1,726
Views
6
CrossRef citations to date
0
Altmetric
Rheumatoid Arthritis

A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, , & ORCID Icon show all
Pages 543-555 | Received 29 Jul 2020, Accepted 07 Oct 2020, Published online: 09 Nov 2020

References

  • O’Dell JR. Therapeutic strategies for rheumatoid arthritis. N Engl J Med 2004;350(25):2591–602.
  • Aletaha D, Smolen JS. Diagnosis and management of rheumatoid arthritis: a review. JAMA 2018;320(13):1360–72.
  • Furst DE. The risk of infections with biologic therapies for rheumatoid arthritis. Semin Arthritis Rheum. 2010;39(5):327–46.
  • Ramiro S, Sepriano A, Chatzidionysiou K, Nam JL, Smolen JS, van der Heijde D, et al. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2017;76(6):1101–36.
  • Takeuchi T, Kameda H. The Japanese experience with biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol. 2010;6(11):644–52.
  • O’Shea JJ, Kontzias A, Yamaoka K, Tanaka Y, Laurence A. Janus kinase inhibitors in autoimmune diseases. Ann Rheum Dis. 2013;72 Suppl 2(2):ii111–5.
  • Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685–99.
  • Takeuchi T, Tanaka Y, Iwasaki M, Ishikura H, Saeki S, Kaneko Y. 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. 2016;75(6):1057–64.
  • Tanaka Y, Takeuchi T, Tanaka S, Kawakami A, Iwasaki M, Song YW, et al. 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. 2019;78(10):1320–32.
  • Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Iwasaki M, Katayama K, et al. 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. 2019;78(10):1305–19.
  • Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Song Y-W, Chen Y-H, et al. Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan. Arthritis Res Ther. 2020;22(1):47.
  • Markham A, Keam SJ. Peficitinib: first global approval. Drugs. 2019;79(8):887–91.
  • Astellas Pharma Korea, Inc. Drug details: 50 mg Smyraf (peficitinib hydrobromide). 2020. Available from: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=202000404 [last accessed 4 Mar 2020].
  • Astellas Pharma Korea, Inc. Drug details: 100 mg Smyraf (peficitinib hydrobromide). 2020. Available from: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=202000403 [last accessed 4 Mar 2020].
  • Astellas Pharma Taiwan, Inc. Drug details: 50 mg Smyraf (peficitinib hydrobromide). 2020. Available from: https://info.fda.gov.tw/MLMS/H0001D.aspx?Type=Lic&LicId=52027856 [last accessed 4 Mar 2020].
  • Astellas Pharma Taiwan, Inc. Drug details: 100 mg Smyraf (peficitinib hydrobromide). 2020. Available from: https://info.fda.gov.tw/MLMS/H0001D.aspx?Type=Lic&LicId=52027857 [last accessed 4 Jun 2020].
  • Taylor PC. Clinical efficacy of launched JAK inhibitors in rheumatoid arthritis. Rheumatology. 2019;58(Suppl 1):i17–26.
  • Duggan S, Keam SJ. Upadacitinib: first approval. Drugs. 2019;79(16):1819–28.
  • Harigai M. Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis. Rheumatology. 2019;58(1):i34–42.
  • European Medicines Agency. EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots. Available from: https://www.ema.europa.eu/en/medicines/human/referrals/xeljanz [last accessed 29 July 2020].
  • Genovese MC, Greenwald M, Codding C, Zubrzycka-Sienkiewicz A, Kivitz AJ, Wang A, et al. 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. 2017;69(5):932–42.
  • Kivitz AJ, Gutierrez-Urena SR, Poiley J, Genovese MC, Kristy R, Shay K, et al. Peficitinib, a JAK inhibitor, in the treatment of moderate-to-severe rheumatoid arthritis in patients with an inadequate response to methotrexate. Arthritis Rheumatol. 2017;69(4):709–19.
  • Genovese MC, Greenwald MW, Gutierrez-Ureña SR, Cardiel MH, Poiley JE, Zubrzycka-Sienkiewicz A, et al. Two-year safety and effectiveness of peficitinib in moderate-to-severe rheumatoid arthritis: a phase IIb, open-label extension study. Rheumatol Ther. 2019;6(4):503–20.
  • Cancer Registry and Statistics. Cancer Information Service, National Cancer Center, Japan (Monitoring of Cancer Incidence in Japan (MCIJ)). National estimates: cancer incidence data (1975-2013). Available from: https://ganjoho.jp/reg_stat/statistics/dl/index.html [last accessed 29 July 2020].
  • Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012;18(13 Supp l):S295–302.
