Table 2

Percentage of patients achieving efficacy end points at week 52 (mITT population)

Sifalimumab (%)
End pointTotal number of patientsPlacebo (%)200  mg*p Value600 mg*p Value1200  mg*p Valuep Values
Cochran–Armitage test
 PGA ≤0.543129.634.30.49946.30.01343.00.039NC
 Meeting oral corticosteroid taper criteria**36834.435.40.91448.30.06550.00.026NC
Post hoc
 50% joints‡‡15536.853.70.08657.90.03160.50.024NC
 Clinical SLEDAI43148.658.30.14459.30.09763.60.023NC
  • 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.