% CI
Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI score by at least 100 points or being in clinical remission:
70 point response is defined as reduction in CDAI score by at least 70 points
* Patient population consisted of patients who failed or were intolerant to TNF blocker therapy † Patient population consisted of patients who failed or were intolerant to corticosteroids or immunomodulators (e.g., 6-mercaptopurine, azathioprine, methotrexate) and previously received but not failed a TNF blocker or were never treated with a TNF blocker. ‡ Infusion dose of STELARA ® using the weight-based dosage regimen specified in Table 1. § 0.001≤ p < 0.01 ¶ p < 0.001
Clinical Response (100 point), Week 6 53 (21%) 84 (34%)§ 12%
(4%, 20%) 60 (29%) 116 (56%)¶ 27%
(18%, 36%)
Clinical Remission, Week 8 18 (7%) 52 (21%)¶ 14%
(8%, 20%) 41 (20%) 84 (40%)¶ 21%
(12%, 29%)
Clinical Response (100 point), Week 8 50 (20%) 94 (38%)¶ 18%
(10%, 25%) 67 (32%) 121 (58%)¶ 26%
(17%, 35%)
70 Point Response, Week 6 75 (30%) 109 (44%)§ 13%
(5%, 22%) 81 (39%) 135 (65%)¶ 26%
(17%, 35%)
70 Point Response, Week 3 67 (27%) 101 (41%)§ 13%
(5%, 22%) 66 (32%) 106 (51%)¶ 19%
(10%, 28%)
Study CD-3
The maintenance study (CD-3), eva luated 388 patients who achieved clinical response (≥100 point reduction in CDAI score) at Week 8 of induction with STELARA® in studies CD-1 or CD-2. Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg STELARA® every 8 weeks or placebo for 44 weeks (see TABLE 10).
Table 10: Clinical Response and Remission in CD-3 (Week 44; 52 weeks from initiation of the induction dose)
Placebo* 90 mg STELARA® every 8 weeks Treatment difference and 95% CI
N=131† N=128†
Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI of at least 100 points or being in clinical remission
* The placebo group consisted of patients who were in response to STELARA ® and were randomized to receive placebo at the start of maintenance therapy. † Patients who achieved clinical response to STELARA ® at the end of the induction study. ‡ p < 0.01 § 0.01≤ p < 0.05 ¶ Patients in remission at the end of maintenance therapy who were in remission at the start of maintenance therapy. This does not account for any other time point during maintenance therapy.
Clinical Remission 47 (36%) 68 (53%)‡ 17%
(5%, 29%)
Clinical Response 58 (44%) 76 (59%)§ 15%
(3%, 27%)
Clinical Remission in patients in remission at the start of maintenance therapy¶ 36/79 (46%) 52/78 (67%)‡ 21%
(6%, 36%)
At Week 44, 47% of patients who received STELARA® were corticosteroid-free and in clinical remission, compared to 30% of patients in the placebo group.
At Week 0 of Study CD-3, 34/56 (61%) STELARA® treated patients who previously failed or were intolerant to TNF blocker therapies were in clinical remission and 23/56 (41%) of these patients were in clinical remission at W |
