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June 2025

A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis

Rheumatology 2025;64:3657–66 doi: org/10.1093/rheumatology/keaf066

Denton et al. showed that SC administration of immunoglobulin is generally well-tolerated in patients with dcSSc. Denton et al. evaluated the safety of IgPro20 in adults with dcSSc by recording of AEs, TEAEs, AE of special interests, ISRs and associated clinical tests. The secondary objectives were assessing PK and relative bioavailability of IgPro20, and the safety profile and PK of IgPro10. The ISR rate was low with no severe or serious TEAEs affecting the skin reported, despite moderate-to-severe skin involvement in all subjects and pathological skin features. Overall safety, PK and bioavailability profiles of IgPro20, and safety and PK of IgPro10 were similar to those observed in other indications.

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