Background and purpose: Although there is extensive evidence about the safety of monoclonal antibodies against calcitonin gene-related peptide (anti-CGRP mAbs) in combination with traditional drugs, scarce data are available on the safety of their combination with other mAbs. This study aimed to evaluate the 6-month effectiveness and tolerability of anti-CGRP mAbs in combination with other mAbs for different diseases. Methods: Patients included in the Italian Headache Registry and treated concomitantly with an anti-CGRP mAb and another mAb were included. Effectiveness outcomes for migraine included reduction from baseline of monthly headache days (MHDs), Migraine Disability Assessment (MIDAS) score, Headache Impact Test-6 (HIT-6) scores, and Patients' Global Impression of Change (PGIC) scale. Adverse events (AEs) were recorded. Results: Thirty-eight patients were included. In 27 patients (71.1%), the anti-CGRP mAb was added to a previously ongoing mAb. Nine patients (23.7%) discontinued one of the two mAbs before the end of treatment (seven discontinued the anti-CGRP mAb and two the other mAb). One patient discontinued for AEs. Anti-CGRP mAbs were discontinued due to ineffectiveness (n = 5, 55.5%) and one each (11.1%) for clinical remission and lost to follow-up. MHDs significantly decreased from baseline to 3 months (p < 0.0001) and 6 months (p < 0.001), as did the MIDAS and the HIT-6 scores at 3 and 6 months (p < 0.001). For anti-CGRP mAbs, 27.4% of patients reported PGIC ≥ 5 at 3 months and 48.3% at 6 months. Mild AEs associated with introduction of a second mAb were detected in six patients (15.8%). Conclusions: In this real-world study, anti-CGRP mAbs showed safety and effectiveness when administered concomitantly with other mAbs.
Association of anti‐calcitonin gene‐related peptide with other monoclonal antibodies for different diseases: A multicenter, prospective, cohort study / Iannone, Luigi Francesco; Romozzi, Marina; Russo, Antonio; Saporito, Gennaro; De Santis, Federico; Ornello, Raffaele; Sances, Grazia; Vaghi, Gloria; Tassorelli, Cristina; Albanese, Maria; Guerzoni, Simona; Casalena, Alfonsina; Vollono, Catello; Calabresi, Paolo; Prudenzano, Maria Pia; Mampreso, Edoardo; Volta, Giorgio Dalla; Valente, Maria Rosaria; Avino, Gianluca; Chiarugi, Alberto; Sacco, Simona; Pistoia, Francesca; null, null. - In: EUROPEAN JOURNAL OF NEUROLOGY. - ISSN 1351-5101. - STAMPA. - 31:(2024), pp. e16450.0-e16450.0. [10.1111/ene.16450]
Association of anti‐calcitonin gene‐related peptide with other monoclonal antibodies for different diseases: A multicenter, prospective, cohort study
Iannone, Luigi Francesco;Albanese, Maria;Chiarugi, Alberto;
2024
Abstract
Background and purpose: Although there is extensive evidence about the safety of monoclonal antibodies against calcitonin gene-related peptide (anti-CGRP mAbs) in combination with traditional drugs, scarce data are available on the safety of their combination with other mAbs. This study aimed to evaluate the 6-month effectiveness and tolerability of anti-CGRP mAbs in combination with other mAbs for different diseases. Methods: Patients included in the Italian Headache Registry and treated concomitantly with an anti-CGRP mAb and another mAb were included. Effectiveness outcomes for migraine included reduction from baseline of monthly headache days (MHDs), Migraine Disability Assessment (MIDAS) score, Headache Impact Test-6 (HIT-6) scores, and Patients' Global Impression of Change (PGIC) scale. Adverse events (AEs) were recorded. Results: Thirty-eight patients were included. In 27 patients (71.1%), the anti-CGRP mAb was added to a previously ongoing mAb. Nine patients (23.7%) discontinued one of the two mAbs before the end of treatment (seven discontinued the anti-CGRP mAb and two the other mAb). One patient discontinued for AEs. Anti-CGRP mAbs were discontinued due to ineffectiveness (n = 5, 55.5%) and one each (11.1%) for clinical remission and lost to follow-up. MHDs significantly decreased from baseline to 3 months (p < 0.0001) and 6 months (p < 0.001), as did the MIDAS and the HIT-6 scores at 3 and 6 months (p < 0.001). For anti-CGRP mAbs, 27.4% of patients reported PGIC ≥ 5 at 3 months and 48.3% at 6 months. Mild AEs associated with introduction of a second mAb were detected in six patients (15.8%). Conclusions: In this real-world study, anti-CGRP mAbs showed safety and effectiveness when administered concomitantly with other mAbs.I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.