New phase 3 data have shown that a significantly greater proportion of adult patients with moderate-to-severe Crohn’s disease receiving ustekinumab (Stelara, Janssen) subcutaneous (SC) maintenance therapy were in clinical remission at one year compared with placebo-treated patients.
The IM-UNITI maintenance study showed that 53% of patients receiving a 90-mg SC injection of ustekinumab every eight weeks (Q8W) and 49% of patients receiving a 90-mg SC injection of ustekinumab every 12 weeks (Q12W) were in clinical remission at week 44 (the study’s primary endpoint) compared with 36% of patients receiving placebo (P = 0.005 and P = 0.040, respectively). The study involved 388 patients who had achieved a clinical response eight weeks after a single intravenous infusion of ustekinumab in the UNITI-1 and UNITI-2 phase 3 induction studies.
Major secondary endpoints of the IM-UNITI trial included clinical response (i.e., an improvement in a Crohn’s Disease Activity Index [CDAI] score of at least 100 points after ustekinumab induction); clinical remission among patients in remission after induction; corticosteroid-free remission; and clinical remission in patients refractory to or intolerant of anti-tumor necrosis factor-alpha therapies at week 44.
Clinical response was maintained in a significantly greater proportion of patients receiving ustekinumab 90 mg SC Q8W (59%) or ustekinumab 90 mg SC Q12W (58%) compared with patients given placebo (44%) (P = 0.018 and P = 0.033, respectively).
Of the patients who were in clinical remission at the start of the study, 67% treated with ustekinumab 90 mg SC Q8W and 56% of those treated with ustekinumab 90 mg SC Q12W were in clinical remission at week 44 compared with 46% of patients given placebo (P < 0.01 and P = not significant, respectively).
A significantly higher percentage of patients treated with ustekinumab 90 mg SC Q8W (47%) and a significantly higher percentage of patients treated with ustekinumab 90 mg SC Q12W (43%) who were not receiving concomitant corticosteroids were in clinical remission at week 44 compared with 30% of patients given placebo (P = 0.004 and nominal P = 0.035, respectively).
Ustekinumab is a biologic therapy that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn’s disease. It is currently approved in the United States for the treatment of adult patients (18 years of age or older) with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Ustekinumab is also approved for the treatment of adult patients (18 years of age or older) with active psoriatic arthritis and can be used alone or in combination with methotrexate. An application seeking approval of ustekinumab for the treatment of patients with moderately to severely active Crohn’s disease is currently under review at the FDA.
Source: Janssen; May 23, 2016.