Clinical meaningfulness of a British Isles Lupus Assessment Group-based Composite Lupus Assessment response in terms of patient-reported outcomes in moderate to severe systemic lupus erythematosus: a post-hoc analysis of the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab
Lancet Rheumatol 2022;4:e198–207
Patient-reported outcomes (PROs) are an important aspect of evaluating therapies in clinical trials, as well as clinical practice, and are important for assessment of treatment benefits in patients with SLE. However, the BICLA, used as a validated global measure of treatment response in SLE clinical trials, does not include PROs.
To this end, Strand, et al. evaluated the clinical meaningfulness of a BICLA response from the patient perspective by analysing PROs by BICLA responses with anifrolumab or placebo in patients with moderate-to-severe SLE, using data from the Phase 3 TULIP-1 and TULIP-2 trials.