Autoimmune Cytopenias

At the ISTH 2021 Congress, held virtually from July 17–21, an international multicenter team provided information (abstract PB0830) about ADVANCE SC, a multicenter, randomized, double-blinded, placebo-controlled trial phase 3 trial (ClinicalTrials.gov Identifier: NCT04687072) that will evaluate the efficacy and safety of the FcRn antagonist efgartigimod PH20 administered subcutaneously in adults with persistent or chronic ITP. In a phase 2 trial in patients with primary ITP, they note, efgartigimod was well tolerated and associated with rapid reduction of total IgG levels, clinically relevant increases in platelet counts, and reduction in the number of patients with bleeding episodes. The researchers describe eligibility requirements for the trial in their abstract. Concurrent ITP treatments that are permitted include corticosteroids, oral immunosuppressants, dapsone/danazol, fostamatinib, and/or oral TPO-RAs. Recruitment is ongoing in Asia-Pacific, Europe, Japan, Latin America, the Middle East, Africa, and the United States, and trial participants will be eligible for continuation into ADVANCE SC+, a long-term open-label extension trial.