Table 3

Subgroup analysis results: Remission at week 8, stratified by baseline Mayo score, extensive colitis, concomitant medications, baseline CRP level, and weight tertiles

Placebo N=130ADA 80/40 N=130ADA 160/80 N=130
Mayo <10, N838185
 Remission, n (%)10 (12.0)11 (13.6)17 (20.0)
 Difference from placebo* (95% CI)1.5 (–8.7 to 11.8)8.0 (–3.1 to 19.0)
Mayo ≥10, N474945
 Remission, n (%)2 (4.3)2 (4.1)7 (15.6)
 Difference from placebo (95% CI)−0.2 (−8.2 to 7.8)11.3 (−0.8 to 23.4)
Extensive colitis, N737060
 Remission, n (%)11 (15.1)7 (10.0)12 (20.0)
 Difference from placebo (95% CI)−5.1 (−15.9 to 5.7)4.9 (−8.1 to 18.0)
No extensive colitis, N576070
 Remission, n (%)1 (1.8)6 (10.0)12 (17.1)
 Difference from placebo (95% CI)8.2 (−0.1 to 16.6)15.4 (5.9 to 24.9)
Corticosteroid (without IMM), N554848
 Remission, n (%)6 (10.9)5 (10.4)10 (20.8)
 Difference from placebo (95% CI)−0.5 (−12.6 to 11.7)11.3 (−3.0 to 25.7)
IMM (without corticosteroid), N182528
 Remission, n (%)02 (8.0)6 (21.4)
 Difference from placebo (95% CI)8.7 (−2.8 to 20.2)20.7 (5.9 to 35.4)
IMM + corticosteroid, N342623
 Remission, n (%)2 (5.9)4 (15.4)2 (8.7)
 Difference from placebo (95% CI)8.4 (−6.8 to 23.6)4.1 (−11.2 to 19.5)
No corticosteroid + no IMM, N233131
 Remission, n (%)4 (17.4)2 (6.5)6 (19.4)
 Difference from placebo (95% CI)−10.4 (−27.5 to 6.7)−1.0 (−20.5 to 18.5)
Aminosalicylates, N9898105
 Remission, n (%)11 (11.2)7 (7.1)18 (17.1)
 Difference from placebo (95% CI)−4.1 (−12.1 to 4.0)5.9 (−3.6 to 15.5)
No aminosalicylates, N323225
 Remission, n (%)1 (3.1)6 (18.8)6 (24.0)
 Difference from placebo (95% CI)15.6 (0.8 to 30.4)20.9 (3.1 to 38.7)
CRP <10 mg/l, N9587101
 Remission, n (%)7 (7.4)9 (10.3)21 (20.8)
 Difference from placebo (95% CI)3.0 (−5.3 to 11.3)13.4 (3.9 to 22.9)
CRP ≥10 mg/l, N324025
 Remission, n (%)4 (12.5)4 (10.0)2 (8.0)
 Difference from placebo (95% CI)−2.5 (−17.3 to 12.3)−4.5 (−20.1 to 11.1)
Weight < 70.0 kg, N354045
 Remission, n (%)5 (14.3)6 (15.0)11 (24.4)
 Difference from placebo (95% CI)0.7 (−15.3 to 16.7)10.2 (−6.9 to 27.2)
Weight ≥70.0 kg, <82.0 kg, N434833
 Remission, n (%)3 (7.0)3 (6.3)8 (24.2)
 Difference from placebo (95% CI)−0.7 (−11.0 to 9.5)17.3 (0.8 to 33.8)
Weight ≥82.0 kg, N524252
 Remission, n (%)4 (7.7)4 (9.5)5 (9.6)
 Difference from placebo (95% CI)1.8 (−9.6 to 13.3)1.9 (−8.9 to 12.7)
  • * Difference in proportion between active treatment group and placebo.

  • Azathioprine and 6-mercaptopurine.

  • ADA, adalimumab; CI, confidence interval; CRP, C-reactive protein; IMM, immunomodulator.