European journal of neurology · 2025
Effects of Pausing and Re-Initiating Fremanezumab After Continuous 24-Month Treatment for Preventing Difficult-To-Treat Migraine: Prospective, Multicenter, Real-World Data From the GRASP Study Group.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Argyriou Andreas A, Dermitzakis Emmanouil V, Xiromerisiou Georgia, Chondrogianni Maria, Foska Aikaterini, Soldatos Panagiotis, Mavraki Eleni, Rikos Dimitrios, Litsardopoulos Pantelis, Tsivgoulis Georgios, Vikelis Michail
Аннотация
OBJECTIVE: This study, designed by the Greek Research Alliance for Studying headache and Pain (GRASP), aimed to (i) prospectively evaluate the effects of treatment cessation in fremanezumab-responsive patients after 2 years exposure and (ii) assess variations in response rates after migraine worsening and treatment re-initiation.
METHODS: We analyzed 149 patients with high-frequency episodic (HFEM) or chronic migraine (CM), who completed 24 months of fremanezumab, and mandatorily paused fremanezumab and re-initiated it after their migraine worsened. To assess longitudinal variations mostly in monthly migraine/headache days (MMD/MHD) and other efficacy variables, patients were interviewed at baseline (T0), at month 3 (T1), month 24 (T2), treatment pause period (T3), and at month 3 after fremanezumab re-initiation (T4). The primary objective was to assess the ≥ 50% and ≥ 75% response rates at T4, compared to T3 and T2.
RESULTS: Migraine relapsed in previous responders at T3, while fremanezumab re-initiation was not equally effective, as evidenced by lower ≥ 50% response rates, mostly in CM. At T4, 6 (9.7%) previously responsive HFEM patients and 27 (31%) previously responsive CM patients failed to obtain ≥ 50% MMD/MHD reduction, compared to T3. The rate of both HFEM and CM super-responders, obtaining a ≥ 75% response at T3, also dropped at T4.
CONCLUSION: Discontinuation of fremanezumab after month 24 leads to rising MMD/MHDs. After fremanezumab re-initiation, a relatively reduced effectiveness in the first 3 months might occur, compared with the pre-fremanezumab cessation. Overall, our findings doubt the rationale behind mandated anti-CGRP treatment pauses in migraine prophylaxis.
METHODS: We analyzed 149 patients with high-frequency episodic (HFEM) or chronic migraine (CM), who completed 24 months of fremanezumab, and mandatorily paused fremanezumab and re-initiated it after their migraine worsened. To assess longitudinal variations mostly in monthly migraine/headache days (MMD/MHD) and other efficacy variables, patients were interviewed at baseline (T0), at month 3 (T1), month 24 (T2), treatment pause period (T3), and at month 3 after fremanezumab re-initiation (T4). The primary objective was to assess the ≥ 50% and ≥ 75% response rates at T4, compared to T3 and T2.
RESULTS: Migraine relapsed in previous responders at T3, while fremanezumab re-initiation was not equally effective, as evidenced by lower ≥ 50% response rates, mostly in CM. At T4, 6 (9.7%) previously responsive HFEM patients and 27 (31%) previously responsive CM patients failed to obtain ≥ 50% MMD/MHD reduction, compared to T3. The rate of both HFEM and CM super-responders, obtaining a ≥ 75% response at T3, also dropped at T4.
CONCLUSION: Discontinuation of fremanezumab after month 24 leads to rising MMD/MHDs. After fremanezumab re-initiation, a relatively reduced effectiveness in the first 3 months might occur, compared with the pre-fremanezumab cessation. Overall, our findings doubt the rationale behind mandated anti-CGRP treatment pauses in migraine prophylaxis.