In a cohort of patients who experienced 4-14 migraine days/month, treatment with atogepant continued to improve patients’ migraine status regardless of prior medication failures.
New findings from the phase 3 ELEVATE trial (NCT04740827) suggest that atogepant (Qulipta; AbbVie), an FDA-approved preventive medication for chronic and episodic migraine, may be a potentially beneficial option for patients who previously fail several classes of oral medications.
Presented at the 9th Congress of the European Academy of Neurology (EAN), held July 1-4, in Budapest, Hungary, ELEVATE featured 309 adults who previously failed 2-4 classes of conventional oral preventive migraine medication. Following treatment with atogepant, these patients, who came into the study experiencing 4-14 migraine days/month on average, saw significant improvement in Headache Impact Test-6 (HIT-6) total scores at weeks 4, 8, and 12 (P <.0001 vs placebo).
Led by Cristina Tassorelli, MD, PhD, professor and chair of neurology at the University of Pavia, the trial comprised of individuals with episodic migraine who were treated with atogepant 60 mg once daily or placebo for a 12-week period. Change in HIT-6 total score at week 12 was an alpha-controlled secondary end point for the European Union. In addition to HIT-6 change, the analysis also observed percentage of participants with at least a 5-point improvement on the end point.
At weeks 4, 8, and 12, a significantly greater proportion of atogepant-treated individuals were HIT-6 responders, as indicated by a 5-point improvement (P <.0001). At week 4, 62.7% of atogepant-treated patients were responders compared with 34.0% of those on placebo. The rate increased by the end of the analysis, with 74.3% of treated patients considered responders vs 37.8% of those on placebo.
Atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, was originally approved in September 2021 for patients with episodic migraine based on data from the phase 3 ADVANCE study (NCT02848326). Earlier this year, in April, the FDA expanded its indication to include the prevention of chronic migraine in adults, with the phase 3 PROGRESS trial (NCT03855137) as the basis for the expansion.
Tassorelli and colleagues recently presented a matching-adjusted indirect comparison analysis at the 2023 American Headache Society Annual Meeting in which atogepant 60 mg once daily outperformed rimegepant (Nurtec ODT; Biohaven Pharmaceuticals), another FDA-approved CGRP-targeting medication. Comprised of 2 phase 3 atogepant trials and 1 phase 2/3 rimegepant trial, the study used a Bucher comparison utilizing the aggregated data to compare differences in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Role Function-Restrictive (RFR) domain scores after 12 weeks of treatment.2
In total, the analysis included 252 patients in the pooled atoegpent 60 mg QD group and 348 patients in the rimegepant 75 mg QOD group, with baseline characteristics that were balanced after weighting. Across weeks 1-12, atogepant-treated patients demonstrated a statistically significant greater reduction in mean MMDs vs rimegepant (mean difference, –1.65; 95% CI, –2.49 to –0.81; P <.001). Despite the fact that the atogepant 60 mg QD group had similar odds of experiencing a treatment-emergent adverse event (OR, 0.91; 95% CI, 0.56-1.45; P = .7366) and numerically higher odds of discontinuation because of any reason (OR, 1.43; 95% CI, 0.69-3.06) vs rimegepant, neither difference was statistically significant.
Prior to EAN, findings from ELEVATE were presented at the 2023 American Academy of Neurology Annual Meeting. Peter J. Goadsby, MD, PhD, DSc, a professor of neurology at both the University of California San Francisco and King’s College, London, sat down with NeurologyLive® in an interview at the AAN 2023 to discuss the findings from the study from a clinical perspective. In the link below, he talked about the limitations of the study design as well as the adverse events of the treatment observed in patients.