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References: 1. Burch et al. Headache. 2018;58(4):496-505; 2. IHS 2018. Cephalalgia. 2018;38(1):1-211; 3. Gillard et al. Value in Health. 2012;15(3):485-95;4. Lombard et al. The Journal of Headache and Pain. 2020;21:41; 5. Lipton et al. N Engl J Med. 2019;381:142-9. Disclosures: This study was sponsored by Biohaven Pharmaceuticals. KJ and EP were consultants paid by Biohaven Pharmaceuticals. LH and GL (add initials of other Biohaven ppl) are employed by and own stock/stock options in Biohaven Pharmaceuticals. RBL has received honoraria and research support from Biohaven Pharmaceuticals; he is also a stockholder. Utility Mapping of Rimegepant by Change in Monthly Migraine Days Karissa Johnston, PhD 1 ; Gilbert L’Italien, PhD 2 , Evan Popoff, MSc 1 ; Robert Croop MD 2 ; Alexandra Thiry, PhD 2 ; Linda Harris, MPH 2 ; Vladimir Coric, MD 2 ; Richard Lipton, MD 3 1 Broadstreet Health Economics & Outcomes Research, Vancouver, BC; 2 Biohaven Pharmaceuticals, New Haven, CT; 3 Albert Einstein College of Medicine, Bronx, NY American Headache Society 2020 Annual Meeting | Virtual Poster • To map disease-specific MSQv2 (Study 201, NCT03266588) to EQ-5D utilities. This allows MSQv2 to be compared with scores from other diseases and to incorporate into health economic evaluations Objective • Migraine is a disabling neurologic disease that affects 15.3% of American adults and is associated with a high personal and socioeconomic burden 1, 2 • Rimegepant, a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, was recently approved by the US Food and Drug Administration (FDA) as an acute treatment of migraine • CGRP inhibition is also a proven mechanism for preventive treatment • Rimegepant was evaluated for the acute treatment of migraine in 3 Phase III, multicenter, single-dose, placebo-controlled studies of similar design, as well as in a 52-week open-label, long-term safety study (NCT03461757; NCT03235479; NCT03237845; NCT03266588) • In this study data from the long-term safety study were used to assess the impact of rimegepant on migraine attack frequency as measured by monthly migraine days (MMDs), with health-related quality of life (HRQoL) as measured by the Migraine-specific Quality of Life (MSQv.2) instrument, and EQ-5D Background • Study 201 of rimegepant was a multicenter, open-label study where adults with moderate to severe migraine were separated into 3 enrollment groups based on the number of moderate to severe MMDs at baseline • Patients with 2 to 8 MMDs and those with 9 to 14 MMDs were assigned rimegepant 75 mg as needed (PRN) for up to 52 weeks, while those with 4 to 14 MMDs were assigned to rimegepant 75 mg every other day (QOD) supplemented by PRN on nonscheduled days for up to 12 weeks • In addition to safety assessments, this study also explored the reduction in MMDs over time, MSQv2 questionnaire scores were recorded at baseline and at 12-week intervals until the end of the study, and long-term outcomes were assessed to allow for estimation of potential preventive effects • Outcomes assessed over time for patients receiving rimegepant were MMD, MSQv2, and mapped EQ-5D utilities • In Study 201, MSQv2 was assessed at baseline and week 12 for the QOD+PRN group, and at baseline and at weeks 12, 24, 36, and 52 for the 2 PRN groups • MSQv2 was characterized by 3 HRQoL dimensions – Role Function Restrictive (RR) has 7 items and measures migraine impact on normal activities such as work, productivity, daily activities, energy, tiredness, concentration, leisure, and relationships – Role Function Preventive (RP) has 4 items and measures the impact of migraine on interrupting performance of normal activities – Emotional Function (EF) has 3 items and measures migraine's effect on emotional function • MSQv2 values were mapped to EQ-5D utilities using a validated algorithm by Gillard et al 3 • Values were compared between baseline and end of study using paired t-tests, in addition to visual comparison; all analyses were stratified by study enrollment group Methods Table 1. MMD, MSQv2, and EQ-5D at Baseline and Change From Baseline to End of Study a Results • At baseline, MSQv2 data were available for 1,800 patients: 1,033 with 2-8 MMD in the PRN group, 481 with 9-14 MMD in the