Publications

メトトレキサート無使用またはわずかな使用歴の活動性関節リウマチ患者におけるメトトレキサート併用フィルゴチニブ, フィルゴチニブ単剤, メトトレキサート: フェーズ3, 無作為化コントロール対照FINCH 3 試験

Ann Rheum Dis. 2021 Jan 15:annrheumdis-2020-219213.

Westhovens R,

Rigby WF,

van der Heijde D,

Ching DW,

Stohl W,

Kay J,

Chopra A,

Bartok B,

Matzkies F,

Yin Z,

Guo Y,

Tasset C,

Sundy JS,

Jahreis A,

Mozaffarian N,

Messina OD,

Landewé R BM,

Atsumi T,

Burmester GR

Filgotinib doses in combination with MTX have shown improved signs, symptoms and physical function in patients with RA and limited or no prior MTX exposure. FIL 200mg monotherapy did not have a superior ACR20 response rate versus MTX. This 52-week, phase 3 study evaluated FIL in 1252 patients with RA. Patients were randomised to FIL 200mg + MTX or FIL 100mg + MTX, FIL 200 mg monotherapy, or MTX monotherapy. The primary endpoint was the proportion patients achieving ACR20 at week 24. Safety was e...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 3

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Filgotinib 対 Placebo 対 Adalimumab: フェーズ III 無作為化臨床試験

Ann Rheum Dis. 2021 Jan 27:annrheumdis-2020-219214

Combe B,

Kivitz A,

Tanaka Y,

van der Heijde D,

Simon JA,

Baraf HSB,

Kumar U,

Matzkies F,

Bartok B,

Ye L,

Guo Y,

Tasset C,

Sundy JS,

Jahreis A,

Genovese MC,

Mozaffarian M,

Landewé RBM,

Bae S-C,

Keystone EC,

Nash P

Filgotinib improved RA signs and symptoms, physical function, and inhibited radiographic progression. FIL 200mg plus MTX, but not FIL 100mg plus MTX showed non-inferiority to ADA plus MTX, based on DAS28(CRP) low disease activity. FIL was also well tolerated in RA patients with inadequate response to MTX.This 52-week, phase 3 randomised clinical trial (FINCH 1) evaluated the efficacy and safety of FIL in patients with RA randomised to FIL 200 or 100mg, ADA 40mg, or placebo, all with background M...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 3

免疫介在性炎症疾患をヤヌスキナーゼ阻害薬で治療する際に考慮すべきこと: コンセンサス声明

2021 Jan;80(1):71-87. doi: 10.1136/annrheumdis-2020-218398. Epub 2020 Nov 6.

Nash P,

Kerschbaumer A,

Dorner T,

Dougados M,

Fleischmann RM,

Geissler K,

McInnes I,

Pope JE,

van der Heijde D,

Stoffer-Marx M,

Takeuchi T,

Trauner M,

Winthrop KL,

de Wit M,

Aletaha D,

Baraliakos X,

Boehncke W-H,

Emery P,

Isaacs JD,

Kremer J,

Lee EB,

et al

JAKi are approved in various immune-mediated inflammatory diseases. With five JAKi now licensed, this paper reviews key points to consider in their use to assist clinicians, patients, and other stakeholders once the decision is made to commence JAKi.The consensus was developed by a Steering Committee and an expanded Task Force using EULAR standard operating procedures. The committee included patients as well as experts in rheumatology, gastroenterology, haematology, dermatology, and infectious d...

Keywords:

• JAK,
• Review

免疫介在性炎症性疾患におけるヤヌスキナーゼ阻害薬使用時に考慮すべき点: システマテイックレビュー

RMD Open 2020;6:e001374 doi:10.1136/rmdopen-2020-001374

Kerschbaumer A,

Smolen JS,

Nash P,

Doerner T,

Dougados M,

Fleischmann R,

Geissler K,

McInnes IM,

Takeuchi T,

Trauner M,

Winthrop K,

de Wit M,

Boehncke W-H,

Falzon L,

van der Heijde D

Trials of JAKi have been conducted in many therapy areas, including rheumatology, dermatology and gastroenterology. In 2019, a task force was set up to create a consensus to guide clinicians on how to use JAKi in clinical practice. This systematic literature review conducted in 2019 support this consensusIn line with EULAR’s standardised operating procedures for recommendations, a literature search was conducted in EMBASE, Medline and the Cochrane Library databases. To evaluate the efficacy of t...

