August 2020

関節リウマチ治療におけるメトトレキサート併用または非併用でのバリ シチニブの長期有効性と安全性: バリシチニブ単剤継続または、メトト レキサート単剤またはメトトレキサート併用Eバリシチニブからスイッチ でのバリシチニブ単剤の経験

Arthritis Care Res (Hoboken) 2020;72(8):1112-1121

This 24-week update from the baricitinib RA-BEYOND LTE study follows patients previously treated in the pivotal study RA-BEGIN. It demonstrates the maintained safety and efficacy of baricitinib monotherapy, and the effects of concurrent MTX treatment on response rates and patient reported outcomes. Previous P3 study RA-BEGIN demonstrated the superior efficacy of 4mg baricitinib compared to MTX monotherapy up to 52 weeks, with no major safety events being identified. At the end of the trial, pati...

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メトトレキサート未治療の中等度から重度の活動性関節リウマチ患者に おけるウパダシチニブの有効性と安全性 (SELECT-EARLY): 無作為化, 二 重盲検, 実薬対照, 多施設多国試験

Arthritis Rheumatol 2020

Upadacitinib monotherapy demonstrated superior clinical, radiographic, and patient-reported outcomes versus methotrexate in methotrexate-naïve RA patients.This 48-week double-blind active comparator study investigated upadacitinib monotherapy in patients with early RA, who were either methotrexate-naïve, or who had very limited exposure. 947 patients were randomised to once-daily upadacitinib 15 or 30 mg, or weekly methotrexate. Unusually, there were two separate primary endpoints, selected for ...

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July 2020

乾癬性関節炎に対する薬物治療: 乾癬性関節炎診療に対するEULAR リコメンデーション改訂の ためのシステマティック文献レビュー

Annals of the Rheumatic Diseases 2020;79:778-786

This SLR reviewed data on pharmacological treatment of PsA. Findings informed the 2019 EULAR taskforce when updating recommendations for PsA management. Overall, no new safety signals were reported. Encouragingly, LTEs of JAKi did not report any venous thromboembolic events or PEs. Efficacy was demonstrated for a range of bDMARD and tsDMARD therapies in various disease domains. Efficacy varied between PsA manifestations and between therapies. Observational data demonstrated efficacy when switchi...

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活動性乾癬性関節炎に対するTofacitinibの安全性と有効性: オープンラベル長期延長試験であるOPAL Balanceの中間解析

Rheumatol Ther 2020 doi.org/10.1007/s40744-020-00209-4

This 3-year, open-label, LTE study follows PsA patients previously treated in pivotal studies OPAL Broaden and OPAL Beyond. It demonstrates maintained safety and efficacy of tofacitinib up to 36 and 30 months, respectively. No new safety concerns are highlighted. Previous P3 studies, OPAL Broaden and OPAL Beyond, demonstrated safety and efficacy of 5mg and 10mg tofacitinib BID in PsA. These patients rolled over to OPAL Balance for a period of 36 months. 686 participants were used in this interim...

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バイオナイーブ関節リウマチ患者とバイオスイッチ患者におけ る7 生物製剤とtofacitinibの継続率: ANSWER コホート試験

Arthritis Res Ther 2020;22:142

This paper is based upon a long-term cohort study, namely the ANSWER cohort, an observational multi-centre registry of RA patients in the Kansai district of Japan. Analyses demonstrate a difference in observed drug retention between bDMARDs-naïve and bDMARDs-switched patients. 7 bDMARD treatments were compared in patients with no prior exposure to biologics, with abatacept showing the greatest retention rate. In patients that had switched between these same bDMARDs or to tofacitinib throughout t...

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June 2020

スイスにおけるRA患者の観察研究で, TNF阻害薬, 機序の 異なる生物学的製剤, tofacitinibの有効性は同等

RMD Open 2020;6:e001174 doi:10.1136/rmdopen-2020-001174

This nested cohort study found that, in Switzerland, there was a generally limited overall drug maintenance for b/tsDMARD options in RA. Using data from SCQM-RA – a prospective longitudinal registry, overall maintenance (drug survival) was calculated for TNFi, bDMARD-OMA or JAKi in patients with RA.After adjusting for potential confounding factors, there was a higher hazard of drug discontinuation with TNFi compared with tofacitinib; no significant difference was observed between non-TNF bDMARDs...

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バリシチニブの一時中断: 関節リウマチ患者における中断 の特徴と臨床アウトカムへの影響

Arth Res Ther 2020;22:115 doi.org/10.1186/s13075-020-02199-8

This study aimed to characterize temporary interruptions of baricitinib and describe their impact on efficacy and safety. Brief interruptions during phase 3 baricitinib trials were associated with minor increases in symptoms which were resolved following treatment. In life-long, chronic conditions such as RA, interruption of therapy is common for various reasons, such as side effects, non-compliance, or because a patient requires surgery. Concerns have been raised that these treatment breaks cou...

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メトトレキサートに効果不十分な関節リウマチ患者における バリシチニブ: Phase 3試験結果

Clin Exp Rheumatol . Jul-Aug 2020;38(4):732-741. Epub 2020 May 20.

This study conducted mainly in Chinese patients with RA, and an inadequate response to MTX, showed that baricitinib 4mg was associated with significant improvements and consistent with the findings from previous clinical trials.The efficacy and safety of baricitinib have been assessed in several clinical trials, predominantly in Caucasian populations. However, evidence on the efficacy and safety of baricitinib in Chinese patients is limited, with only one of the main clinical trial program studi...

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May 2020

関節リウマチにおけるフェネブルチニブのプラセボまたはアダリムマ ブの比較: 無作為化プラセボ対照フェーズII治験 (ANDES Study)

Arthritis Rheumatol. 2020 Sep; 72(9): 1435–1446.

In this randomised phase II trial with MTX treatment-refractory RA patients, greater efficacy was observed with fenebrutinib 150 mg once daily or 200 mg twice daily compared to placebo, while response rates were numerically similar to those observed with adalimumab. BTK inhibitors have demonstrated clinical efficacy in B cell malignancies and multiple sclerosis, although there is limited clinical evidence of its efficacy in RA. Fenebrutinib (FEN) an orally active and selective non-covalent inhib...

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April 2020

活動性関節リウマチ患者におけるTofacitinib, Baricitinib, Upadacitinib, Filgotinib のアダリムマブと比較した相対的有効性

Z Rheumatol. 2020 DOI: 10.1007/s00393-020-00750-1

This Bayesian network meta-analysis, comparing the relative efficacy and safety of JAK inhibitors, determined BARI 4mg + MTX and UPA 15mg + MTX were the most effective. The analysis included 5451 patients with an inadequate response to MTX and active RA, from four RCTs. Relative effects were converted into a probability allowing each treatment to be ranked. BARI and UPA had significantly higher ACR20 response rates than ADA 40mg + MTX whilst TOF 5mg and FIL 200mg had comparable ACR20 response ra...

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