June 2023

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

Ann Rheum Dis 2023;82:1049–1058

Reinisch, et al. show that filgotinib treatment has no effect on semen parameters for men with active inflammatory diseases. This contrasts with pre-clinical studies that showed fertility issues in male animals.

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Filgotinib Decreases Both Vertebral Body and Posterolateral Spine Inflammation in Ankylosing Spondylitis: Results from The TORTUGA Trial

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 of filgotinib on sacroiliac joint magnetic resonance imaging structural lesions at 12 weeks in patients with active ankylosing spondylitis (TORTUGA trial)

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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Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): A phase 2b/3 double-blind, randomised, placebo-controlled trial

The Lancet 2021;397:2372–2384 doi: 10.1016/S0140-6736(21)00666-8

Treatment of patients with UC with filgotinib 200 mg was associated with an increase in clinical remission at Week 10 and Week 58. The proportion of patients with clinical remission at Week 58 was significantly greater in patients who continued FIL 200 mg therapy throughout the trial. The incidence of TEAEs was similar across all treatment groups.

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December 2021

Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221051

Integrated analysis evaluates the safety of filgotinib among patients with RA treated for a median of 1.6 years.Winthrop, et al. analysed data from seven trials, including long-term extension studies, and found that rates of TEAEs, grade ≥3 TEAEs, serious TEAEs and TEAEs leading to study drug discontinuation were comparable for filgotinib and placebo. In addition, analysis of AEs of special interest showed a generally similar incidence for filgotinib 200 mg and 100 mg....

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March 2021

Safety and Efficacy of Filgotinib: Up to 4-Year Results From an Open-Label Extension Study of Phase 2 Rheumatoid Arthritis Programs

J Rheumatol. 2021 Feb 1:jrheum.201183. DOI: 10.3899/jrheum.201183.

A long-term extension study of filgotinib showed consistent safety profile and sustained efficacy with the drug for up to four years. The DARWIN 3 study, for patients who previously completed either the 24-week DARWIN 1 study (filgotinib + MTX) or the DARWIN 2 study (filgotinib monotherapy), enrolled 739 patients with RA. At the time of analysis, 440 patients had received four years or more of filgotinib. Exposure-adjusted incidence rate per 100 patient-years-of-exposure for TEAEs was 24.6 in th...

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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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Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Psoriatic Arthritis (EQUATOR): Results from a Randomised, Placebo-controlled, Phase 2 Trial

Lancet. 2018 Dec 1;392(10162):2367-2377. DOI 10.1016/ S0140-6736(18)32483-8

In this first clinical trial of filgotinib in patients with PsA, filgotinib was effective in treating the signs and symptoms of active PsA across various disease manifestations.The EQUATOR trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 191 adult patients from 25 sites in seven countries. Patients with active moderate-to-severe PsA and an insufficient response or intolerance to at least one csDMARD were assigned 1:1 to receive filgotinib 200 mg or placebo o...

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