PRN group, and 286 with 4-14 MMD in the QOD+PRN group • The median age of participants was 42 years and 3.7% were 65 years of age or older • More than 80% of participants were white and 89% were female, and the median number of historical moderate-to-severe attacks per month was 8 • MMD (SD) at baseline was 7.02 (3.74) for the PRN [2-8] group, 9.03 (3.90) for the QOD + PRN [4-14] group, and 12.23 (4.64) for the PRN [9-14] group • Rimegepant reduced MMD by 0.47 (4.89) for the PRN [2-8] group, by 3.31 (3.51) in the QOD + PRN [4-14] group and by 2.94 (5.95) in the PRN [9-14] group • The mapping analysis found that the groups with the greatest decrease in MMD had the highest increase in EQ-5D (Table 1) • For all MSQv2 domains outcomes improved over each study visit (Table 1, Figure 1) 2-8 MMD PRN (n=1,033) 4-14 MMD QOD+PRN (n=286) 9-14 MMD PRN (n=481) MMD at baseline 7.02 (3.74) 9.03 (3.90) 12.23 (4.64) MMD change from baseline −0.47 (4.89) −3.31 (3.51) −2.94 (5.95) MSQv2- RP at baseline 69.28 (20.45) 68.06 (19.73) 64.47 (20.75) MSQv2 - RP change from baseline 13.78 (19.77) 18.98 (20.17) 15.60 (20.55) MSQv2 - RR at baseline 54.56 (18.25) 52.26 (17.38) 48.70 (18.44) MSQv2 - RR change from baseline 16.82 (20.15) 24.27 (18.61) 19.86 (20.01) MSQv2 - EF at baseline 63.70 (25.62) 60.84 (25.47) 54.87 (26.23) MSQv2 - EF change from baseline 16.72 (25.16) 24.02 (24.41) 19.49 (27.69) Mapped EQ-5D utility at baseline 0.66 (0.12) 0.65 (0.11) 0.63 (0.12) Mapped EQ-5D utility change from baseline 0.09 (0.12) 0.12 (0.11) 0.10 (0.13) EF, emotional function; MMD, monthly migraine days; MSQv2, migraine-specific quality of life; n, number of participants in each group; RP, role preventive; RR, role restrictive; SD, standard deviation a All MMD, MSQv2, and EQ-5D values are mean (SD) Conclusions • Rimegepant was associated with reduced MMD and increased MSQv2 scores in up to 1 year of treatment in Study 201. When MSQv2 scores were mapped to EQ- 5D, there was associated improvement in EQ-5D utilities. • This improvement was observed in all patient-groups and was most pronounced in those with higher MMD and those taking Rimegepant on a fixed plus as-needed dosing schedule. • A study of 1,413 patients who compared responders to insufficient triptan responders showed a benefit of +0.07 associated with triptan response, less pronounced than the benefits observed here for rimegepant. 4 • This study provides new information about the effects of different rimegepant dosing regimens on MMD, MSQv2, and EQ-5D utility scores. This information could be useful for economic evaluations and decision making. • Rimegepant has a favorable safety and efficacy profile as an acute treatment for migraine. 5 Rimegepant is also currently being assessed in a phase III trial as a preventive treatment for migraine (NCT03732638), and future work will be assessing clinical and HRQoL benefits of rimegepant relative to placebo. Figure 3. Change From Baseline in Monthly Migraine Days and EQ-5D • Similar trends in improvement were observed across MSQv2 subdomains, and all differences were statistically significant. However, the largest improvements in all MSQv2 subdomains were observed with the scheduled QOD + PRN rimegepant regimen • At baseline, EQ-5D utilities were 0.66, 0.63, and 0.65 for the PRN [2-8], PRN [9-14], and QOD+PRN [4-14] groups, respectively. At end-of-study, utilities had increased by +0.09, +0.11 and +0.12 for the 3 groups (P<0.001 for all comparisons with baseline) (Figure 2) • Utility increased over time for all time points for all enrollment groups. Only 2 time points are available for the QOD + PRN [4-14] group because data for this group were only collected at baseline and at 12 weeks • At the enrollment group level there was an inverse relationship between change in MMD and change in EQ-5D over the course of the study, with greatest decrease in MMD associated with greatest increase in EQ-5D (Figure 3) Figure 2. EQ-5D Utilities Mapped From MSQv2 Data Figure 1. MSQv2 Domains Over Time in Study 201, Separated by Enrollment Group MSQv2 Domain MSQv2 = migraine-specific quality of life MMD, monthly migraine day This material is being made available for informational purposes only through Biohaven Medical Affairs. To download a copy of this poster, scan QR code.
