Abstract
Migraine is a neurological disease with recurrent headache pain, accompanied by e. g. photophobia or nausea. Number of headache days classifies to episodic or chronic migraine (EM/CM). The anti-Calcitonin-Gene-Related-Peptide (CGRP) antibody fremanezumab offers a new type of prophylaxis. In Phase-3-trial FOCUS patients with CM or EM were randomized in 1:1:1 ratio to receive subcutaneous fremanezumab quarterly (single dose: 675 mg), fremanezumab monthly (CM/EM: 675/225 mg as loading dose and 225 mg at week 4/8) or placebo. During the German market access process, the Gemeinsamer Bundesausschuss (G-BA) defined different patient populations. The G-BA defined valproic acid in Annex VI to Section K of the pharmaceutical directive (Off-label use) as last-line medication. Therefore, a subpopulation comprised of patients with inadequate response to valproic acid is therefore only suitable for Best-Supportive-Care (BSC). Results for placebo + BSC (n=83) vs. fremanezumab + BSC (quarterly/monthly n=86/92) are presented. On fremanezumab, significantly more patients reached reduction by ≥ 50 % of monthly migraine days (quarterly: RRs = 4.03, p = 0.0001, monthly: 3.38, p = 0.0009). A reduction of ≥ 50 % of monthly headache days of at least moderate severity was also seen (RRs = 1.72, p = 0.0374, 2.28, p = 0.0007). Patients experienced significantly less days with nausea or vomiting and photophobia or phonophobia (Hedges’ g = -0.58 [-0.889, -0.271], -0.66 [-0.970, -0.360], -0.82 [-1.132, -0.502], -1.02 [-1.333, -0.702]). Patients used significantly less acute migraine-specific medication (Hedges’ g = -0.68 [-0.992, -0.370], -0.92 [-1.232, -0.607]). Migraine-Specific Quality of Life (MSQoL) demonstrated an improved health-related QoL (role functioning restrictive: monthly RRs = 1.35, p = 0.0134, preventive: 1.71, p = 0.0016, 1.56, p = 0.0094). Fremanezumab as migraine prophylaxis resulted in a lower frequency of headache compared to placebo treatment in patients who previously failed valproic acid.
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