Treatment Patterns of Biologic Disease-Modifying Antirheumatic Drugs and Janus Kinase Inhibitors in Patients with Rheumatoid Arthritis in Japan: A Claims-Based Cohort Study

Overview

Journal Drugs Real World Outcomes

Date 2024 Apr 10

PMID 38598110

Authors

Masahiko Miyashiro

Teita Asano

Yutaka Ishii

Celine Miyazaki

Hirohito Shimizu

Junya Masuda

Affiliations

Soon will be listed here.

Abstract

Background: Reports on treatment patterns of biologic disease-modifying antirheumatic drugs (bDMARDs)/Janus kinase inhibitors (JAKi) for rheumatoid arthritis (RA) in clinical practice are still sparse in Japan, especially in combination with conventional synthetic DMARDs (csDMARDs).

Objectives: The aim of this study was to investigate treatment patterns of bDMARD/JAKi in the treatment of RA in real-world clinical practice in Japan.

Method: A retrospective cohort study was conducted using the Japanese Medical Data Vision health claims database. The inclusion criteria required a recorded diagnosis of RA, defined by ICD-10 codes, in patients aged 18 years and older on the index date. We analyzed 39,903 RA patients treated with DMARDs from 2008 to 2020.

Results: Among analyzed subjects, 10,196 patients (25.6%) were prescribed bDMARDs/JAKi in combination with csDMARDs, and 3067 patients (7.7%) were prescribed these drugs without csDMARDs. Among the bDMARDs/JAKi, tumor necrosis factor inhibitors (TNFi) were the most commonly prescribed DMARD overall, and also the most common first-line therapy, accounting for 60.0% or 45.5% of patients prescribed these drugs in combination with or without csDMARDs, respectively. Switching, temporary discontinuation (restarting with the same agents), and discontinuation of bDMARDs/JAKi were observed in 3150 (30.9%), 1379 (13.5%), and 2025 (19.9%) patients with csDMARDs, and in 849 (27.7%), 513 (16.7%), and 833 (27.2%) patients without csDMARDs, respectively.

Conclusions: Real-world treatment trajectories of bDMARDs/JAKi with and without csDMARDs was analyzed in RA patients in Japan between 2008 and 2020. TNFi were the predominant first-line therapy, and likely to be switched to different classes. Understanding the current treatment patterns, including discontinuation, is important to find an optimal treatment strategy for RA patients.

References

Smolen J . Insights into the treatment of rheumatoid arthritis: A paradigm in medicine. J Autoimmun. 2020; 110:102425. DOI: 10.1016/j.jaut.2020.102425. View

Nakashita T, Ando K, Takahashi K, Motojima S . Possible effect of abatacept on the progression of interstitial lung disease in rheumatoid arthritis patients. Respir Investig. 2016; 54(5):376-9. DOI: 10.1016/j.resinv.2016.03.001. View

Tanaka Y . Recent progress in treatments of rheumatoid arthritis: an overview of developments in biologics and small molecules, and remaining unmet needs. Rheumatology (Oxford). 2021; 60(Suppl 6):vi12-vi20. PMC: 8709568. DOI: 10.1093/rheumatology/keab609. View

Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H . Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2007; 67(2):189-94. DOI: 10.1136/ard.2007.072967. View

Yamanaka H, Nagaoka S, Lee S, Bae S, Kasama T, Kobayashi H . Discontinuation of etanercept after achievement of sustained remission in patients with rheumatoid arthritis who initially had moderate disease activity-results from the ENCOURAGE study, a prospective, international, multicenter randomized study. Mod Rheumatol. 2015; 26(5):651-61. DOI: 10.3109/14397595.2015.1123349. View

Aguilar-Lozano L, Castillo-Ortiz J, Vargas-Serafin C, Morales-Torres J, Sanchez-Ortiz A, Sandoval-Castro C . Sustained clinical remission and rate of relapse after tocilizumab withdrawal in patients with rheumatoid arthritis. J Rheumatol. 2013; 40(7):1069-73. DOI: 10.3899/jrheum.121427. View

