reg; group compared with placebo at Week 24.
Physical Function
STELARA® treated patients showed improvement in physical function compared to patients treated with placebo as assessed by HAQ-DI at Week 24. In both studies, the proportion of HAQ-DI responders (≥0.3 improvement in HAQ-DI score) was greater in the STELARA® 45 mg and 90 mg groups compared to placebo at Week 24.
14.3 Crohn's Disease
STELARA® was eva luated in three randomized, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of 220 to 450). There were two 8-week intravenous induction studies (CD-1 and CD-2) followed by a 44-week subcutaneous randomized withdrawal maintenance study (CD-3) representing 52 weeks of therapy.
Studies CD-1 and CD-2
In studies CD-1 and CD-2, 1409 patients were randomized, of whom 1368 (CD-1, n=741; CD-2, n=627) were included in the final efficacy analysis. Induction of clinical response (defined as a reduction in CDAI score of greater than or equal to 100 points or CDAI score of less than 150) at Week 6 and clinical remission (defined as a CDAI score of less than 150) at Week 8 were eva luated. In both studies, patients were randomized to receive a single intravenous administration of STELARA® at either approximately 6 mg/kg, placebo (see TABLE 1), or 130 mg (a lower dose than recommended).
In Study CD-1, patients had failed or were intolerant to prior treatment with a TNF blocker: 29% patients had an inadequate initial response (primary non-responders), 69% responded but subsequently lost response (secondary non-responders) and 36% were intolerant to a TNF blocker. Of these patients, 48% failed or were intolerant to one TNF blocker and 52% had failed 2 or 3 prior TNF blockers. At baseline and throughout the study, approximately 46% of the patients were receiving corticosteroids and 31% of the patients were receiving immunomodulators (azathioprine, 6-mercaptopurine, methotrexate). The median baseline CDAI score was 319 in the STELARA® approximately 6 mg/kg group and 313 in the placebo group.
In Study CD-2, patients had failed or were intolerant to prior treatment with corticosteroids (81% of patients), at least one immunomodulator (6-mercaptopurine, azathioprine, methotrexate; 68% of patients), or both (49% of patients). Additionally, 69% never received a TNF blocker and 31% previously received but had not failed a TNF blocker. At baseline, and throughout the study, approximately 39% of the patients were receiving corticosteroids and 35% of the patients were receiving immunomodulators (azathioprine, 6-mercaptopurine, methotrexate). The median baseline CDAI score was 286 in the STELARA® and 290 in the placebo group.
In these induction studies, a greater proportion of patients treated with STELARA® achieved clinical response at Week 6 and clinical remission at Week 8 compared to placebo (see TABLE 9 for clinical response and remission rates). Clinical response and remission were significant as early as Week 3 in STELARA®-treated patients and continued to improve through Week 8.
Table 9: Induction of Clinical Response and Remission in CD-1* and CD-2†
CD-1
n=741 CD-2
n=627
Placebo
N=247 STELARA®‡
N=249 Treatment difference and 95% CI Placebo
N=209 STELARA®‡
N=209 Treatment difference and 95 |
