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.
|