Karina Jahnz-Rozyk, Poland

Military Institute of Medicine Department of Internal Medicine, Pneumonology, Allergology, and Clinical Immunology

Presenter of 1 Presentation

Poster Display Therapy

REGISTRY TO COLLECT LONG TERM SAFETY DATA FROM PREGNANT WOMEN TREATED WITH RECOMBINANT HUMAN HYALURONIDASE (RHUPH20)-FACILITATED SUBCUTANEOUS IMMUNOGLOBULIN (FSCIG): INTERIM RESULTS

Lecture Time
10:13 - 10:14
Room
Poster Area
Date
20.09.2019, Friday
Session Time
10:00 - 17:00
Board Number
161
Presentation Topic
Therapy

Abstract

Background and Aims

To report interim data from an ongoing non-interventional, 2-arm, prospective, uncontrolled, open-label, multicenter, post-authorization registry study in Europe and North America to evaluate the safety of women who become pregnant during or after treatment with facilitated subcutaneous immunoglobulin (fSCIG), and to assess fetal and infant growth/development (NCT02556775).

Methods

Women who became pregnant during or after fSCIG exposure were encouraged to participate. During the study, patients either continued to receive fSCIG treatment or an alternate treatment (with a licensed human immunoglobulin product other than fSCIG or an alternative treatment as determined by the physician) in countries where fSCIG treatment during pregnancy is restricted. Assessments were performed per standard of care and data were obtained from medical records during the pregnancy. Data were also assessed on fetal development, and the growth and development of the infant for 2 years post-delivery. The study duration is ~6 years from initiation. Enrollment completed in 2017; however, the study is ongoing.

Results

A total of 16 patients (9 pregnant women and 7 infants) were enrolled. Seven pregnant women were included in the fSCIG-treatment arm and 2 in the alternate-treatment arm. As of February 28, 2019, 7 adverse events were reported for mothers receiving fSCIG; none were assessed as related to fSCIG. All 7 infants were live births and had normal Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) scores.

Conclusions

To date, there were no adverse events related to fSCIG in patients who became pregnant during or after fSCIG treatment and all infants born were normal according to APGAR scores.

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