Progressive Modifications in Migraine Course Following Multiple Treatment Cycles with Anti-CGRP Monoclonal Antibodies: Findings from the Multicenter, Prospective I-GRAINE Study.
Piero Barbanti1, Cinzia Aurilia1, Gabriella Egeo1, Paola Torelli3, Florindo d'Onofrio4, Bianca Orlando1, Cinzia Finocchi5, Sabina Cevoli6, Antonio Carnevale7, Giulia Fiorentini1, Simone Quintana8, Monica Laura Bandettini di Poggio9, Marco Russo8, Stefano Bonassi2, Alice Mannocci10
1Headache and Pain Unit, 2Clinical and Molecular Epidemiology, IRCCS San Raffaele, 3Headache Center, Department of Medicine and Surgery, Headache Center, Univerisity of Parma, Unit of Neurology, University of Parma, 4Headache Center Neurology Unit, San Giuseppe Moscati Hospital, 5San Paolo Hospital, Headache Center, 6IRCCS Istituto delle Scienze Neurologiche di Bologna, 7Headache Center, San Filippo Neri Hospital, 8Headache Centre, Neurology Unit, AUSL IRCCS Reggio Emilia, 9Headache Center, IRCCS Ospedale Policlinico San Martino, 10Department for the Promotion of Human Sciences and Quality of Life, University San Raffaele
Objective:

This study aimed to assess how multiple (n=3) 12-month treatment cycles (TC) with anti-CGRP monoclonal antibodies (mAbs) impacts on migraine course by comparing migraine frequency after the discontinuation of the first, second and third TC (D1, D2 and D3, respectively).

Background:
There is limited understanding on the effects of multiple anti-CGRP mAbs TC on migraine course.
Design/Methods:

This real-life, multicenter, prospective study involved consecutive patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who had experienced multiple (>3) treatment failures and were treated with ≥3 consecutive treatment cycles (TC) of anti-CGRP mAbs. Primary endpoint was the variation in ≥ 50% response rate (RR) at D3 vs D1 and D2. Secondary endpoints included variations in monthly migraine days (MMD) for HFEM or monthly headache days (MHD) for CM, monthly analgesic medications (MAM), Numeric Rating Scale (NRS), and Headache Impact Test (HIT-6) scores, ≥75% RR and relapse from episodic migraine to CM and from no-medication overuse (MO) to MO at D3 vs D1 and D2.

Results:

Two-hundred-twelve patients completed 3 TC. The ≥ 50% RR at weeks 45–48 during the first, second and third TC were 92.9%, 94.8% and 96.2%, respectively. Corresponding rates at D1, D2 and D3 were 25%, 53.8% (p <0.001 vs D1) and 77.8% (p <0.001 vs D1 and D2). Significant reductions (p < 0.001) in MMD, MHD, MAM, NRS, and HIT-6 scores and ≥75% RR were observed at D3 compared to D1 and D2. At D3, the relapse rate from episodic to chronic migraine was 0.9% (p = 0.06, vs D2), 7.1%, at D2 (p < 0.001, vs D1) and 24.1% at D1. Similarly, only 1.4% of patients relapsed from no-MO to MO at D3, compared to 48.3% at D1 (p < 0.001) and 12.3% at D2 (p < 0.001).

Conclusions:
Multiple TC could progressively modify the course of migraine.
10.1212/WNL.0000000000208804
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