A Potential Biomarker for Predicting Antibody Treatment Efficacy in Migraine

Researchers showed high migraine induction capabilities with calcitonin gene-related peptide (CGRP) in people with migraine who responded to erenumab treatment compared to data from previous CGRP provocation experiments.

A recent study in The Journal of Headache and Pain showed high migraine induction capabilities with calcitonin gene-related peptide (CGRP) in participants with migraine responsive to erenumab treatment.

The authors sought to investigate the association between anti-CGRP treatment efficacy and susceptibility to CGRP-induced migraine-like attacks. 

The study population included 13 participants who previously participated in the episodic (n=7) and chronic (n=6) migraine erenumab trials (ClinicalTrials.gov identifiers: NCT02483585 and NCT02066415). Most of the participants were women (n=12) and within the age range of 22 to 53 years old.

Researchers evaluated the efficacy of anti-CGRP monoclonal antibody treatment via participants’ questionnaire. Treatment efficacy was based on the participants’ last month of receiving the monoclonal antibody treatment regimen (1.5 µg/min human α-CGRP) or placebo isotonic saline infusions over 20 minutes on 2 study days. Participants rated headache intensity and recorded headache characteristics. 

Pharmacologically induced migraine attacks were determined based on modified criteria.

The study results showed that 77% of participants developed migraine-like attacks after CGRP treatment compared with 0% of participants after placebo treatment (P =.002), of which 20% “reported poor response to treatment.” The 3 participants who did not develop migraine-like attacks were those with chronic migraine, of which 1 participant was a poor responder.

The CGRP treatment group exhibited higher area under the curve (AUC) for headache intensity at both 0 to 90 min (P =.009) and 2 to 12 h (P =.014). The CGRP group also exhibited higher AUC for heart rate (P <.001) and lower AUC for mean arterial pressure (P <.001). Finally, the “[p]ositive predictive value for CGRP-induced attacks in erenumab high responders was 0.80… and sensitivity was 0.80.” The “negative predictive value was 0.33.”

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The lack of a larger group of poor responders, the lack of a large-scale prospective provocation study, and insufficient number of non-responders were noted as study limitations.

The authors concluded that participants with migraine responsive to erenumab treatment have high susceptibility to CGRP. CGRP could be the basis for a biomarker for monoclonal antibody treatment response and could serve as a powerful tool in the selection of anti-migraine therapeutics by clinicians.

Disclosures: This study was in part supported by the Lundbeck Foundation. Messoud Ashina is a consultant or scientific advisor for Alder, Allergan, Amgen, Lilly, Novartis, and Teva. He has also served as a principal investigator for Alder, Amgen, Novartis, and Teva. Sabrina Khan has acted as invited speaker for Novartis.

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Christensen CE, Younis S, Deen M, Khan S, Ghanizada H, Ashina M. Migraine induction with calcitonin gene-related peptide in patients from erenumab trials [published online November 8, 2018]. J Headache Pain. doi: 10.1186/s10194-018-0927-2

This article originally appeared on Neurology Advisor