Table 2

Disease activity and patient-reported outcomes at baseline, week 8 and week 22

Efficacy measuresBaselineWeek 8Week 22
Golimumab+MTXPlacebo+MTXGolimumab+MTXPlacebo+MTXP value for
group difference
Golimumab+MTXPlacebo+MTXP value for group difference
DAS CRP2.1 (1.7–2.7)2.4 (1.9–2.9)1.12 (0.7–1.61)1.8 (1.31–2.34)0.0020.91 (0.68–1.36)1.8 (1.18–2.19)0.000
Swollen joint count7 (4–8.3)5 (4–10.3)1 (0–3)4 (1.5–8)0.0030 (0–1.25)2 (0–4)0.042
Tender joint count9.5 (4–15.3)10 (5.3–15.5)1 (0–4)5 (3–9.8)0.0190 (0–4)3 (1–5)0.019
PASI (in group with BSL PASI >2.5)5.75 (4.0–7.55)4.95 (3.5–8.45)0.65 (0–3.05)2.7 (0.75–4.25)0.2100.55 (0–1.9)0.5 (0–1.95)0.924
No of patients with enthesitis47430.594240.209
No of patients with dactylitis98550.836010.313
ESR (mm/h)20.5 (6.5–33.3)15.5 (5–30.5)2 (2–5)8 (5–19)0.0032 (2–18)8 (2–13)0.566
CRP (mg/dL)4.5 (1.2–13)7.1 (2.2–16.6)0.75 (0.3–2.95)2.9 (1.25–7.75)0.0791.1 (1.48–2.85)3.6 (1.2–7.0)0.144
VAS patient global (mm)48(26–59)36 (25–54)21 (6–36)31 (16–46)0.1849 (4–32)31 (14–57)0.038
VAS patient pain (mm)44 (29–64)34 (17–7)11 (3–24)30 (16–38)0.0036 (2–18)34 (6–58)0.001
VAS physician (mm)48 (37–53)46 (37–64)10 (6–25)33 (19–50)0.0004 (1–20)18 (9–33)0.047
BASDAI40.5 (29.9–56.3)47.1 (19.1–56.9)36.5 (16.3–59.6)41.6 (22.5–61.0)0.28718.1 (4.9–23)24.6 (11.7–49.5)0.022
HAQ0.38 (0.19–1.0)0.63 (0.19–1.47)0 (0–0.3)0.43 (0.03–0.84)0.0030 (0–0.125)0.25 (0–0.5)0.403
SF36 PCS41.1 (35.8–48.1)43.6 (36.1–48.5)47.0 (40.9–55.1)48.8 (45.3–53.0)0.05650.1 (43.7–52.2)50.7 (44.5–52.1)0.543
SF36MCS47.9 (40.7–55.4)51.6 (47.4–56.6)51.7 (40.7–56.8)50.3 (44.2–56.5)0.04150.7 (40.0–55.5)50.9 (37.8–52.7)0.125
DLQI2 (0–7)2 (0–5.75)1 (0–3.5)1 (0–5)0.8911 (0–3)0 (0–3.5)0.272
  • Values are median (p25, p75) or No of patients.

  • BASDAI, Bath ankylosing spondylitis disease activity index; CRP, C-Reactive Protein; DLQI, Dermatology Life Quality Index; ESR, Erythrocyte Sedimentation Rate; HAQ, Health Assessment Questionnaire; PASI, psoriasis activity and severity index; SF36, Short form 36 Physical Component Score; SF36 MCS, Short form 36 Mental Component Score; VAS, Visual Analogue Scale.