Nakajima A, Sakai R, Inoue E, Harigai M . Prevalence of patients with rheumatoid arthritis and age-stratified trends in clinical characteristics and treatment, based on the National Database of Health Insurance Claims and Specific Health Checkups of Japan. Int J Rheum Dis. 2020; 23(12):1676-1684. DOI: 10.1111/1756-185X.13974. View

Smolen J, Aletaha D, McInnes I . Rheumatoid arthritis. Lancet. 2016; 388(10055):2023-2038. DOI: 10.1016/S0140-6736(16)30173-8. View

Kaneko Y, Sakurai M, Snijder R, Kokubo S, Kato D . A retrospective, longitudinal study of rheumatoid arthritis treatment patterns with Janus kinase inhibitors and other disease-modifying antirheumatic drugs in Japan. Mod Rheumatol. 2022; 33(3):448-459. DOI: 10.1093/mr/roac046. View

10.

Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J . Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009; 36(5):898-906. DOI: 10.3899/jrheum.080791. View

11.

Sugihara T, Ishizaki T, Hosoya T, Iga S, Yokoyama W, Hirano F . Structural and functional outcomes of a therapeutic strategy targeting low disease activity in patients with elderly-onset rheumatoid arthritis: a prospective cohort study (CRANE). Rheumatology (Oxford). 2014; 54(5):798-807. DOI: 10.1093/rheumatology/keu395. View

12.

Takabayashi K, Ando F, Ikeda K, Fujita S, Nakajima H, Hanaoka H . Trend in prescription and treatment retention of molecular-targeted drugs in 121,131 Japanese patients with rheumatoid arthritis: A population-based real-world study. Mod Rheumatol. 2021; 32(5):857-865. DOI: 10.1093/mr/roab126. View

13.

Smolen J, Emery P, Fleischmann R, van Vollenhoven R, Pavelka K, Durez P . Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet. 2013; 383(9914):321-32. DOI: 10.1016/S0140-6736(13)61751-1. View

14.

Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T . Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients. Ann Rheum Dis. 2011; 70(12):2148-51. PMC: 3212697. DOI: 10.1136/ard.2011.151092. View

15.

Kawahito Y, Morinobu A, Kaneko Y, Kohno M, Hirata S, Kishimoto M . Drug treatment algorithm and recommendations from the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis-secondary publication. Mod Rheumatol. 2022; 33(1):21-35. DOI: 10.1093/mr/roac017. View

16.

Mori S, Ueki Y . Outcomes of dose reduction, withdrawal, and restart of tofacitinib in patients with rheumatoid arthritis: a prospective observational study. Clin Rheumatol. 2019; 38(12):3391-3400. DOI: 10.1007/s10067-019-04721-z. View

17.

Smolen J, Landewe R, Bergstra S, Kerschbaumer A, Sepriano A, Aletaha D . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2022; 82(1):3-18. DOI: 10.1136/ard-2022-223356. View

18.

AlMutairi K, Nossent J, Preen D, Keen H, Inderjeeth C . The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int. 2020; 41(5):863-877. DOI: 10.1007/s00296-020-04731-0. View

19.

Ghiti Moghadam M, Vonkeman H, Ten Klooster P, Tekstra J, van Schaardenburg D, Starmans-Kool M . Stopping Tumor Necrosis Factor Inhibitor Treatment in Patients With Established Rheumatoid Arthritis in Remission or With Stable Low Disease Activity: A Pragmatic Multicenter, Open-Label Randomized Controlled Trial. Arthritis Rheumatol. 2016; 68(8):1810-7. DOI: 10.1002/art.39626. View

20.

Komano Y, Tanaka M, Nanki T, Koike R, Sakai R, Kameda H . Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol. 2011; 38(7):1258-64. DOI: 10.3899/jrheum.101009. View