English version of Japanese guidance for the use of oral Janus kinase inhibitors (JAK1 and TYK2 inhibitors) in the treatments of psoriasis.
JAK1 inhibitor
TYK2 inhibitor
deucravacitinib
psoriasis
upadacitinib
Journal
The Journal of dermatology
ISSN: 1346-8138
Titre abrégé: J Dermatol
Pays: England
ID NLM: 7600545
Informations de publication
Date de publication:
May 2023
May 2023
Historique:
revised:
08
03
2023
received:
01
03
2023
accepted:
12
03
2023
medline:
4
5
2023
pubmed:
3
5
2023
entrez:
3
5
2023
Statut:
ppublish
Résumé
This is the English version of Japanese guidance for the use of oral Janus kinase (JAK) inhibitors (JAK1 and tyrosine kinase 2 [TYK2] inhibitors) in the treatments of psoriasis. Several cytokines, such as interleukin (IL)-6, IL-7, IL-12, IL-21, IL-22, IL-23, interferon (IFN)-α, and IFN-γ, are involved in the pathogenesis of psoriasis (including psoriatic arthritis). As oral JAK inhibitors hinder the JAK-signal transducers and activators of transcription signal transduction routes involved in the signal transduction of these cytokines, they may be effective for the treatment of psoriasis. JAK has four types: JAK1, JAK2, JAK3, and TYK2. Regarding the use of oral JAK inhibitors for the treatment of psoriasis in Japan, indications of the JAK1 inhibitor upadacitinib were extended also to psoriatic arthritis in 2021, and the use of the TYK2 inhibitor deucravacitinib for plaque-type psoriasis, pustular psoriasis, and erythrodermic psoriasis became covered by health insurance in 2022. This guidance was developed for board-certified dermatologists who specialize in the treatment of psoriasis and to promote the proper use of oral JAK inhibitors. In the package inserts and guides for appropriate use, upadacitinib and deucravacitinib are classified as a "JAK inhibitor" and a "TYK2 inhibitor", respectively, and it is possible that there may be differences in safety between the two drugs. The safety of these drugs will be evaluated for the future by the postmarketing surveillance for molecularly targeted drugs for psoriasis of the Japanese Dermatological Association.
Identifiants
pubmed: 37132187
doi: 10.1111/1346-8138.16797
doi:
Substances chimiques
Cytokines
0
Interleukin-6
0
JAK1 protein, human
EC 2.7.10.2
Janus Kinase 1
EC 2.7.10.2
Janus Kinase 2
EC 2.7.10.2
Janus Kinase Inhibitors
0
TYK2 Kinase
EC 2.7.10.2
TYK2 protein, human
EC 2.7.10.2
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e138-e150Informations de copyright
© 2023 Japanese Dermatological Association.
Références
Ciccia F, Crispino N. JAK/STAT pathway and nociceptive cytokine signalling in rheumatoid arthritis and psoriatic arthritis. Clin Exp Rheumatol. 2021;39:668-75.
Parmentier JM, Voss J, Graff C, Schwartz A, Argiriadi M, Friedman M, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). BMC Rheumatol. 2018;2:23.
Gonciarz M, Pawlak-Buś K, Leszczyński P, Owczarek W. TYK2 as a therapeutic target in the treatment of autoimmune and inflammatory diseases. Immunotharapy. 2021;13:1135-50.
AbbVie GK. Package inserts Rinvoq® (upadacitinib hydrate) tablets. (Revised May 2022). [cited 2022 November 14]. Available from: https://www.info.pmda.go.jp/go/pack/3999048G2024_1_09/ (in Japanese)
Bristol-Myers Squibb KK. Package inserts Sotyktu® (Deucravacitinib) tablets. (Created September 2022). [cited 2022 November 14]. Available from: https://file.bmshealthcare.jp/bmshealthcare/pdf/package/Tyk2.pdf?date=20221018 (in Japanese)
AbbVie GK. Guide for the proper use of Janus kinase (JAK) inhibitor, Rinvoq® (upadacitinib hydrate) tablets. (Created May 2022). [cited 2022 November 14]. Available from: https://a-connect.abbvie.co.jp/-/media/assets/pdf/products/rinvoq/RINVOQ_useguide.pdf (in Japanese)
Bristol-Myers Squibb KK. Guide for the proper use of Sotyktu® (Deucravacitinib) tablets. (Created September 2022). [cited 2022 November 14]. Available from: https://file.bmshealthcare.jp/bmshealthcare/pdf/guide/Tyk2-guide.pdf?date=20221018 (in Japanese)
Mclnnes IB, Anderson JK, Magrey M, Merola JF, Liu Y, Kishimoto M, et al. Trial of upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med. 2021;384:1227-39.
Mclnnes IB, Kato K, Magrey M, Merola JF, Kishimoto M, Pacheco-Tena C, et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021;7:e001838.
Mease PJ, Lertratanakul A, Anderson JK, Papp K, Van den Bosch F, Tsuji S, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80:312-20.
Mease PJ, Lertratanakul A, Papp KA, van den Bosch FE, Tsuji S, Dokoupilova E, et al. Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 56-week data from the randomized controlled phase 3 SELECT-PsA 2 study. Rheumatol Ther. 2021;8:903-19.
Armstrong AW, Gooderham M, Warren RB, Papp KA, Strober B, Thaçi D, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88:29-39.
Strober B, Thaçi D, Sofen H, Kircik L, Gordon KB, Foley P, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 program for evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88:40-51.
Tokuda H, Harigai M, Kameda H, Tomono K, Takayanagi N, Watanabe A, et al. Consensus statements for medical practice: biological agents and lung disease [abridged English translation by the Japanese respiratory society]. Respir Investig. 2017;55:229-51.
Drafting Committee for Hepatitis Management Guidelines. The Japan Society of Hepatology. Japan Society of Hepatology Guidelines for the Management of Hepatitis B Virus Infection: 2019 update. Hepatol Res. 2020;50:791-816.
Koike R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K, et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol. 2009;19:351-7.
Guideline Committee, Japan College of Rheumatology/guideline committee for RA therapeutic medicine: guidance for the use of TNF inhibitors for rheumatoid arthritis (RA). Tokyo: Japan College of Rhumatology; 2020 (Revised on February 1, 2020) [cited 2022 November 14]. Available from: https://www.ryumachi-jp.com/info/guideline_tnf.pdf (In Japanese).
Saeki H, Mabuchi T, Asahina A, Abe M, Igarashi A, Imafuku S, et al. English version of Japanese guidance for use of biologics for psoriasis (the 2022 version). J Dermatol. 2023;50:e41-68.
Nash P, Kerschbaumer A, Dörner T, Dougados M, Fleischmann RM, Geissler K, et al. Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement. Ann Rheum Dis. 2021;80:71-87.
Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386:316-26.
Strangfeld A, Richter A, Siegmund B, Herzer P, Rockwitz K, Demary W, et al. Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs. Ann Rheum Dis. 2017;76:504-10.