Changes in clinical and serological measures from baseline in SRI responders versus non-responders at Week 52
| SRI responders (n=761) | SRI non-responders (n=923) | p Value | Adjusted p value* | |
|---|---|---|---|---|
| Clinical measures | ||||
| SELENA-SLEDAI, n (%) | ||||
| ≥4-point reduction | 761 (100) | 35 (3.8) | <0.001† | <0.001‡ |
| ≥7-point reduction | 307 (40.3) | 12 (1.3) | <0.001† | <0.001‡ |
| Mean no. of organ domains with improvement, per patient (SE)§ | ||||
| BILAG | 1.45 (0.03) | 0.40 (0.02) | <0.001¶ | <0.001** |
| SELENA-SLEDAI | 2.00 (0.03) | 0.39 (0.02) | <0.001¶ | <0.001** |
| No new BILAG A score and ≤1 new B score, n (%) | 699 (91.9) | 331 (35.9) | <0.001† | <0.001** |
| Mean % change in PGA score from baseline in all patients (SE) | −58.3 (1.17) (n=761) | −13.7 (2.03) (n=923) | <0.001¶ | <0.001‡ |
| Mean % change in PGA score from baseline in patients with no worsening (SE) ≥0.3-point increase, n†† | −58.3 (1.17) 761 | −34.9 (1.75) 455 | <0.001¶ | <0.001‡ |
| Corticosteroid dose, n (%) | ||||
| Dose decrease to ≤7.5 mg/d from >7.5 mg/d at baseline†† | 120/471 (25.5) | 70/505 (13.9) | <0.001† | <0.001‡ |
| Dose increase to >7.5 mg/d from ≤7.5 mg/d at baseline‡‡ | 12/290 (4.1) | 89/418 (21.3) | <0.001† | <0.001‡ |
| SFI flare, n (%) | ||||
| Any | 532 (69.9) | 763 (82.7) | HR 0.58 95% CI 0.52 to 0.65 <0.001§§ | <0.001††† |
| Severe | 47 (6.2) | 269 (29.1) | HR 0.13 95% CI 0.09 to 0.17 <0.001§§ | <0.001††† |
| Serological measures | ||||
| Anti-dsDNA antibodies | ||||
| Median % change in patients positive (≥30 IU/L) at baseline (Q1, Q3)¶¶ | −34.2 (−57.04, −0.50) (n=434) | −26.1 (−50.81, 6.76) (n=479) | 0.01*** | 0.129** |
| Normalisation in patients positive at baseline, n (%)¶¶ | 69/479 (14.4) | 47/434 (10.8) | 0.10† | 0.243‡ |
| C3 | ||||
| Median % change in patients with low C3 (<90 mg/dL) at baseline (Q1, Q3)¶¶ | 14.5 (1.25, 35.46) (n=292) | 9.0 (−4.88, 26.51) (n=293) | 0.001*** | 0.009** |
| Normalisation in patients with low C3 at baseline, n (%)¶¶ | 89/292 (30.5) | 74/293 (25.3) | 0.16† | 0.044‡ |
| C4 | ||||
| Median % change (Q1,Q3) in patients with low C4 (<16 mg/dL) at baseline (Q1, Q3)¶¶ | 40.0 (13.33, 81.82) (n=361) | 28.6 (0.00, 63.64) (n=379) | 0.003*** | 0.049** |
| Normalisation in patients with low C4 at baseline, n (%)¶¶ | 134/361 (37.1) | 112/379 (29.6) | 0.03† | 0.013‡ |
*The analysis was adjusted for the baseline value for each listed parameter using the following methods of analysis.
†Likelihood ratio test.
‡logistic regression test.
§Improved from British Isles Lupus Assessment Group (BILAG) A to B score or better, or from B to C score or better; dropout=failure.
¶2-sample t test.
**Analysis of covariance test.
††Last observation carried forward.
‡‡Dropout=failure.
§§Log-rank test.
¶¶Based on modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) analysis that excluded anti-dsDNA and complement items from determination of 4-point decrease in Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) component of SRI; includes patients with data available at Week 52/primary visit.
***Wilcoxon test.
†††Cox test.
anti-dsDNA, antidouble-stranded DNA; C, complement; PGA, Physician's Global Assessment; Q, quartile; SFI, SLE Flare Index.