Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency
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ORIGINAL ARTICLE
Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency Bas M. Smits 1 & Ilona Kleine Budde 2 & Esther de Vries 3,4 & Ineke J. M. ten Berge 5 & Robbert G. M. Bredius 6 & Marcel van Deuren 7 & Jaap T. van Dissel 8 & Pauline M. Ellerbroek 9 & Michiel van der Flier 1,10 & P. Martin van Hagen 11 & Chris Nieuwhof 12 & Bram Rutgers 13 & Lieke E. A. M. Sanders 1 & Anna Simon 7 & Taco W. Kuijpers 14 & Joris M. van Montfrans 1 Received: 30 April 2020 / Accepted: 1 August 2020 # The Author(s) 2020
Abstract Background Patients 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. Objective To compare the efficacy of PA and IRT in a randomized crossover trial. Methods A 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. Results The 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). Conclusion We 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 Implication Given the costs and associated side-effects of IRT, it should be reserved for patients with persistent infections despite treatment with PA. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10875-020-00841-3) contains supplementary material, which is available to authorized users. * Joris M. van Montfrans [email protected]
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Department of Infectious Diseases, Leiden University Medical Centre, University of Leiden, Leiden, The Netherlands
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Division of Internal Medicine and Dermatology, Department of Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands
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Department of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA Utrecht, The Netherlands
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Clinical Operations, Sanquin Plasma Products B.V, Amsterdam, The Netherlands
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Pediatric Infectious Diseases and Immunology, Radboudumc Amalia Children’s Hospital, Nijmegen, The Netherlands
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Depar
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