Table 2

Summary of percentage change from baseline in HAQ-DI and SF-36 physical component scores in patients receiving secukinumab 10 mg/kg or matching placebo (two intravenous injections, 21 days apart)

Secukinumab (N=24)Placebo (N=13)p Value
HAQ-DI*
Baseline, mean (SD)1.64 (0.66)1.20 (0.71)
Week 6, mean (SD)–20.6 (30.3)0.25 (14.0)0.002
 Patients with reduction from baseline >0.3 (n/nT;† %)7/20 (35.0%)0/10 (0.0%)0.038
Week 12, mean (SD)–27.94 (35.5)6.34 (25.5)0.004
 Patients with reduction from baseline >0.3 (n/nT;† %)9/21 (42.9%)1/11 (9.1%)0.056
Week 24/EOS, mean (SD)–19.68 (30.037)17.09 (54.5)0.019
 Patients with reduction from baseline >0.3 (n/nT;† %)9/23 (39.1%)1/11 (9.1%)0.077
SF-36 physical component score‡
Baseline, mean (SD)30.8 (10.0)36.1 (9.0)
Week 6, mean (SD)15.2 (28.4)–0.51 (29.6)0.030
Week 12, mean (SD)20.4 (32.6)–3.25 (19.4)0.037
Week 24/EOS, mean (SD)15.2 (28.1)–2.61 (26.0)0.148
  • *p value comparison is for mean changes from baseline, secukinumab versus placebo.

  • †n, number of subjects with HAQ-DI reduction from baseline >0.3; nT, total number of subjects at visit with non-missing HAQ-DI values at baseline and at visit.

  • ‡p value comparison is for mean changes from baseline, secukinumab versus placebo (mixed-effect model).

  • EOS, end of study; HAQ-DI, Health Assessment Questionnaire Disability Index; SF-36, Short Form Health Survey.