcitonin gene-related peptide, for migraine prevention in patients with documented inadequate response to 2-4 prior preventive treatment classes. This subgroup analysis aimed to evaluate acute medication use in fremanezumab treated patients who had baseline medication overuse (MO; any acute medication ≥15 days/month or triptans, ergots, or combination medications ≥10 days/month).In the double-blind (DB) period (DBP) of FOCUS, patients were randomised (1:1:1) to quarterly/monthly fremanezumab, or placebo. Patients completing the DBP entered the open-label extension (OLE) and received monthly fremanezumab; results from OLE are stratified by DB randomisation group. Changes from baseline in monthly average days of acute medication use and proportions of patients reverting to no MO were evaluated.Patients with MO (427/838) had significant reductions in acute medication use with quarterly (least squares mean change, −3.8) or monthly (−4.7) fremanezumab during the DBP, versus placebo (−0.7; P<0.0001), which increased in OLE (quarterly, −6.1; monthly, −6.9; placebo, −5.0). A higher proportion of patients treated with quarterly or monthly fremanezumab reverted to no MO during the DBP, versus placebo (39% and 42% vs 13%), which further increased during the OLE (quarterly, 48%; monthly, 46%; placebo, 41%).Fremanezumab patients with prior inadequate response to 2-4 prior classes of preventive medications and MO experienced a reduction in acute headache MO.

ObjectiveTo evaluate adverse events (AEs) in a subgroup of migraine patients with baseline cardiovas- cular (CV) medication use in this pooled analysis of three phase 3 trials of fremanezumab.MethodsThis analysis included data from the HALO EM, HALO CM, and FOCUS studies, in which patients were randomized 1:1:1 to subcutaneous quarterly or monthly fremanezumab or matched placebo over 12 weeks. AEs were evaluated for patients with baseline CV medication use.ResultsOverall, 280 of 2,842 patients (9–11% across treatment groups) in this pooled population were receiving CV medications at baseline, most commonly agents acting on the renin-angiotensin system (3–4%) and beta-blockers (3–4%). In the placebo, quarterly fremanezumab, and monthly fremanezumab groups, respectively, 53%, 66%, and 64% of patients reported at least 1 AE, and the most common AEs were injection-site-related (pain [19%, 29%, and 20%], erythema [10%, 20%, and 13%], and induration [8%, 18%, and 24%]). Cardiovascular AEs (CVAEs) were infrequent; no individual CVAE was reported for >1 patient in any treatment group. No safety signals were identified.ConclusionIn this pooled analysis, fremanezumab treatment was well tolerated over 12 weeks, with low incidences of CVAEs, comparable to placebo, in patients with migraine using CV medications at baseline.JMarzella@cellohealth.com52