Abstract
BackgroundPatients with an IgG subclass deficiency (IgSD) ± specific polysaccharide antibody deficiency (SPAD) often present with recurrent infections. Previous retrospective studies have shown that prophylactic antibiotics (PA) and immunoglobulin replacement therapy (IRT) can both be effective in preventing these infections; however, this has not been confirmed in a prospective study.ObjectiveTo compare the efficacy of PA and IRT in a randomized crossover trial.MethodsA total of 64 patients (55 adults and 9 children) were randomized (2:2) between two treatment arms. Treatment arm A began with 12 months of PA, and treatment arm B began with 12 months of IRT. After a 3-month bridging period with cotrimoxazole, the treatment was switched to 12 months of IRT and PA, respectively. The efficacy (measured by the incidence of infections) and proportion of related adverse events in the two arms were compared.ResultsThe overall efficacy of the two regimens did not differ (p = 0.58, two-sided Wilcoxon signed-rank test). A smaller proportion of patients suffered a related adverse event while using PA (26.8% vs. 60.3%, p < 0.0003, chi-squared test). Patients with persistent infections while using PA suffered fewer infections per year after switching to IRT (2.63 vs. 0.64, p < 0.01).ConclusionWe found comparable efficacy of IRT and PA in patients with IgSD ± SPAD. Patients with persistent infections during treatment with PA had less infections after switching to IRT.Clinical ImplicationGiven the costs and associated side-effects of IRT, it should be reserved for patients with persistent infections despite treatment with PA.
Highlights
Low or absent levels of circulating specific antibodies are the hallmark of primary antibody deficiencies (PADs), which cover a spectrum of antibody deficiency syndromes ranging from IgG subclass deficiency (IgSD) and impaired specific polysaccharide antibody production to agammaglobulinemia as the most severe antibody deficiency disease manifestation [1,2,3]
Patients with IgSD ± specific polysaccharide antibody deficiency (SPAD) present with similar symptoms ranging from asymptomatic to recurrent upper and lower respiratory tract infections (URTI/LRTI) [10, 14, 15]
Data from 8 participants were partially censored for the per-protocol analysis because they were treated with intravenous immunoglobulins (IVIG) in addition to antibiotic prophylaxis (N = 3 during immunoglobulin replacement therapy (IRT) treatment and N = 5 during prophylactic antibiotics (PA) treatment) or had no documented intake of antibiotics for part of the study period
Summary
Low or absent levels of circulating specific antibodies are the hallmark of primary antibody deficiencies (PADs), which cover a spectrum of antibody deficiency syndromes ranging from IgG subclass deficiency (IgSD) and impaired specific polysaccharide antibody production to agammaglobulinemia as the most severe antibody deficiency disease manifestation [1,2,3]. For severe types of PAD such as common variable immunodeficiency (CVID) and X-linked agammaglobulinemia (XLA), evidence-based treatment guidelines involving immunoglobulin replacement therapy (IRT) have been developed [6,7,8,9,10,11]. For the less severe forms of PAD such as IgSD ± specific polysaccharide antibody deficiency (SPAD), guidelines are lacking, and both prophylactic antibiotics and IRT are used. IgG subclass deficiency (IgSD) ± specific polysaccharide antibody deficiency (SPAD) often present with recurrent infections. Previous retrospective studies have shown that prophylactic antibiotics (PA) and immunoglobulin replacement therapy (IRT) can both be effective in preventing these infections; this has not been confirmed in a prospective study
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