FINCH 2 Study: Novel Drug Improves RA Symptoms in DMARD-Refractory Individuals
Filgotinib may aid in symptom relief among individuals with rheumatoid arthritis (RA) who are refractory to biologic disease-modifying antirheumatic drug (bDMARD) therapy, according to results from the FINCH 2 trial. The findings indicate that more individuals who had received filgotinib achieved clinical response at 12 weeks than those who received placebo.
A tumor necrosis factor (TNF) inhibitor is often the first targeted therapy for the treatment of RA after an inadequate response to initial pharmacotherapy with a conventional synthetic DMARD (csDMARD). However, discontinuation rates of TNF inhibitor use due to ineffectiveness and adverse events have raised concern.
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For the study, the researchers randomly assigned participants to filgotinib, 200 mg (n = 148); filgotinib, 100 mg (n = 153); or placebo (n = 148) once daily with continued concomitant stable csDMARD therapy.
The American College of Rheumatology criteria (ACR20) was used to determine the proportion of participants who achieved at least 20% improvement in RA symptoms, which was the primary endpoint of the study.
Of the 448 participants who received treatment, 381 had completed the study.
Overall, 66.0% of participants who had received filgotinib, 200 mg, and 57.5% of participants who had received filgotinib, 100 mg, achieved clinical response compared with 31.3% of those who had received placebo.
Among a subset of participants with prior exposure to 3 or more bDMARDs, 70.3% who had received filgotinib, 200 mg, and 58.8% who had received filgotinib, 100 mg, achieved clinical response, compared with 17.6% who received placebo.
The most common adverse events observed by researchers were nasopharyngitis (10.2%) among the filgotinib, 200 mg, group; headache, nasopharyngitis, and upper respiratory infection (5.9% each) among the filgotinib, 100 mg, group; and RA (6.1%) among the placebo group.
“Further research is needed to assess longer-term efficacy and safety,” the researchers concluded.
—Colleen Murphy
Reference:
Genovese MC, Kalunian K, Gottenberg J, et al. Effect of filgotinib vs placebo on clinical response in patients with moderate to severe rheumatoid arthritis refractory to disease-modifying antirheumatic drug therapy: the FINCH 2 randomized clinical trial. JAMA. 2019;322(4):315-325. doi:10.1001/jama.2019.9055.