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
  • [1] [Anonymous], 2017, ARTHRITIS RHEUMA S10
  • [2] Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden
    Askling, J
    Fored, CM
    Brandt, L
    Baecklund, E
    Bertilsson, L
    Cöster, L
    Geborek, P
    Jacobsson, LT
    Lindblad, S
    Lysholm, J
    Rantapää-Dahlqvist, S
    Saxne, T
    Romanus, V
    Klareskog, L
    Feltelius, N
    [J]. ARTHRITIS AND RHEUMATISM, 2005, 52 (07): : 1986 - 1992
  • [3] How comparable are rates of malignancies in patients with rheumatoid arthritis across the world? A comparison of cancer rates, and means to optimise their comparability, in five RA registries
    Askling, Johan
    Berglind, Niklas
    Franzen, Stefan
    Frisell, Thomas
    Garwood, Christopher
    Greenberg, Jeffrey D.
    Ho, Meilien
    Holmqvist, Marie
    Horne, Laura
    Inoue, Eisuke
    Michaud, Kaleb
    Nyberg, Fredrik
    Pappas, Dimitrios A.
    Reed, George
    Tanaka, Eiichi
    Tran, Trung N.
    Verstappen, Suzanne M. M.
    Yamanaka, Hisashi
    Wesby-van Swaay, Eveline
    Symmons, Deborah
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2016, 75 (10) : 1789 - 1796
  • [4] Atsumi T, 2017, MOD RHEUMATOL, V27, pS98
  • [5] Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety Assessment of Biologic ThERapy (SABER) Study
    Baddley, John W.
    Winthrop, Kevin L.
    Chen, Lang
    Liu, Liyan
    Grijalva, Carlos G.
    Delzell, Elizabeth
    Beukelman, Timothy
    Patkar, Nivedita M.
    Xie, Fenglong
    Saag, Kenneth G.
    Herrinton, Lisa J.
    Solomon, Daniel H.
    Lewis, James D.
    Curtis, Jeffrey R.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2014, 73 (11) : 1942 - 1948
  • [6] Cardiovascular safety findings in patients with rheumatoid arthritis treated with tofacitinib, an oral Janus kinase inhibitor
    Charles-Schoeman, Christina
    Wicker, Pierre
    Gonzalez-Gay, Miguel A.
    Boy, Mary
    Zuckerman, Andrea
    Soma, Koshika
    Geier, Jamie
    Kwok, Kenneth
    Riese, Richard
    [J]. SEMINARS IN ARTHRITIS AND RHEUMATISM, 2016, 46 (03) : 261 - 271
  • [7] Risk of tuberculosis, serious infection and lymphoma with disease-modifying biologic drugs in rheumatoid arthritis patients in Taiwan
    Chiu, Ying-Ming
    Lang, Hui-Chu
    Lin, Hsiao-Yi
    Yang, Ming-Ta
    Fang, Chi-Hui
    Yang, Ya-Wen
    Schabert, Vernon F.
    Tang, Boxiong
    [J]. INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, 2014, 17 : 9 - 19
  • [8] Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis
    Clowse, Megan E. B.
    Feldman, Steven R.
    Isaacs, John D.
    Kimball, Alexandra B.
    Strand, Vibeke
    Warren, Richard B.
    Xibille, Daniel
    Chen, Yan
    Frazier, Donald
    Geier, Jamie
    Proulx, James
    Marren, Amy
    [J]. DRUG SAFETY, 2016, 39 (08) : 755 - 762
  • [9] Analysis of Infections and All-Cause Mortality in Phase II, Phase III, and Long-Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis
    Cohen, Stanley
    Radominski, Sebastiao C.
    Gomez-Reino, Juan J.
    Wang, Lisy
    Krishnaswami, Sriram
    Wood, Susan P.
    Soma, Koshika
    Nduaka, Chudi I.
    Kwok, Kenneth
    Valdez, Hernan
    Benda, Birgitta
    Riese, Richard
    [J]. ARTHRITIS & RHEUMATOLOGY, 2014, 66 (11) : 2924 - 2937
  • [10] 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
    Cohen, Stanley B.
    Tanaka, Yoshiya
    Mariette, Xavier
    Curtis, Jeffrey R.
    Lee, Eun Bong
    Nash, Peter
    Winthrop, Kevin L.
    Charles-Schoeman, Christina
    Thirunavukkarasu, Krishan
    DeMasi, Ryan
    Geier, Jamie
    Kwok, Kenneth
    Wang, Lisy
    Riese, Richard
    Wollenhaupt, Juergen
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2017, 76 (07) : 1253 - 1262