Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis

被引:156
作者
Harigai, Masayoshi [1 ]
机构
[1] Tokyo Womens Med Univ, Sch Med, Div Epidemiol & Pharmacoepidemiol, Dept Rheumatol, Tokyo, Japan
关键词
Janus kinase; RA; safety; tofacitinib; baricitinib; adverse event; infection; herpes zoster; malignancy; thromboembolism; INTERSTITIAL LUNG-DISEASE; NECROSIS FACTOR THERAPY; LONG-TERM SAFETY; SERIOUS INFECTION; OPPORTUNISTIC INFECTIONS; POSTMARKETING SURVEILLANCE; JAPANESE PATIENTS; TREATED PATIENTS; BRITISH-SOCIETY; HERPES-ZOSTER;
D O I
10.1093/rheumatology/key287
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
To facitinib and baricitinib are two of the currently available Janus kinase (JAK) inhibitors for the treatment of patients with RA. Randomized controlled trials have shown that these JAK inhibitors are as efficacious as biological DMARDs. Safety profiles of these JAK inhibitors in randomized controlled trials and their long-term extension studies have been demonstrated; however, real world evidence remains to be established to bridge the gap between randomized controlled trials and rheumatology clinics. Fundamentally, no difference in the screening, prevention, and monitoring of infections between JAK inhibitors and biological DMARDs exists. However, increased risk of herpes zoster is probably common to all JAK inhibitors. No indication of increased risk for malignancy in patients with RA treated with JAK inhibitors has been reported. To evaluate risks of relatively rare serious adverse events such as thromboembolic events, gastrointestinal perforation, and interstitial lung disease in clinical settings, accumulation of cases with these events are needed. Continuous pharmacovigilance activity is absolutely warranted to establish the safety of JAK inhibitors in patients with RA and other rheumatic diseases.
引用
收藏
页码:34 / 42
页数:9
相关论文
共 62 条
  • [11] Development and Validation of a Risk Score for Serious Infection in Patients With Rheumatoid Arthritis
    Crowson, Cynthia S.
    Hoganson, Deana D.
    Fitz-Gibbon, Patrick D.
    Matteson, Eric L.
    [J]. ARTHRITIS AND RHEUMATISM, 2012, 64 (09): : 2847 - 2855
  • [12] Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis
    Curtis, Jeffrey R.
    Xie, Fenglong
    Yun, Huifeng
    Bernatsky, Sasha
    Winthrop, Kevin L.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2016, 75 (10) : 1843 - 1847
  • [13] Tofacitinib, an oral Janus kinase inhibitor: analysis of malignancies across the rheumatoid arthritis clinical development programme
    Curtis, Jeffrey R.
    Lee, Eun Bong
    Kaplan, Irina V.
    Kwok, Kenneth
    Geier, Jamie
    Benda, Birgitta
    Soma, Koshika
    Wang, Lisy
    Riese, Richard
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2016, 75 (05) : 831 - 841
  • [14] Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy - Results from the British Society for Rheumatology Biologics Register
    Dixon, W. G.
    Watson, K.
    Lunt, M.
    Hyrich, K. L.
    Silman, A. J.
    Symmons, D. P. M.
    [J]. ARTHRITIS AND RHEUMATISM, 2006, 54 (08): : 2368 - 2376
  • [15] Frequency of infection in patients with rheumatoid arthritis compared with controls - A population-based study
    Doran, MF
    Crowson, CS
    Pond, GR
    O'Fallon, WM
    Gabriel, SE
    [J]. ARTHRITIS AND RHEUMATISM, 2002, 46 (09): : 2287 - 2293
  • [16] Elli Lilly and Company, JAP PACK INS BAR
  • [17] Elli_ Lilly_ and_ company_ Limited, 2018, SUMM PROD CHAR OL 2
  • [18] Fleischmann R, 2017, RMD OPEN, V3, DOI 10.1136/rmdopen-2017-000491
  • [19] HLA-A*31:01 and methotrexate-induced interstitial lung disease in Japanese rheumatoid arthritis patients: a multidrug hypersensitivity marker?
    Furukawa, Hiroshi
    Oka, Shomi
    Shimada, Kota
    Tsuchiya, Naoyuki
    Tohma, Shigeto
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2013, 72 (01) : 153 - 155
  • [20] Harigai M, 2017, MOD RHEUMATOL, V27, pS97