s, and/or immunomodulatory agents were permitted, and 79% of patients continued to receive at least one of these medications.
Induction of clinical remission (defined as CDAI < 150) was eva luated in two studies. In Study CD-I, 299 TNF-blocker naïve patients were randomized to one of four treatment groups: the placebo group received placebo at Weeks 0 and 2, the 160/80 group received 160 mg Humira at Week 0 and 80 mg at Week 2, the 80/40 group received 80 mg at Week 0 and 40 mg at Week 2, and the 40/20 group received 40 mg at Week 0 and 20 mg at Week 2. Clinical results were assessed at Week 4.
In the second induction study, Study CD-II, 325 patients who had lost response to, or were intolerant to, previous infliximab therapy were randomized to receive either 160 mg Humira at Week 0 and 80 mg at Week 2, or placebo at Weeks 0 and 2. Clinical results were assessed at Week 4.
Maintenance of clinical remission was eva luated in Study CD-III. In this study, 854 patients with active disease received open-label Humira, 80 mg at week 0 and 40 mg at Week 2. Patients were then randomized at Week 4 to 40 mg Humira every other week, 40 mg Humira every week, or placebo. The total study duration was 56 weeks. Patients in clinical response (decrease in CDAI ≥70) at Week 4 were stratified and analyzed separately from those not in clinical response at Week 4.
Induction of Clinical Remission
A greater percentage of the patients treated with 160/80 mg Humira achieved induction of clinical remission versus placebo at Week 4 regardless of whether the patients were TNF blocker naïve (CD-I), or had lost response to or were intolerant to infliximab (CD-II) (see Table 11).
Table 11. Induction of Clinical Remission in Studies CD-I and CD-II (Percent of Patients) CD-I CD-II
Placebo
N=74 Humira 160/80 mg
N=76 Placebo
N=166 Humira 160/80 mg
N=159
Week 4
Clinical remission 12% 36%* 7% 21%*
Clinical response 34% 58%** 34% 52%**
Clinical remission is CDAI score < 150; clinical response is decrease in CDAI of at least 70 points.
* p<0.001 for Humira vs. placebo pairwise comparison of proportions
** p<0.01 for Humira vs. placebo pairwise comparison of proportions
Maintenance of Clinical Remission
In Study CD-III at Week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis. At Weeks 26 and 56, greater proportions of patients who were in clinical response at Week 4 achieved clinical remission in the Humira 40 mg every other week maintenance group compared to patients in the placebo maintenance group (see Table 12). The group that received Humira therapy every week did not demonstrate significantly higher remission rates compared to the group that received Humira every other week.
Table 12. Maintenance of Clinical Remission in CD-III (Percent of Patients) Placebo 40 mg Humira
every other week
N=170 N=172
Week 26
Clinical remission 17% 40%*
Clinical response 28% 54%*
Week 56
Clinical remission 12% 36%*
Clinical response 18% 43%*
Clinical remission is CDAI score < 150; clinical response is decrease in CDAI of at least 70 points.
*p<0.001 for Humira vs. placebo pairwise comparisons of proportions
Of those in response at Week 4 who attained remission during the study, patients in the Humira every other week group maintained remission for a lon |
