Concurrent atogepant, ubrogepant safe, well-tolerated for migraine at 12 weeks
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Key takeaways:
- Adults with migraine were given atogepant 60 mg once daily and ubrogepant 100 mg as needed.
- No hepatic safety issues or new safety signals within the study were recorded.
SAN DIEGO — Concurrent use of atogepant for preventive treatment of episodic migraine and ubrogepant for acute migraine treatment was safe and well-tolerated at 12 weeks, according to a study.
“For people with migraine, all need an acute treatment while only about 40% meet criteria for consideration of preventive therapy,” Jessica Ailani, MD, clinical professor of neurology at MedStar’s Georgetown University Hospital and director of the MedStar Georgetown Headache Center, told Healio in an email regarding the study presented at the American Headache Society Annual Scientific Meeting. “Anti-[calcitonin gene-related peptide] therapies represent one of the few migraine-specific options for acute treatment and the only migraine specific preventive treatment option available at this time.”
Ailani and colleagues initiated the TANDEM clinical trial, a phase 4, two-period, multicenter, open-label study conducted in the United States, to assess safety and efficacy of calcitonin gene-related peptides atogepant and ubrogepant administered concurrently, for acute migraine.
The study included a total of 263 adults diagnosed with migraine, with or without aura, and fewer than 15 headache days per month. In period 1, participants were administered atogepant 60 mg once daily for 12 weeks, while in period 2, ubrogepant 100 mg as needed was added to atogepant to address breakthrough migraine attacks (up to eight per month) for 12 weeks. Additionally, an optional second ubrogepant dose or the participants’ own acute medication could be used in period 2 to address headaches that were unresolved within 2 to 24 hours post dose.
The primary endpoint was the safety and tolerability of concurrent administration of atogepant and ubrogepant.
From the initially enrolled cohort, 262 individuals were treated in period 1 (Safety Population 1), with 218 continuing to treatment in period 2 (Safety Population 2).
According to results, the mean number of ubrogepant use days was 6.6 over the 12 weeks of period 2 (n = 188).
In Safety Population 1, 49.6% of participants experienced a treatment-emergent adverse event (TEAE) compared with 43.1% from Safety Population 2. The most common TEAEs in both safety populations were COVID-19, fatigue, nausea, decreased appetite and constipation.
In Safety Population 2, 9.9% of participants discontinued any treatment due to TEAEs, with one serious TEAE recorded from each period (period 1, ureterolithiasis; period 2, myelopathy), but both were considered unrelated to study treatment. The researchers also found no hepatic safety issues or new safety signals within the study.
“Clinically answering this question closes a gap,” Ailani told Healio. “It allows clinicians to have some knowledge about short-term safety of combining these specific treatments and allows for open dialogue with their patients to improve choices in both preventive and acute treatment.”