A Potential Biomarker for Predicting Antibody Treatment Efficacy in Migraine

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Compared with placebo, the area under the curve for headache intensity was greater after CGRP at 0-90 min and 2-12 h.
Compared with placebo, the area under the curve for headache intensity was greater after CGRP at 0-90 min and 2-12 h.

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.

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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.”

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.

Reference

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

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