Table 2

Mean change from baseline to week 24 in exploratory patient-reported outcomes in the ITT population treated with romilkimab versus placebo

Placebo
QW
(n=49)
Romilkimab
200 mg QW
(n=48)
SHAQ—VAS for overall disease severity
 Baseline mean (SD)54.00 (27.62)42.71 (30.95)
 LS mean (SE) change from baseline–7.30 (3.12) (n=48)–12.72 (3.16) (n=47)
 LS mean (SE) difference (95% CI), p value–5.42 (4.48) (–14.32 to 3.48), 0.11
SHAQ—VAS for pain severity
 Baseline mean (SD)36.82 (26.72)28.65 (28.28)
 LS mean (SE) change from baseline1.18 (3.44) (n=48)–6.94 (3.46) (n=47)
 LS mean (SE) difference (95% CI), p value–8.12 (4.91) (–17.87 to 1.63), 0.0507
SHAQ—VAS for gastrointestinal function
 Baseline mean (SD)15.39 (22.25)7.54 (17.84)
 LS mean (SE) change from baseline5.40 (3.06) (n=48)3.21 (3.08) (n=47)
 LS mean (SE) difference (95% CI), p value–2.20 (4.38) (–10.90 to 6.51), 0.31
SHAQ—VAS for breathing function
 Baseline mean (SD)18.80 (23.96)10.38 (18.13)
 LS mean (SE) change from baseline2.32 (2.63) (n=48)0.14 (2.66) (n=47)
 LS mean (SE) difference (95% CI), p value–2.18 (3.78) (–9.70 to 5.33), 0.28
SHAQ—VAS for vascular function (Raynaud’s phenomenon)
 Baseline mean (SD)39.90 (28.82)29.98 (32.07)
 LS mean (SE) change from baseline–4.26 (3.24) (n=48)–8.46 (3.27) (n=47)
 LS mean (SE) difference (95% CI), p value–4.20 (4.64) (–13.43 to 5.02), 0.18
SHAQ—VAS for digital ulcer impact on activity
 Baseline mean (SD)23.44 (32.78) (n=48)15.00 (29.25) (n=47)
 LS mean (SE) change from baseline0.08 (3.38) (n=48)–6.10 (3.41) (n=46)
 LS mean (SE) difference (95% CI), p value–6.18 (4.81) (–15.74 to 3.38), 0.10
EQ-5D-5L
 Baseline mean (SD)0.58 (0.24)0.64 (0.18)
 LS mean (SE) change from baseline0.00 (0.03) (n=48)0.07 (0.03) (n=47)
 LS mean (SE) difference (95% CI), p value0.07 (0.04) (–0.01 to 0.15), 0.0363
  • Decline in SHAQ=improvement; increase in EQ-5D-5L=improvement.

  • EQ-5D-5L, European Quality of Life-5 Dimension-5 Level; ITT, intent-to-treat; LS, least squares; QW, one time per week; SHAQ, Scleroderma Health Assessment Questionnaire; VAS, Visual Analogue Scale.