Safety and Tolerability of Ubrogepant for the Acute Treatment of Migraine in Participants Taking Atogepant for the Preventive Treatment of Episodic Migraine: Results from the TANDEM Trial
Elimor Brand-Schieber1, Richard Lipton2, Andrew Blumenfeld3, Molly Yizeng He1, Jonathan Smith1, Joel Trugman1, Rosa de Abreu Ferreira1, Jessica Ailani4
1AbbVie, 2Albert Einstein College of Medicine, 3Headache Center of Southern California, 4Georgetown University Hospital
Objective:
This study evaluated safety and tolerability of ubrogepant for acute treatment of migraine in participants taking atogepant for preventive treatment of episodic migraine (EM).
Background:
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved in U.S. for preventive treatment of migraine in adults. Ubrogepant is a CGRP receptor antagonist approved in U.S. for acute treatment of migraine with/without aura in adults.
Design/Methods:
TANDEM, a phase 4, two-period, multicenter, open-label study conducted in U.S., enrolled adults with migraine, with/without aura, and <15 headache days/month. Period 1: participants treated with atogepant 60mg once daily (QD) for 12 weeks. Period 2: ubrogepant 100mg as needed (PRN) was added to atogepant for treatment of breakthrough migraine attacks (up to 8/month) for 12 weeks; optional second ubrogepant dose or participants’ own acute medication could be used to rescue unresolved headaches within 2-24 hours post-dose. Primary endpoint was safety and tolerability of atogepant and ubrogepant administered concomitantly.
Results:
Of 263 participants enrolled, 262 were treated in Period 1 (Safety Population 1) and 218 continued and were treated in Period 2 (Safety Population 2). Mean number of ubrogepant use days was 6.6 (SD, 5.03; min, max, 1, 24) over 12 weeks of Period 2 (n=188). In Safety Population 1, 49.6% of participants experienced a treatment-emergent adverse event (TEAE) versus 43.1% in Safety Population 2. Most common TEAEs (≥5%) in Safety Populations 1 and 2 were COVID-19 (8.4%, 3.2%), fatigue (6.5%, 1.4%), nausea (6.1%, 0.9%), decreased appetite (5.7%, 0.9%), and constipation (5.3%, 0.9%). 9.9% of participants discontinued any treatment due to TEAEs. There was 1 serious TEAE in each Period (Period 1, ureterolithiasis; Period 2, myelopathy); both considered unrelated to study treatment.
Conclusions:
Use of atogepant 60mg QD for preventive treatment of EM and ubrogepant 100mg PRN for acute treatment of migraine over 12 weeks was safe and well tolerated.