Safety and Effectiveness of Nonsteroidal Tapinarof Cream 1% Added to Ongoing Biologic Therapy for Treatment of Moderate to Severe Plaque Psoriasis.

The aim of this prospective, open-label, single-center study was to evaluate the effectiveness and safety of nonsteroidal tapinarof cream 1% added to ongoing biologic therapy in patients with plaque psoriasis who did not adequately respond to a biologic alone. Males and females aged 18 years and older with moderate to severe plaque psoriasis (≥3% body surface area [BSA] involvement) who had been receiving a biologic for 24 weeks or more applied tapinarof cream 1% once daily for 12 weeks. Patients were followed an additional 4 weeks after treatment discontinuation through week 16 to assess for a remittive (maintenance) effect. The primary end point was the proportion of patients achieving the National Psoriasis Foundation's treat-to-target (TTT) goal of 1% or less BSA involvement at week 12. Of the 30 patients enrolled (mean age, 55.4 years; 66.7% [20/30] male), 20 completed the study. The proportion of patients reaching the TTT goal increased over time to 52.4% (11/21) at week 12 and 40% (8/20) at week 16. Mean percentage of BSA involvement and physician's global assessment (PGA) score, composite PGA multiplied by mean percentage of BSA involvement (PGA×BSA), and psoriasis area severity index (PASI) scores also improved with tapinarof cream added to biologic therapy up to week 12 and were maintained until week 16. Few adverse events (AEs), no serious AEs, and no AE-related discontinuations were reported. In conclusion, adding nonsteroidal tapinarof cream to an ongoing biologic was tolerable in our study population and potentially can help patients achieve the TTT goal, preserving safety and cost associated with their current biologic therapy.