Abstract
BACKGROUND: DMB-3115 is a biosimilar to Stelara (hereinafter referred to as ustekinumab). OBJECTIVES: To evaluate the clinical similarity of DMB-3115 with ustekinumab in patients with moderate-to-severe plaque psoriasis. METHODS: In this phase 3, randomized, double-blind, parallel-arm study, adults with moderate-to-severe plaque psoriasis were randomized to receive DMB-3115 or ustekinumab (weeks 0-28), followed by re-randomization to continue treatment or switch to DMB-3115 (weeks 28-52). The primary efficacy endpoints were percent change in Psoriasis Area and Severity Index score from baseline to week 8 and week 12. The safety endpoint was the incidence of adverse events. RESULTS: A total of 598 patients were randomized to receive DMB-3115 (n = 299) or ustekinumab (n = 299). The least squares mean percent changes in Psoriasis Area and Severity Index score from baseline to week 8 were 77.5% (DMB-3115) and 77.9% (ustekinumab), and from baseline to week 12 were 87.6% (DMB-3115) and 87.9% (ustekinumab). Rates of treatment-emergent adverse events were similar between treatments during period 1 (DMB-3115: 47.5%; ustekinumab: 49.8%) and period 2 (DMB-3115: 18.7%; ustekinumab: 21.2%; switched to DMB-3115: 18.3%). LIMITATIONS: Data were only through week 52. CONCLUSIONS: DMB-3115 showed a similar clinical efficacy and safety profile to ustekinumab in patients with moderate-to-severe plaque psoriasis.