SUMMARY: Previously collected data suggests there is not a pattern of malformations in the newborn of mothers maintained on Neoral during pregnancy. In addition to retrospective reports, the new Neoral Registry will involve enrollment of patients before the outcome of the pregnancy is known, thereby collecting data prospectively. Patients can self-enroll or enroll through their healthcare provider
PHILADELPHIA, March 31 /PRNewswire/ — In a collaboration with industry, physicians at Thomas Jefferson University Hospital, Philadelphia, are evaluating the outcomes of pregnancy in women with rheumatoid arthritis and psoriasis who have been treated with Neoral® (cyclosporine, USP). A three-year grant from Novartis was awarded to Jefferson to develop this U.S. national registry for pregnant women with rheumatoid arthritis or psoriasis who are treated with Neoral.
The Food and Drug Administration approved Neoral for use in the United States in May 1997 for severe active rheumatoid arthritis (RA) inadequately controlled by standard immunosuppressive therapy. In June 1997, Neoral was also approved for the treatment of severe recalcitrant plaque psoriasis (PSO) for patients who were intolerant or unresponsive to at least one other systemic therapy. The FDA asked Novartis to establish a registry for pregnant PSO and RA patients exposed to Neoral during pregnancy and to collect data on their outcomes.
Since 1991 the National Transplantation Pregnancy Registry (NTPR) at Thomas Jefferson University has followed the outcomes of pregnancies in transplant patients as well as those pregnancies fathered by male transplant recipients. Almost all of these recipients are on immunosuppressive anti-rejection therapy, which can include Neoral.
“We were contacted by Novartis because of our extensive experience with tracking immunosuppressant use in pregnancy in the transplant population,” said Vincent T. Armenti, M.D., Ph.D., Professor of Surgery at Jefferson Medical College, Thomas Jefferson University, and principal investigator for both the Neoral Registry and the NTPR. Having developed the NTPR and thus having the experience of tracking pregnancy outcomes with exposure to immunosuppressants, Novartis felt that a registry developed at Jefferson could provide the information requested by the FDA.
Since its establishment in 1991, the NTPR has followed more than 2,000 pregnancy outcomes in transplant recipients. The NTPR currently uses a retrospective data collection method.
“From analyses of data collected by the NTPR, we have not found a specific pattern of malformations in the newborn of mothers maintained on Neoral during pregnancy,” said Dr. Armenti. In addition to retrospective reports, the new Neoral Registry will involve enrollment of patients before the outcome of the pregnancy is known, thereby collecting data prospectively. Patients can self-enroll or enroll through their healthcare provider
“We will be very much dependent on the cooperation of physicians and patients nationwide, said Dr. Armenti. We are interested in all cases as the numbers may be limited and it will be very important to track as many cases as possible.” As new drugs are released and there is a need to monitor their safety during pregnancy, pregnancy registries with university and industry collaboration will be an important resource for healthcare providers.
In addition to Dr. Armenti, a team of collaborating physicians for the Neoral Registry includes: Ronald J. Wapner, M.D., Professor of Obstetrics and Gynecology and Director, of the Division of Maternal-Fetal Medicine; Amy Levine, M.D., Assistant Professor of Obstetrics and Gynecology (Maternal-Fetal Medicine); J. Bruce Smith, M.D., Professor of Medicine (Rheumatology); Magaly Del Monaco, D.O., Assistant Professor of Dermatology and Cutaneous Biology (Dermatology); and Michael J. Moritz, M.D., Associate Professor of Surgery and Director of the Division of Transplantation (Surgery).
Source: Thomas Jefferson