Change from baseline 196 200 197 97 99 97 N 4.89 6.22 1.09 4.29 4.67 1.4(7.094) (9.333) (8.747) (5.892) (8.594) (8.758) Mean (SD) 1.15 3.90 a 5.80 a 0.00 2.70c 3.50a Median Mental component summary Baseline N 203 203 204 104 102 104 Mean (SD) 43.51 42.77 43.48 42.11 43.27 42.81 (10.848) (10.908) (11.608) (12.507) (12.911) (11.953) 43.90 42.00 41.65 41.80 43.70 41.40 Median Change from baseline 196 200 197 97 99 97 N 1.53 3.35 4.79 0.63 3.01 3.52 (9.582) (10.016) (10.054) (8.238) (11.144) (11.274) Mean (SD) 0.25 2.65b 4.40a 0.00 0.70b 2.20b Median a p≤0.001 b p=NS c p<0.05 CROHN’S DISEASE The safety and efficacy of STELARA were evaluated in three randomised, double-blind, placebo-controlled clinical trials in adult patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score of 220 to 450). The clinical development program consisted of two 8-week IV induction studies (UNITI-1 and UNITI-2) followed by a subcutaneous randomised withdrawal maintenance study (IM-UNITI) representing 52 weeks of therapy. Induction of Clinical Response and Remission UNITI-1 and UNITI-2 studies included 1409 (UNITI-1 n=769; UNITI-2 n=640) patients. In both studies, patients were permitted to concomitantly receive oral 5-ASA compounds, immunomodulators, corticosteroids, and/or antibiotics. Patients were randomised to receive a
Change from baseline N 196 200 197 97 99 97 Mean (SD) 1.4(7.094) 4.89 (9.333) 6.22 (8.747) 1.09 (5.892) 4.29 (8.594) 4.67 (8.758) Median 1.15 3.90 a 5.80 a 0.00 2.70c 3.50a Mental component summary Baseline N 203 203 204 104 102 104 Mean (SD) 43.51 (10.848) 42.77 (10.908) 43.48 (11.608) 42.11 (12.507) 43.27 (12.911) 42.81 (11.953) Median 43.90 42.00 41.65 41.80 43.70 41.40 Change from baseline N 196 200 197 97 99 97 Mean (SD) 1.53 (9.582) 3.35 (10.016) 4.79 (10.054) 0.63 (8.238) 3.01 (11.144) 3.52 (11.274) Median 0.25 2.65b 4.40a 0.00 0.70b 2.20b a p≤0.001 b p=NS c p<0.05 CROHN’S DISEASE The safety and efficacy of STELARA were evaluated in three randomised, double-blind, placebo-controlled clinical trials in adult patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score of 220 to 450). The clinical development program consisted of two 8-week IV induction studies (UNITI-1 and UNITI-2) followed by a subcutaneous randomised withdrawal maintenance study (IM-UNITI) representing 52 weeks of therapy. Induction of Clinical Response and Remission UNITI-1 and UNITI-2 studies included 1409 (UNITI-1 n=769; UNITI-2 n=640) patients. In both studies, patients were permitted to concomitantly receive oral 5-ASA compounds, immunomodulators, corticosteroids, and/or antibiotics. Patients were randomised to receive a
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