Real-world Evidence of Adding Atogepant to OnabotulinumtoxinA for Control of Chronic Migraine: A Retrospective Chart Review
Andrew Blumenfeld1, Laszlo Mechtler2, Lisa Cook1, Christopher Rhyne3, Brian Jenkins4, Olivia Hughes5, Brett Dabruzzo6, Aubrey Adams6, Merle Diamond7
1The Los Angeles Headache Center, 2Dent Neurologic Institute, 3Norton Neuroscience Institute, 4Neuroscience Group, 5ICON Plc, 6AbbVie Inc., 7Diamond Headache Clinic
Objective:
To collect real-world data to evaluate the effectiveness, safety, and tolerability of adding atogepant to onabotulinumtoxinA as combination preventive treatment for chronic migraine (CM).
Background:
Combination use of atogepant and onabotulinumtoxinA has the potential to be more effective than either alone for the preventive treatment of CM.
Design/Methods:
This retrospective, longitudinal, multi-center chart review included adults with CM receiving ≥2 consecutive onabotulinumtoxinA cycles before ≥3mo of onabotulinumtoxinA and atogepant combination treatment. Charts at first atogepant prescription (index date) and 2 onabotulinumtoxinA injection visits (~3 and 6mo post-index) were reviewed for change from baseline in monthly headache days (MHDs), ≥50% reduction in MHDs, and rates and types of adverse events (AEs). Charts with CGRP agents for migraine prevention during baseline (~3mo pre-index) were excluded.
Results:
31 charts met eligibility criteria (mean age 46.7 years, 94% female). Atogepant 60 mg and 30 mg were administered QD to 30 and 1 patients, respectively. Throughout the study, patients received a mean dose of 170U onabotulinumtoxinA. Pre-onabotulinumtoxinA, the mean MHD was 24.0d, reduced by a mean -8.15d (95%CI -11.44,-4.85; n=25) after onabotulinumtoxinA pre-index (mean 3.97yr). MHD additionally decreased by mean -4.53d [95%CI -7.44,-1.61] after ~3mo of combination treatment (n=31) and -8.75d total [95%CI -13.21, -4.29] after ~6mo of combination treatment in patients with data available (n=23). Nearly half of patients (n=14/31) achieved ≥50% reduction in MHDs ~3mo post-index. Overall, 95% CIs indicate that reductions from baseline were statistically significant. No new safety signals were identified when atogepant was added to onabotulinumtoxinA. The most commonly reported AEs (≥5%) were constipation and fatigue.
Conclusions:
This real-world pilot study of patients with CM demonstrated clinically meaningful treatment benefit in the reduction of headache days with onabotulinumtoxinA alone and additive benefits with co-administration of atogepant. Safety results were consistent with the known safety profiles of onabotulinumtoxinA and atogepant.