September 2024

A multicentre randomized double-blind placebo-controlled phase III study of the efficacy and safety of xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis

Br J Dermatol. 2024 Aug 14;191:336-343 doi:10.1093/bjd/ljae062

Cai et al. demonstrated that xeligekimab significantly improved the Psoriasis Area and Severity Index (PASI) scores in patients with moderate-to-severe plaque psoriasis, with 90.7% achieving PASI 75 at week 12. Xeligekimab was well-tolerated with no unexpected safety concerns.

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October 2023

乾癬性関節炎患者におけるグセルクマブの長期安全性: 乾癬と乾癬性関節炎を対象とした11つのフェーズ II/III試験の統合解析

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

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January 2022

オピオイド鎮痛薬使用中の関節リウマチ患者の疼痛軽減: バリシチニブのフェーズ3試験の事後解析

ACR Open Rheumatol. 2021. Epub ahead of print. doi: 10.1002/acr2.11380

This post hoc analysis shows that pain reduction was similar between opioid users and nonusers with baricitinib 2 mg and 4 mg, but not adalimumab.Use of opioids to treat RA-related pain has increased, yet long-term use has been associated with reduced efficacy and safety concerns. In addition, the misuse of opioids has resulted in a public health crisis in the United States and highlights the need for safe, effective nonaddictive alternatives for pain management. As such, Pope, et al. assessed p...

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October 2020

関節リウマチ治療におけるbaricitinibの有効性: 実臨床における線維化およびバイオマーカーに対する修飾効果

Int Immunopharmacol. 2020 Sep;86:106748.

BARI demonstrated to be a safe immune modulator that reduces the concentrations biomarkers of lung fibrosis and inflammation in RA patients, including a subgroup with interstitial lung involvement. Professor Alessandro and colleagues analysed the effects of baricitinib in a population of RA and RA-ILD patients in a real-life setting, describing any changes in lung function parameters, serum inflammatory biomarkers and fibrotic biomarkers after 6 months of treatment. Fifteen patients were recruit...

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June 2019

自己免疫モデルにおけるBTK阻害薬Evorutinib有効性と薬力学モデル

J Immunol 2019;202:2888–2906. DOI: 10.4049/jimmunol.1800583

BTK is involved in both adaptive and innate immune responses and mediates signalling of several immune receptors of relevance to RA and SLE pathogenesis. Targeting BTK is a promising approach therefore for autoimmune disorders with aberrant B cell responses. Evobrutinib is a novel, highly specific, and irreversible BTK inhibitor. In vivo and animal models showed that evobrutinib modulated B cell and innate immune cell activation, was efficacious, and prevented joint damage. The potency of evobru...

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July 2018

従来型抗リウマチ薬に効果不十分な関節リウマチ患者におけるウパダシチニブの安全性と有効性 (SELECT-NEXT): 無作為化二重盲検プラセボ対照フェーズ3治験

Lancet 2018;391:2503–12

Patients with moderate-to-severe active RA had significant improvements in clinical signs and symptoms with upadacitinib (UPA) compared with placebo.In Phase 2 studies, UPA showed favourable efficacy when administered twice daily as an immediate-release formulation at doses of 6–12 mg in patients with active RA who had TNFi-IR.1,2 An extended-release formulation allowing once-daily (QD) administration was developed for Phase 3 studies. SELECT-NEXT was a double-blind, multicentre, Phase 3 study t...

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June 2018

従来型抗リウマチ薬に効果不十分の関節リウマチ患者における，構造的関節破壊の画像的進行に対する有効性

RMD Open. 2018 May 8;4(1):e000662. DOI: 10.1136/rmdopen-2018-000662

Once daily baricitinib (BARI) inhibited radiographic progression of structural joint damage in patients with an inadequate response or intolerance to csDMARDs over 48 weeks.Current treatment goals aim to use DMARDs to inhibit structural joint damage and prevent long-term functional disability. In RA-BUILD¹, BARI was shown to significantly reduce radiographic joint damage progression in patients with active RA, with an intolerance or inadequate response to csDMARDs. Here, the authors report the l...

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トファシチニブ治療による関節リウマチ患者の長期的画像および患者立脚型評価: ORAL Start および ORAL Scan 事後解析

Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7

Tofacitinib (TOF) therapy reduced the progression of structural joint damage at 2 years, in patients of all disease states, compared with patients given methotrexate (MTX). Early intervention with DMARDs aim to prevent the development of future RA symptoms and inhibit the progression of structural damage to the joints. This post-hoc analysis uses data from two Phase 3 TOF studies, to examine the efficacy of early intervention with TOF on long-term radiographic outcomes and disease activity state...

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January 2018

トシリズマブまたはメトトレキサートを用いたT2T戦略における新規診断早期関節リウマチ患者の患者立脚型評価

Rheumatology (Oxford) 2017 Dec 1;56(12):2179-2189 doi: 10.1093/rheumatology/kex319

Patient-reported outcomes (PROs) vastly improved in the first 24 weeks post-initiation of tocilizumab (TCZ) therapies compared to methotrexate (MTX) monotherapy in the U-Act-Early trial.U-Act-Early was a two-year, treat-to-target study that compared the safety and efficacy of TCZ and MTX treatment strategies in DMARD-naïve patients with early RA. Sustained remission was classed as more effective in patients given TCZ monotherapy or combination therapy with MTX compared to MTX alone. TCZ therapie...

September 2017

Patient-reported Outcomes from a Phase 3 Study of Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Secondary Analyses from the RA-BEAM Study

Ann Rheum Dis 2017;76(11):1853-1861. doi: 10.1136/annrheumdis-2017-211259

This paper describes the patient-reported outcome (PRO) data collected in RA-BEAM, a Phase 3 study of baricitinib compared with both placebo and adalimumab in patients with RA and an inadequate response to MTX.PRO measures evaluated include health-related quality of life (HRQOL), physical function, disability, fatigue, sleep, mental health status, work productivity and work activity impairment. The RA-BEAM study demonstrated that patients treated with baricitinib experienced a greater improveme...

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