Skip to main content

Table 3 Response criteria: LSM difference between canakinumab and placebo for HAQ and FACIT-F scores at week 12

From: Efficacy and safety of the human anti-IL-1beta monoclonal antibody canakinumab in rheumatoid arthritis: results of a 12-week, phase II, dose-finding study

Variable

Canakinumab 150 mg SC q4wk, n = 69

Canakinumab 300 mg SC q2wk, n = 64

Canakinumab 300 mg SC q2wk + 600 mg IV loading dose, n = 71

HAQ score

   

Baseline, mean (SD)

1.643 (0.6106)

1.572 (0.6106)

1.613 (0.4879)

Difference vs. placebo in LS mean change (95% CI)

-0.2 (-0.3, 0.0)

-0.1 (-0.3, 0.1)

-0.1 (-0.3, 0.0)

p-value

0.036*

0.253

0.171

FACIT-F score

   

Baseline, mean (SD)

25.6 (12.51)

25.8 (11.87)

22.5 (9.26)

Difference vs. placebo in LS mean change (95% CI)

4.4 (1.3, 7.5)

2.5 (-0.7, 5.6)

3.5 (0.4, 6.7)

p-value

0.006*

0.120

0.028*

  1. *Statistical significance (2-sided) vs. placebo. Statistical model is analysis of covariance adjusting for treatment and center with baseline value as a covariate
  2. Abbreviations: CI, confidence interval; FACIT-F, Functional Assessment of Chronic Illness Therapy--Fatigue; HAQ, Health Assessment Questionnaire; IV, intravenous; LSM, least-squares mean; q2wk, every 2 weeks; q4wk, every 4 weeks; SC, subcutaneous; SD, standard deviation