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Multicenter Study
. 2024 Dec;31(12):e16450.
doi: 10.1111/ene.16450. Epub 2024 Sep 16.

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

Luigi Francesco Iannone  1 , Marina Romozzi  2 , Antonio Russo  3 , Gennaro Saporito  4 , Federico De Santis  4 , Raffaele Ornello  4 , Grazia Sances  5 , Gloria Vaghi  5   6 , Cristina Tassorelli  5   6 , Maria Albanese  7 , Simona Guerzoni  8 , Alfonsina Casalena  9 , Catello Vollono  2 , Paolo Calabresi  2 , Maria Pia Prudenzano  10 , Edoardo Mampreso  11 , Giorgio Dalla Volta  12 , Maria Rosaria Valente  13 , Gianluca Avino  14 , Alberto Chiarugi  1   15 , Simona Sacco  4 , Francesca Pistoia  4 ; Italian Headache Registry (RICe) study group
Collaborators, Affiliations
Multicenter Study

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

Luigi Francesco Iannone et al. Eur J Neurol. 2024 Dec.

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.

Keywords: CGRP; migraine; monoclonal antibodies; pharmacokinetic; pharmacological interactions.

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Conflict of interest statement

L.F.I. has received fees and honoraria for advisory boards or speaker panels from Teva, Eli Lilly, Lundbeck, Pfizer, and AbbVie. G.Sap. has received fees and honoraria for advisory boards or speaker panels from Eli Lilly, Lundbeck, Pfizer, and Teva. G.V. has received personal fees from Lundbeck. M.A. has received personal fees from Eli Lilly, Lundbeck, Teva, Pfizer, and AbbVie/Allergan. P.C. has received research support, speaker honoraria, and support to attend national and international conferences from AbbVie, Bayer Schering, Bial, Biogen‐Dompè, Biogen‐Idec, Eisai, Genzyme, Lundbeck, Lusofarmaco, Merck‐Serono, Novartis, Prexton, Teva, UCB Pharma, and Zambon. R.O. reports personal fees and nonfinancial support from Allergan‐AbbVie, Eli Lilly, Novartis, Pfizer, and Teva. S.G. has received fees and honoraria for advisory boards, speaker panels, or clinical investigation studies from Novartis, Teva, Eli Lilly, Pfizer, Lundbeck, Angelini, and AbbVie. S.S. reports personal fees from Abbott, Allergan‐AbbVie, AstraZeneca, Boehringer, Eli Lilly, Lundbeck, Novartis, Novo Nordisk, Pfizer, and Teva and research grants from Novartis and Uriach. The other authors have no conflicting interests.

Figures

FIGURE 1
FIGURE 1
Flowchart of patients. All values in the flowchart represent the number of patients if not otherwise specified. aPatients with coadministration. bOne patient discontinued both monoclonal antibodies (mAbs). CGRP, calcitonin gene‐related peptide.
FIGURE 2
FIGURE 2
Number of monthly headache days and days with analgesics use per month at baseline, 3 months, and 6 months of treatment with calcitonin gene‐related peptide monoclonal antibodies in combination with another monoclonal antibody. Error bars represent 95% confidence interval.
FIGURE 3
FIGURE 3
Response rates in the population with coadministration of monoclonal antibodies. Percentages are calculated of the total number of patients per follow‐up as reported in Table S3.
See this image and copyright information in PMC

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