Intravenous Immunoglobulin Appears Effective in Chronic ITP

Researchers, led by Judit Demeter, evaluated the safety and efficacy profiles of a novel 10% human intravenous immunoglobulin, BT595, in the treatment of adult patients with chronic immune thrombocytopenia (ITP). Their study, published in Transfusion Medicine, reported that BT595 effectively increased platelet counts with response rates similar to other comparable preparations.

A total of 62 patients underwent up to 14 days of screening. Of those patients, 34 were randomized and received at least 1 treatment dose followed by a 28-day observational period. The cohort had a mean years of age of 45.7 ± 16.86 years, 58.8% were female, and 7 (20.6%) had refractory ITP. The study’s primary efficacy end point was response, as defined by European Medicines Agency (EMA) criteria, and safety analysis covered treatment-emergent adverse events (TEAEs).

Intravenous Immunoglobulin Effectively Increases Platelets in ITP

According to the article, 18 (52.9%) out of 34 patients achieved an EMA response, with a complete response seen in 11 (32.4%). The median time to response was 1 day (range, 1-4 days), and the median duration of response was 28 days. In a subgroup of 19 patients with a platelet count <20 × 10⁹/L at baseline, a platelet response ≥50 × 10⁹/L per US Food and Drug Administration (FDA) criteria was achieved by 18 patients at day 8.

The researchers reported 1 (2.9%) patient experienced a serious TEAE, anemia, which was deemed not related to the study treatment. Otherwise, the most frequent infusion reaction was headache in 14.7% of all patients, while all other infusion reactions occurred in 1 (2.9%) patient (pyrexia, hemolysis, skin reaction, tinnitus, and Coombs test positivity). Finally, between a 2- and 5-day treatment schedule, the authors observed the 5-day schedule exhibited fewer side effects with similar efficacy.

Overall, Demeter and colleagues suggested BT595 was effective in patients with ITP. “Assessment of response by using FDA criteria additionally demonstrated not only the efficacy of BT595, but also underlined the differences in response rates seen by using the 2 different criteria for defining response,” the authors closed.

Related: Evaluating T-Cell Large Granular Lymphocytes in ITP Population