Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial.

Autor:	Mayekar RV; Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Mumbai, India., Paradkar GV; Department of Obstetrics and Gynaecology, Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Thane, India., Bhosale AA; Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Mumbai, India., Sachan R; Department of Obstetrics and Gynaecology, King George's Medical University, Lucknow, India., Beeram S; Department of Obstetrics and Gynaecology, Gandhi Medical College and Hospital, Secunderabad, India., Anand AR; Department of Obstetrics and Gynaecology, Grant Medical College and Sir J.J. Group of Hospitals, Mumbai, India., Mundle SR; Department of Obstetrics and Gynaecology, Government Medical College and Hospital, Nagpur, India., Trivedi Y; Department of Obstetrics and Gynaecology, AMC MET Medical College and Sheth LG General Hospital, Ahmedabad, India., Md R; Department of Obstetrics and Gynaecology, Apollo BGS Hospital, Mysore, India., Patole KP; Department of Obstetrics and Gynaecology, Dr. Vasantrao Pawar Medical College and Research Centre, Nashik, India., Sambarey PW; Department of Obstetrics and Gynaecology, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India., Daftary GV; Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India., John J; Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India., Divekar GH; Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India.
Jazyk:	angličtina
Zdroj:	Obstetrics & gynecology science [Obstet Gynecol Sci] 2020 May; Vol. 63 (3), pp. 315-322. Date of Electronic Publication: 2020 Apr 21.
DOI:	10.5468/ogs.2020.63.3.315
Abstrakt:	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. Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101. Competing Interests: Conflict of Interest: The author Gautam Vinod Daftary is the managing director at Bharat Serums and Vaccines Limited. The authors James John and Ganesh Harishchandra Divekar are full-time paid employees of Bharat Serums and Vaccines Limited. (Copyright © 2020 Korean Society of Obstetrics and Gynecology.)
Databáze:	MEDLINE
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