New Registry Tracks Health of Pregnant Women Taking Neoral®

Thanks to a three-year grant from Novartis, a global pharmaceutical company, physicians at Thomas Jefferson University Hospital have launched a study tracking the safety during pregnancy of a new medication taken by women to treat rheumatoid arthritis or psoriasis. The interdisciplinary study will permit the creation of the first national registry to help assure health and safety for such women.

“Having this registry will hopefully enable us to inform these women taking Neoral® that it is safe if they become pregnant. The registry should yield reliable information and, hopefully, peace of mind for both patient and practitioner,” explains Vincent T. Armenti, MD, PhD, Professor of Surgery, principal investigator for the registry. 

“The registry is a nice example of Thomas Jefferson University Hospital linking with industry in response to a patient need – safety during pregnancy,” he adds.

To develop the new registry, Novartis turned to Dr. Armenti because of his work with the National Transplantation Pregnancy Registry (NTPR) established in 1991 at Jefferson. The NTPR follows the outcomes of female transplant recipients who become pregnant or male recipients who father pregnancies after transplant.

“We have several years experience using Neoral® for immunosuppressive therapy in the transplant population. Although there could be some overlap, the new registry targets a different patient population – pregnant women with either rheumatoid arthritis or psor.

Interdisciplinary Scope
The Federal Drug Administration (FDA) approved Neoral® in 1997 to treat severe cases of both rheumatoid arthritis, a disease marked by degeneration of the joints, and psoriasis, a skin disease marked by vivid blemishes. The fact that the two chronic diseases have no direct relation medically other than they both involve inflammation widens the interdisciplinary scope of the study. 

Speaking for dermatology, Magaly P. Del Monaco, DO, Clinical Assistant Professor of Dermatology and Cutaneous Biology, says: “For patients with severe psoriasis, we are sometimes limited as to what medication we can use. We know Neoral® definitely helps psoriasis. So if a woman of childbearing age is taking this medication, and the study confirms its safety during pregnancy, then we will be able to continue treatment if she becomes pregnant.” 

The FDA requires that Neoral® be monitored in this patient population to track potential side effects on pregnant women and their children.

Adds Dr. Armenti: “The multidisciplinary aspect is a key strength of the new study. Novartis came to us first because of our transplant experience with Neoral®. We added expertise from other faculty and clinical disciplines. This is the advantage of industry collaborating with a medical university having the interdisciplinary expertise to create this kind of resource.” 

Other members of the multidisciplinary team of Jefferson specialists include: Ronald J. Wapner, MD, Professor of Obstetrics and Gynecology, and Director, Division of Maternal-Fetal Medicine; Amy Levine, MD, Assistant Professor of Obstetrics and Gynecology (maternal-fetal medicine); J. Bruce Smith, MD, Professor of Medicine (rheumatology); and Michael J. Moritz, MD, Associate Professor of Surgery and Director of the Division of Transplantation.

For more information or to register for the study, please call 1-888-522-5581 or send an e-mail to Neoral.Registry@mail.tju.edu. Visit the website at http://www.jeffersonhealth.org/tjuh/neoralregistry/

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