In a nutshell
This study investigated the effectiveness of filgotinib (FGB) in patients with unresponsive rheumatoid arthritis (RA).
They found that FGB improves RA management at 12 weeks.
Some background
Rheumatoid arthritis (RA) is a chronic condition. Inflammation leads to painful swelling in the joints. RA is treated with disease-modifying anti-rheumatic drugs (DMARDs). Standard treatment includes conventional DMARDs (csDMARDs) e.g. methotrexate. Biological DMARDs (bDMARDs) are also used as a first-line treatment. Tumor necrosis factor inhibitors (TNFi) are bDMARDs. Managing RA can be difficult. Patients may become unresponsive to medication over time. Identifying new drug targets to overcome this is very important.
Janus kinase (JAK) inhibitors are a new type of DMARD. Blocking JAK enzymes inactivates a specific cellular pathway. The end result is a reduction in the level of inflammatory chemicals and cells. Filgotinib (FGB) is a JAK1 inhibitor. It may be safe for use in RA. It is unclear if FGB is effective in managing RA symptoms in unresponsive RA patients.
Methods & findings
This study included 381 patients with moderate-severe RA. Patients were randomly assigned to one of 3 treatment groups. They included placebo (inactive drug), 100 mg FGB and 200 mg FGB. Patients were allowed to continue csDMARD treatment. Laboratory tests were conducted to measure inflammation. The study lasted 24 weeks. The primary outcome was an improvement of at least 20% in RA symptoms (ACR20 score).
At week 12, ACR20 responses were 66% and 57.5% in patients treated with 200 mg and 100 mg FGB. This compares to an ACR20 of 31.1% in placebo patients. FGB treatment also improved quality of life scores. Laboratory results showed an improvement in inflammatory markers with FGB treatment.
Infections were the most common side effects in FGB-treated patients (34 – 36.1%). This compared to 25.7% in placebo patients.
The bottom line
The authors concluded that FGB improves RA management at 12 weeks in patients with unresponsive RA.
The fine print
This was a relatively short-term study. More studies are needed to determine long-term safety and effectiveness with FGB treatment.
Published By :
Journal of the American Medical Association (JAMA)
Date :
Jul 23, 2019