Publications

関節リウマチ治療における，Tofacitinib の 9.5年間の有効性 と安全性: グローバル，オープンラベル，長期延長試験の最 終結果

Arthritis Res Ther. 2019 Apr 5;21(1):89.

Wollenhaupt J,

Lee EB,

Curtis JR,

Silverfield J,

Terry K,

Soma K,

Mojcik C,

DeMasi R,

Strengholt S,

Kwok K,

Lazariciu I,

Wang L,

Cohen S

TOF 5 mg and 10mg BID demonstrated a consistent safety profile and sustained efficacy for up to 9.5 years in this open-label LTE ORAL Sequel study.TOF 5 mg and 10 mg BID demonstrated consistent safety (as monotherapy and combination therapy) and efficacy within this open-label LTE study of RA patients. As RA requires long-term treatment, it’s important to assess the long-term efficacy and safety of RA therapies to understand the potential lifelong impact on patient health and quality of life. Th...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Efficacy,
• LTE

日本人活動性関節リウマチ患者におけるバリシチニブの中央値1.6年の治療期間における安全性評価: フェーズ2および3治験の統合解析

Mod Rheumatol. 2019 Feb 20:1-23. DOI: 10.1080/14397595.2019.1583711

Harigai M,

Takeuchi T,

Smolen JS,

Winthrop KL,

Nishikawa A,

Rooney TP,

Saifan CG,

Issa M,

Isaka Y,

Akashi N,

Ishii T,

Tanaka Y

In this integrated analysis, BARI showed an acceptable safety profile in Japanese patients with up to 3.2 years of exposure. Other than incidences of herpes zoster (HZ), no major differences were noted with BARI safety in Japanese patients with RA, compared to the patients in the integrated database.BARI has previously demonstrated significant clinical efficacy and acceptable safety. Japanese patients who participated in the BARI clinical development programme, were comparable to those from the ...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Phase 3

関節リウマチ患者におけるメトトレキサート併用トファシチニブ: 24ヶ月，フェーズ 3 ORAL Scan 試験からの臨床的有効性，　　画像的アウトカムおよび安全性

Arthritis Rheumatol. 2019 Jun;71(6):878-891

van der Heijde D,

Strand V,

Tanaka Y,

Keystone E,

Kremer J,

Zerbini CAF,

Cardiel MH,

Stanley Cohen S,

Nash P,

Song YW,

Tegzová D,

Gruben D,

Wallenstein G,

Connell CA,

Fleischmann R; ORAL Scan investigators

RA patients receiving TOF 5 or 10 mg BID plus MTX showed sustained clinical and radiographic treatment effects through months 12-24. The safety profile was consistent with previous TOF studies. The 12-month data from the ORAL Scan study have been previously reported. This report assesses durability of responses, including structural damage progression, and safety with TOF through 24 months. Patients were randomized 4:4:1:1 to receive TOF 5 or 10 mg BID, or PBO advanced to TOF with stable, backgr...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• Radiographic

関節リウマチフェーズ3におけるトファシチニブ単剤または従来型抗リウマチ薬併用の安全性プールデータ

Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006.

Kivitz AJ,

Cohen S,

Keystone E,

van Vollenhoven RF,

Haraoui B,

Kaine J,

Fan H,

Connell CA,

Bananis E,

Takiya L,

Fleischmann R

In this pooled analysis of Phase 3 Tofacitinib (TOF) trials, safety profiles were generally similar between patients receiving monotherapy and combination therapy. Although selected adverse events of interest showed lower incidence rates (IRs) for TOF monotherapy patients.TOF has been studied as monotherapy and in combination with csDMARDs. In this post-hoc analysis, data were pooled from six Phase 3 TOF studies in RA patients to further examine the safety profile when used as monotherapy or in ...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• Meta analysis

Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Ankylosing Spondylitis (TORTUGA): Results from a Randomized, Placebo-controlled, Phase 2 Trial

Lancet 2018 Dec 1;392(10162):2378-2387. DOI 10.1016/S0140-6736(18)32463-2

Van der Heijde D,

Baraliakos X,

Gensler LS,

Maksymowych WP,

Tseluyko V,

Nadashkevich O,

Abi-Saab W,

Tasset C,

Meuleners L,

Besuyen R,

Hendrikx T,

Mozafarian N,

Liu K,

Greer JM,

Deodhar A,

Landewé R

In this first clinical trial of filgotinib in patients with active AS, filgotinib significantly reduced disease activity, and the signs and symptoms of AS compared with placebo. The TORTUGA trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 263 adult patients from 30 sites in seven countries. Patients with active AS and an inadequate response or intolerance to two or more NSAIDs were assigned 1:1 to receive filgotinib 200 mg or placebo once daily for 12 weeks....

