Publications

中等症から重症の関節リウマチ患者におけるbaricitinibの3年治療: 長期試験結果

Rheumatology 2020; doi:10.1093/rheumatology/keaa576

Smolen JS,

Xie L,

Jia B,

Taylor PC,

Burmester G,

Tanaka Y,

Elias A,

Cardoso A,

Ortmann R,

Walls C,

Dougados M

Three year follow up data for baricitinib demonstrated efficacy in populations that span the clinical disease continuum in RA, including DMARD-naïve, MTX-IR, csDMARD-IR, and bDMARD-IR and was well tolerated. This study evaluated achievement and maintenance of LDA, remission and physical functioning in patients treated with baricitinib for up to 3 years. Data were analysed from two 52-week, Phase 3 studies (RA-BEAM and RA-BEGIN), and one ongoing long-term extension (RA-BEYOND). Patients completin...

Keywords:

• JAK,
• Baricitinib,
• LTE,
• Efficacy

関節リウマチにおけるウパダシチニブ 対 アバタセプトの試験

N Engl J Med 2020;383:1511–21 DOI: 10.1056/NEJMoa2008250

Rubbert‑Roth A,

Enejosa J,

Pangan AL,

Haraoui B,

Rischmueller M,

Khan N,

Zhang Y,

Martin N,

Xavier RM

In patients with refractory RA to bDMARDs, upadacitinib was found to be superior to abatacept in DAS28-CRP change from baseline and the achievement of remission at week 12.612 bDMARD-IR patients were randomised 1:1 to UPA 15 mg QD or ABA, each in combination with stable synthetic DMARDs. At Week 12, patients with <20% decrease in TJC and Swollen joint count (SJC) had background medication adjusted or added. All patients completing Week 24 were eligible to remain in an open-label, long-term exten...

Keywords:

• JAK,
• Updacitinib

関節リウマチの臨床試験とアメリカのCorrona RAレジストリにおけるTofacitinibと生物学的DMARDsの年齢別 (<65 vs ≥65 歳)の 感染症と重篤感染症発生率

Ann Rheum Dis 2020; DOI: 10.1136/annrheumdis-2020-218992

Winthrop KL,

Citera G,

Gold D,

Henrohn D,

Connell CA,

Shapiro AB,

Shi H,

Onofrei AM,

Pappas DA,

Schulze-Koops H

Reports from clinical trials and the US Corrona RA registry showed that serious infection event (SIE) incidence was higher in older versus younger patients with RA receiving 10 mg BID of TOF and ADA, however, SIE risk was similar between age groups with TOF 5 mg BID and ADA.Data were collected from Phase II–IV tofacitinib studies, and the US Corrona RA registry. The clinical data set evaluated patients receiving TOF 5 and 10 mg BID versus TNFi (ADA/ETN) in RA patients aged ≥50 years. The EMA rec...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Real-World,
• Infections

活動性関節リウマチ患者のBaricitinib の臨床試験 における感染症

Annals of the Rheumatic Diseases, May 2020

Winthrop KL,

Harigai M,

Genovese MC,

Lindsey S,

Takeuchi T,

Fleischmann R,

Bradley JD,

Byers NL,

Hyslop DL,

Issa M,

Nishikawa A,

Rooney TP,

Witt S,

Dickson CL,

Smolen JS,

Dougados M

Baricitinib, an oral selective JAK1 and JAK2 inhibitor,8 demonstrated significant clinical efficacy in phase 3 RA trials. Pooled data from these trials, including a long-term extension (LTE), inform the safety profile for baricitinib, mainly to evaluate the incidence of infection in patients with active rheumatoid arthritis (RA), with a focus on serious infection, tuberculosis (TB), herpes zoster (HZ) and opportunistic infection (OI). The data collected were from eight double-blind randomised tr...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Infections

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

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

Ebina K,

Hirano T,

Maeda Y,

Yamamoto W,

Hashimoto M,

Murata K,

Takeuchi T,

Shiba H,

Son Y,

Amuro H,

Onishi A,

Akashi K,

Hara R,

Katayama M,

Yamamoto K,

Kumanogoh A,

Hirao M

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...

Keywords:

• JAK,
• TNF,
• Tofacitinib,
• Real-World

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

Finckh A,

Tellenbach C,

Herzog L,

Scherer A,

Moeller B,

Ciurea A,

von Muehlenen I,

Gabay C,

Kyburz D,

Brulhart L,

Müller R,

Hasler P,

Zufferey P

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...

Keywords:

• JAK,
• Tofacitinib,
• Real-World,
• Efficacy

関節リウマチにおける妊娠中のバリシチニブ曝露

Ther Adv Musculoskelet Dis. 2020;12:1759720X19899296

Costanzo G,

Firinu D,

Losa F,

Deidda M,

Barca MP,

Del Giacco S.

Broad and focused studies are required to have an insight of safety for small molecules, such as JAK inhibitors in the case of accidental exposure before or during pregnancy.This case study’s objective describes a case report of a 43-year-old woman affected by RA who became pregnant during BARI treatment. She has had two previous pregnancies at term without complications. After failure of bDMARDs due to loss of efficacy and adverse drug reactions, the patient was started on BARI when it became a...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Pregnancy / Fertility

RA診療におけるEULAR推奨– 2019 アップデートとJAK阻害薬に関する共同声明

Ann Rheum Dis. 2020 Jan 22. pii: annrheumdis-2019-216655.

Smolen JS,

Landewé RBM,

Bijlsma JWJ,

Burmester GR,

Dougados M,

Kerschbaumer A,

McInnes IB,

Sepriano A,

et al.

The EULAR recommendations for the management of RA have become increasingly useful in providing rheumatologists, patients, payers and other stakeholders with the evidence-based guidance and views of experts on the optimal use and sequence of pharmaceutical therapies in patients with RA. Over the course of the last decade, the evolution of the treatment landscape has already required two updates. The release of the new addition updates the 2016 recommendations.An international task force consider...

Keywords:

• EULAR