November 2019

Analyses Exposition-Réponse de l'Efficacité et de l'Innocuité de l'Upadacitinib Dans des Études de Phases 2 et 3 Pour Étayer l'Évaluation Bénéfices-Risques Dans la Polyarthrite Rhumatoïde

Clin Pharmacol Ther . 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671.

UPA 15 mg provided the optimal benefit-risk in RA through maximizing efficacy with only small incremental benefit with 30 mg, and with consistency across RA subpopulations and with UPA monotherapy or combination with csDMARDs. Exposure-response analyses were conducted using combined data from two Phase 2b and five Phase 3 studies in order to characterise the relationship between plasma exposure and efficacy, as well as to select safety parameters using the totality of the data in subjects with R...

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Efficacité et Innocuité Comparées du Péficitinib 25, 50, 100 et 150 mg Chez les Patients Atteints de Polyarthrite Rhumatoïde Active : Une Méta-Analyse Bayésienne en Réseau d'Essais Contrôlés Randomisés

Clin Drug Investig .2020 Jan;40(1):65-72. doi: 10.1007/s40261-019-00863-9.

PEF 50, 100, and 150 mg once daily was effective in treating active RA, without causing a significant risk for AEs.Intracellular pathways, including JAK and Tyk-2, are critical for immune cell activation, pro-inflammatory cytokine production, and cytokine signaling. PEF has been developed for use in RA, but the comparative efficacy and safety of regimens and dosages has not been established. A Bayesian network meta-analysis was conducted to combine direct and indirect evidence to assess the rela...

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Le Tofacitinib Module la Réponse Immunitaire des Cellules T CD4+ Spécifiques du VZV in vitro Dans les Lymphocytes de Patients Atteints de Polyarthrite Rhumatoïde

Rheumatology (Oxford) 2019;58(11):2051–60

TOF significantly modulated the Th1 response to Varicella-zoster-virus (VZV). The poor VZV-specific cellular immune responses in patients with RA may be considered in recommendations regarding appropriate vaccination strategies for enhancing the VZV-specific Th1 response.Previous studies have shown that treatment with JAKinibs increases HZ incidence compared with conventional DMARDs. This cross-sectional in vitro study aimed to investigate the effect of TOF on the VZV-specific T cell immune resp...

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October 2019

Évolution des Taux Lipidiques et de l'Incidence des Événements Cardiovasculaires Après un Traitement au Tofacitinib chez les Patients Atteints de Rhumatisme Psoriasique : Une Analyse Regroupée des Études de Phase 3 et de Prolongation à Long Terme

Arthritis Care Res (Hoboken) 2019;71(10):1387–95

Serum lipid level increases at month 3 following TOF treatment in PsA were consistent with observation in RA and psoriasis. The risk of CV disease is higher in people with PsA versus the general population – comparable with the well-documented rates seen in RA and diabetes. The reasons for this are not fully elucidated, but it has been suggested that there is an association between peripheral joint inflammation and lipid dysregulation in PsA. This post hoc analysis of pooled data from OPAL Broad...

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September 2019

Devenir de la réduction de dose, du retrait et de la reprise du Tofacitinib chez des patients atteints de polyarthrite rhumatoïde: une étude prospective d'observation

Clin Rheumatol. 2019 Aug 9. DOI: 10.1007/s10067-019-04721-z

Following achievement of remission or low disease activity (LDA), a dose reduction strategy of TOF to a 5mg QD dose was preferable to immediate withdrawal of TOF, with lower relapse rates.Clinical remission or LDA early in the disease course is a target for every RA patient. Although maintaining a state of remission or LDA is beneficial to patients, the AEs and costs associated with DMARDs, have significant burdens on patients during life-long RA treatment. This long-term study was performed to ...

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August 2019

Effet du Filgotinib par rapport au placebo sur la réponse clinique chez des patients atteints de Polyarthrite Rhumatoïde modérée à sévère réfractaire au traitement antirhumatismal modificateur de la maladie: l'essai clinique randomisé FINCH 2

JAMA 2019 322(4):315-325

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...

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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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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

Tuberculose, hépatite B et zona chez des patients atteints de polyarthrite rhumatoïde traités au Tofacitinib

Immunotherapy. 2019 Mar;11(4):321-333.

The risk of TB and hepatitis B virus (HBV) appears to be no greater with TOF than with bDMARDs. Most cases of TB during TOF studies occurred in regions with high background rate of TB, including east Asian countries. TOF is also associated with a higher rate of herpes zoster (HZ) compared with bDMARDs. DMARDs used to treat RA can increase the risk of infections by causing a degree of immunosuppression. A range of bacterial and viral infections have been observed in association with DMARD therapy...

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