In a nutshell
This study investigated the effect of filgotinib (Jyseleca) on patient-reported outcomes (PROs) and health-related quality of life (HRQoL) in patients that had active rheumatoid arthritis (RA). The study showed that filgotinib improved PROs in these patients and can be a treatment option for patients with insufficient responses to methotrexate (Otrexup; MTX), biological disease-modifying anti-rheumatic drugs (bDMARDs), and those that are MTX-naive (have never received MTX).
RA is an inflammatory disease that causes pain and swollen joints. Medications to manage RA include anti-inflammatory drugs such as corticosteroids, MTX, or bDMARDs. However, there are still patients that do not respond adequately to these medications. New treatments are needed for these patients.
Filgotinib is a once-daily administered oral medication used to treat RA, known as a Janus-kinase 1 (JAK1) preferential inhibitor. It causes a reduction in inflammation. The results from three Phase 3 studies that included patients with inadequate responses to MTX or bDMARDs and those not treated with MTX (MTX-naive) for early RA, indicated improved symptoms and function. However, there is a need to further analyze PROs measured during these studies to assess the effect of filgotinib on HRQoL in these patients.
Methods & findings
This study analyzed the PROs of three Phase 3 trials. One trial involved 1249 MTX-naive patients that received 200 mg of filgotinib with MTX (FIL200+MTX) or 100 mg of filgotinib with MTX (FIL100+MTX). The second trial included 1755 patients with an inadequate response (IR) to MTX (MTX-IR). Patients had received 200 mg of filgotinib with MTX (FIL200+MTX), 100 mg of filgotinib with MTX (FIL100+MTX), 40 mg of adalimumab with MTX (ADA+MTX), or a placebo (PBO) with MTX. The placebo group was assigned to FIL100+MTX and FIL200+MTX from week 24 to week 52. The final trial included 448 patients with an IR to bDMARDs (bDMARD-IR). Patients received FIL100, FIL200, or PBO with background stable conventional synthetic DMARDs (csDMARDs) for up to 24 weeks. Patients were assessed using standard PRO measurements.
Patients on once-daily 100 mg or 200 mg doses of filgotinib with MTX or csDMARDs who were MTX-naive or had an IR to MTX or bDMARDs developed improved functional status, physical health-related quality of life (HRQL), reduced fatigue, better work productivity, and improved disease activity. Filgotinib and MTX resulted in similar or better improvements compared to ADA+MTX in patients with an IR to MTX for up to 52 weeks.
The bottom line
The study showed that once-daily filgotinib, given at 200 mg or 100 mg in combination with MTX or csDMARDs, resulted in improved functional status, HRQL, fatigue, work impairment, and disease-activity measures in patients with active RA.
The fine print
The study with bDMARD-IR was short and included a small number of patients.
Published By :
Arthritis Research & Therapy
Jan 03, 2022
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