Publications

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

Efeito de Baricitinib e Adalimumabe na Redução da Dor e na Melhor da Função em Pacientes com Artrite Reumatoide com Baixa Atividade de Doença: Análise Exploratória de RA-BEAM

J Clin Med. 2019 Sep 5;8(9). pii: E1394

Fautrel B,

Kirkham B,

Pope JE,

Takeuchi T,

Gaich C,

Quebe A,

Zhu B,

de la Torre I,

De Leonardis F,

Taylor PC

Post hoc analyses from RA-BEAM concluded that BARI 4 mg QD or ADA 40 mg Q2W resulted in improvements in pain, physical function, fatigue and work productivity in patients with RA, independent of the treatment’s impact on inflammation. Among patients achieving remission or LDA, greater improvements in pain and physical function were seen with BARI than with ADA or PBO.Of 1010 patients included in the analysis at Week 24, 168 were in remission, 310 were in remission/LDA and 700 were not in remissi...

Keywords:

• JAK,
• Baricitinib,
• Phase 3,
• Pain

Eficácia e Segurança de Peficitinib (ASP015K) em Pacientes com Artrite Reumatoide com Resposta Inadequada a Metotrexate: Resultados de um Estudo Fase III Randomizado, Duplo-Cego, controlado com Placebo (RAJ4) no Japão

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

Efeito de Filgotinib vs Placebo na Resposta Clínica de Pacientes com Artrite Reumatoide Moderada a Grave Refratária à Terapia com Drogas Anti-Reumáticas Modificadoras de Doença: O Estudo Randomizado FINCH 2

JAMA 2019 322(4):315-325

Genovese MC,

Kalunian K,

Gottenberg JE,

Mozaffarian N,

Bartok B,

Matzkies F,

Gao J,

Guo Y,

Tasset C,

Sundy JS,

de Vlam K,

Walker D,

Takeuchi T

Among RA patients with an inadequate response or intolerance to bDMARDs, filgotinib (FIL) doses, compared to PBO resulted in significantly greater proportions achieving a clinical response at Wk12.Patients with active RA despite treatment with bDMARD therapy need treatment options. The FINCH 2 Phase 3 study compared the effects of FIL vs PBO for the treatment of RA patients with inadequate response or intolerance to ≥1 prior bDMARDs. Patients were randomized in a 1:1:1 ratio, receiving FIL 200 m...

Keywords:

• JAK,
• Filgotinib,
• Phase 3

Perfil de Segurança de Baricitinib em Pacientes Japoneses com Artrite Reumatoide Ativa com mais de 1.6 Anos de Tempo Médio de Tratamento: Uma Analise Integrada de Ensaios Fase 2 e 3.

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

Segurança Cardiovascular Durante o Tratamento com Baricitinib na Artrite Reumatóide.

Arthritis Rheumatol. 2019 Jul;71(7):1042-1055.

Taylor PC,

Weinblatt ME,

Burmester GR,

Rooney TP,

Witt S,

Walls CD,

Issa M,

Salinas CA,

Saifan C,

Zhang X,

Cardoso A,

González-Gay MA,

Takeuchi T

This study indicates no association between exposure to BARI and MACE, arterial thrombotic events (ATE), or congestive heart failure (CHF). Overall IRs for venous thromboembolic event (VTE) in BARI-treated patients falls within the reported range for patients with RA.RA patients have a greater risk of cardiovascular (CV) diseases of arterial ischemic origin, and an increased risk of VTE. Studied frequencies of thromboembolic events in RA populations in the last decade has been reported as 2–3x h...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Cardiovascular