Pediatric subset of primary immunodeficiency patients treated with SCIG: post hoc analysis of SHIFT and IBIS pooled data
- PDF / 926,352 Bytes
- 8 Pages / 595.276 x 790.866 pts Page_size
- 84 Downloads / 148 Views
Allergy, Asthma & Clinical Immunology Open Access
SHORT REPORT
Pediatric subset of primary immunodeficiency patients treated with SCIG: post hoc analysis of SHIFT and IBIS pooled data Viviana Moschese1* , Clementina Canessa2, Antonino Trizzino3, Baldassarre Martire4, Giorgio Maria Boggia5 and Simona Graziani1 on behalf of the SHIFT and IBIS Study Groups
Abstract Background: Primary immunodeficiencies (PID) constitute a heterogeneous group of more than 350 monogenetic diseases. PID patients with antibody impairment require lifelong administration of immunoglobulin G replacement therapy, administered either intravenously (IVIG) or subcutaneously (SCIG). Although the effectiveness of weekly and biweekly (every other week) SCIG administration has been shown in several trials, data on the viability of these two regimens in pediatric PID patients are sparse. Methods: Data on the pediatric subsets of PID patients enrolled in SHIFT (weekly) and IBIS (biweekly) studies were pooled and analyzed to indirectly compare two different 20%-concentrated SCIG ( Hizentra®) regimens. The primary endpoints were to evaluate trough IgG levels and cumulative monthly doses; the secondary endpoint was to analyze incidence of infections. Results: Fifteen and 13 children from the SHIFT and IBIS studies were included, respectively. Cumulative 20%-concentrated SCIG monthly dose was slight lower for the biweekly regimen (Δ = − 2.04, 90% CI − 8.3 to 4.23). However, the trough IgG levels were similar between the two groups (Δ = 0.28, 90% CI − 0.51 to 1.07) and constantly above the threshold of 5 g/L. After adjusting for potential confounders, the annualized rate of infections was similar between SHIFT and IBIS patients (incidence rate ratio = 1.09, 90% CI 0.72–1.67); only 1 serious bacterial infection was experienced by a patient in the IBIS group. Conclusion: In pediatric PID patients, weekly and biweekly Hizentra® administrations appeared equally effective treatment options. Keywords: Pediatric patients, Primary immunodeficiency, SHIFT study, IBIS study, Immunoglobulin, Infection rate Introduction Primary immunodeficiencies (PIDs) include several genetic and immune dysregulation disorders that affect various components of the innate and adaptive immune systems. Predominant antibody deficiencies (PAD) are the most common PID defects and are characterized *Correspondence: [email protected] 1 Pediatric Immunopathology and Allergology Unit, University of Rome Tor Vergata, Policlinico Tor Vergata, Viale Oxford, 81, 00133 Rome, Italy Full list of author information is available at the end of the article
by an impairment of B-cell development and function. Most patients have hypogammaglobulinemia and suffer from recurrent bacterial infections, mainly affecting respiratory and gastrointestinal tracts. Immunoglobulin G (IgG) replacement therapy is considered an “essential” medication to be administered lifelong [1] in order to achieve the highest possible protection against infections, including serious bacterial infections (SBIs), i.e.
Data Loading...
