Table 15. Hospitalisations to Week 56 (ITT population) 40 mg 40 mg Combined adalimumab adalimumab Placebo fortnightly every week Adalimumab n=261 n=260 n=257 n= 517 n (%) n (%) n (%) n (%) All-cause Hospitalisation 47 (18) 25 (9.6)* 29 (11.3)* 54 (10.4)* CD Related Hospitalisation 31 (11.9) 16 (6.2)* 18 (7.0)* 34 (6.6)* – Major Surgery 11 (4.2) 1 (0.4)* 2 (0.8)* 3 (0.6)* *p≤ 0.05 Clinical remission results presented in Table 16 remained relatively constant irrespective of previous TNF antagonist exposure. Of trial in response at Week 4 who attained remission during the study, patients in adalimumab maintenance groups maintained remission for a significantly longer time that patients in the placebo maintenance group (see Figure 5). Among patients who were not in response by Week 12, therapy continued beyond 12 weeks did not result in significantly more responses. The group that received adalimumab every week did not show significantly higher remission rates than the group that received adalimumab fortnightly.
Table 15. Hospitalisations to Week 56 (ITT population) Placebo 40 mg adalimumab fortnightly 40 mg adalimumab every week Combined Adalimumab n=261 n (%) n=260 n (%) n=257 n (%) n= 517 n (%) All-cause Hospitalisation 47 (18) 25 (9.6)* 29 (11.3)* 54 (10.4)* CD – Related Hospitalisation 31 (11.9) 16 (6.2)* 18 (7.0)* 34 (6.6)* Major Surgery 11 (4.2) 1 (0.4)* 2 (0.8)* 3 (0.6)* *p≤ 0.05 Clinical remission results presented in Table 16 remained relatively constant irrespective of previous TNF antagonist exposure. Of in response at Week 4 who attained remission during the study, patients in adalimumab maintenance groups maintained remission for a significantly longer time that patients in the placebo maintenance group (see Figure 5). Among patients who were not in response by Week 12, therapy continued beyond 12 weeks did not result in significantly more responses. The group that received adalimumab every week did not show significantly higher remission rates than the group that received adalimumab fortnightly. trial
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