November 2022

Efficacité et sécurité du Filgotinib chez les patients présentant un risque élevé de mauvais pronostic et ayant montré une réponse inadéquate au MTX : Analyse post hoc de l'étude FINCH 1

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00498-x

Post hoc analysis from the FINCH 1 study highlights filgotinib as a potential beneficial treatment option for patients with RA who have had inadequate response to MTX and have high risk of disease progression and poor prognosis.

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June 2022

Le filgotinib diminue l'inflammation du corps vertébral et de la colonne postéro-latérale dans la spondylarthrite ankylosante : Résultats de l'essai TORTUGA

Rheumatology 2022;61:2388–2397. doi: 10.1093/rheumatology/keab758

Maksymowych et al., assessed the effects of filgotinib on inflammatory and structural changes at various spinal locations, based on MRI measures in patients with active ankylosing spondylitis in the TORTUGA trial. Correlations between changes in the inflammation score and clinical outcomes were also evaluated.

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Impact du filgotinib sur les lésions structurelles de l'articulation sacro-iliaque obtenues par imagerie par résonance magnétique à 12 semaines chez les patients atteints de spondylarthrite ankylosante active (essai TORTUGA)

Rheumatology 2022;61:2063–71 doi:10.1093/rheumatology/keab543

Maksymowych et al., carried out a post-hoc analysis to assess the effect of filgotinib on MRI measures of structural change in the SI joint in patients with active AS in the TORTUGA trial. This study evaluated lesions using SPARCC SSS definitions for erosion, backfill, fat metaplasia and ankylosis by two independent scoring readers.

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September 2021

Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3

RMD Open. 2021;7(2):e001621.

Post hoc analysis of the phase III FINCH study shows that filgotinib may be an alternative treatment option for patients with RA who have poor prognostic factors (PPFs), especially those not responding to standard treatment such as methotrexate (MTX).PPFs are associated with severe disease and risk for disease progression in patients with RA. Consequently, the 2019 EULAR management guidelines for RA recommend early treatment escalation for patients with PPFs who have inadequate response to first...

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May 2020

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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November 2018

Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Ankylosing Spondylitis (TORTUGA): Results from a Randomized, Placebo-controlled, Phase 2 Trial

Lancet 2018 Dec 1;392(10162):2378-2387. DOI 10.1016/S0140-6736(18)32463-2

In this first clinical trial of filgotinib in patients with active AS, filgotinib significantly reduced disease activity, and the signs and symptoms of AS compared with placebo. The TORTUGA trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 263 adult patients from 30 sites in seven countries. Patients with active AS and an inadequate response or intolerance to two or more NSAIDs were assigned 1:1 to receive filgotinib 200 mg or placebo once daily for 12 weeks....

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Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis

N Engl J Med 2017; 377:1537-50. DOI: 10.1056/NEJMoa1615975

In the Phase 3 OPAL Broaden trial of patients with active psoriatic arthritis (PsA) with inadequate response to ≥1 csDMARD, superior efficacy was observed in patients treated with tofacitinib (TOF) compared with those given placebo. Patients were randomised to: 5 mg TOF BID, 10 mg TOF BID, 40 mg adalimumab administered subcutaneously q2W, or placebo with a switch to 5 mg TOF at Month 3. Adalimumab was used as an active control in the study. A variety of primary and secondary endpoints were used ...

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Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors

N Engl J Med 2017;377:1525–36.

The study data presented that tofacitinib (TOF) improves efficacy response rates in patients with severe psoriatic arthritis (PsA) who have an inadequate response to TNF inhibitors.The Phase 3 Oral Psoriatic Arthritis Trial (OPAL) Beyond study evaluated patients with active PsA who had inadequate responses to more than one TNFi. Patients were randomised 2:2:1:1 to 5 mg TOF BID or 10 mg TOF BID for 6 months; or PBO, with a switch to 5 mg TOF BID or to 10 mg BID at 3 months.Primary endpoints were ...

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October 2015

Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs

Annals of the Rheumatic Diseases. 2015 Aug 14. doi:pii: annrheumdis-2014-207178.

This study evaluated the efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in patients with inadequate response to sDMARDs or bDMARDs. Findings from this study show both doses of tofacitinib were associated with improvements in efficacy parameters at month 3 versus placebo, and clinical response was numerically greater with bDMARD-naïve versus bDMARD-IR patients (95% CI overlapping). Safety parameters were generally similar; however, patients receiving glucocorticoids had more ...

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