ADVANCE IV: Swift responses on efgartigimod in ITP

Participants with primary immune thrombocytopenia (ITP) who were treated with efgartigimod mostly experienced quick increases in platelet counts, as soon as 1 week after treatment initiation. Responses continued to increase after week 12, indicating that some participants need more time to experience the beneficial effects of efgartigimod.

The current treatment options for ITP, an IgG-mediated autoimmune disorder, are suboptimal due to delayed response times, adverse events, limited efficacy, and a limited influence on patients’ quality of life. Prof. Catherine Broome (Georgetown University, DC, USA) introduced her talk: “New therapeutics are therefore needed and we assessed efgartigimod, an inhibitor of the neonatal Fc receptor (FcRn) and its interaction with IgG, in this context” [1].

The phase 3 ADVANCE IV study (NCT04188379) included 131 participants with persistent or chronic ITP who had received 2 or 1 prior and 1 concurrent ITP therapy with an average of 2 platelet (PLT) counts of <30 × 10⁹/L during screening. Participants were randomised 1:1 to efgartigimod or placebo. The current study analysed the time-to-treatment response over the course of the study.

After 1 week of treatment, 38.4% of the participants had already achieved a platelet count of ≥ 30 x 10⁹/L, compared with 11.1% of the participants receiving placebo (see Figure). At week 6, 31.8% of the participants in the efgartigimod arm had reached 2 consecutive platelet counts of ≥ 50 x 10⁹/L compared with 2.2% of the participants in the placebo arm. “We observed that some individuals needed more time to achieve a platelet response on efgartigimod, with mean rates increasing from 31.8% at week 6 to 44.0% at week 12, and 53.5% at week 18,” commented Prof. Broome.

Figure: The platelet count increases significantly in the efgartigimod group compared with placebo by week 1 already [1]



Overall, early increases in platelet counts were documented in participants with ITP who were treated with efgartigimod. However, mean response rates still increased after 12 weeks of therapy, indicating that some participants needed more time to respond.

1. Broome CM, et al. Time to achieve platelet count response after intravenous efgartigimod in adults with primary immune thrombocytopenia: a phase 3, multicentre, double-blinded, placebo-controlled, randomised clinical trial (ADVANCE IV). Abstract 689, 65^th ASH Annual Meeting, 9–12 December 2023, San Diego, CA, USA.

 

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Posted on 7 February 202427 March 2024