medwireNews: A pooled analysis of data from the FINCH 1–3 studies has shown that 24 weeks of filgotinib treatment is well tolerated by a broad group of patients with rheumatoid arthritis (RA), with an adverse event profile similar to that of its comparators.
A poster presented by Kevin Winthrop, from Oregon Health & Science University in Portland, USA, at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, outlined the phase III FINCH trials, which have investigated the safety and efficacy of the selective Janus Kinase 1 inhibitor filgotinib in patients with moderate to severely active RA, who:
- had an inadequate response to methotrexate (FINCH 1);
- were receiving conventional DMARDs and had an inadequate response to biologic therapies (FINCH 2); and
- were initiating methotrexate for the first time alone or in conjunction with filgotinib or receiving filgotinib monotherapy (FINCH 3).
Efficacy analyses, previously reported by medwireNews, have shown that the drug leads to “statistically significant and clinically meaningful improvements in the signs and symptoms of RA, physical functioning, and quality of life measures,” Winthrop and co-investigators remark.
In the current analysis, Winthrop and team assessed the safety of the drug among 3452 patients across FINCH 1–3, 2088 of whom had received filgotinib.
The researchers report that at week 24, the treatment-emergent adverse event (TEAE) rate was similar between patients who received filgotinib either as 200 mg/day monotherapy, or at a dose of 100 mg or 200 mg/day in combination with methotrexate or a conventional synthetic (cs)DMARD, at 53.8%, 62.7% and 63.9%, respectively.
There was also no difference in the TEAE rate between patients who received filgotinib and those who received placebo plus methotrexate or a csDMARD, at 59.1%, or adalimumab plus methotrexate, at 56.9%.
The most common TEAEs in the filgotinib group, occurring in more than 10% of patients, were nasopharyngitis, upper respiratory tract infection, urinary tract infection, bronchitis, and influenza Laboratory abnormalities occurred at similar rates with filgotinib and placebo or active control and were mostly mild to moderate (grade 1 and 2).
Among the TEAEs of special interest, the frequency of major adverse cardiac events, herpes zoster virus, deep vein thrombosis, and pulmonary embolism was low (<1.0%), and similar across treatment groups. In addition, there were no cases of tuberculosis or gastrointestinal perforation.
Winthrop and co-authors conclude: “Although gathered over a short duration (24 weeks), pooled data from this large safety database describing a broad population of patients with RA highlights the favorable safety and tolerability profile of filgotinib in patients with RA both as a monotherapy and in conjunction with [methotrexate]/csDMARD.”
By Laura Cowen
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