Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study

The Journal of Headache and Pain

Simone Quintana¹  Paola Torelli¹  Nicoletta Brunelli²  Claudia Altamura²  Fabrizio Vernieri²  Carmelina Maria Costa²  Gabriella Egeo³  Piero Barbanti⁴  Sabina Cevoli⁵  Valentina Favoni⁵  Renata Rao⁶  Florindo d’Onofrio⁷  Massimo Filippi⁸  Bruno Colombo⁸  Roberta Messina⁸ 

[1] Department of Medicine and Surgery, Parma and Neurology Unit, AOU di Parma, University of Parma, Parma, Italy;Headache and Neurosonology Unit, Neurology, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy;Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy;Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy;San Raffaele University, Rome, Italy;IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy;Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy;Neurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy;Neurology, Neurorehabilitation and Neurophysiology Units, IRCCS Ospedale San Raffaele and University ‘Vita e Salute’, Milan, Italy;

关键词: Calcitonin gene-related peptide;    Monoclonal antibodies;    Migraine treatment;    Real-world;    Discontinuation;   

DOI  :  10.1186/s10194-021-01363-y

来源: Springer

【 摘 要 】

BackgroundMonoclonal antibodies anti-calcitonin gene-related peptide (mAbs anti-CGRP) pathway are effective and safe on migraine prevention. However, some drug agencies limited these treatments to one year due to their high costs. This study aimed at evaluating the effect of discontinuing mAbs anti-CGRP on monthly migraine days (MMDs) and disability in high-frequency episodic (HFEM) and chronic migraine (CM) patients.MethodsThis observational longitudinal cohort study was conducted at 10 Italian headache centres. Consecutive adult patients were followed-up for three months (F-UP1–3) after discontinuation of a one-year erenumab/galcanezumab treatment. The primary endpoint was the change in F-UP MMDs. Secondary endpoints included variation in pain intensity (Numerical Rating Scale, NRS), monthly acute medication intake (MAMI), and HIT-6 scores. We also assessed from F-UP1 to 3 the ≥50% response rate, relapse rate to CM, and recurrence of Medication Overuse (MO).ResultsWe enrolled 154 patients (72.1% female, 48.2 ± 11.1 years, 107 CM, 47 HFEM); 91 were treated with erenumab, 63 with galcanezumab. From F-UP1 to F-UP3, MMDs, MAMI, NRS, and HIT-6 progressively increased but were still lower at F-UP3 than baseline (Friedman’s analysis of rank, p < .001). In the F-UP1–3 visits, ≥50% response rate frequency did not differ significantly between CM and HFEM patients. However, the median reduction in response rate at F-UP3 was higher in HFEM (− 47.7% [25th, − 79.5; 75th,-17.0]) than in CM patients (− 25.5% [25th, − 47.1; 75th, − 3.3]; Mann-Whitney U test; p = .032). Of the 84 baseline CM patients who had reverted to episodic migraine, 28 (33.3%) relapsed to CM at F-UP1, 35 (41.7%) at F-UP2, 39 (46.4%) at F-UP3. Of the 64 baseline patients suffering of medication overuse headache ceasing MO, 15 (18.3%) relapsed to MO at F-UP1, 26 (31.6%) at F-UP2, and 30 (42.3%, 11 missing data) at F-UP3. Lower MMDs, MAMI, NRS, and HIT-6 and higher response rate in the last month of therapy characterized patients with ≥50% response rate at F-UP1 and F-UP3 (Mann-Whitney U test; consistently p < .01).ConclusionMigraine frequency and disability gradually increased after mAbs anti-CGRP interruption. Most patients did not relapse to MO or CM despite the increase in MMDs. Our data suggest to reconsider mAbs anti-CGRP discontinuation.

【 授权许可】

CC BY