Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency

BM Smits; I Kleine Budde; E de Vries; IJ Berge; RG Bredius; M van Deuren; JTJ van Dissel; PM Ellerbroek; Michiel Flier; P.M. van Hagen; C Nieuwhof; B Rutgers; LEAM Sanders; A Simon; TWJ Kuijpers; JM van Montfrans

doi:10.1007/s10875-020-00841-3

Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency

BM Smits, I Kleine Budde, E de Vries, IJ Berge, RG Bredius, M van Deuren, JTJ van Dissel, PM Ellerbroek, Michiel Flier, P.M. van Hagen, C Nieuwhof, B Rutgers, LEAM Sanders, A Simon, TWJ Kuijpers, JM van Montfrans

Internal Medicine

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Pages (from-to)	382-392
Number of pages	11
Journal	Journal of Clinical Immunology
Volume	41
Issue number	2
DOIs	https://doi.org/10.1007/s10875-020-00841-3
Publication status	Published - 2021

Bibliographical note

Funding Information:
This study was sponsored by the Sanquin Plasma Products, Amsterdam, the Netherlands.

Funding Information:
We wish to acknowledge the assistance provided by R. Albers-Strik, J. van Esch, and M. van Aartrijk in patient recruitment and data collection, which was greatly appreciated. Moreover, we would like to thank G. Rijkers for measuring the specific polysaccharide antibodies and Prof. P.J.J. Hooykaas and M. van der Burg for measuring the B cell subsets in the blood samples of our patients. We thank Sanquin Home Service for making it possible for patients to have IVIG infusions at home and for collecting blood samples.

Publisher Copyright:
© 2020, The Author(s).

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Smits, BM., Kleine Budde, I., de Vries, E., Berge, IJ., Bredius, RG., van Deuren, M., van Dissel, JTJ., Ellerbroek, PM., Flier, M., van Hagen, P. M., Nieuwhof, C., Rutgers, B., Sanders, LEAM., Simon, A., Kuijpers, TWJ., & van Montfrans, JM. (2021). Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency. Journal of Clinical Immunology, 41(2), 382-392. https://doi.org/10.1007/s10875-020-00841-3

@article{0366e4d48fc34ecb93ef531e09ba74b4,

title = "Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency",

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.",

author = "BM Smits and {Kleine Budde}, I and {de Vries}, E and IJ Berge and RG Bredius and {van Deuren}, M and {van Dissel}, JTJ and PM Ellerbroek and Michiel Flier and {van Hagen}, P.M. and C Nieuwhof and B Rutgers and LEAM Sanders and A Simon and TWJ Kuijpers and {van Montfrans}, JM",

note = "Funding Information: This study was sponsored by the Sanquin Plasma Products, Amsterdam, the Netherlands. Funding Information: We wish to acknowledge the assistance provided by R. Albers-Strik, J. van Esch, and M. van Aartrijk in patient recruitment and data collection, which was greatly appreciated. Moreover, we would like to thank G. Rijkers for measuring the specific polysaccharide antibodies and Prof. P.J.J. Hooykaas and M. van der Burg for measuring the B cell subsets in the blood samples of our patients. We thank Sanquin Home Service for making it possible for patients to have IVIG infusions at home and for collecting blood samples. Publisher Copyright: {\textcopyright} 2020, The Author(s).",

year = "2021",

doi = "10.1007/s10875-020-00841-3",

language = "English",

volume = "41",

pages = "382--392",

journal = "Journal of Clinical Immunology",

issn = "0271-9142",

publisher = "Springer New York",

number = "2",

}

Smits, BM, Kleine Budde, I, de Vries, E, Berge, IJ, Bredius, RG, van Deuren, M, van Dissel, JTJ, Ellerbroek, PM, Flier, M, van Hagen, PM, Nieuwhof, C, Rutgers, B, Sanders, LEAM, Simon, A, Kuijpers, TWJ & van Montfrans, JM 2021, 'Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency', Journal of Clinical Immunology, vol. 41, no. 2, pp. 382-392. https://doi.org/10.1007/s10875-020-00841-3

TY - JOUR

T1 - Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency

AU - Smits, BM

AU - Kleine Budde, I

AU - de Vries, E

AU - Berge, IJ

AU - Bredius, RG

AU - van Deuren, M

AU - van Dissel, JTJ

AU - Ellerbroek, PM

AU - Flier, Michiel

AU - van Hagen, P.M.

AU - Nieuwhof, C

AU - Rutgers, B

AU - Sanders, LEAM

AU - Simon, A

AU - Kuijpers, TWJ

AU - van Montfrans, JM

N1 - Funding Information: This study was sponsored by the Sanquin Plasma Products, Amsterdam, the Netherlands. Funding Information: We wish to acknowledge the assistance provided by R. Albers-Strik, J. van Esch, and M. van Aartrijk in patient recruitment and data collection, which was greatly appreciated. Moreover, we would like to thank G. Rijkers for measuring the specific polysaccharide antibodies and Prof. P.J.J. Hooykaas and M. van der Burg for measuring the B cell subsets in the blood samples of our patients. We thank Sanquin Home Service for making it possible for patients to have IVIG infusions at home and for collecting blood samples. Publisher Copyright: © 2020, The Author(s).

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

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U2 - 10.1007/s10875-020-00841-3

DO - 10.1007/s10875-020-00841-3

M3 - Article

C2 - 33206257

SN - 0271-9142

VL - 41

SP - 382

EP - 392

JO - Journal of Clinical Immunology

JF - Journal of Clinical Immunology

IS - 2

ER -

Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency

Abstract

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