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P-035 - Real-world treatment outcomes and patterns of rimegepant for the treatment of migraine in the Guangdong-Hong Kong-Macao Greater Bay Area of China: interim results.

POSTER ABSTRACT
Location:  Exhibit Hall

    Author/Presenter(s)

  • yX

    yongteng Xu, MD

    Attending doctor
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • jj

    jie jiang, PhD

    Professor at the Department of Pharmacy, Jinan University
    Jinan University
    Guangzhou, Guangdong, China (People's Republic)

  • sP

    sudan Peng, MD

    Attending doctor
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • JW

    Jinyuan Wang, MD

    Resident doctor
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • JJ

    Jingru Jiang, PhD

    Resident
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • sx

    songhua xiao, MD

    Director of Neurology Department
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • zl

    zhonglin liu, MD

    Chief Physician and Professor of Neurology
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • JL

    Jin Li, n/a

    Director of Pharmacy Department
    Guangzhou United Family Hospital
    Guangzhou, Guangdong, China (People's Republic)

  • Jc

    Jifu cai, n/a

    Associate consultant physician in neurology
    Hongkong University Shenzhen Hospital
    Shenzhen, Guangdong, China (People's Republic)

  • YL

    Yi Li, MD

    Chief Physician and Professor of Neurology
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • yc

    ying chen, MD

    Attending doctor
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • hl

    honghong li, MD

    Attending doctor
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • xr

    xiaoming rong, MD

    Associate Chief Physician of Neurology
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • lh

    lei he, MD

    Chief Physician and Professor of Neurology
    Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

  • LR

    Li Ren, MD

    Director of Neurology Department
    Foshan Fosun Chancheng Hospital
    Foshan, Guangdong, China (People's Republic)

  • YJ

    Yan Ji, MD

    Deputy Director of Neurology department
    Guangdong Clifford Hospital
    Guangzhou, Guangdong, China (People's Republic)

  • SL

    Sha Li, PhD

    Associate Professor at the Department of Pharmacy
    Jinan University
    Guangzhou, Guangdong, China (People's Republic)

  • Yamei Tang, PhD; MD

    Vice-president
    Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China (People's Republic)

Abstract Title: Real-world treatment outcomes and patterns of rimegepant for the treatment of migraine in the Guangdong-Hong Kong-Macao Greater Bay Area of China: interim results.

Background: Background

Rimegepant has been approved for the acute and preventive treatment of episodic migraine in the United States, the European Union and Hong Kong. At the initiation phase of this real-world study, rimegepant had not yet received New Drug Application (NDA) approval in Mainland China. However, rimegepant can be prescribed in specified hospitals in the Guangdong-Hong Kong-Macao Greater Bay Area facilitated by the “Hong Kong and Macao Medicine and Equipment Connect” policy. This policy enables patients to gain early access to innovative medication before it gets official NDA approval in Mainland China. The efficacy and safety of rimegepant for the acute and preventive treatment of migraine have been established through well-designed randomized controlled trials1-3. However, there is no real-world data on the effectiveness of rimegepant for both acute and preventive treatment among Chinese migraineurs. This is the first study in China to evaluate migraine patients’ changes in quality of life, functionality, work productivity, migraine-related impairment, and treatment satisfaction after rimegepant treatment. To the best of our knowledge, this is also the first study to observe the treatment patterns of rimegepant in real-world clinical settings.

Purpose/Objectives: Purpose
This study was designed to evaluate the effectiveness and treatment patterns of rimegepant in real-world clinical practice among Chinese migraineurs. The primary objective was to assess the impact of rimegepant on the quality of life (QoL), functionality, and work productivity of these individuals, as well as their satisfaction with the treatment. The secondary objective was to analyze the treatment patterns of rimegepant, including the purpose of the prescription (i.e., for acute treatment or preventive treatment), as well as the contexts in which it is used, the timing and frequency of administration, and monthly tablet utilization.


