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The Effect of Two Different Dosages of Intravenous Immunoglobulin on the Incidence of Recurrent Infections in Patients with Primary Hypogammaglobulinemia: A Randomized, Double-Blind, Multicenter Crossover Trial

Heleen W. Eijkhout, MD; Jos W.M. van der Meer, MD, PhD; Cees G.M. Kallenberg, MD, PhD; Ron S. Weening, MD, PhD; Jaap T. van Dissel, MD, PhD; Lieke A.M. Sanders, MD, PhD; Paul F.W. Strengers, MD; Henriët Nienhuis, MSc; Peter Th.A. Schellekens, MD, PhD, Inter-University Working Party for the Study of Immune Deficiencies
[+] Article and Author Information

From CLB, Academic Medical Center, and Parexel Mirai, Amsterdam; University Hospital Nijmegen, Nijmegen; University Hospital Groningen, Groningen; Leiden University Medical Center, Leiden; and University Hospital for Children, Utrecht, the Netherlands.


Acknowledgments: The authors thank the internists, pulmonologists, and pediatricians who participated in the study; the nurses who provided medical care to the patients, the pharmacists who provided study medication, and the patients who participated. They also thank Professor W.G. van Aken for commenting on the manuscript; Machteld Tissing and Angelique van den Broek for data entry; and T.H. The, K. Brinkman, J.C.C. Borleffs, C.A.J.J. Jaspers, A.J.P. Veerman, P.J. van den Broek, M.C. Wallis-Spit, A.M. Hemmes, E.J.F.M. ten Berge, J.J.M. Peters, F.A.E. Nabben, L. Ausema, J.W. van 't Wout, and H.H.M. Hassing for provision of study materials or patients.

Grant Support: By Sanquin Blood Supply Foundation, Amsterdam, the Netherlands.

Requests for Single Reprints: Heleen W. Eijkhout, MD, CLB, Medical Department, Plesmanlaan 125, 1066 CX Amsterdam, the Netherlands; e-mail, H_Eijkhout@CLB.nl.

Current Author Addresses: Drs. Eijkhout and Strengers: CLB, Medical Department, Plesmanlaan 125, 1066 CX Amsterdam, the Netherlands.

Dr. van der Meer: Department of Medicine, University Hospital Nijmegen, Geert Grooteplein Zuid 8, 6525 GA Nijmegen, the Netherlands.

Dr. Kallenberg: Department of Clinical Immunology, University Hospital Groningen, Hanzeplein 1, 9713 GZ Groningen, the Netherlands.

Dr. Weening: Department of Paediatrics, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

Dr. van Dissel: Department of Infectious Diseases, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands.

Dr. Sanders: Department of Immunology, University Hospital for Children, Lundlaan 6, 3584 EA Utrecht, the Netherlands.

Ms. Nienhuis: Parexel Mirai, Herman Heijermansweg 20, Box 75079, 1070 AB Amsterdam, the Netherlands.

Dr. Schellekens: Department of Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

Author Contributions: Conception and design: H.W. Eijkhout, J.W.M. van der Meer, C.G.M. Kallenberg, R.S. Weening, J.T. van Dissel, P.Th.A. Schellekens.

Analysis and interpretation of the data: H.W. Eijkhout, C.G.M. Kallenberg, J.T. van Dissel, E.A.M. Sanders, H. Nienhuis, P.Th.A. Schellekens.

Drafting of the article: H.W. Eijkhout, H. Nienhuis, P.Th.A. Schellekens.

Critical revision of the article for important intellectual content: J.W.M. van der Meer, C.G.M. Kallenberg, E.A.M. Sanders, P.F.W. Strengers, P.Th.A. Schellekens.

Final approval of the article: H.W. Eijkhout, J.W.M. van der Meer, C.G.M. Kallenberg, R.S. Weening, J.T. van Dissel, E.A.M. Sanders, P.F.W. Strengers, H. Nienhuis, P.Th.A. Schellekens.

Provision of study material or patients: J.W.M. van der Meer, C.G.M. Kallenberg, R.S. Weening, J.T. van Dissel, E.A.M. Sanders, P.Th.A. Schellekens.

Statistical expertise: H. Nienhuis.

Obtaining of funding: H.W. Eijkhout, J.W.M. van der Meer.

Collection and assembly of data: H.W. Eijkhout, P.F.W. Strengers.


Ann Intern Med. 2001;135(3):165-174. doi:10.7326/0003-4819-135-3-200108070-00008
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Patients with primary hypogammaglobulinemia, such as X-linked agammaglobulinemia and common variable immunodeficiency, have recurrent infections, predominantly of the respiratory and intestinal tract (12). Most respiratory infections in these patients are caused by Haemophilus influenzae and Streptococcus pneumoniae and, without proper treatment, may lead to severe pneumonia, bronchiectasis, decreased pulmonary function, and death (1, 36). Recurrent Giardia lamblia infections may result in chronic diarrhea, whereas chronic Campylobacter jejuni infections may cause recurrent bacteremia and cellulitis (1, 34, 78). In patients with X-linked agammaglobulinemia, persistent enterovirus infections, notably those caused by echovirus, are associated with chronic meningoencephalitis (3, 6).

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Figures

Grahic Jump Location
Figure 1.
Flow of patients through the study.

IVIG = intravenous immunoglobulin.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Kaplan–Meier estimate of survivor function.

The solid line represents patients receiving high-dose therapy; the dotted line represents patients receiving standard-dose therapy.

Grahic Jump Location

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Summary for Patients

Improving Protection against Infection in People without Enough Immunoglobulin

The summary below is from the full report titled “The Effect of Two Different Dosages of Intravenous Immunoglobulin on the Incidence of Recurrent Infections in Patients with Primary Hypogammaglobulinemia. A Randomized, Double-Blind, Multicenter Crossover Trial.” It is in the 7 August 2001 issue of Annals of Internal Medicine (volume 135, pages 165-174). The authors are HW Eijkhout, JWM van der Meer, CGM Kallenberg, RS Weening, JT van Dissel, EAM Sanders, PFW Strengers, H Nienhuis, and PThA Schellekens, for the Inter-University Working Party for the Study of Immune Deficiencies.

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