Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE-1 and PROMISE-2.

PURPOSE: In the PROMISE-1 (Prevention of Migraine via Intravenous ALD403 Safety and Efficacy-1) and PROMISE-2 (Prevention of Migraine via Intravenous ALD403 Safety and Efficacy-2) clinical trials, eptinezumab 100 mg and 300 mg met the primary efficacy end point, significantly reducing mean monthly migraine days across weeks 1 to 12. Clinical efficacy was also shown across key secondary end points. However, to determine if clinical efficacy varies across subgroups, it is necessary to determine efficacy in patients with different sociodemographic features and headache characteristics. These post hoc analyses of patients in PROMISE-1 and PROMISE-2 evaluated the impact of intrinsic factors on the efficacy and safety of eptinezumab in subgroups defined according to baseline demographic and migraine disease characteristics. METHODS: PROMISE-1 and PROMISE-2 were Phase III, parallel-group, double-blind, randomized, placebo-controlled trials of repeat quarterly intravenous infusions of eptinezumab or placebo in adults with episodic (PROMISE-1) or chronic (PROMISE-2) migraine. FINDINGS: Demographic and baseline characteristics were similar across treatment groups in both the PROMISE-1 and the PROMISE-2 studies. Analyses did not show a clear pattern of baseline demographic characteristics driving treatment effects except for the obesity subgroups. For the ≥50% migraine responder rate in the obese class I (body mass index 30.0-35.0 kg/m2) subgroup, although separation from placebo was not as large (<10% separation compared with ≥10% separation across most baseline demographic factors), both doses showed improved ≥50% migraine responder rate compared with placebo, with slightly better results in patients receiving eptinezumab 300 mg. IMPLICATIONS: Eptinezumab treatment showed consistent clinically relevant reductions from baseline in mean monthly migraine days compared with placebo based on ≥50% migraine responder rate across clinically important intrinsic subgroups of adults with episodic or chronic migraine. CLINICALTRIALS: gov identifiers: NCT02559895 (PROMISE-1) and NCT02974153 (PROMISE-2).

Implementation of effective, self-sustaining headache services in the Republic of Georgia: Evaluation of their impact on headache-related disability and quality of life of people with headache.

Background Headache disorders are widespread and disabling. They are common in Georgia, especially headache on ≥15 days/month (HA ≥ 15), but there are no headache services. Objective We established headache services meeting local needs, investigating feasibility, consumer uptake and satisfaction, and cost, with an exit strategy bequeathing effective, self-sustaining services that could be rolled out nationwide. Methods We created headache centres in Tbilisi and Gori offering free expert care for three visits over three months, and affordable medication thereafter. The primary outcome measure was the percentage of patients using the service beyond the free period - a measure of both satisfaction and sustainability. Results Of 1,445 patients (age 43.7 ± 12.4 years; 10.5% male), 49.8% had episodic migraine, 22.5% episodic tension-type headache, 25.7% HA ≥ 15 (24.5% overusing medication) and 2.0% trigeminal autonomic cephalalgias. Only 454 (31.4%) and 51 (3.5%) returned for second and third visits; in these, headache improved and treatment costs decreased. As information about the service spread, five other headache clinics opened in Tbilisi and Kutaisi (western Georgia). Pharmaceutical companies reduced prices (sumatriptan 100 mg from US$7 to US$1). Conclusion The study failed to achieve its primary outcome, but sustainable headache services operating to international standards were successfully implemented nonetheless, with demand increasing.