RAPTIVA® Pregnancy Registry

For Additional Information:

FOLLOW, the RAPTIVA® Pregnancy Registry
3900 Paramount Parkway
Morrisville, NC 27560
877-RAPTIVA (877-727-8482) Option 3

FOLLOW, the RAPTIVA® Pregnancy Registry is designed to monitor pregnancy outcomes in women exposed to Raptiva. The Registry is a post-marketing commitment to the FDA. The Registry was implemented in January 2005 and is currently open for enrollment.

What is Raptiva?
Raptiva (efalizumab) is a recombinant humanized immunoglobulin G1 (IgG1) kappa isotype monoclonal antibody that binds specifically to human CD11a and inhibits binding of lymphocyte function-associated antigen-1 (LFA-1) to intercellular adhesion molecule-1 (ICAM-1). Raptiva was approved by the Food and Drug Administration (FDA) in October 2003 for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

What is the Registry?
The Raptiva Pregnancy Registry is a voluntary, prospective registry designed to obtain observational data on pregnancy outcomes of women who are exposed to Raptiva during pregnancy or within 6 weeks of conception.

Why is the Registry important?
In medical practice, it is common to encounter women of childbearing potential who have psoriasis. The purpose of this Registry is to study the safety of Raptiva when used within 6 weeks prior to or at any time during pregnancy. It is not possible to study exposures in pregnancy any other way. Currently, there is limited information on Raptiva exposure during pregnancy and its effect on pregnancy outcomes. Therefore, data collected in this Registry may be used to assist clinicians and patients in weighing risks of Raptiva exposure in pregnancy. The Registry is an essential component of the ongoing efforts to expand the understanding of the safety effects of Raptiva exposure.

How to participate in the Registry
The patient contacts the Raptiva Pregnancy Registry and a representative will obtain the patient's verbal consent to participate and collect enrollment information. Follow-up will be conducted by telephone interview with the pregnant woman and with all relevant Heath Care Providers. Data collected by telephone interview are minimal and targeted and are obtained at each trimester and at outcome of pregnancy through the obstetric health care provider. Additional follow-up will be conducted for all live births when infants are 6 and 12 months of age through the pediatric health care provider.

Why should I participate?
The Registry will provide information to physicians and patients regarding the safety of Raptiva exposure during pregnancy. This Registry is the primary source for collecting and evaluating exposures to Raptiva in pregnancy. Your contribution to this program enables you and your colleagues to assist in this public health initiative. The success of the Registry relies on participation of patients and health care providers.