Percentage of patients achieving efficacy end points at week 52 (mITT population)
| Sifalimumab (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| End point | Total number of patients | Placebo (%) | 200 mg* | p Value | 600 mg* | p Value | 1200 mg* | p Value | p Values Cochran–Armitage test |
| Primary | |||||||||
| SRI(4) | 431 | 45.4 | 58.3 | 0.057 | 56.5 | 0.094 | 59.8 | 0.031 | 0.053 |
| IFN-high | 350 | 42.0 | 57.5 | 0.042 | 50.0 | 0.264 | 57.5 | 0.038 | 0.104 |
| IFN-low | 81 | 60.0 | 61.9 | 0.886 | 85.0 | 0.094 | 70.0 | 0.502 | 0.248 |
| Region† | |||||||||
| 1 | 296 | 54.1 | 60.0 | 0.458 | 62.2 | 0.331 | 65.8 | 0.149 | NC |
| 2 | 135 | 26.5 | 54.5 | 0.019 | 44.1 | 0.102 | 47.1 | 0.073 | NC |
| Secondary | |||||||||
| CLASI‡ | 127 | 48.6 | 72.7 | 0.044 | 57.6 | 0.498 | 73.1 | 0.049 | NC |
| Fatigue§ | 413 | 30.5 | 38.1 | 0.270 | 42.2 | 0.077 | 35.6 | 0.453 | NC |
| Predefined | |||||||||
| PGA ≤0.5 | 431 | 29.6 | 34.3 | 0.499 | 46.3 | 0.013 | 43.0 | 0.039 | NC |
| mSRI(5) | 430 | 39.3 | 50.9 | 0.071 | 43.5 | 0.458 | 54.2 | 0.024 | NC |
| mSRI(6) | 430 | 37.4 | 50.0 | 0.051 | 43.5 | 0.301 | 53.3 | 0.016 | NC |
| mSRI(7) | 388 | 24.5 | 40.8 | 0.008 | 43.0 | 0.004 | 44.4 | 0.002 | NC |
| mSRI(8) | 384 | 24.5 | 37.5 | 0.034 | 41.3 | 0.008 | 41.8 | 0.008 | NC |
| IFN-high | 312 | 20.3 | 35.1 | 0.027 | 35.5 | 0.027 | 41.3 | 0.004 | NC |
| IFN-low | 72 | 42.1 | 47.4 | 0.714 | 68.8 | 0.114 | 44.4 | 0.894 | NC |
| BICLA¶ | 429 | 36.1 | 45.4 | 0.177 | 46.7 | 0.114 | 48.1 | 0.072 | NC |
| IFN-high | 349 | 31.8 | 44.8 | 0.080 | 44.3 | 0.084 | 48.8 | 0.021 | NC |
| IFN-low | 80 | 55.0 | 47.6 | 0.624 | 57.9 | 0.891 | 45.0 | 0.526 | NC |
| SLEDAI−2K4 | 431 | 45.4 | 58.3 | 0.057 | 58.3 | 0.050 | 61.7 | 0.014 | NC |
| Meeting oral corticosteroid taper criteria** | 368 | 34.4 | 35.4 | 0.914 | 48.3 | 0.065 | 50.0 | 0.026 | NC |
| Flares†† | 431 | 19.4 | 20.4 | 0.803 | 11.1 | 0.095 | 13.1 | 0.192 | NC |
| Post hoc | |||||||||
| 50% joints‡‡ | 155 | 36.8 | 53.7 | 0.086 | 57.9 | 0.031 | 60.5 | 0.024 | NC |
| Clinical SLEDAI | 431 | 48.6 | 58.3 | 0.144 | 59.3 | 0.097 | 63.6 | 0.023 | NC |
p Values in bold are, in the context of this study, statistically significant (p≤0.098).
*Days 1, 15 and 29, and then every 28 days thereafter.
†Region 1 (high standard-of-care response): central America, South America, eastern Europe and Asia; Region 2 (low standard-of-care response): North America, western Europe and South Africa.
‡CLASI ≥10 at baseline with ≥4-point reduction (improvement) by week 52.
§>3-point improvement from baseline in FACIT-F score.
¶BICLA responder: reduction of baseline BILAG-2004 index ‘A’ to ‘B/C/D’ and ‘B’ to ‘C/D’, no BILAG-2004 index worsening in other organ systems (no new ‘A’ or ‘B’), increase in total SLEDAI-2K of <1 and increase of PGA of <0.3.
**Percentage who met predefined criteria for oral corticosteroids taper: no increase in corticosteroids in the prior 3 months, SLEDAI-2K improvement ≥6 and PGA ≤0.5.
††Increase in disease activity resulting in an increased steroid use greater than baseline dosage.
‡‡≥50% decrease in both swollen and tender joint counts from baseline in patients with ≥8 swollen and ≥8 tender joints at baseline.
BICLA, BILAG-2004-based Combined Lupus Assessment; BILAG-2004, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; FACIT-F, Functional Assessment of Chronic Illness Therapy−Fatigue; IFN, interferon; mITT, modified intention-to-treat; mSRI, modified SLE Responder Index; NC, not calculated; PGA, Physician's Global Assessment; SLEDAI-2K4, at least a 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000; Clinical SLEDAI, at least a 4-point reduction in clinical components (no laboratory components) of Systemic Lupus Erythematosus Disease Activity; SRI(4), SLE Responder Index.