  • Yamanaka H, Askling J, Berglind N, Franzen S, Frisell T, Garwood C, et al. Infection rates in patients from five rheumatoid arthritis (RA) registries: contextualising an RA clinical trial programme. RMD Open. 2017;3(2):e000498.
  • Chen YC, Yoo DH, Lee CK, Li KJ, Won JE, Wu WS, et al. Safety of baricitinib in East Asian patients with moderate-to-severe active rheumatoid arthritis: an integrated analysis from clinical trials. Int J Rheum Dis. 2020;23(1):65–73.
  • Lee EB, Yamanaka H, Liu Y, Tsai WC, Chen C, Kwok K, et al. Efficacy and safety of tofacitinib for the treatment of rheumatoid arthritis in patients from the Asia-Pacific region: post-hoc analyses of pooled clinical study data. Int J Rheum Dis. 2019;22(6):1094–106.
  • Nakajima A, Urano W, Inoue E, Taniguchi A, Momohara S, Yamanaka H. Incidence of herpes zoster in Japanese patients with rheumatoid arthritis from 2005 to 2010. Mod Rheumatol. 2015;25(4):558–61.
  • Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, et al. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017;76(7):1253–62.
  • Tanaka Y, Atsumi T, Amano K, Harigai M, Ishii T, Kawaguchi O, et al. Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: subgroup analyses of four multinational phase 3 randomized trials. Mod Rheumatol. 2018;28(4):583–91.
  • Winthrop KL, Yamanaka H, Valdez H, Mortensen E, Chew R, Krishnaswami S, et al. Herpes zoster and tofacitinib therapy in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014;66(10):2675–84.
  • Franks AL, Slansky JE. Multiple associations between a broad spectrum of autoimmune diseases, chronic inflammatory diseases and cancer. Anticancer Res. 2012;32(4):1119–36.
  • Krathen MS, Gottlieb AB, Mease PJ. Pharmacologic immunomodulation and cutaneous malignancy in rheumatoid arthritis, psoriasis, and psoriatic arthritis. J Rheumatol. 2010;37(11):2205–15.
  • Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275–85.
  • Harigai M, Takeuchi T, Smolen JS, Winthrop KL, Nishikawa A, Rooney TP, et al. Safety profile of baricitinib in Japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: an integrated analysis of Phase 2 and 3 trials. Mod Rheumatol. 2020;30(1):36–43.
  • Gion Y, Iwaki N, Takata K, Takeuchi M, Nishida K, Orita Y, et al. Clinicopathological analysis of methotrexate-associated lymphoproliferative disorders: comparison of diffuse large B-cell lymphoma and classical Hodgkin lymphoma types. Cancer Sci. 2017;108(6):1271–80.
  • Taylor PC, Weinblatt ME, Burmester GR, Rooney TP, Witt S, Walls CD, et al. Cardiovascular safety during treatment with baricitinib in rheumatoid arthritis. Arthritis Rheumatol. 2019;71(7):1042–55.
  • Liang H, Danwada R, Guo D, Curtis JR, Kilpatrick RD, Hendrickson B, et al. Incidence of inpatient venous thromboembolism in treated patients with rheumatoid arthritis and the association with switching biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) in the real-world setting. RMD Open. 2019;5(2):e001013.
  • Scott IC, Hider SL, Scott DL. Thromboembolism with Janus kinase (JAK) inhibitors for rheumatoid arthritis: how real is the risk? Drug Saf. 2018;41(7):645–53.
  • Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, et al. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014;66(11):2924–37.
  • Combe B, Balsa A, Winthrop K, Tony H-P, Genovese MC, Harigai M, et al. Safety summary results of baricitinib focusing on serious infections events and preselected comorbidities. Rheumatology. 2018;57(3):147–8.
  • Yamada T, Nakajima A, Inoue E, Tanaka E, Taniguchi A, Momohara S, et al. Incidence of malignancy in Japanese patients with rheumatoid arthritis. Rheumatol Int. 2011;31(11):1487–92.
  • Curtis JR, Schulze-Koops H, Takiya L, Mebus CA, Terry KK, Biswas P, et al. Efficacy and safety of tofacitinib in older and younger patients with rheumatoid arthritis. Clin Exp Rheumatol. 2017;35(3):390–400.
  • White MC, Holman DM, Boehm JE, Peipins LA, Grossman M, Henley JS. Age and cancer risk: a potentially modifiable relationship. Am J Prev Med. 2014;46(3 Suppl 1):S1–16.
  • Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(4):234–43.
  • Wollenhaupt J, Lee EB, Curtis JR, Silverfield J, Terry K, Soma K, et al. 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. 2019;21(1):1–18.