MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention

Abstract

Background Erenumab was approved in Europe for migraine prevention in patients with ≥ 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement. The Spanish Neurological Society started a prospective registry to evaluate real-world effectiveness and tolerability, and all Spanish headache experts were invited to participate. We present their first results. Methods Patients fulfilled the ICHD-3 criteria for migraine and had ≥ 4 MMDs. Sociodemographic and clinical data were registered as well as MMDs, monthly headache days, MHDs, prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and patient-reported outcomes (PROs): headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), and patient global improvement change (PGIC). A > 50% reduction of MMDs after 12 weeks was considered as a response. Results We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 Spanish hospitals from February 2019 to June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Patients had failed a mean of 7.8 preventive treatments at baseline (botulinum toxin type A—BoNT/A—had been used by 95.2% of patients). Most patients (67.6%) started with erenumab 70 mg. Sixty-one percent of patients were also simultaneously taking oral preventive drugs and 27.6% were getting simultaneous BoNT/A. Responder rate was 37.1% and the mean reduction of MMDs and MHDs was -6.28 and -8.6, respectively. Changes in PROs were: MIDAS: -35 points, HIT-6: -11.6 points, PIGC: 4.7 points. Predictors of good response were prior HIT-6 score < 80 points (p = 0.01), ≤ 5 prior preventive treatment failures (p = 0.026), absence of MOH (p = 0.039), and simultaneous BoNT/A treatment (p < 0.001). Twenty percent of patients had an adverse event, but only two of them were severe (0.9%), which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%). Conclusions In real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients.

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

“…The negative effect on outcome of the number of prior treatment failures shown in this study was also reported in some other real-world studies (24,32). Although the LIBERTY RCT (15) was taken as evidence that erenumab is effective in patients with EM even after failure of two to four previous treatment failures, the reported 50% responder rate of 30% is clearly lower than in the pivotal RCTs for EM (50%) (12) or CM (41%) (14).…”

“…A number of "real-world" studies and registries of migraine treatment with erenumab in North American (18)(19)(20)(21)(22)(23)(24)(25), European (26)(27)(28)(29)(30)(31)(32)(33), or Australian patients (34) have been published recently and included mainly patients with CM (Supplementary Table 1). With one exception (21), all the studies from North America were retrospective (18-20, 22, 23, 26), while all studies but two (26,30) studies from other geographic areas had a prospective design.…”

“…However, in the subsequent open-label extension follow-up, 34.5% of patients with EM discontinued monthly 70 mg erenumab after 1year, 21% either because of lack of efficacy or because they requested so, which is not otherwise specified, but probably encompasses inefficacy (5). In real-world studies, drop-out rates for lack of efficacy range from 1.4-1.9 after 12 weeks (31,32) to 40% after 6 months (19,27). None of patients with CM withdrew because their migraine remitted, contrasting with 9.5% of patients with CM who did so in a Spanish registry (32).…”

“…In real-world studies, drop-out rates for lack of efficacy range from 1.4-1.9 after 12 weeks (31,32) to 40% after 6 months (19,27). None of patients with CM withdrew because their migraine remitted, contrasting with 9.5% of patients with CM who did so in a Spanish registry (32).…”

“…Other identified predictors of treatment success with erenumab are as follows: unilateral headache in EM (31), less severe disability (32,33), absence of tension-type headache, good response to triptans (25), and higher baseline migraine frequency in CM (31,33), although the opposite has also been reported (40).…”