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. 2019 Jun 1;32(2):70-75.
doi: 10.1089/ped.2018.0967. Epub 2019 Jun 17.

Subcutaneous Immunoglobulin Twenty Percent Every Two Weeks in Pediatric Patients with Primary Immunodeficiencies: Subcohort Analysis of the IBIS Study

Clementina Canessa  1 , Vera Gallo  2 , Claudio Pignata  2 , Antonino Trizzino  3 , Simona Graziani  4 , Baldassarre Martire  5 , Viviana Moschese  4 , Valentina Palladino  6 , Giorgio Maria Boggia  7 , Andrea Matucci  8 , Antonio Pecoraro  9 , Giuseppe Spadaro  9 , Alessandra Vultaggio  8 , Chiara Azzari  1
Affiliations

Subcutaneous Immunoglobulin Twenty Percent Every Two Weeks in Pediatric Patients with Primary Immunodeficiencies: Subcohort Analysis of the IBIS Study

Clementina Canessa et al. Pediatr Allergy Immunol Pulmonol. .

Abstract

Background: Subcutaneous immunoglobulin G (SCIG) may be a better option than intravenous immunoglobulin G (IVIG) for patients with primary immunodeficiencies (PID) due to reduced systemic and serious adverse reactions and easier administration. The Infusione Bimensile di Immunoglobuline Sottocute (IBIS) study investigated the effects of Hizentra®, a 20%-concentrated SCIG, administered biweekly in patients with PID. This subanalysis aimed to evaluate clinical and laboratory outcomes in the IBIS pediatric subcohort. Methods: Thirteen children with PID were observed for 12 months retrospectively (with previous IVIG/SCIG) and prospectively with biweekly Hizentra. Results: Mean ± standard deviation serum IG levels during the retrospective (833.8 ± 175.7 mg/dL) and the prospective (842.0 ± 188.0 mg/dL) phases were comparable; there were also no differences in the number of infections. Conclusions: Biweekly Hizentra is a noninferior option with respect to previous IVIG/SCIG-based treatment.

Keywords: children; immunoglobulin; pediatric; primary immunodeficiencies; subcutaneous.

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Conflict of interest statement

G.M.B. is an employee of CSL Behring. C.C., V.G., C.P., A.T., S.G., B.M., V.M., V.P., A.M., A.P., G.S., A.V., and C.A. declare no conflicts of interest.

Figures

<b>FIG. 1.</b>
FIG. 1.
Design of the IBIS study. IBIS, Infusione Bimensile di Immunoglobuline Sottocute; IVIG, intravenous immunoglobulin G; SCIG, subcutaneous immunoglobulin; T, time.
<b>FIG. 2.</b>
FIG. 2.
Serum IgG trough levels during the retrospective and prospective phases when patients received subcutaneous immunoglobulins. FPFV, first patient first visit; IgG, immunoglobulin G; LPLV, last patient last visit.
<b>FIG. 3.</b>
FIG. 3.
Comparison of (A) IgG levels, (B) number of infections, (C) rate of infections, (D) antibiotic therapy.
See this image and copyright information in PMC

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