Dataset Information

Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201).

ABSTRACT:

Background

The objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks.

Methods

Eligible subjects were adults with ≥1 year history of migraine and ≥ 6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000-201; NCT03266588). Mean MMD were calculated at each 4-week period, along with mean monthly tablets taken. Migraine-specific quality of life (MSQv2) data were mapped to EQ-5D utilities and used to characterize HRQoL over time. A published network meta-analysis was used to characterize pain hours as well as time periods spent migraine free.

Results

One thousand forty four subjects were included in this post-hoc analysis. Overall mean MMD were 10.9 at baseline and decreased to 8.9 by week 52. Tablet use remained stable over the follow-up period. A total of 0.08 incremental QALYs were associated with rimegepant use.

Conclusion

For subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one-year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks.

Trial registration

ClinicalTrials.gov identifier NCT03266588 .

SUBMITTER: Johnston K

PROVIDER: S-EPMC8903552 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201).

Johnston Karissa K Harris Linda L Powell Lauren L Popoff Evan E Coric Vladimir V L'Italien Gilbert G Schreiber Curtis P CP

The journal of headache and pain 20220117 1

<h4>Background</h4>The objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks.<h4>Methods</h4>Eligible subjects were adults with ≥1 year history of migraine and ≥ 6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000-201; N ...[more]

PMID: 35038983

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Project description:ObjectiveRimegepant is an orally administered small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist, with demonstrated efficacy in the acute treatment of migraine. Recent estimates from a single-arm trial (BHV3000-201) have also shown evidence of long-term preventive effects in monthly migraine days (MMDs) and health-related quality of life (HRQoL). This study aimed to compare MMDs and HRQoL data for oral rimegepant to those obtained in placebo-controlled trials for injectable anti-CGRP monoclonal antibodies (mAbs) galcanezumab and erenumab.MethodsMatching-adjusted indirect comparisons (MAICs) were conducted using rimegepant subject-level data and published aggregate-level results from mAb trials. Rimegepant baseline characteristics were matched to the pooled subject characteristics from EVOLVE-I/II (galcanezumab vs. placebo; n = 1773) and STRIVE (ereumab vs. placebo; n = 955) by reweighting the rimegepant subjects to more closely match the distributions observed in these trials. To align with inclusion criteria of the mAb trials, only the subset of rimegepant subjects with a history of 4-14 MMDs were included (n = 257). Weighted mean differences were used to calculate adjusted change in MMDs, Migraine Disability Assessment Test (MIDAS) score, and Migraine-Specific Quality of Life Questionnaire version 2 (MSQv2) scores from baseline to week 12.ResultsWhen matched to the EVOLVE trials, rimegepant was superior to placebo with a mean difference in MMD change from baseline [95% confidence interval] of -1.16 [-1.80, -0.52] and was not statistically significantly different from galcanezumab 0.59 [-0.13, 1.32]. When matched to the STRIVE trial, rimegepant was superior to placebo -1.59 [-2.15, -1.03] and was not statistically significantly different from erenumab -0.06 [-0.61, 0.50]. Rimegepant showed superior MIDAS and MSQv2 results compared with placebo in both EVOLVE trials and in the STRIVE trial, no statistically significant differences from galcanezumab and erenumab regarding MIDAS, and favorable results compared with erenumab across all MSQv2 domains, while being generally similar to galcanezumab across all MSQv2 domains.ConclusionsWhen adjustments were made to reflect baseline characteristics in published literature, supporting data from BHV3000-201 suggest that rimegepant every other day is an effective therapy in reducing disability and MMDs and enhancing migraine-specific HRQoL. These data support the preventive benefit observed in randomized trials of rimegepant and further validate its efficacy for both acute and preventive treatment of migraine.

Project description:BackgroundEptinezumab's impact on self-reported work productivity in adults with migraine and 2‒4 prior preventive migraine treatment failures is not fully understood.MethodologyElectronic diaries captured monthly migraine days (MMDs) reported by patients enrolled in the randomized, double-blind, placebo-controlled DELIVER trial (NCT04418765). The migraine-specific Work Productivity and Activity Impairment questionnaire, administered at baseline and each monthly visit, was a secondary outcome of DELIVER and used to model changes from baseline in self-reported monthly hours of absenteeism (decreased work attendance) and presenteeism (reduced work efficiency while at work with a migraine) in Canada, as the base case. Path analysis illustrated eptinezumab's impact on work productivity beyond MMDs.ResultsAs MMDs increased, monthly hours of absenteeism increased linearly while those of presenteeism increased quadratically. Best-fit models were improved after including an eptinezumab treatment effect, showing benefit over placebo after controlling for MMD frequency. Compared to placebo, patients treated with eptinezumab (pooled) had a modeled reduction from baseline of 7.2 h/month (absenteeism) (95% CI: -9.9, -4.5; P < 0.001) and 21.4 h/month (presenteeism) (95% CI: -26.3, -16.5; P < 0.001) over weeks 1‒24. Beyond MMD reductions, improvements in patient-identified most bothersome symptom (PI-MBS) and reductions in percent of severe migraine attacks contributed to eptinezumab's effect.ConclusionsEptinezumab decreased absenteeism and presenteeism based on patient reports, with data highlighting the importance of considering the PI-MBS. The greater change from baseline than placebo in self-reported absenteeism and presenteeism was only partly explained by changes in MMDs, presenting a potential opportunity to decrease the cost of migraine in the workplace.Trial registrationClinicalTrials.gov (Identifier: NCT04418765); EudraCT (Identifier: 2019-004497-25).

