medwireNews: Filgotinib, given in combination with methotrexate, may be a promising treatment option for methotrexate-naïve patients with moderate-to-severe rheumatoid arthritis (RA), indicate findings from the FINCH 3 trial.
The phase III study, presented at the EULAR 2019 congress in Madrid, Spain, included 1249 participants who were randomly assigned to receive the selective Janus kinase (JAK)1 inhibitor at a dose of 200 mg or 100 mg once daily in combination with weekly methotrexate, filgotinib 200 mg/day monotherapy, or methotrexate monotherapy.
Rene Westhovens, from KU Leuven in Belgium, reported that the 416 patients given filgotinib 200 mg plus methotrexate were significantly more like to achieve the primary endpoint of an ACR20 response at week 24 than the 416 given methotrexate alone, at rates of 81.0% versus 71.4%.
The ACR20 response rate among the 207 individuals in the filgotinib 100 mg plus methotrexate arm was also significantly higher than that in patients given methotrexate monotherapy (80.2 vs 71.4%), but there was no significant difference in ACR20 response rates among participants given filgotinib 200 mg monotherapy (n=210) versus methotrexate (78.1 vs 71.4%).
This to me is a little problematic; does the [filgotinib] monotherapy really work?
Click through to watch Roy Fleischmann’s take on these results
Westhovens said that ACR50 response rates at week 24 were significantly higher in the filgotinib 200 mg plus methotrexate, filgotinib 100 mg plus methotrexate, and filgotinib 200 mg monotherapy groups versus the placebo arm (61.5, 57.0, and 58.1 vs 45.7%, respectively), as were ACR70 response rates (43.8, 40.1, and 40.0 vs 26.0%, respectively).
Average mTSS score – indicative of radiographic progression – increased by 0.20 and 0.22 points in the 200 mg and 100 mg combination therapy groups, respectively, from baseline to week 24, and decreased by 0.04 points in the filgotinib monotherapy group, compared with a 0.52-point increase in the methotrexate arm.
“I think the most important data are [those showing] almost no radiographic progression” among filgotinib-treated patients, said Westhovens. The proportion of participants with no change in mTSS score from baseline to week 24 was 80.8% in the filgotinib 200 mg plus methotrexate group, 76.5% in the 100 mg plus methotrexate group, 82.7% in the filgotinib monotherapy arm, and 72.4% for those given methotrexate alone.
Reporting the safety findings, Westhovens noted that “over the four arms there was almost no difference in side effects.” Rates of treatment-emergent adverse events in the filgotinib 200 mg plus methotrexate, filgotinib 100 mg plus methotrexate, filgotinib monotherapy, and methotrexate monotherapy arms were 65.9%, 69.6%, 53.8%, and 62.7%, respectively. The corresponding rates of serious adverse events were 4.1%, 2.4%, 4.8%, and 2.9%.
The presenter noted that serious infections occurred in “very low numbers” in the FINCH 3 study, and were “equally distributed over the four arms.” He added that there were “very few” cases of herpes zoster infection, which affected 0.5% of participants in each group.
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Ann Rheum Dis 2019; 78: 259–261 (abstract)
European Congress of Rheumatology 2019; Madrid, Spain: 12–15 June
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