Filgotinib (ulcerative colitis) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Filgotinib (Colitis ulcerosa) – Nutzenbewertung gemäß § 35a SGB V (Version 2.0; Status: 16 May 2022). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A21-155 Filgotinib (ulcerative colitis) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A21-155 Version 2.0 Filgotinib (ulcerative colitis) 16 May 2022 Institute for Quality and Efficiency
Filgotinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Filgotinib (rheumatoide Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 January 2021). Please note: This translation is provided as a service by IQWiG to English -language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A20-90 Filgotinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A20-90 Version 1.0 Filgotinib (rheumatoid arthritis) 13 January 2021 Institute for Quality and Efficiency in Health Care (IQWiG
Filgotinib (Jyseleca) - ulcerative colitis Published 09 May 2022 1 Product update SMC2467 filgotinib 100mg and 200mg film-coated tablets (Jyseleca®) Galapagos Biotech 8 April 2022 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs ) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated submission filgotinib (Jyseleca®) is accepted for use within NHSScotland. Indication under review: for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy
Filgotinib (Jyseleca) - rheumatoid arthritis 1 Published 10 October 2022 1 SMC2475 filgotinib 100mg and 200mg film-coated tablets (Jyseleca®) Galapagos NPV 09 September 2022 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a resubmission filgotinib (Jyseleca®) is accepted for restricted use within NHSScotland. Indication under review: for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Filgotinib may
Filgotinib (Jyseleca) - Treatment of moderate to severe active rheumatoid arthritis 1 Published 13 September 2021 1 SMC2365 _____________________________________________________ filgotinib 100mg and 200mg film-coated tablets (Jyseleca®) Gilead Sciences, Inc 6 August 2021 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission filgotinib (Jyseleca®) is accepted for restricted use within NHSScotland. Indication under review: filgotinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who
Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. This post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib. FINCH 1-3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according
Efficacy and safety of selective JAK 1 inhibitor filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: comparative study with filgotinib and tocilizumab examined by clinical index as well as musculoskeletal ultrasou
Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study. DARWIN 3 (ClinicalTrials.gov: NCT02065700) assessed the safety and efficacy of filgotinib in a long-term extension (LTE) of two phase II randomised controlled rheumatoid arthritis (RA) trials. Eligible patients completing the 24-week DARWIN 1 (filgotinib plus methotrexate) and DARWIN 2 (filgotinib monotherapy) trials could enrol. Patients received filgotinib 200 mg/day, except 15 men who received filgotinib 100 mg/day. The primary endpoints were safety and tolerability, which were assessed by the incidence of treatment-emergent adverse events (TEAEs). Safety and efficacy analyses included all enrolled patients who received ≥1 dose of filgotinib in DARWIN 3. 739
Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies The phase 2 MANTA and MANTA-RAy studies aimed to determine if the oral Janus kinase 1 preferential inhibitor filgotinib affects semen parameters and sex hormones in men with inflammatory diseases . MANTA (NCT03201445) and MANTA-RAy (NCT03926195) included men (21-65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis), respectively. Eligible participants had semen parameters in the normal range per the WHO definition. In each study, participants were randomised 1:1 to receive once-daily, double-blind filgotinib
Efficacy and Safety of Filgotinib for the Treatment of Perianal Fistulizing Crohn's Disease [DIVERGENCE 2]: a Phase 2, Randomized, Placebo-Controlled Trial. There is an unmet need for the treatment of perianal fistulizing Crohn's disease [PFCD]. This study evaluated the efficacy and safety of the Janus kinase 1 preferential inhibitor filgotinib, for the treatment of PFCD. This phase 2, double -blind, multicentre trial enrolled adults with PFCD and prior treatment failure. Participants were randomized [2:2:1] to receive filgotinib 200 mg, filgotinib 100 mg, or placebo once-daily orally for up to 24 weeks. The primary endpoint was combined fistula response [reduction from baseline of at least one draining external opening determined by physical assessment, and no fluid collections >1 cm
Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis. To assess cigarette smoking's effects on efficacy of the preferential Janus kinase (JAK) 1 inhibitor filgotinib and drug persistence in patients with rheumatoid arthritis (RA). Efficacy in non-smokers, former smokers, and current smokers from phase 3 filgotinib trials was analyzed, including patients with inadequate response (IR) to methotrexate (MTX) or biologic disease-modifying antirheumatic drugs (bDMARDs) or who were MTX-naïve. Proportions achieving Disease Activity Score in 28 joints with C-reactive protein (DAS28[CRP]) ≤ 3.2 were compared using logistic regression. Retrospective claims-based switching data were reviewed. Week 12
Filgotinib in Active Noninfectious Uveitis: The HUMBOLDT Randomized Clinical Trial. Noninfectious uveitis is a leading cause of visual impairment with an unmet need for additional treatment options. To assess the efficacy and safety of filgotinib, a Janus kinase 1 (JAK1) preferential inhibitor, for the treatment of noninfectious uveitis. The HUMBOLDT trial was a double-masked, placebo-controlled , phase 2, randomized clinical trial conducted from July 2017 to April 2021 at 26 centers in 7 countries. Eligible participants (aged ≥18 years) had active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite at least 2 weeks of treatment with oral prednisone (10-60 mg per day). Participants were randomly assigned 1:1 to receive filgotinib, 200 mg, or placebo orally once daily
Efficacy and safety of filgotinib for ulcerative colitis: A real-world multicenter retrospective study in Japan. While filgotinib, an oral Janus kinase (JAK) 1 preferential inhibitor, is approved for moderately to severely active ulcerative colitis (UC), real-world studies assessing its short- and long-term efficacy and safety are limited. This is a multicenter, retrospective study of UC patients who started filgotinib between March 2022 and September 2023. The primary outcome was clinical remission, defined as a partial Mayo score ≤1 with a rectal bleeding score of 0, or Simple Clinical Colitis Activity Index (SCCAI) ≤2 with a blood-in-stool score of 0. Secondary outcomes included clinical response, corticosteroid-free remission, and endoscopic improvement. Outcomes were assessed at 10
Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years. To update the long-term safety profile of filgotinib, a Janus kinase-1 preferential inhibitor, in patients with moderate-to-severe rheumatoid arthritis. Data from seven trials were integrated (NCT01888874, NCT01894516, NCT02889796, NCT02873936 , NCT02886728, NCT02065700 and NCT03025308). Patients received once-daily filgotinib 100 mg or 200 mg. Exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure (PYE) were calculated for treatment-emergent adverse events (TEAEs). Post hoc analyses assessed patients aged <65 and ≥65 years. Patients (N=3691) received filgotinib for a median (maximum) of 3.8 (8.3) years (12 541 PYE). Rates of TEAEs
Long-term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4 years of follow-up in the SELECTION open-label long-term extension study. Filgotinib, an oral, once-daily, Janus kinase 1 preferential inhibitor, is an approved treatment for moderately to severely active ulcerative colitis. The aim of this study is to assess the safety and efficacy of continued filgotinib therapy over ~4 years in the long-term extension of the phase 2b/3 SELECTION trial (SELECTIONLTE; NCT02914535). In this interim analysis of SELECTIONLTE, SELECTION completers (week 10 responders to filgotinib who completed the maintenance study) continued their assigned treatment (double-blind filgotinib 200 mg [FIL200] or filgotinib 100 mg
Efficacy and safety of filgotinib in patients with rheumatoid arthritis: week 156 interim results from a long-term extension study. Janus kinase inhibitors are an effective option for achieving sustained remission or low disease activity in patients with rheumatoid arthritis (RA) following inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs. Filgotinib is a Janus kinase 1-preferential inhibitor available in two doses for moderate-to-severe RA. We report the long-term efficacy and safety of filgotinib. In the ongoing long-term extension study FINCH 4 (NCT03025308), patients continue filgotinib 200 mg or 100 mg from FINCH 1, 2 or 3 or receive filgotinib 200 mg or 100 mg de novo. Efficacy assessments up to week 156 include American College of Rheumatology 20