Photo Credit: arb Elkin

The following is a summary of “A Phase 2 randomised trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis,” published in the February 2025 issue of Rheumatology by Denton et al. 

Researchers conducted a retrospective study to evaluate the safety of IgPro20 in adults with diffuse cutaneous systemic sclerosis (dcSSc). They also assessed the pharmacokinetics, bioavailability of IgPro20, and the safety and pharmacokinetics of IgPro10. 

They conducted a prospective, multicentre, randomized, open-label, crossover Phase 2 study (NCT04137224) in patients (≥18 years) with dcSSc. They assigned 16 weeks of IgPro20 (0.5 g/kg/week) followed by 16 weeks of IgPro10 (2 g/kg/4 weeks over 2–5 sessions) or vice versa. They assessed treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), infusion site reactions (ISRs), clinical tests, pharmacokinetics, and bioavailability. 

The results showed that 27 patients were randomized (9 October 2019–31 August 2021). TEAEs occurred in 22 patients (81.5%), with 107 events (IgPro20: 49, IgPro10: 58), mostly mild/moderate. SAEs occurred in 6 patients (22.2%), with 10 events (IgPro20: 6, IgPro10: 4); no treatment-related SAEs or deaths were reported. IgPro20 ISR rate was 2 per 100 infusions. Maximum immunoglobulin G concentration was lower with IgPro20 (23.7 [1.2] g/l) vs IgPro10 (46.1 [1.2] g/l). Dose-normalized, baseline-corrected AUC0–tau was lower with IgPro20 (44.8 [1.4] h*g/l) vs IgPro10 (60.2 [1.4] h*g/l). IgPro20 bioavailability relative to IgPro10 was 76.1%. 

Investigators found that in patients with dcSSc, the safety, pharmacokinetics, and bioavailability of IgPro20 and IgPro10 were similar to those in other approved indications. 

Source: academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keaf066/8002919