Keywords:

• JAK,
• Review

合成および生物学的DMARDs: 関節リウマチ診療に対する EULAR リコメンデーションに情報提供したシステマティック 文献レビュー

Annals of the Rheumatic Diseases 2020;79:760-770

Sepriano A,

Kerschbaumer A,

Smolen JS,

Van Der Heijde D,

Dougados M,

Van Vollenhoven R,

McInnes IB,

Bijlsma JW,

Burmester GR,

De Wit M,

Falzon L,

Landewé R

This SLR informed the 2019 EULAR taskforce updating recommendations for RA management. Overall, no new safety signals were reported. The known safety profile of bDMARDs was confirmed and extended to tsDMARDS. IL-6i associated lower intestinal perforation has been further confirmed, while VTE and PE concerns in JAKi treatment need further evaluation.Previous updates for the EULAR recommendations on RA pharmacological management were conducted in 2016. In this SLR safety of csDMARDs, tsDMARDs, and...

Keywords:

• Safety,
• EULAR

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

Kerschbaumer A,

Smolen JS,

Dougados M,

De Wit M,

Primdahl J,

McInnes I,

Van Der Heijde D,

Baraliakos X,

Falzon L,

Gossec L

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...

Keywords:

• EULAR

関節リウマチ患者におけるMTX併用Tofacitinib: 24か月間の フェーズ3 ORAL Scan試験からの患者報告アウトカム結果

Clin Exp Rheumatol . Sep-Oct 2020;38(5):848-857. Epub 2019 Dec 19.

Strand V,

van der Heijde D,

Tanaka Y,

Keystone E,

Kremer J,

Zerbini C A F,

Cardiel M H,

Cohen S,

Nash P,

Song Y-W,

Tegzová D,

Gruben D,

Wallenstein G,

Connell C A,

Fleischmann R

In the ORAL SCAN study, patients receiving TOF 5 mg or 10 mg BID reported significant improvements in patient-reported outcomes at month 3 compared with placebo, which were maintained through 24 months of treatment.RA causes a significant health and socioeconomic burden and affects all aspects of health related quality of life. ORAL Scan included patients with active RA and inadequate response to MTX who were randomised to receive TOF 5 mg or 10 mg BID plus MTX or PBO. This study evaluated the i...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL

Highlights of 2019

Please click the links below to go to the CSF review of each paper

McInnes. I

2019 was another remarkable year in cytokine signalling. We can be optimistic that clinical practice for inflammatory arthritis will continue to improve, with promising long-term safety data supporting the use of established JAK inhibitors; tofacitinib and baricitinib, in addition to exciting phase III clinical data for filgotinib and newly approved upadacitinib. You can find the most notable papers, as selected by CSF Steering Committee Chair Professor Iain McInnes, with links to their respecti...

Keywords:

• Review

メソトレキセートに効果不十分の関節リウマチ患者におけるPeficitinib (ASP015K) の有効性と安全性: 日本で実施された Phase III 無作 為化二重盲検プラセボ対照臨床試験結果 (RAJ4)

Ann Rheum Dis 2019 DOI: 10.1136/annrheumdis-2019-215164

Takeuchi T,

Tanaka Y,

Tanaka S,

Kawakami A,

Iwasaki M,

Katayama K,

Rokuda M,

Izutsu H,

Ushijima S,

Kaneko Y,

Shiomi T,

Yamada E,

van der Heijde D

Peficitinib (PEF) 100 and 150 mg demonstrated robust clinical and structural efficacy in patients with RA who have an inadequate response to MTX. In Japan, two JAK inhibitors, TOF and BARI are currently available for RA patients with an inadequate response to conventional therapies. This randomized phase 3 study (RAJ4), assessed the efficacy and safety of two PEF doses in combination with MTX compared to PBO, in Japanese MTX-IR. Patients were randomized 1:1:1 to PBO, PEF 100 mg and 150 mg with M...

Keywords:

• JAK,
• Peficitinib,
• Phase 3

Efficacy and Safety of Filgotinib for Patients With Rheumatoid Arthritis Naïve to Methotrexate Therapy: FINCH 3 Primary Outcome Results

EULAR 2019 Abstract LB0003 Presentation

Westhovens R,

Rigby WFC,

van der Heijde D,

Ching DWT,

Bartok B,

Matzkies F,

Yin Z,

Guo Y,

Tasset C,

Sundy JS,

Mozaffarian N,

Messina OD,

Landewé RBM,

Atsumi T,

Burmester GR

Filgotinib is an orally administered, selective inhibitor of JAK1. Filgotinib has shown good efficacy and was well tolerated for the treatment of RA in Phase 2 and 3 studies evaluating MTX-IR or bDMARD-IR patients. The objective of this study was to compare the efficacy and safety of filgotinib with and without MTX in patients with RA who were naïve to MTX therapy....

Keywords:

• JAK,
• Filgotinib,
• Phase 3