Additional Relevant Details Janssen Research & Development, LLC (Janssen) Phase 3 data presented for the first time at Digestive Disease Week 2016 showed that a significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving STELARA (ustekinumab) subcutaneous (SC) maintenance therapy were in clinical remission at one year. The Phase 3 IM-UNITI maintenance study, which evaluated 388 patients who achieved clinical response eight weeks after a single intravenous infusion of STELARA in the UNITI-1 and UNITI-2 Phase 3 induction studies, showed that 53 percent of patients receiving a STELARA 90 mg SC injection every eight weeks (Q8W) and 49 percent of patients receiving a STELARA 90 mg SC injection every 12 weeks (Q12W) were in clinical remission at week 44, the study's primary endpoint, compared with 36 percent of patients receiving placebo (P = 0.005 and P = 0.040, respectively). Clinical remission was defined by a Crohn's Disease Activity Index (CDAI) score of less than 150 points; CDAI is a symptom-based disease assessment tool commonly used in clinical trials to quantify Crohn's disease activity.