Lupus & antiphospholipid syndrome
Evaluation of the Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL) clinician-reported outcome (clinician-reported (ClinRO)) and patient-reported outcome (patient-reported (PRO)): prespecified analysis of the phase III ustekinumab trial in patients with SLE
Authors' conclusion
The LFA-REAL ClinRO and PRO showed varied levels of correlations (weak to strong) with existing physician-based lupus disease activity measures and patient-reported outcome instruments, respectively and were able to more accurately capture organ-specific mucocutaneous and musculoskeletal manifestations.
Study context
- Population
- Patients with active SLE in the phase III ustekinumab trial (mean [SD] age 43.5 [8.9]; 93.4% female)482 (93.4%) female
- Participants
- 516 patients
- Primary endpoint
- Correlations of LFA-REAL ClinRO and PRO with clinician-reported and patient-reported SLE disease activity measures
- Follow-up
- Baseline, week 24 and week 52
Methodological detailsprespecified analysis, double-blind, placebo-controlled, parallel-group, multicentre (140 sites in 20 countries)
- Prespecified analysis
- Double-blind
- Placebo-controlled
- Parallel-group
- Multicentre (140 sites in 20 countries)
Primary result
As reported in the abstract
Correlations (r) at baseline, week 24 and week 52
- LFA-REAL ClinRO vs PGA: r=0.39, 0.65 and 0.74
- p<0.001
- LFA-REAL ClinRO vs BILAG: r=0.43, 0.67 and 0.73
- p<0.001
- LFA-REAL ClinRO vs SLEDAI-2K: r=0.35, 0.60 and 0.62
- p<0.001
- ClinRO arthralgia/arthritis score vs active joint counts: r=0.54, 0.73 and 0.68
- p<0.001
- ClinRO mucocutaneous global score vs CLE Disease Area and Severity Index total activity: r=0.57, 0.77 and 0.81
- p<0.001
- LFA-REAL PRO vs FACIT-Fatigue: r=−0.60, −0.55 and −0.58
- p<0.001
- LFA-REAL PRO vs Lupus QoL physical health: r=−0.42, −0.47 and −0.46
- p<0.001
- LFA-REAL PRO vs SF-36v2 vitality: r=−0.40, −0.43 and −0.58
- p<0.001
- LFA-REAL PRO vs SF-36v2 Physical Component Summary: r=−0.45, −0.53 and −0.53
- p<0.001
- LFA-REAL ClinRO vs PRO: r=0.32, 0.45 and 0.50
- p<0.001
Original publication
Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): prespecified analysis of the phase III ustekinumab trial in patients with SLE. Lupus Sci Med. Published 3 April 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →