Journal Article

Association of anti‐calcitonin gene‐related peptide with other monoclonal antibodies for different diseases: A multicenter, prospective, cohort study

Calabresi, Paolo, Chiarugi, Alberto, Sances, Grazia, Albanese, Maria, Sacco, Simona, Mampreso, Edoardo, Lo Castro, Flavia, De Santis, Federico, Iannone, Luigi Francesco, Guerzoni, Simona, Burgalassi, Andrea, Bolchini, Marco, Casalena, Alfonsina, Ghiotto, Natascia, Mercuri, Nicola Biagio, Tassorelli, Cristina, De Cesaris, Francesco, Saporito, Gennaro, Cortinovis, Matteo, Romozzi, Marina, Bovenzi, Roberta, Pistoia, Francesca, Vigani, Giulia, Vollono, Catello, Boscain, Francesca, Valente, Maria Rosaria, Nociti, Viviana, Ornello, Raffaele, Vaghi, Gloria, Russo, Antonio, Avino, Gianluca, De Icco, Roberto, Prudenzano, Maria Pia, Volta, Giorgio Dalla

2024

Overview

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.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc
• Subject: Adult / Aged / Antibodies, Monoclonal - therapeutic use / Calcitonin / Calcitonin gene-related peptide / Calcitonin Gene-Related Peptide - antagonists & inhibitors / Calcitonin Gene-Related Peptide - immunology / CGRP / Cohort Studies / Drug development / Effectiveness / Female / Headache / Headaches / Humans / Impact tests / Male / Middle Aged / Migraine / Migraine Disorders - drug therapy / Migraine Disorders - immunology / Monoclonal antibodies / Original / Patients / Peptides / pharmacokinetic / pharmacological interactions / Prospective Studies / Registries / Remission / Safety / Treatment Outcome