Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real‐world data from a Greek registry

Abstract

Objective: To prospectively assess the efficacy and safety of fremanezumab for migraine prophylaxis in patients with failure of at least three previous preventive treatments.Changes in disability as quality-of-life outcomes after fremanezumab treatment were also examined.Methods: Two hundred and four patients with either high-frequency EM (HFEM) or chronic migraine (CM), who attained at least three consecutive monthly sessions with fremanezumab 225 mg and otherwise met the inclusion criteria, were included in the study.The crude response (at least 50% reduction in monthly headache days [MHD]) rates to fremanezumab were assessed. Scores in the following efficacy outcomes were then compared from baseline to the last efficacy evaluation follow-up: (i) MHD, (ii) monthly days with moderate/severe peak headache intensity, and (iii) monthly days with intake of abortive medication. The disability was evaluated with the Migraine Disability Assessment; the quality of life (QOL) status was assessed with the Headache Impact-6 Test, and the EQ-5D questionnaire. Results:In the majority of HFEM cases (n = 81/97; 83.5%) and CM patients (n = 67/107; 62.6%), fremanezumab proved effective in reducing the MHDs by at least 50% and was associated with clinically meaningful improvement in all other efficacy variables. The migraine-related disability experienced by our patients decreased and their QOL increased. We recorded just 36 cases reporting mild adverse events, including pain, rash or pruritus (n = 26), flu-like symptoms (n = 8), and hair loss (n = 2). Conclusion:With our prospective results, we provide further real-world data to support the favorable benefit/risk profile of fremanezumab in the prophylaxis of both HFEM and CM.

A Scoping Review and Meta-Analysis of Anti-CGRP Monoclonal Antibodies: Predicting Response

“…Consequently, the reported median number of previous medication failures in study cohorts ranged from 4 to 7, representing a therapy-resistant or difficult-to-treat subset of migraine patients. Within this population, there was a small but consistent negative association between the number of previous CM: chronic migraine [47,48,50,[53][54][55][56][57][58][59][61][62][63]65,66,68,69,74,75,78].…”

“…Fourteen studies were excluded either because they were based on the same cohort as an included study or because they did not provide measures of the association of interest. We included 38 studies [ 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 ] in this review, which are summarized in Tables S1–S3 . The PRISMA flow diagram of the literature search process is displayed in Figure 1 .…”

“…In Lee et al [ 60 ] the absence of all accompanying symptoms, defined as nausea, vomiting, photophobia, and phonophobia during headache attacks was predictive of a nonresponse to CGRP(-R) mAbs (OR: 0.314, 95% CI: 0.118–0.834). There was no difference in response rates between migraine with and without aura [ 69 ].…”

“…HFEM: high-frequency episodic migraine. CM: chronic migraine [ 47 , 48 , 50 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 61 , 62 , 63 , 65 , 66 , 68 , 69 , 74 , 75 , 78 ].…”

“…(B): ORs showing the effect of each added previous prophylactic failure on the outcome of treatment success. HFEM: high-frequency episodic migraine.CM: chronic migraine[47,48,50,[53][54][55][56][57][58][59][61][62][63]65,66,68,69,74,75,78].…”