Ann Rheum Dis: The safety and efficacy of Bailey wood monotherapy for systemic lupus erythematosus in children.

The ongoing Phase 2, Randomized, Placebo-Controlled, Double-Blind Study assessed the efficacy, safety, and pharmacodynamics of intravenous bellewood monotherapy against systemic lupus erythematosus (cSLE) in children.
patients (5-17 years of age) were randomly grouped for intravenous 10mg/kg or placebo treatment every 4 weeks, in addition to standard SLE treatment.
end point: SLE Respondent Index (SRI4) Response Rate (Week 52).
Key secondary endpoints: proportion of patients who met the pediatric rheumatology international trial organization/American Rheumatology Society (PRINTO/ACR) response using 50 and 30 substitution definitions (week 52), and the proportion of patients who achieved continuous response through SRI4 and the overall parental well-being assessment (parental overall assessment) (weeks 44-52).
evaluated safety and pharmacodynamics.
study is not sufficient for statistical testing.
a total of 93 patients were randomly grouped (Bailey wood monoantial group, n=53; placebo group, n=40).
week 52, the SRI4 respondents in the Bellewood monoantigen group were more likely than placebos (52.8% vs. 43.6%; OR 1.49 (95% CI 0.64-3.46).
30 substitution (52.8% vs 27.5%; OR 2.92 (95% CI 1.19-7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15-6.54)) responses were more common than in the placebo group.
SRI4 (Bailey wood monoantigen 43.4%; placebo 41.0%; The same is true of the continuing response of OR 1.08 (95% CI 0.46-2.52) and the overall parent assessment (Bailey wood monoantin 59.1%; placebo 33.3%; OR 3.49 (95% CI 1.23-9.91).
reported severe adverse events in 17.0 per cent of baileys and 35.0 per cent of placebo patients;
week 52, the geometric mean (95%CI) of baileywood mono-valley concentration was 56.2 (45.2-69.8) sg/mL.
intravenous pharmacodynamics and benefit-risk conditions in children with SLE were consistent with adult studies, and a dose of 10 mg/kg per 4 weeks was appropriate.
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