Efeito de Filgotinib vs Placebo na Resposta Clínica de Pacientes com Artrite Reumatoide Moderada a Grave Refratária à Terapia com Drogas Anti-Reumáticas Modificadoras de Doença: O Estudo Randomizado FINCH 2
Among RA patients with an inadequate response or intolerance to bDMARDs, filgotinib (FIL)
doses, compared to PBO resulted in significantly greater proportions achieving a clinical response at Wk12.
Patients with active RA despite treatment with bDMARD therapy need treatment options. The FINCH 2 Phase 3 study compared the effects of FIL vs PBO for the treatment of RA patients with inadequate response or intolerance to ≥1 prior bDMARDs.
Patients were randomized in a 1:1:1 ratio, receiving FIL 200 mg, 100 mg, or PBO QD. Prior to randomization, bDMARDs were discontinued ≥4 weeks. The primary endpoint was the proportion of patients achieving ACR20 response at Wk12. Secondary endpoints included the change from baseline in HAQ-DI score, DAS28(CRP) ≤3.2, DAS28(CRP) <2.6, ACR50/70, and patient’s and physician's global assessment of disease at Wk24.
Statistically significant improvements in ACR20 was achieved by FIL 200 mg (66%) and 100 mg (57.5%) at Wk12 and was maintained through Wk24. FIL treated patients also had significantly greater ACR50/70 and improvements in DAS28-CRP compared to PBO. The most common AEs for FIL 200 mg was nasopharyngitis (10.2%), whereas, headache, nasopharyngitis, and upper respiratory infection (5.9% each) was most common for FIL 100 mg. However, with TEAEs of special interest, four uncomplicated HZ cases were observed with no opportunistic infections, active TB, malignancies, gastrointestinal perforations.
FIL 100 mg and 200 mg compared to PBO resulted in significantly greater proportion of patients achieving a clinical response at Wk12. However, further research is still required to assess
longer-term efficacy and safety.