Clinical and biomarker outcomes
| 120 Q2W n=381 | 120 Q4W n=378 | Placebo n=379 | |
|---|---|---|---|
| SRI-5 | 121 (31.8) p=0.409 | 133 (35.2) p=0.052 | 111 (29.3) |
| Components of SRI-5 | |||
| ≥5 point improvement in SELENA-SLEDAI score | 122 (32.0) p=0.618 | 134 (35.4) p=0.105 | 116 (30.6) |
| No worsening in BILAG* | 247 (64.8) p=0.038 | 234 (61.9) p=0.177 | 219 (57.8) |
| No worsening in PGA† | 245 (64.3) p=0.062 | 232 (61.4) p=0.263 | 220 (58.0) |
| Other clinical outcomes | |||
| Severe flares on the SELENA-SLEDAI Flare Index | |||
| Median time to first severe flare, days HR for severe flares (95% CI) | 169 0.94 (0.67 to 1.32) p=0.724 | 146 0.79 (0.55 to 1.13) p=0.204 | 141 |
| Corticosteroid sparing‡ | 46 (23.4) p=0.280 | 35 (17.5) p=0.747 | 37 (18.9) |
| BFI, LSM change | −1.31 p=0.163 | −1.38 p=0.081 | −1.01 |
| SELENA-SLEDAI, LSM change | −5.1 p=0.832 | −5.4 p=0.492 | −5.2 |
| PGA score, LSM change | −23.5 p=0.770 | −23.9 p=0.587 | −23.1 |
| SLEDAI-2K, LSM change | −5.0 p=0.342 | −5.2 p=0.141 | −4.8 |
| SLICC, LSM change | 0.03 p=0.964 | 0.03 p=0.921 | 0.03 |
| Biomarkers | |||
| Anti-dsDNA, IU, LSM change | −25.6 p<0.001 | −22.3 p<0.001 | −4.1 |
| Anti-dsDNA positive at baseline | n=228 | n=231 | n=226 |
| Normalisation at week 52 | 32 (14) | 36 (16) | 20 (9) |
| Complement C3, g/L, mean change | 0.046 p=0.002 | 0.047 p=0.007 | 0.015 |
| Complement C4, g/L, mean change | 0.031 p<0.001 | 0.031 p<0.001 | 0.005 |
| Low complement (C3 and/or C4) at baseline | n=161 | n=168 | n=182 |
| Normalised at week 52 | 47 (29) | 61 (36) | 40 (22) |
All data are n (%) unless indicated otherwise.
*No new BILAG A and no more than one new BILAG B.
†Worsening defined as an increase of ≥0.3 points from baseline.
‡Percent of patients able to decrease corticosteroid dose by at least 25% to ≤7.5 mg/day prednisone for at least three consecutive months from weeks 24 to 52 without an increase in dose of either antimalarials or immunosuppressants at any time during the treatment period.
Anti-dsDNA, anti-double-stranded DNA; BFI, Brief Fatigue Inventory; BILAG, British Isles Lupus Assessment Group index; LSM, least-squares mean change from baseline, PGA, physician's global assessment; Q2W, every two weeks; Q4W, every four weeks; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment—Systemic Lupus Erythematosus Disease Activity Index; SLE, systemic lupus erythematosus; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SLICC, Systemic Lupus International Collaborating Clinics; SRI-5, SLE Responder Index 5.