Keywords:

• JAK,
• Filgotinib,
• Phase 2

Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Psoriatic Arthritis (EQUATOR): Results from a Randomised, Placebo-controlled, Phase 2 Trial

Lancet. 2018 Dec 1;392(10162):2367-2377. DOI 10.1016/ S0140-6736(18)32483-8

Mease P,

Coates LC,

Helliwell PS,

Stanislavchuk M,

Rychlewska-Hanczewska A,

Dudek A,

Abi-Saab W,

Tasset C,

Meuleners L,

Harrison P,

Besuyen R,

Van der Aa A,

Mozafarian N,

Greer JM,

Kunder R,

Van den Bosch F,

Gladman DD

In this first clinical trial of filgotinib in patients with PsA, filgotinib was effective in treating the signs and symptoms of active PsA across various disease manifestations.The EQUATOR trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 191 adult patients from 25 sites in seven countries. Patients with active moderate-to-severe PsA and an insufficient response or intolerance to at least one csDMARD were assigned 1:1 to receive filgotinib 200 mg or placebo o...

Keywords:

• JAK,
• Filgotinib,
• Phase 2

活動性関節リウマチ患者におけるトファシチニブとバリシチニブの有効性および安全性の比較: 無作為化対照試験のBayesian Network Meta-analysis

Z Rheumatol. 2018 Sep 6. DOI 10.1007/s00393-018-0531-5

Bae SC and Lee YH

Tofacitinib (TOF) 10mg and baricitinib (BARI) 4mg, in combination with methotrexate (MTX), were the most efficacious treatments in RA patients with an inadequate response to DMARDs or biologics. Both combination treatments presented acceptable safety profiles and were not associated with a significant risk of serious adverse events.This study employed a Bayesian approach to Meta-Analysis; combining the available evidence across a network of Randomised Controlled trials (RCTs).Twelve RCTs contai...

Keywords:

• JAK,
• Baricitinib,
• Tofacitinib,
• Efficacy,
• Safety,
• Meta analysis

活動性関節リウマチ患者におけるバリシチニブの中央値2年間の安全性

J Rheumatol. 2019 Jan;46(1):7-18. DOI: 10.3899/jrheum.171361

Smolen J,

Genovese M,

Takeuchi T,

Hyslop D,

Macias W,

Rooney T,

Chen L,

Dickson C,

Riddle Camp J,

Cardillo T,

Ishii T and Winthrop K

Baricitinib (BARI) showed an acceptable 5.5-year safety profile in this integrated analysis of patients with moderate-to-severe, active RA.This study evaluated the safety profile of the oral, once daily Janus kinase inhibitor, BARI, in adults with moderately to severely active RA. Data from eight randomised clinical trials and one long-term extension study were pooled and analysed for placebo comparison and dose response.There were 3492 patients who received BARI for a total of 6637 patient-yea...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Review

Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltiMMa-1 and UltiMMa-2): Results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled Phase 3 trials

Lancet. 2018;392:650–61. doi: 10.1016/S0140-6736(18)31713-6

Gordon KB,

Strober B,

Lebwohl M,

Augustin M,

Blauvelt A,

Poulin Y,

Papp KA,

Sofen H,

Puig L,

Foley P,

Ohtsuki M,

Flack M,

Geng Z,

Gu Y,

Valdes JM,

Thompson EHZ,

Bachelez H

Here, the authors reported risankizumab to be both efficacious when compared to both placebo and ustekinumab in the treatment of moderate to severe plaque PsO. This publication aimed to describe two Phase 3 replicate studies, UltiMMa-1 and UltiMMa-2, which assessed the efficacy and safety of risankizumab compared with placebo or ustekinumab in patients with moderate-to-severe chronic plaque PsO.

Keywords:

• Efficacy,
• Phase 3,
• Risankizumab,
• Safety,
• Ustekinumab

MTXに効果不十分の関節リウマチ患者に対するサリルマブ の2年結果: 安全性, 有効性および画像的アウトカム

Rheumatology 2018;57:1423–1431 DOI: 10.1093/rheumatology/key121

Genovese MC,

van Adelsberg J,

Fan C,

Graham NMH,

van Hoogstraten H,

Parrino J,

Mangan EK,

Spindler A,

Huizinga TWJ,

van der Heijde D,

for the EXTEND study investigators

Two-year treatment of active, moderate-to-severe RA with sarilumab, along with dose reduction in the event of laboratory abnormalities, resulted in durable efficacy outcomes and a safety profile consistent with previous reports involving IL-6R inhibition. Durable long-term safety and efficacy, reduced joint damage progression, and conserving health-related quality of life and work productivity are important goals of therapy in RA.1 Sarilumab significantly reduced disease activity, improved physi...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3,
• Safety,
• Radiographic