Atogepant for the preventive treatment of chronic migraine: results from the PROGRESS phase 3 trial
Patricia Pozo-Rosich1, Jessica Ailani2, Messoud Ashina3, Peter Goadsby4, Richard Lipton5, Uwe Reuter6, Hua Guo7, Brittany Schwefel7, Ramesh Boinpally7, Emily McCusker7, Sung Yun Yu7, Michelle Finnegan7, Joel Trugman7
1Vall d’Hebron University Hospital & Vall d’Hebron Institute of Research, Universitat Autonoma of Barcelona, 2Georgetown Headache Center, Georgetown University Hospital, 3Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, 4NIHR-Wellcome Trust King's Clinical Research Facility, King's College London & University of California, 5Albert Einstein College of Medicine, 6Department of Neurology, Charité-Universitätsmedizin Berlin & Universitätsmedizin Greifswald, 7AbbVie
To evaluate efficacy, safety, and tolerability of atogepant for preventive treatment of chronic migraine (CM).
Atogepant is an oral CGRP receptor antagonist approved in the US for preventive treatment of episodic migraine.
PROGRESS(NCT03855137) was a 12-week phase 3 trial in adults with CM who were randomized to atogepant (30mg twice daily [BID], 60mg once daily [QD]) or placebo. Primary efficacy endpoint was change from baseline in mean monthly migraine days (MMDs) over 12 weeks. A key secondary endpoint was proportion of participants with ≥50% reduction in 3-month average of MMDs.
Of 778 participants (89.2% completed double-blind treatment period), 773 were in safety population (average age=42.1 years; average BMI=25.5 kg/m2; 87.6% female; 59.4% White; 36.4% Asian), and 755 in modified intent-to-treat (mITT) population. Baseline mean MMDs (mITT population) were 18.6 – 19.2 across groups. Mean change from baseline across 12 weeks was −7.5 days for atogepant 30mg BID, −6.9 for atogepant 60mg QD, and -5.1 for placebo (atogepant 30mg BID vs. placebo, p<0.0001, atogepant 60mg QD vs. placebo, p=0.0009). Reduction of ≥50% in 3-month average of MMDs was achieved by 42.7% of participants in the atogepant 30mg BID group, 41.0% in the atogepant 60mg QD group and 26.0% in the placebo group (30mg BID vs. placebo, p=0.0003, 60mg QD vs. placebo, p=0.0009). Treatment-emergent adverse events (TEAEs) were reported by 56.4% (atogepant 30mg BID), 63.2% (atogepant 60mg QD) and 49.4% (placebo) of participants. Most frequent TEAEs (≥5% any group): constipation (10.9% atogepant 30mg BID, 10.0% atogepant 60mg QD, 3.1% placebo); nausea (7.8% atogepant 30mg BID, 9.6% atogepant 60mg QD, 3.5% placebo). Serious TEAEs were reported by 1.6% (atogepant 30mg BID), 2.7% (atogepant 60mg QD) and 1.2% (placebo) of participants; none considered treatment-related.
Atogepant demonstrated statistically significant reductions in mean monthly migraine days among participants with CM and was safe and generally well-tolerated.