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KMID : 1143220200630030315
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Obstetrics & Gynecology Science
2020 Volume.63 No. 3 p.315 ~ p.322
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Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial
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Mayekar Rahul Vishwanath
Paradkar Gopalkrishna Vinayak
Bhosale Archana Anilkumar
Sachan Rekha
Beeram Sumalatha
Anand Ashok Ramachandra
Mundle Shuchita Ramesh
Trivedi Yamini
Rashmi
Patole Kiran Pandharinath
Sambarey Pradip Wamanrao
Daftary Gautam Vinod
Divekar Ganesh Harishchandra
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Abstract
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Objective: To 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.
Methods: This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not 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 administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test.
Results: A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group?all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D.
Conclusion: The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.
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KEYWORD
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Rho(D) immune globulin, Recombinant proteins, Newborn hemolytic disease, Rh isoimmunization
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