Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305)

Abstract

Introduction:The objectives of this study were to (1) report long-term health-related quality of life (HRQoL) outcomes among patients using rimegepant preventatively in BHV3000-305 (NCT03732638) open-label extension (OLE) and (2) map Migraine-Specific Quality of Life questionnaire version 2.1 (MSQv2) to EQ-5D-3L utility values over the double-blind treatment (DBT; 0-12 weeks) and the OLE (13-64 weeks) to assess the influence of treatment on these values. Methods: This was a post hoc analysis using data from a rimegepant study for the prevention of migraine (BHV3000-305). Adult patients with migraine took either rimegepant 75 mg or placebo every other day (EOD) during the DBT phase. All patients received rimegepant during the OLE. MSQv2 was measured at baseline, weeks 12, 24, and 64. A validated algorithm was used to map MSQv2 scores to EQ-5D utilities.Results: Baseline data were available for 347 patients treated with placebo and 348 treated with rimegepant in the DBT period, who continued to the OLE. Baseline EQ-5D utilities were similar between trial arms: 0.598 for placebo and 0.614 for rimegepant. EQ-5D improved from baseline to week 12 and utilities increased by ? 0.09 for placebo and ? 0.10 for rimegepant (p value = 0.011). By 24 weeks, at which point patients who were originally randomized to placebo had received rimegepant 75 mg EOD for 12 weeks, HRQoL measures (MSQv2 and EQ-5D) were similar across groups, demonstrating rapid onset of treatment effect. This HRQoL improvement was durable out to 64 weeks. Conclusion: Compared to placebo, treatment with rimegepant 75 mg was associated with greater improvement in EQ-5D utilities during the 12-week DBT phase. Patients originally randomized to placebo experienced a similar improvement in EQ-5D utilities after switching to rimegepant during the OLE, demonstrating that benefits are realized within 12 weeks of active treatment. This preventive effect was durable out to 64 weeks and was associated with an additional increase in HRQoL over time. Trial Registration: NCT03732638.

The pharmacotherapeutic management of episodic and chronic migraine with gepants

“…As a health state utility mapping of rimegepant for the preventive treatment of migraine, a secondary evaluation of trial BHV3000-305 conducted by Croop et al [14] was designed to analyze the outcomes of long-term health-related quality of life of the rimegepant group with 4-18 MMDs in an open-label extension period and to map MSQv2 to EQ-5D-4 L utility values over the 12-week-long double-blind treatment and open-label extension (13-64 weeks) periods. The results showed that rimegepant was superior to placebo in the double-blind treatment phase, revealed a similar improvement in MSQv2, and mapped health state utility values in both trial arms (originally taking either verum or placebo) over the 52week open-label extension phase, where all patients were on rimegepant 75 mg every other day [59].…”

Modeling Monthly Migraine-Day Distributions Using Longitudinal Regression Models and Linking Quality of Life to Inform Cost-Effectiveness Analysis: A Case Study of Fremanezumab in Japanese-Korean Migraine Patients

“…Our results also showed that using a disease-specific HRQOL questionnaire can sometimes be more sensitive in capturing the health utilities compared with the generally accepted EQ-5D-5L, especially in diseases with a paroxysmal nature such as migraine, where the period of awareness of symptoms can be short. This leads to higher utility values when using the EQ-5D, compared with questionnaires with a longer recall period like the MSQ [ 34 ]. This is likely not specific to our data as it was confirmed by two other studies in EM and CM patients that were conducted in the UK [ 35 , 36 ].…”

The history and rationale of the development of new drugs for migraine treatment

“…Of the gepants, both atogepant and rimegepant were tested for migraine prevention. 101 102 103 Atogepant seems to be the most promising of this class of drugs, since it bears the best efficacy data 101 104 105 106 107 108 109 and was described as effective also for preventing chronic migraine. 110 Table 4 summarizes the clinical pharmacology of the available gepants.…”