Objective:

Quantify the proportion of phase III galcanezumab study participants with episodic migraine (EM) and clinically meaningful improvement in the Migraine Disability Assessment (MIDAS) despite monthly migraine headache day (MHD) reduction <50%.

Background:

The American Headache Society (AHS) Consensus Statement states continued treatment with monoclonal antibodies (mAbs) to calcitonin gene-related peptide (CGRP) or its receptor is supported by either: 1) ≥50% MHD reduction or 2) clinically meaningful improvement in migraine-specific patient-reported outcome measures (eg. MIDAS).

Design/Methods:

Data were pooled for participants with EM treated with galcanezumab 120 or 240 mg versus placebo in EVOLVE-1, EVOLVE-2, and CONQUER phase III studies and who experienced >0% and <50% MHD reduction during the trial period. Clinically meaningful MIDAS improvement is defined by the AHS Consensus Statement as either 1) reduction of ≥5 points for baseline score 11-20 or 2) reduction of ≥30% for baseline score >20.

Results:

1551 phase III study participants had a MHD improvement >0%, mean age was 41.5 (SD=11.4) years; 84.8% were female; baseline MHD frequency was: 9.2 (SD=2.9) days. Within this group, MHD improvement was <50% in 35.7% (n=276) and 41.2% (n=240) of treatment group participants and 64.3% (n=417) and 57.3% (n=340) of the placebo group participants at 3 months and 6 months respectively. Of this group with MHD improvement >0% and <50%, clinically significant MIDAS improvement was seen in 58.0% (n=160) of the treatment group participants versus 50.6% (n=211) for placebo at 3 months (OR 1.26, 95% CI [0.92, 1.73], p=0.144) and 62.5% (n=150) of treatment group participants versus 52.9% (n=180) for placebo at 6 months (OR 1.47, 95% CI [1.05, 2.06], p=0.024).

Conclusions:

In phase III galcanezumab trials, a majority of participants with EM who experienced >0% and <50% MHD reduction achieved clinically meaningful improvement in disability. At 6 months, this improvement is statistically superior to placebo.