General health status in patients with moderate to severe ulcerative colitis receiving ustekinumab: results from the Phase III UNIFI induction and maintenance studies

Background and Aim: The UNIFI studies evaluated the safety and efficacy of ustekinumab (UST) intravenous (IV) induction and subcutaneous (SC) maintenance in patients with moderately to severely active ulcerative colitis (UC). We evaluated patient‐reported outcomes related to general health status in these studies. Methods: In the induction study, eligible patients were randomized to a single IV dose of placebo (PBO) (n = 319), UST 130 mg (n = 320), or UST ∼6 mg/kg (n = 322). Patients who were in clinical response 8 weeks after receiving UST induction were eligible for the maintenance study and were randomized to SC PBO (n = 175), UST 90mg q12w (n = 172), or UST 90mg q8w (n = 176). General health status was assessed using the 36‐item Short‐Form Health Survey (SF‐36) and the visual analog scale of EuroQoL‐5D Health Questionnaire (EQ VAS). SF‐36 measured eight (Table presented) functional areas that were summarized into physical and mental component summary (PCS and MCS, respectively) scores. EQ VAS ranges from 0 to 100. Higher SF‐36 and EQ VAS scores indicate better health status. Results: At baseline of the induction study, mean SF‐36 PCS and MCS scores were below the US general population norm of 50 and were indicative of patients with significantly impaired general health status (Table 1). Eight weeks after IV induction, patients receiving UST reported significantly greater improvements in mean SF‐36 PCS and MCS and EQ VAS scores compared with the PBO group (P < 0.001). Statistically significant differences between UST and PBO were observed for each of the individual subscales of the SF‐36 (P ≤ 0.002). Through Week 44 of the maintenance study, mean SF‐36 PCS scores worsened in the PBO group, were maintained in the UST q12w group, and improved in the UST q8w group (Table 2). Mean SF‐36 MCS score also worsened in the PBO group and was maintained in the UST q12w and q8w groups (P ≤ 0.009). The proportions of patients with clinically meaningful improvements in SF‐36 PCS and MCS (≥ 5 points) and EQ VAS (> 10 points) scores from induction baseline to maintenance Week 44 were significantly greater in the UST groups compared with PBO (P ≤ 0.001). Conclusion: Patients reported significantly greater improvements in general health status after UST IV induction compared with PBO. In patients who responded to UST IV induction, improvements were sustained or increased with 44 weeks of SC UST maintenance therapy.