Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS – A Novel Therapeutic Opportunity
Fig 2
Proteinuria was monitored as a safety assessment throughout the study.
Proteinuria was routinely measured at the hospital using Multistix (Siemens) and reported as negative, trace or grade 1–4. Data represents proteinuria in individual subjects at the indicated time-points after treatment. A-C) A mild but significant increase in proteinuria was seen on day 1 (P = 0.0003) and day 2 (P = 0.0002) after treatment with 0.12 and 0.24 mg/kg IdeS. D) On day 7 there were no significant (P = 0.80) differences between groups. The groups (nPlacebo = 9, n0.01 = 8, n0.04 = 4, n0.12 = 4 and n0.24 = 4) were compared using Kruskal-Wallis, One-Way ANOVA. The P-values shown in the graph represent comparisons of the mean rank of each dose-group with the placebo group using Dunn’s Multiple Comparison. The placebo group represents a pool of all subjects treated with placebo from all dose-groups.