17
(continued)
Adalimumab
Reinisch et al. [
18
]
Induction (ULTRA-1)
576 patients with moderate-to-severe UC despite corticosteroids or immunosuppressants
Randomized 1:1:1 to 160 mg at week 0, 80 mg at week 2, 40 mg at weeks 4 and 6 (ADA160/80), 80 mg at week 0, 40 mg at weeks 2, 4, and 6 (ADA80/40), or placebo
Clinical response at week 8 achieved in 54.6% of the ADA160/80 group, 51.5% of the ADA80/40 group, and 44.6% of the placebo group
Clinical remission at week 8 achieved in 18.5% of patients in the ADA160/80 group (
P = 0.031),
10.0% in the ADA80/40 group (P
= 0.833), and 9.2% in the placebo
group
Study protocol amended and led to two analyses (ITT-A3,
N = 390
and ITT-E,
N
= 576)
a
Mucosal improvement occurred in 46.9% of the ADA160/80 group, 37.7% of the ADA80/40 group, and 41.5% of the placebo group
Sandborn et al. [
19
]
Maintenance (ULTRA-2)
494 patients with moderate-to-severe UC who received concurrent treatment with oral corticosteroids or immunosuppressants, 40% of study population had prior TNF exposure
Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week or placebo
Clinical response at week 8 occurred in 50.4% of adalimumab-treated patients and 34.6% of placebo-treated patients (
P < 0.001)
Overall clinical remission at week 8 achieved in 16.5% of adalimumab-treated patients and 9.3% of placebo-treated patients (
P = 0.19)
Overall clinical remission at week 52 achieved in 17.3% of adalimumab-treated patients and 8.5% of placebo patients (
P = 0.004)
Mucosal improvement at week 8 achieved in 41.1% and 31.7%, respectively, for adalimumab and placebo groups (
P
= 0.032). Mucosal
improvements at week 52 were 25.0% and 15.4%, respectively, for adalimumab and placebo groups (P
= 0.009)
Clinical response at week 52 occurred in 30.2% of adalimumab-treated patients and 18.3% of placebo-treated patients (
P < 0.002)
2 Antitumor Necrosis Factor Agents in Ulcerative Colitis