Publications

Résultats cliniques chez les patients passant de l'adalimumab au baricitinib en non-réponse et / ou dans le plan de l'étude: phase III chez des patients atteints de polyarthrite rhumatoïde

Ann Rheum Dis. 2019 Jul;78(7):890-898.

Tanaka Y,

Fautrel B,

Keystone EC,

Ortmann RA,

Xie L,

Zhu B,

Issa M,

Patel H,

Gaich CL,

de Bono S,

Rooney TP,

Taylor PC

Switching from ADA to BARI without a lengthy washout period can be executed with acceptable safety and tolerability and was associated with maintained disease control. Switching therapies in RA is commonplace in myriad scenarios including inadequate responses, intolerances and patient preference. Assessing the safety and efficacy of new treatments such as BARI, in the context of use as a replacement therapy, is beneficial. A previous study (RA-BEACON) has demonstrated that safely switching from ...

Keywords:

• JAK,
• Baricitinib,
• Phase 3

Caractérisation et Modifications des Sous-Types de Lymphocytes chez les patients traités au Baricitinib avec une Polyarthrite Rhumatoïde: Une Analyse Intégrée

Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680

Tanaka Y,

McInnes IB,

Taylor PC,

Byers NL,

Chen L,

de Bono S,

Issa M,

Macias WL,

Rogai V,

Rooney TP,

Schlichting DE,

Zuckerman SH,

Emery P

This review shows that changes in lymphocyte subsets were largely within normal reference ranges and were not associated with efficacy or safety end points. BARI is a selective JAK1/JAK2 inhibitor, approved for the treatment of moderate to severe RA. BARI treatment is associated with changes to circulating lymphocyte and lymphocyte subsets, however detailed analyses of these effects, and their relevance to efficacy and safety is lacking. This study investigated the changes in lymphocyte cell sub...

Keywords:

• JAK,
• Baricitinib,
• Basic Science,
• MOA

Profil Lipidique et Effet du Traitement aux Statines dans des Études Groupées de Phase II et Phase III sur le Baricitinib

Ann Rheum Dis. 2018 Jul;77(7):988-995. DOI 10.1136/annrheumdis-2017-212461

Taylor PC,

Kremer JM,

Emery P,

Zuckerman SH,

Ruotolo G,

Zhong J,

Chen L,

Witt S,

Saifan C,

Kurzawa M,

Otvos JD,

Connelly MA,

Macias WL,

Schlichting DE,

Rooney TP,

de Bono S,

McInnes IB

Baricitinib (BARI) was associated with increased lipid levels; baseline statins did not alter these profiles. The introduction of statins during treatment reduced total cholesterol and LDL-C.The use of anti-inflammatory drugs in RA patients has been shown to alter lipid levels and is associated with reduced atherogenic risk. Increases in lipid levels, specifically HDL-C and LDL-C, have been observed in Phase 2 BARI studies1.This study analysed data from seven randomised RA Phase 2/3 studies of ...

Keywords:

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

Effects of Baricitinib on Radiographic Progression of Structural Joint Damage at 1 year in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Synthetic Disease-modifying Antirheumatic Drugs

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

van der Heijde D,

Dougados M,

Chen YC,

Greenwald M,

Drescher E,

Klar R,

Xie L,

de la Torre I,

Rooney TP,

Witt SL,

Schlichting DE,

de Bono S,

Emery P

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...

Keywords:

• JAK,
• Baricitinib,
• Phase 3,
• Radiographic

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

Keystone EC,

Taylor PC,

Tanaka Y,

Gaich C,

DeLozier AM,

Dudek A,

Velasco Zamora J,

Covarrubias Cobos JA,

Rooney T,

de Bono S,

Arora V,

Linetzky B,

Weinblatt ME

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...

Keywords:

• JAK,
• Baricitinib,
• Phase 3,
• PRO / QoL

Baricitinib in Patients with Inadequate Response or Intolerance to Conventional Synthetic DMARDs: Results from the RA-BUILD Study

Ann Rheum Dis 2017;76:88–95.

Dougados M,

van der Heijde D,

Chen Y-C,

Greenwald M,

Drescher E,

Liu J,

Beattie S,

Witt S,

de la Torre I,

Gaich C,

Rooney T,

Schlichting D,

de Bono S,

Emery P

Baricitinib improved symptoms of RA in the RA-BUILD trial, a Phase 3 study of baricitinib in patients with moderately to severely active RA, refractory to or intolerant to csDMARDs. As well as providing a short-term (24 weeks) benefit, there appeared to be joint damage benefit, considered a marker of long-term disability.RA-BUILD was a 24-week randomised, double-blind, placebo-controlled parallel-group study. Patients were randomised 1:1:1 to receive once-daily doses of placebo (n=228) or barici...

Keywords:

• JAK,
• Baricitinib,
• Phase 3

Baricitinib, Methotrexate, or Combination in Patients with Rheumatoid Arthritis and no or Limited Prior Disease-Modifying Antirheumatic Drug Treatment

Arthritis Rheumatol 2016. DOI 10.1002/art.39953. Accepted article

Fleischmann F,

Schiff M,

van der Heijde D,

Ramos-Remus C,

Spindler A,

Stanislav M,

Zerbini CAF,

Gurbuz S,

Dickson C,

de Bono S,

Schlichting D,

Beattie S,

Kuo W-L,

Rooney T,

Macias W,

Takeuchi T

In this 52-week study of patients receiving initial therapy for RA, baricitinib alone or in combination with MTX demonstrated superior efficacy compared with MTX alone.Patients naïve to csDMARD (no or <3 doses of MTX) or bDMARD were randomised 4:3:4 (N=588) toMTX QW, baricitinib 4 mg QD or baricitinib 4 mg QD + MTX QW. The primary endpoint assessment was noninferiority of baricitinib monotherapy to MTX based on ACR20 response at Week 24.Not only was the primary endpoint met, baricitinib monother...

Keywords:

• JAK,
• Baricitinib,
• Phase 3