Tofacitinib em Artrite Psoriásica: Sinais e Sintomas e Qualidade de Vida Relacionada à Saúde em dois Estudos Randomizados de Fase 3
Considering the multi-domain nature of PsA, effective treatments must demonstrate efficacy across a range of clinical and patient-reported outcomes. Dermatologic symptoms often precede rheumatic manifestations in people with PsA, typically by 10 years. Tofacitinib demonstrated significant improvements across a range of outcomes including burdensome dermatologic symptoms.
This post hoc analysis included data from two double-blind, Phase 3 studies in patients with active PsA and an inadequate response to a range of previous therapies. All patients had active plaque psoriasis at screening and continued to receive a stable dose of one csDMARD during the study. Patients were randomised to tofacitinib 5 or 10 mg BID, adalimumab 40 mg EOW (OPAL Broaden) or placebo. Dermatologic endpoints included PASI and Physician’s Global Assessment of Psoriasis, and the impact of treatment on nail psoriasis, itch, quality of life, and joint symptoms were also recorded
In both studies, the percentage achieving PASI90 increased to Month 3 with tofacitinib, with significant differences versus placebo at Month 1. PASI75 and PASI90 improvements were seen in tofacitinib patients with both mild and moderate/severe skin disease. Improvements were also seen in itch, quality of life and joint symptoms. All active treatment groups demonstrated improvements to end of study in change in Nail Psoriasis Severity Index, but none were statistically significant.