WHAT IS ALREADY KNOWN ON THIS TOPIC In the anifrolumab clinical development programme for patients with systemic lupus erythematosus (SLE), clinical efficacy outcomes in favour of anifrolumab were consistently observed across the composite endpoints BILAG-based Composite Lupus Assessment (BICLA) and SLE Responder Index (SRI(4)) in the phase 3 TULIP-2 trial and the phase 2b MUSE trial, but not in the phase 3 TULIP-1 trial, for which SRI(4) treatment differences did not reach statistical significance.
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Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials.
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