Treatment of Inflammatory Bowel Disease with Biologics

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