Methods: Methods

This study was a single-arm, prospective, multicenter, observational study (NCT06221267). A total of 120 eligible outpatients with migraine prescribed rimegepant for acute or preventive treatment were continuously enrolled and followed for 4 weeks. Baseline information, including demographics, physical assessments, medical history, clinical characteristics of migraine, and previous anti-migraine treatments, will be collected. The therapeutic effect of rimegepant in treating migraine will be assessed through questionnaires designed to evaluate patient satisfaction with previous medications and rimegepant treatment, as well as rimegepant's impact on quality of life, functionality, and work productivity. Additionally, data on the treatment patterns of rimegepant will be collected after enrollment, including the purpose of the prescription, the scenarios in which it is used, the timing of its use (limited to acute treatment), the frequency of administration, and any concomitant anti-migraine medications (including traditional Chinese medicine).

Results: Results

Up to April 30th, 2024, 45 patients who completed four weeks follow-up were included in the interim analysis. Of these, 82.2% (37/45) were prescribed rimegepant for acute treatment as needed (PRN) and 17.8% (8/45) for preventive treatment (use on every other day, EOD). The mean age of the participants was 37.7 years and 77.8% (35/45) were female. The mean monthly migraine days (MMDs) across the whole group were 8.7, with 7.4 MMDs reported in the acute treatment group and 14.8 MMDs in the preventive treatment group. Around 42.2% (19/45) of patients had 4 or less MMDs and 15.6% (7/45) patients had 15 or more MMDs. Besides, 93.3%（42/45）of the patients reported having 3 or more accompanying symptoms during migraine attacks. The most common accompanying symptoms were nausea (84.4%), photophobia (66.6%) and phonophobia (64.4%). Concurrently, 24.4% (11/45) of the patients had anxiety symptoms, 17.8% (8/45) suffered from sleep disorders and 6.7% (3/45) had depressive symptoms. During the four weeks of treatment, the average number of tablets used per patient was 3 for acute treatment and 9.1 for preventive treatment. Notably, rimegepant treatment was associated with a significant increase in EuroQol-5-Dimensions 5-Level (EQ-5D-5L) scores, improving by an average of 6.5±13.4 (p = 0.002). Additionally, rimegepant effectively reduced the negative impact of migraine on work and life, demonstrated by a decrease in Headache Impact Test (HIT-6) scores by 4.8±7.1 (p < 0.0001), a reduction in absenteeism scores from the Work Productivity and Activity Impairment - General Health (WPAI-GH) by 6.6±17.6 (p = 0.049), and a decrease in presenteeism scores from WPAI-GH by 18.6±26.6 (p < 0.001). According to the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), patients reported notable improvements after rimegepant treatment, which included increased effectiveness (21.1±32.1, p < 0.0001), improved convenience (5.7±16.2, p = 0.023), fewer side effects (15.6±30.9, p = 0.002), and higher global satisfaction (21.7±27.6, p < 0.0001).

Conclusions/Implications for future research and/or clinical care: Conclusion

After four weeks of treatment with rimegepant, patients experienced clinically meaningful improvements in their overall quality of life, functionality, and work productivity, as well as higher treatment satisfaction. The majority of enrolled patients were treated for acute migraine attacks. It is speculated that prolonged use of rimegepant could lead to even greater benefits for migraine patients. Consequently, further long-term investigations are warranted to explore the sustained benefits of rimegepant treatment for migraine patients.


References: 1. Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. Jan 2 2021;397(10268):51-60. doi:10.1016/S0140-6736(20)32544-7

2. Yu S, Kim BK, Guo A, et al. Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. Jun 2023;22(6):476-484. doi:10.1016/S1474-4422(23)00126-6

3. Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. Aug 31 2019;394(10200):737-745. doi:10.1016/S0140-6736(19)31606-X



Disclosure：

This study was funded by Pfizer.