Variables | IV Placebo, n = 237 | IV Golimumab, 2 mg/kg, n = 237 |
---|---|---|
Change in total PsA-modified SvdHa, mean (SD) | 1.95 (0.26) | −0.36 (0.14) |
Estimated mean (95% CI) | 1.95 (1.40–2.51) | −0.36 (−0.66 to −0.07) |
Estimated mean difference (SE) | −2.32 (0.32) | |
pb | < 0.001 | |
Change in total PsA-modified SvdHa, mean (SD), by: | ||
MTX use at baseline | 2.14 (4.14) | −0.36 (1.91) |
pb | < 0.001 | |
No MTX use at baseline | 1.58 (3.84) | −0.36 (2.77) |
pb | 0.001 | |
NSAID use at baseline | 2.16 (3.92) | −0.57 (2.13) |
Posthoc pb | < 0.001 | |
No NSAID use at baseline | 1.48 (4.35) | 0.18 (2.37) |
Posthoc pb | 0.037 | |
Oral corticosteroid use at baseline | 1.17 (2.50) | 0.11 (2.59) |
Posthoc pb | 0.029 | |
No oral corticosteroid use at baseline | 2.27 (4.49) | −0.53 (2.05) |
Posthoc pb | < 0.001 | |
Change in total hand PsA-modified SvdH, mean (SD) | 1.22 (3.07) | −0.36 (1.67) |
Change in total feet PsA-modified SvdH, mean (SD) | 0.66 (1.80) | −0.02 (1.08) |
Change in erosion score,c mean (SD) | 1.27 (2.81) | −0.29 (1.74) |
pd | < 0.001 | |
Change in JSN score,c mean (SD) | 0.61 (1.67) | −0.08 (1.09) |
pd | < 0.001 | |
Patients with ≥ 1 joint with erosion score = 0 at baselinee | 213 | 230 |
Patients with no new erosions at Week 24 in joints with erosion score = 0 at baseline, n (%) | 115 (54.0) | 171 (74.3) |
% difference (95% CI)f | 20.3 (11.52–29.02) | |
pg | < 0.001 | |
Patients with ≥ 1 joint with JSN score = 0 at baselinee | 214 | 229 |
Patients with no new JSN at Week 24 in joints with JSN score = 0 at baseline, n (%) | 162 (75.7) | 205 (89.5) |
% difference (95% CI)f | 13.7 (6.74–20.65) | |
pg | < 0.001 |
↵a Change from baseline in total PsA-modified SvdH based on imputed data using multiple imputation for missing data and using predictive mean matching method. Summary statistics calculated from patients with observed data and the average of the 100 imputations for each patient with missing data.
↵b P value derived by pooling over 100 imputed samples using the standard error of the mean.
↵c Change from baseline in erosion and JSN scores based on imputed data using linear extrapolation for missing data.
↵d P values based on ANCOVA on the van der Waerden scores, controlling for baseline MTX usage (yes, no).
↵e Erosion and JSN scores are based on observed values. Only patients with ≥ 1 joint with a score = 0 at baseline and ≥ 1 corresponding non-missing score at Week 24 were included.
↵f The 95% CI are based on Wald statistic controlling for baseline MTX usage (yes, no).
↵g P values are based on CMH test controlling for baseline MTX usage (yes, no). CMH: Cochran-Mantel-Haenszel; IV: intravenous; JSN: joint space narrowing; MTX: methotrexate; NSAID: nonsteroidal antiinflammatory drug; PsA: psoriatic arthritis; SE: standard error; SvdH: Sharp/van der Heijde Score.