June 2019

Efficacy and Safety of Filgotinib for Patients With Rheumatoid Arthritis Naïve to Methotrexate Therapy: FINCH 3 Primary Outcome Results

EULAR 2019 Abstract LB0003 Presentation

Filgotinib is an orally administered, selective inhibitor of JAK1. Filgotinib has shown good efficacy and was well tolerated for the treatment of RA in Phase 2 and 3 studies evaluating MTX-IR or bDMARD-IR patients. The objective of this study was to compare the efficacy and safety of filgotinib with and without MTX in patients with RA who were naïve to MTX therapy....

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Efficacy and Safety of Filgotinib for Patients With Rheumatoid Arthritis With Inadequate Response to Methotrexate: FINCH 1 Primary Outcome Results

EULAR 2019 Abstract LB0001 Presentation

Filgotinib is an orally administered, selective inhibitor of JAK1. Filgotinib has shown good efficacy and was well tolerated for the treatment of rheumatoid arthritis (RA) in Phase 2 studies.The objective of this Phase 3 study was to evaluate the efficacy and safety of filgotinib treatment in patients with RA who have had an inadequate response to methotrexate (MTX)....

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Efficacité et modélisation pharmacodynamique de l'évobrutinib, inhibiteur de BTK, dans les modèles de maladie auto-immune

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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Upadacitinib en monothérapie chez des patients atteints de polyarthrite rhumatoïde active et recevant une réponse inadéquate au méthotrexate (SELECT-MONOTHÉRAPIE): étude de phase 3 randomisée, contrôlée par placebo et à double insu

Lancet. 2019 Jun 8;393(10188):2303-2311

UPA monotherapy showed statistically significant improvements in clinical and functional outcomes versus continuing MTX in MTX inadequate-responder patients with RA. Despite its proven effectiveness and safety, many patients are unable to tolerate MTX due to its side-effects. Therapies that can be used without concomitant MTX therefore, have an important place in RA management. In previous studies, UPA has shown efficacy in combination with stable background csDMARDs in RA patients who are DMARD...

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May 2019

Innocuité et efficacité du Tofacitinib allant jusqu'à 9,5 ans dans le traitement de la polyarthrite rhumatoïde: résultats finaux d'une étude de prolongation globale, ouverte et à long terme

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

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...

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April 2019

Données relatives à l'efficacité et à l'innocuité fondées sur les conditions historiques ou préexistantes observées au départ chez les patients atteints de polyarthrite rhumatoïde active traités au baricitinib

Ann Rheum Dis. 2019 Aug;78(8):1135-1138.

In a post-hoc analysis, BARI 4 mg showed similar efficacy and safety during placebo-controlled and LTE observation periods regardless of the presence or absence of select comorbidities in RA patients.Patients with RA have a high prevalence of comorbidities. This post-hoc analysis investigated the effect of select comorbidities (depression, osteoporosis, hepatic, cardiovascular or pulmonary disorders) on the efficacy and safety of BARI 4 mg QD in patients with moderate-to-severe active RA and ina...

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March 2019

Profil d’innocuité du Baricitinib chez des patients Japonais atteints d’une polyarthrite rhumatoïde avec un temps de traitement d’une moyenne d’1,6 ans : analyse intégrée des essais de phases 2 et 3

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

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 ...

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Méta-analyse en réseau du traitement par le tofacitinib versus les traitements biologiques chez les patients atteints de polyarthrite rhumatoïde sévère à modérée

J Clin Pharm Ther. 2019 Jun;44(3):384-396.

This study suggests that many bDMARDs and tsDMARDs can be considered equivalent therapeutic alternatives in bDMARD-naïve RA patients, with inadequate response to csDMARDs.In the absence of randomised controlled trials comparing drugs, indirect comparisons and network meta-analysis may provide information to help select an optimal treatment alternative. In this network meta-analysis, 27 randomized controlled trials were analysed to assess the possibility that some drugs on the market may be consi...

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February 2019

Tofacitinib in Combination with Methotrexate in Patients with Rheumatoid Arthritis: Clinical Efficacy, Radiographic and Safety Outcomes from the 24-Month Phase 3 ORAL Scan Study

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

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...

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January 2019

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

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...

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