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

## TL;DR

This study tested the safety and effectiveness of two immunoglobulin treatments in patients with a skin and connective tissue disease called diffuse cutaneous systemic sclerosis.

## Contribution

The study provides new safety and pharmacokinetic data for IgPro20 and IgPro10 in diffuse cutaneous systemic sclerosis patients.

## Key findings

- Most adverse events were mild or moderate, with no treatment-related serious adverse events reported.
- IgPro20 had lower maximum IgG concentration and bioavailability compared to IgPro10.
- Safety profiles of both treatments were consistent with other approved uses.

## Abstract

The primary objective was the safety of s.c. immunoglobulin, IgPro20 (Hizentra, CSL Behring) in adults with dcSSc. Secondary objectives included pharmacokinetics and relative bioavailability of IgPro20, and safety and pharmacokinetics of IVIG, IgPro10 (Privigen, CSL Behring).

In this prospective, multicentre, randomized, open-label, crossover phase 2 study (NCT04137224), patients (aged ≥18 years) with dcSSc were assigned to 16 weeks of IgPro20 (0.5 g/kg/week) followed by 16 weeks of IgPro10 (2 g/kg/4 weeks over two to five sessions), or vice versa. Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), infusion site reactions (ISRs), clinical tests, pharmacokinetic and bioavailability were assessed.

Twenty-seven patients were randomized from 9 October 2019 to 31 August 2021. In total, 22 patients (81.5%) experienced 107 TEAEs (IgPro20, 49; IgPro10, 58); most were mild/moderate. Six patients (22.2%) experienced 10 SAEs (IgPro20, 6; IgPro10, 4); no treatment-related SAEs and no deaths were reported. IgPro20 ISR rate was low (2 per 100 infusions). Maximum IgG concentration [mean (s.d.)] was numerically lower following IgPro20 [23.7 (1.2) g/l] vs IgPro10 [46.1 (1.2) g/l], as was the geometric mean dose-normalized, baseline-corrected area under the concentration–time curve from time point 0 to tau [IgPro20, 44.8 (1.4) h*g/l; IgPro10, 60.2 (1.4) h*g/l]. The bioavailability of IgPro20 relative to IgPro10 was 76.1%.

This study shows that in patients with dcSSc, safety, pharmacokinetic and bioavailability profiles of IgPro20, and safety and pharmacokinetics of IgPro10, are similar to those observed in other approved indications.

ClinicalTrials.gov, https://clinicaltrials.gov, NCT04137224