Table 1

Baseline demographics and clinical characteristics of patients in the ITT-A3 population

Placebo (N=130)ADA 80/40 (N=130)ADA 160/80 (N=130)
Male (%)63.160.063.8
Age, years: median (range)37 (18–72)40 (18–75)36.5 (18–75)
Weight, kg: mean (SD)78.7 (17.4)76.8 (15.0)75.5 (14.2)
Disease location (%)*
 Extensive colitis56.253.846.2
 Left-sided colitis32.336.946.9
 Other§11.59.26.9
Disease duration, years: median (range)5.35 (0.3–34.1)6.91 (0.3–39.7)6.06 (0.2–34.4)
Mayo score, mean (SD)8.7 (1.56)9.0 (1.62)8.8 (1.61)
 Endoscopy subscore2.5 (0.52)2.5 (0.50)2.4 (0.50)
 Rectal bleeding subscore1.6 (0.79)1.7 (0.78)1.7 (0.88)
 PGA subscore2.2 (0.50)2.3 (0.62)2.2 (0.57)
 Stool frequency subscore2.4 (0.74)2.5 (0.72)2.4 (0.78)
CRP, mg/l: median (range)3.2 (0.18–280)6.4 (0.03–193)3.3 (0.13–109)
Concomitant medication, n (%)
 Corticosteroid (without IMM)55 (41.5)48 (36.9)48 (36.9)
 IMM (without corticosteroid)18 (13.8)25 (19.2)28 (21.5)
 Corticosteroid + IMM34 (26.1)26 (20.0)23 (17.7)
 No corticosteroid, no IMM23 (17.7)31 (23.8)31 (23.8)
 Aminosalicylates**98 (75.4)99 (76.2)105 (80.8)
  • * Totals may not equal 100% because of rounding.

  • Corresponding to Montreal classification E3.

  • Corresponding to Montreal classification E2.

  • § Other: Includes different information regarding location as provided by the investigator; for example, rectosigmoiditis, proximal ascending, distal transverse colon, rectosigmoid + caecal inflammation (patchiness), and other locations. Patients with proctitis were excluded.

  • Rectal bleeding subscore=0 for 6.9%, 6.9%, and 10.8% of patients in placebo, ADA 80/40, and ADA 160/80 groups, respectively. Differences were not statistically significant.

  • ** Includes: mesalazine/mesalamine, olsalazine, balsalazide, sulfasalazine.

  • CRP, C-reactive protein; IMM, immunomodulator; PGA, physician's global assessment.