Efficacy comparison of ustekinumab between anti‐tumor necrosis factor‐ α drug‐naïve and anti‐tumor necrosis factor‐ α drug‐resistant Japanese psoriasis cases

Ustekinumab is highly efficacious for psoriasis; however, it has not been fully clarified whether previous failure in anti‐tumor necrosis factor‐ α ( TNF ‐ α ) therapy affects the treatment response with ustekinumab. Therefore, we evaluated the efficacy of ustekinumab in anti‐ TNF ‐ α ‐naïve and anti‐ TNF ‐ α ‐resistant cases and compared the clinical efficacies of adalimumab and ustekinumab in biologic naïve cases. Thirty‐five patients with plaque psoriasis who showed resistance to conventional therapies were enrolled; 26 patients, who had never been treated with biologics, were allocated to ustekinumab or adalimumab; nine patients who failed to achieve psoriasis area and severity index ( PASI ) 50 at week 16 with one or two TNF ‐ α antagonists were switched to ustekinumab. The end of the study was defined as 52 weeks after starting the first biologic for anti‐ TNF ‐ α ‐naïve patients and after switching to ustekinumab for anti‐ TNF ‐ α ‐resistant patients. The primary outcome measurement was the percentage of patients achieving PASI 75 at week 16. In patients treated with ustekinumab, 87.5% of anti‐ TNF ‐ α ‐naïve and 77.8% of anti‐ TNF ‐ α ‐resistant cases achieved a PASI 75 response at week 16, and no statistically significant difference was found between the treatment response rates ( P  =   0.60). When comparing the treatment efficacy of ustekinumab and adalimumab among anti‐ TNF ‐ α ‐naïve patients, there was also no statistically significant difference in PASI 75 achievement rates (87.5 vs. 83.3%, P  =   0.79). Our study suggests that ustekinumab can be considered as a first‐line biologic for psoriasis and a rescue therapy for anti‐ TNF ‐ α ‐resistant cases.