Comparative effectiveness of JAK inhibitors and biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis
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Background/Aims: We aimed to compare the effectiveness and safety of Janus kinase inhibitors (JAKi) vs. biologic disease-modifying antirheumatic drugs (bDMARD) in Korean patients with rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic DMARDs. Methods: A quasi-experimental, multi-center, prospective, non-randomized study was conducted to compare response rates between JAKi and bDMARDs in patients with RA naïve to targeted therapy. An interim analysis was performed to estimate the proportion of patients achieving low disease activity (LDA) based on disease activity score (DAS)–28– erythroid sedimentation rate (ESR) (DAS28-ESR) at 24 weeks after treatment initiation and to evaluate the development of adverse events (AEs). Results: Among 506 patients enrolled from 17 institutions between April 2020 and August 2022, 346 (196 JAKi group and 150 bDMARD group) were included in the analysis. After 24 weeks of treatment, 49.0% of JAKi users and 48.7% of bDMARD users achieved LDA (p = 0.954). DAS28-ESR remission rates were also comparable between JAKi and bDMARD users (30.1% and 31.3%, respectively; p = 0.806). The frequency of AEs reported in the JAKi group was numerically higher than that in the bDMARDs group, but the frequencies of serious and severe AEs were comparable between the groups. Conclusions: Our interim findings reveal JAKi have comparable effectiveness and safety to bDMARDs at 24 weeks after treatment initiation.
Abstract
Background/Aims: We aimed to compare the effectiveness and safety of Janus kinase inhibitors (JAKi) vs. biologic disease-modifying antirheumatic drugs (bDMARD) in Korean patients with rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic DMARDs. Methods: A quasi-experimental, multi-center, prospective, non-randomized study was conducted to compare response rates between JAKi and bDMARDs in patients with RA naïve to targeted therapy. An interim analysis was performed to estimate the proportion of patients achieving low disease activity (LDA) based on disease activity score (DAS)–28– erythroid sedimentation rate (ESR) (DAS28-ESR) at 24 weeks after treatment initiation and to evaluate the development of adverse events (AEs). Results: Among 506 patients enrolled from 17 institutions between April 2020 and August 2022, 346 (196 JAKi group and 150 bDMARD group) were included in the analysis. After 24 weeks of treatment, 49.0% of JAKi users and 48.7% of bDMARD users achieved LDA (p = 0.954). DAS28-ESR remission rates were also comparable between JAKi and bDMARD users (30.1% and 31.3%, respectively; p = 0.806). The frequency of AEs reported in the JAKi group was numerically higher than that in the bDMARDs group, but the frequencies of serious and severe AEs were comparable between the groups. Conclusions: Our interim findings reveal JAKi have comparable effectiveness and safety to bDMARDs at 24 weeks after treatment initiation.
참고문헌 (28)
- 김형영, "Epidemiology of Rheumatoid Arthritis in Korea", 대한류마티스학회지, 28(2), pp.60~67 (2021), 대한류마티스학회[DOI]
- Smolen JS, "Rheumatoid arthritis", Nat Rev Dis Primers, 4, pp.18001~ (2018)
- Tanaka Y, "Recent progress in treatments of rheumatoid arthritis:an overview of developments in biologics and small molecules, and remaining unmet needs", Rheumatology (Oxford), 60(Suppl 6), pp.vi12~vi20 (2021)
- Fraenkel L, "2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis", Arthritis Care Res(Hoboken), 73, pp.924~939 (2021)
- Burmester GR, "Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors:a randomised phase 3 trial", Lancet, 381, pp.451~460 (2013)
- Fleischmann R, "Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis", N Engl J Med, 367, pp.495~507 (2012)
- van der Heijde D, "Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study", Arthritis Rheum, 65, pp.559~570 (2013)
- van der Heijde D, "Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: clinical efficacy, radiographic, and safety outcomes from a twenty-four-month, phase III study", Arthritis Rheumatol, 71, pp.878~891 (2019)
- Kremer J, "Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis : a randomized trial", Ann Intern Med, 159, pp.253~261 (2013)
- van Vollenhoven RF, "Tofacitinib or adalimumab versus placebo in rheumatoid arthritis", N Engl J Med, 367, pp.508~519 (2012)
- Fleischmann R, "Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b", 4, double-blind, head-to-head, randomised controlled trial, 2017, pp.390, 457~468
- Morrison T, "Shared decision making in rheumatology : a scoping review", Semin Arthritis Rheum, 56, pp.152041~ (2022)
- Sung YK, "Factors for starting biosimilar TNF inhibitors in patients with rheumatic diseases in the real world", PLoS One, 15, pp.e0227960~ (2020)
- Smolen JS, "Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis : 2-year efficacy and safety results from the randomised EXXELERATE study", Lancet, 388, pp.2763~2774 (2016)
- Taylor PC, "Baricitinib versus placebo or adalimumab in rheumatoid arthritis", N Engl J Med, 376, pp.652~662 (2017)
- Weinblatt ME, "Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis", Arthritis Rheumatol, 70, pp.40~48 (2018)
- Lie E, "Treatment strategies in patients with rheumatoid arthritis for whom methotrexate monotherapy has failed : data from the NOR-DMARD register", Ann Rheum Dis, 70, pp.2103~2110 (2011)
- Lauper K, "Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846patients with rheumatoid arthritis in 19 registers from the ‘JAK-pot’ collaboration", Ann Rheum Dis, 81, pp.1358~1366 (2022)
- Barbulescu A, "Effectiveness of baricitinib and tofacitinib compared with bDMARDs in RA:results from a cohort study using nationwide Swedish register data", Rheumatology(Oxford), 61, pp.3952~3962 (2022)
- Bird P, "Real-world evaluation of effectiveness, persistence, and usage patterns of monotherapy and combination therapy tofacitinib in treatment of rheumatoid arthritis in Australia", Clin Rheumatol, 41, pp.53~62 (2022)
- Mori S, "Tofacitinib versus tocilizumab in the treatment of biological-naïve or previous biological-failure patients with methotrexate-refractory active rheumatoid arthritis", RMD Open, 7, pp.e001601~ (2021)
- Mori S, "Tofacitinib therapy for rheumatoid arthritis : a direct comparison study between biologic-naïve and experienced patients", Intern Med, 57, pp.663~670 (2018)
- Shouval A, "Real-world effectiveness of tofacitinib in patients with rheumatoid arthritis : a prospective observational study", Clin Exp Rheumatol, 39, pp.1378~1384 (2021)
- Curtis JR, "Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis", Ann Rheum Dis, 75, pp.1843~1847 (2016)
- Bechman K, "A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis", Rheumatology(Oxford), 58, pp.1755~1766 (2019)
- Pawar A, "Risk of admission to hospital for serious infection after initiating tofacitinib versus biologic DMARDs in patients with rheumatoid arthritis : a multidatabase cohort study", Lancet Rheumatol, 2, pp.E84~98 (2020)
- Ytterberg SR, "Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis", N Engl J Med, 386, pp.316~326 (2022)
- Kremer JM, "Postapproval comparative safety study of tofacitinib and biological disease-modifying antirheumatic drugs : 5-year results from a United States-based rheumatoid arthritis registry", ACR Open Rheumatol, 3, pp.173~184 (2021)
