CGRP pathway monoclonal antibodies for cluster headache

ABSTRACT

Introduction

The involvement of the calcitonin gene-related peptide (CGRP) pathway in primary headache disorders, especially migraine, had led to recent success in the development of new migraine therapies. The CGRP pathway also plays a role in the pathophysiology of cluster headache, so CGRP pathway monoclonal antibodies have been studied in the prevention of cluster headache attacks.     

An observational study on monoclonal antibodies against calcitonin-gene-related peptide and its receptor

Background and purpose

Based on their pharmacological target, two classes of calcitonin-gene-related peptide (CGRP) monoclonal antibodies (mAbs) have been identified: antibodies against the CGRP ligand—galcanezumab, fremanezumab, eptinezumab—and antibodies against the CGRP receptor (CGRP-R), erenumab. The aim of the present study was to compare anti-CGRP versus anti-CGRP-R mAbs in patients with high frequency episodic and chronic migraine.

Methods

All patients on monthly treatment with anti-CGRP mAbs with an available 6 months’ follow-up at January 2022 were included. Data on efficacy outcome were collected following one (T1), three (T3) and six (T6) months of treatment, and included monthly headache/migraine days, the Migraine Disability Assessment Scale (MIDAS) and Headache Impact Test 6 (HIT-6) scores, pain intensity, analgesics consumption and response rates (>50% headache days reduction compared to baseline).

Results

In all, 152 patients were enrolled, of whom 68 were in treatment with anti-CGRP mAbs (49 galcanezumab, 19 fremanezumab) and 84 with the anti-CGRP-R (erenumab). MIDAS scores were significantly lower in the anti-CGRP group at T1 and T3 (respectively p < 0.02 and p < 0.03) as well as the number of mean migraine days at T3 (p < 0.01). At T3 and T6 outcome measures were comparable, although a significantly higher percentage of super-responders was found in the anti-CGRP group (respectively p < 0.04 and p < 0.05), with a similar overall percentage of responders.

Conclusions

The present study on a real-world sample confirms the beneficial effect of both anti-CGRP and anti-CGRP-R mAbs, with a more favorable outcome for anti-CGRP antibodies.