Project description:IntroductionThe 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.MethodsThis 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.ResultsBaseline 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.ConclusionCompared 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 registrationNCT03732638.

Project description:IntroductionAnxiety and depression are frequently associated with migraine, and antidepressant use can complicate treatment. These analyses assessed the safety and tolerability of rimegepant in participants with migraine and anxiety and/or depression, or using selective serotonin reuptake inhibitors (SSRIs) and/or other antidepressants.MethodsData were from a phase II/III safety study of rimegepant for the acute treatment of migraine. Participants with a history of 2-14 migraine attacks per month of moderate or severe pain intensity self-administered rimegepant 75 mg as needed up to once daily for up to 52 weeks. These post hoc subgroup analyses assessed safety according to self-reported history of anxiety (yes or no) or depression (yes or no), and current use of SSRIs (yes or no) or other antidepressants (yes or no).ResultsOf 1800 treated participants, 23.2% (n = 417) had a self-reported history of anxiety, 23.7% (n = 426) had a self-reported history of depression, and 11.2% (n = 202) reported both anxiety and depression. A total of 10.1% (n = 181) of participants were using an SSRI, 10.8% (n = 195) were using other antidepressants, and 1.8% (n = 32) were using both. Across the subgroups with anxiety, without anxiety, with depression, without depression, using SSRIs, not using SSRIs, using other antidepressants, and not using other antidepressants, respectively, similar proportions of participants reported adverse events (67.1%, 58.4%, 62.0%, 60.0%, 64.1%, 60.0%, 66.2%, 59.8%), serious adverse events (3.6%, 2.3%, 2.8%, 2.5%, 3.3%, 2.5%, 5.1%, 2.3%), and discontinuation of rimegepant due to adverse events (4.1%, 2.2%, 3.1%, 2.5%, 5.0%, 2.4%, 3.1%, 2.6%). Numerical improvements in a variety of participant-reported outcomes were also observed at weeks 12 and 52.ConclusionsRimegepant showed favorable safety and tolerability in adults with migraine and a history of anxiety and/or depression and with SSRI and/or other antidepressant use.Trial registrationClinicaltrials.gov: NCT03266588.

Project description:IntroductionTo date, no study has compared the healthcare resource utilization (HCRU), costs, and discontinuation of the two calcitonin gene-related peptide antagonists, galcanezumab (monoclonal antibody subcutaneously injected monthly) and rimegepant (oral gepant taken every other day), for migraine prevention. This study aimed to assess all-cause and migraine-related HCRU, costs, and treatment discontinuation at 12 months following treatment initiation in commercial/Medicare beneficiaries with episodic migraine who received galcanezumab versus rimegepant as preventive migraine treatment.MethodsThis retrospective study used the Merative™ MarketScan® Research Databases (June 2020-June 2023). Adults with episodic migraine were grouped into the galcanezumab (≥ 1 claim) or rimegepant cohort (≥ 1 claim with quantity ≥ 15 during the index period). Changes from baseline in all-cause and migraine-related HCRU and cost between the propensity score-matched cohorts were determined using Wilcoxon signed rank test and chi-square test. Treatment discontinuation was assessed using Kaplan-Meier analysis and Cox proportional hazards model.ResultsAll-cause and migraine-related HCRU and costs increased over the 12-month follow-up in both cohorts. The galcanezumab cohort had a significantly lower increase in mean all-cause total medical + pharmacy costs (21% lower) and migraine-related total medical + pharmacy costs (76% lower) than the rimegepant cohort at the 12-month follow-up (p < 0.0001 for both assessments). Mean (standard deviation) number of days from initiation to discontinuation (> 60-day gap) was 244.6 (135.3) for galcanezumab cohort and 178.1 (141.1) for rimegepant cohort (p < 0.0001). Treatment discontinuation rate was 1.8 times less likely in the galcanezumab cohort than the rimegepant cohort (hazard ratio = 1.81, 95% confidence interval = 1.56-2.10). Similar trends were observed using a 30-day gap.ConclusionAmong matched patients, both cohorts of patients with episodic migraine showed all-cause and migraine-related total cost increases over 12 months. However, the magnitude of the increases was significantly lower for the galcanezumab cohort than for the rimegepant cohort. Treatment discontinuation rate was significantly lower in the galcanezumab versus the rimegepant cohort.

Dataset Information

Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201).

Background

Methods

Results

Conclusion

Trial registration

Publications

Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201).

Similar Datasets

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