Safety and efficacy of peficitinib in Asian patients with rheumatoid arthritis who had an inadequate response or intolerance to methotrexate: results of a multicenter, randomized, double-blind, placebo-controlled phase 3 study
Lancet Regional Health - Western Pacific, The - Trang 100925 - 2023
Tài liệu tham khảo
Gibofsky, 2012, Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis, Am J Manag Care, 18, S295
Fraenkel, 2021, 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis, Arthritis Care Res (Hoboken), 73, 924, 10.1002/acr.24596
Lau, 2019, 2018 Update of the APLAR recommendations for treatment of rheumatoid arthritis, Int J Rheum Dis, 22, 357, 10.1111/1756-185X.13513
Nash, 2021, Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement, Ann Rheum Dis, 80, 71, 10.1136/annrheumdis-2020-218398
Tanaka, 2020, Peficitinib for the treatment of rheumatoid arthritis: an overview from clinical trials, Expert Opin Pharmacother, 21, 1015, 10.1080/14656566.2020.1739649
Tanaka, 2022, Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach, Nat Rev Rheumatol, 18, 133, 10.1038/s41584-021-00726-8
Gao, 2022, Pharmacokinetics and safety of single and multiple doses of peficitinib (ASP015K) in healthy Chinese subjects, Drug Des Devel Ther, 16, 1365, 10.2147/DDDT.S359501
McInnes, 2011, The pathogenesis of rheumatoid arthritis, N Engl J Med, 365, 2205, 10.1056/NEJMra1004965
Holers, 2022, Mechanism-driven strategies for prevention of rheumatoid arthritis, Rheumatol Autoimmun, 2, 109, 10.1002/rai2.12043
Taylor, 2016, A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: a current perspective, Rheumatol Int, 36, 685, 10.1007/s00296-015-3415-x
Tanaka, 2019, Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3), Ann Rheum Dis, 78, 1320, 10.1136/annrheumdis-2019-215163
Takeuchi, 2019, Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan, Ann Rheum Dis, 78, 1305, 10.1136/annrheumdis-2019-215164
van der Heijde, 2000, How to read radiographs according to the Sharp/van der Heijde method, J Rheumatol, 27, 261
Tanaka, 2021, Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis, Arthritis Res Ther, 23, 221, 10.1186/s13075-021-02590-z
Arnett, 1988, The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis, Arthritis Rheum, 31, 315, 10.1002/art.1780310302
Aletaha, 2010, 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League against Rheumatism collaborative initiative, Ann Rheum Dis, 69, 1580, 10.1136/ard.2010.138461
Felson, 1995, American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis, Arthritis Rheum, 38, 727, 10.1002/art.1780380602
2007, A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology response, Arthritis Care Res (Hoboken), 57, 193, 10.1002/art.22552
Takeuchi, 2016, Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study, Ann Rheum Dis, 75, 1057, 10.1136/annrheumdis-2015-208279
Li, 2016, Efficacy and safety results from a Phase 3, randomized, placebo-controlled trial of subcutaneous golimumab in Chinese patients with active rheumatoid arthritis despite methotrexate therapy, Int J Rheum Dis, 19, 1143, 10.1111/1756-185X.12723
Genovese, 2017, Peficitinib, a JAK inhibitor, in combination with limited conventional synthetic disease-modifying antirheumatic drugs in the treatment of moderate-to-severe rheumatoid arthritis, Arthritis Rheumatol, 69, 932, 10.1002/art.40054
Kivitz, 2017, Peficitinib, a JAK inhibitor, in the treatment of moderate-to-severe rheumatoid arthritis in patients with an inadequate response to methotrexate, Arthritis Rheumatol, 69, 709, 10.1002/art.39955
Li, 2018, Efficacy and safety of tofacitinib in Chinese patients with rheumatoid arthritis, Chin Med J (Engl), 131, 2683, 10.4103/0366-6999.245157
Yang, 2020, Efficacy and safety of baricitinib in Chinese rheumatoid arthritis patients and the subgroup analyses: results from study RA-BALANCE, Rheumatol Ther, 7, 851, 10.1007/s40744-020-00231-6
Winthrop, 2017, Herpes zoster and tofacitinib: clinical outcomes and the risk of concomitant therapy, Arthritis Rheumatol, 69, 1960, 10.1002/art.40189
Winthrop, 2014, Herpes zoster and tofacitinib therapy in patients with rheumatoid arthritis, Arthritis Rheumatol, 66, 2675, 10.1002/art.38745
Yamaoka, 2021, The safety profile of upadacitinib in patients with rheumatoid arthritis in Japan, Drug Saf, 44, 711, 10.1007/s40264-021-01067-x
Tanaka, 2022, A pooled analysis of serious infections and herpes zoster-related disease in Asian patients with rheumatoid arthritis treated with peficitinib (ASP015K) over a median of 3 years, Mod Rheumatol, 32, 708, 10.1093/mr/roab069
Kivitz, 2018, A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population, Semin Arthritis Rheum, 48, 406, 10.1016/j.semarthrit.2018.07.006
Wollenhaupt, 2019, Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study, Arthritis Res Ther, 21, 89, 10.1186/s13075-019-1866-2
Bechman, 2019, A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis, Rheumatology (Oxford), 58, 1755, 10.1093/rheumatology/kez087
Fang, 2022, Comparative safety of Janus kinase inhibitors and tumor necrosis factor inhibitors in patients undergoing treatment for rheumatoid arthritis, Int J Rheum Dis, 25, 1254, 10.1111/1756-185X.14414
Winthrop, 2022, Oral surveillance and JAK inhibitor safety: the theory of relativity, Nat Rev Rheumatol, 18, 301, 10.1038/s41584-022-00767-7
Phatak, 2023, Effectiveness and safety of generic tofacitinib in spondyloarthritis: a real-world retrospective analysis from India, Int J Rheum Dis, 26, 487, 10.1111/1756-185X.14570
