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Table 2 Observed response rates in each of the SRI + OCS components in the anifrolumab 300 mg arm and placebo arm of the MUSE trial

From: Increasing power in the analysis of responder endpoints in rheumatology: a software tutorial

Components

Response criteria

Treatment arm

Anifrolumab 300 mg

Placebo

SLEDAI

Improvement of at least 4 points (change from baseline ≤− 4)

58/89

41/76

PGA

No flare/worsening of disease as measured by PGA (change from baseline <0.3)

87/89

75/76

BILAG

No flare/worsening of disease as measured by BILAG (no new Grade A or more than one Grade B compared to baseline)

86/89

72/76

OCS

Sustained reduction in oral corticosteroids

53/95

37/87

Overall SRI + OCS response

Must responds in all four components

34/95

18/87

  1. SLE index is comprised of a continuous SLEDAI outcome, continuous PGA outcome, ordinal BILAG outcome and binary OCS measure