An assessment of data from the PROMISE-2 trial suggests that individuals who respond to treatment in the first month are likely to maintain their response through at least 6 months.
An analysis of data from the PROMISE-2 trial (NCT02974153) of eptinezumab (Vyepti; Lundbeck) in the treatment of chronic migraine suggests that patient response to treatment within the first month is predictive of sustained response to treatment, with findings showing these patients responded to therapy throughout all 6 months of study.1
Ultimately, the majority of patients in the trial (total, n = 1072; 100 mg, n = 356; 300 mg, n = 350; placebo, n = 366) randomized to one of the dosing groups of eptinezumab responded well to treatment within the first month (≥50% responder rates: 100 mg, 54.5% [n = 194]; 300 mg, 60.6% [n = 212]; placebo, 36.1% [n = 132]). Of those, 30.9% (n = 110) in the 100-mg group and 36.9% (n = 129) in the 300-mg group reported at least 75% responder rates, compared to 15.6% (n = 57) of the placebo group.
Of those who achieved a 75% or greater response in Month 1, more than 40% of patients in both treatment groups maintained that response rate for all 5 remaining study months (100 mg: 41.8%; 300 mg: 46.5%), while those responders in the placebo group fell just shy of that mark (36.8%). Notably, more than 80% of those in both eptinezumab groups (100 mg: 81.8%; 300 mg: 85.3%) maintained that response rate for more than 2 months. The placebo responders, meanwhile, fell just shy of that mark as well (78.9%).
The data were presented by Dawn C. Buse, PhD, clinical professor of neurology, Albert Einstein College of Medicine of Yeshiva University, and colleagues, the 2021 American Headache Society (AHS) Annual Scientific Meeting, June 3-6. “These findings could accelerate patient management decisions, including those related to continued preventive treatment, lifestyle modification, bio-behavioral training, and acute headache medication optimization,” Buse and colleagues wrote.
In addition to those with the highest rates of response, 16.6% of both the 100-mg (n = 59) and 300-mg (n = 58) groups reported a response rate between 25% and 49% in Month 1, compared to 22.1% (n = 81) in the placebo group. Of those, more than half in the treatment groups and almost half of the placebo group still achieved 3 or more study months with at least 50% response (100 mg: 52.5%; 300 mg: 51.7%; placebo: 42.0%). Almost 4 times as many eptinezumab-treated patients (100 mg: 23.7%; 300 mg: 25.9%) in those responder groups maintained that response for all 5 months compared with placebo (6.2%).
Of those in the eptinezumab groups, 28.9% (n = 103) and 22.9% (n = 80), respectively, compared with 41.8% (n = 153) of the placebo group were less than 25% responders in Month 1. Even still, at least 1 month of 50% or greater response was achieved by 50.5% (100 mg), 41.3% (300 mg), and 39.9% (placebo) of patients, with more eptinezumab-treated than placebo patients achieving 3 or more months (100 mg: 23.3%; 300 mg: 29.0%; placebo: 13.7%).
Additional data from PROMISE-2 presented at the AHS meeting showed that treatment with eptinezumab (Vyepti; Lundbeck) decreased the monthly frequency of headache days and episodes, as well as reduced the severity of remaining headache episodes and the burdensome features of said episodes.2
Presented by Peter McAllister, MD, medical director, New England Institute for Neurology and Headache, and chief medical officer, New England Institute for Clinical Research, the results also showed that eptinezumab reduced the percent of remaining headache episodes that were deemed migraine attacks. McAllister and colleagues conducted a post-hoc analysis that examined changes in the characteristics of headache episodes in patients with chronic migraine. Patients were randomized to receive eptinezumab 100 mg (n = 356), 300 mg (n = 350), or placebo (n = 366) administered intravenously (IV) every 12 weeks for up to 2 doses.
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