Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial
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ObjectiveTo compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D)in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D. MethodsThis was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who didnot receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs)at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-Dat days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positiveICT results at days 90 and 180 were compared between the groups using Fisher’s exact test. ResultsA total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in theR-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positiveICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group—all weremild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D. ConclusionThe studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic. Trial RegistrationClinical Trials Registry of India Identifier: CTRI/2017/03/008101
Abstract
ObjectiveTo compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D)in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D. MethodsThis was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who didnot receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs)at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-Dat days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positiveICT results at days 90 and 180 were compared between the groups using Fisher’s exact test. ResultsA total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in theR-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positiveICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group—all weremild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D. ConclusionThe studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic. Trial RegistrationClinical Trials Registry of India Identifier: CTRI/2017/03/008101
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