Post-marketing safety evaluation of recombinant anti-rho (D) immunoglobulin for the prevention of maternal rh-isoimmunization: A prospective, multi-centre, phase IV study

Abstract

AntiD is a recombinant anti-D immunoglobulin approved as an immunoprophylaxis treatment in Rh-negative mothers carrying an Rh-positive fetus. This study was conducted to assess the safety and tolerability of AntiD in clinical settings. This was a prospective, multicenter, phase IV, post-marketing safety study of AntiD. The study was conducted at 29 hospitals in India as per regulatory requirements. Three hundred eligible Rh-negative women were administered a single intramuscular dose of either 150 mcg or 300 mcg AntiD within 72 hours of a sensitizing event as per the approved indication. Safety and tolerability were evaluated based on the assessment of adverse events (AEs) and serious adverse events (SAEs) reported during the study.Out of the 300 participants enrolled, 290 completed the study procedures. A total of 54 AEs and 34 treatment-emergent adverse events (TEAEs) were reported by 47 (15.7%) and 30 (10.0%) participants, respectively. Most reported TEAEs were mild, unrelated to the study drug, and were completely resolved during the study. Except for two participants with clinically significant hematological and urinalysis findings consistent with their underlying medical conditions, none of the participants exhibited abnormal clinical or laboratory parameters. Based on the assessment of the different safety parameters, AntiD administered at a dose of either 150 mcg or 300 mcg did not raise any new or significant safety concerns. The current study demonstrated that AntiD is well-tolerated and safe to use for anti-D prophylaxis as per product label indications for the prevention of Rh-isoimmunization in a clinical setting.