June 2020

Interruption Temporaire du Baricitinib : Caractérisation des Interruptions et Effet sur les Résultats Cliniques chez les Patients Atteints de Polyarthrite Rhumatoïde

Arth Res Ther 2020;22:115 doi.org/10.1186/s13075-020-02199-8

This study aimed to characterize temporary interruptions of baricitinib and describe their impact on efficacy and safety. Brief interruptions during phase 3 baricitinib trials were associated with minor increases in symptoms which were resolved following treatment. In life-long, chronic conditions such as RA, interruption of therapy is common for various reasons, such as side effects, non-compliance, or because a patient requires surgery. Concerns have been raised that these treatment breaks cou...

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Profil d'Innocuité du Baricitinib Pour le Traitement de la Polyarthrite Rhumatoïde sur une Période Médiane de 3 ans de Traitement : Une Analyse d'Innocuité Intégrée Mise À Jour

Lancet Rheumatol 2020;2:e347–57

RA is a chronic, life-long disease requiring long-term treatment. As such, it is important to understand the long-term safety profile of DMARDs. In this analysis, baricitinib maintained a stable safety profile during long-term exposure. This baricitinib safety analysis included integrated data from nine Phase 3, 2, and 1b clinical trials, and one long-term extension, with data up to 360 weeks. 3700 patients were included, with maximum follow-up of almost 7 years – representing an additional 3,54...

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Baricitinib Chez les Patients Atteints de Polyarthrite Rhumatoïde Ayant une Réponse Inadéquate au Méthotrexate : Résultats d'une Étude de Phase 3

Clin Exp Rheumatol . Jul-Aug 2020;38(4):732-741. Epub 2020 May 20.

This study conducted mainly in Chinese patients with RA, and an inadequate response to MTX, showed that baricitinib 4mg was associated with significant improvements and consistent with the findings from previous clinical trials.The efficacy and safety of baricitinib have been assessed in several clinical trials, predominantly in Caucasian populations. However, evidence on the efficacy and safety of baricitinib in Chinese patients is limited, with only one of the main clinical trial program studi...

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May 2020

Fénébrutinib Versus Placebo ou Adalimumab Dans la Polyarthrite Rhumatoïde : un Essai de Phase II Randomisé, en Double Aveugle (Étude ANDES)

Arthritis Rheumatol. 2020 Sep; 72(9): 1435–1446.

In this randomised phase II trial with MTX treatment-refractory RA patients, greater efficacy was observed with fenebrutinib 150 mg once daily or 200 mg twice daily compared to placebo, while response rates were numerically similar to those observed with adalimumab. BTK inhibitors have demonstrated clinical efficacy in B cell malignancies and multiple sclerosis, although there is limited clinical evidence of its efficacy in RA. Fenebrutinib (FEN) an orally active and selective non-covalent inhib...

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Évaluation du Virus de l'Hépatite B Dans les Essais Cliniques du Baricitinib Dans la Polyarthrite Rhumatoïde

RMD Open 2020;6:e001095

Although hepatitis B virus (HBV) reactivation was seen in patients with RA treated with DMARDs, including BARI, who had serology suggestive of prior infection, reactivation was transient even with continued BARI treatment and did not account for any clinically relevant AEs.Reactivation of HBV replication is a recognised complication in patients receiving biologic agents for RA, such as DMARDs. Limited data exist on prevalence of occult infection and the incidence of reactivation in RA patients t...

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Analyse Intégrée de l‘Innocuité du Tofacitinib Dans le Rhumatisme Psoriasique À Travers des Études de Phase III et de Prolongation à Long Terme en Comparaison Avec les Données D'observation du Monde Réel

Drug Saf. 2020;43:379-392

Patients with psoriatic arthritis (PsA) had similar safety profile with TOF to that of other systemic therapies in real-world settings, except for the known risk of HZ. Treatment recommendations from EULAR and GRAPPA for patients with PsA vary according to adverse prognostic risk factors, disease manifestations and responsiveness to prior treatment. Safety concerns for most PsA therapies include gastrointestinal AEs, hepatotoxicity, opportunistic infections (OIs) including TB, and SIEs. This stu...

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April 2020

Efficacité et Innocuité Relatives du Tofacitinib, Baricitinib, Upadacitinib et Filgotinib par Rapport à l'Adalimumab Chez les Patients Atteints de Polyarthrite Rhumatoïde Active

Z Rheumatol. 2020 DOI: 10.1007/s00393-020-00750-1

This Bayesian network meta-analysis, comparing the relative efficacy and safety of JAK inhibitors, determined BARI 4mg + MTX and UPA 15mg + MTX were the most effective. The analysis included 5451 patients with an inadequate response to MTX and active RA, from four RCTs. Relative effects were converted into a probability allowing each treatment to be ranked. BARI and UPA had significantly higher ACR20 response rates than ADA 40mg + MTX whilst TOF 5mg and FIL 200mg had comparable ACR20 response ra...

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La Vascularite à IgA , Effet Indésirable du Tofacitinib Pris Pour la Polyarthrite Rhumatoïde

Intern Med. 2020;59(6):817-821

Nephrotoxicity is a key side effect of NSAIDs and DMARDs used to treat RA, while biologics can reportedly cause proliferative glomerulonephritis or crescentic glomerulonephritis. This report reviews a patient on TOF presenting IgA vasculitis as an adverse effect that fully resolved following termination of TOF.Drug induced IgA vasculitis has been previously described for anti-TNFɑ therapies, but this is the first report with JAK inhibitor therapy. This is a case report of a 67-year old woman wit...

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March 2020

Exposition au Baricitinib Pendant la Grossesse en Cas de Polyarthrite Rhumatoïde

Ther Adv Musculoskelet Dis. 2020;12:1759720X19899296

Broad and focused studies are required to have an insight of safety for small molecules, such as JAK inhibitors in the case of accidental exposure before or during pregnancy.This case study’s objective describes a case report of a 43-year-old woman affected by RA who became pregnant during BARI treatment. She has had two previous pregnancies at term without complications. After failure of bDMARDs due to loss of efficacy and adverse drug reactions, the patient was started on BARI when it became a...

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January 2020

Analyse de l'innocuité, de la tolérance, de la pharmacocinétique, de l'occupation cible et de l'intervalle QT du nouvel inhibiteur de la BTK, Evobrutinib chez des volontaires en bonne santé

Clin Transl Sci . 2020 Mar;13(2):325-336. doi: 10.1111/cts.12713. Epub 2019 Nov 29.

In this first in-human phase I, double-blind, placebo-controlled trial, the Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib was well-tolerated, showed linear and time-independent PK, induced long-lasting BTK inhibition, and was not associated with prolongation of QT/QTc interval in healthy subjects. Evobrutinib is an oral BTK inhibitor that has demonstrated efficacy in pre-clinical and autoimmune disease models. BTK is a key regulator of B cell receptor and Fc receptor signalling, and a rat...

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