September 2025

Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): Two phase 3, randomised, placebo-controlled and active-comparator controlled trials

Lancet 2025;406:1363–74 Doi: 10.1016/S0140-6736(25)01576-4

Gold et al. showed that icotrokinra showed superior clinical response rates versus PBO and deucravacitinib in Phase 3 moderate-to-severe plaque PsO trials. Authors evaluated the efficacy and safety of icotrokinra, a targeted oral peptide that selectively binds the IL-23 receptor, compared with both PBO and deucravacitinib in adults with moderate-to-severe plaque PsO.

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August 2025

Real-world effectiveness of tofacitinib on ulcerative colitis-associated spondyloarthropathy: A multicenter prospective study from the Italian group for the study of inflammatory bowel diseases (IG-IBD)

Ther Adv Gastroenterol 2025;18:1–11 Doi: 10.1177/17562848251367559

In patients with UC and refractory spondyloarthritis (SpA)—many of whom had previously failed multiple biologic therapies—TOF demonstrated effectiveness, particularly in those with peripheral SpA. Macaluso et al. assessed the effectiveness of TOF in UC-associated SpA. Articular responses were evaluated using rheumatologic scores.

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March 2025

Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomised placebo-controlled PROTOSTAR study

Br J Dermatol 2025;192:618–628 doi: 10.1093/bjd/ljae502

Prajapati et al. conducted the PROTOSTAR trial to assess guselkumab in paediatric patients with moderate-to-severe plaque psoriasis. Guselkumab significantly improved skin clearance versus placebo at Wk16, with high response rates sustained through Wk52 and a favourable safety profile.

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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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