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Purpose <p>Despite well-conducted replacement therapy with polyvalent immunoglobulins (IgRT), some patients with primary immunodeficiencies (PID) continue to experience recurrent or chronic infections. IgA and IgM, essential for mucosal and complement-mediated immunity, are absent or minimal in standard immunoglobulin products. The aim of this study is to evaluate the safety and clinical evolution profiles in PID patients with undetectable IgA/IgM levels and persistent infections despite standard IgRT, after introduction of an IgA- and IgM-enriched immunoglobulin preparation (IgGAM, Pentaglobin<sup>®</sup>).</p> Methods <p>A compassionate use program (CUP) in France enrolled 20 PID patients with undetectable IgA/IgM levels, receiving IgGAM IV infusions every 7–14 days. Tolerance, infection frequency, hospitalizations, and biological markers (Ig levels, complement activation, salivary IgA) were analyzed prospectively.</p> Results <p>Twenty patients were included in the CUP at the time of analysis. No severe adverse event was reported. Half of the patients experienced mild to moderate hypersensitivity symptoms. Mean antibiotic courses dropped from 5.4 to 2.3/year (<i>p</i> = 0.0009) and mean number of hospitalizations decreased from 2.6 to 1.2/year (<i>p</i> = 0.01). Median serum IgA and IgM levels increased three months after IgGAM start. IgM and low levels of IgA were detected in saliva samples, suggesting at least a transient transfer of IgA/IgM from IgGAM into mucosal fluids.</p> Conclusion <p>In patients with severe PID and undetectable IgA/IgM, IgGAM was associated with reduced infections and hospitalizations. Controlled studies are needed to confirm the benefit of IgA/M enriched immunoglobulin preparations in PID patients with persistent and/or recurrent respiratory or digestive infections.</p>

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IgA and IgM-enriched Immunoglobulins in Primary Immunodeficiencies: a Pilot Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月28日

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  • Aurore Collet,
  • Benjamin Coiffard,
  • Emmanuel Ledoult,
  • Claire Fieschi,
  • Morgane Cheminant,
  • Alexandra Serris,
  • Felipe Suarez,
  • Sébastien Sanges,
  • Antoine Neel,
  • Raphaële Nove-Josserand,
  • Sarah Stabler,
  • Kinan El Husseini,
  • Alice Huault,
  • Pierre Cougoul,
  • Christelle Mausservey,
  • Nadim Cassir,
  • Floriane Mirgot,
  • Bertrand Meresse,
  • Arnaud Dendooven,
  • Sandrine Poizot,
  • Tanguy Le Scornet,
  • Anne-Sophie Bravard,
  • Anne Conrad,
  • Manon Levêque,
  • Jehane Fadlallah,
  • Cléa Melenotte,
  • Chloë Dumas De La Roque,
  • Claire Tinevez,
  • Wadih Abou Chahla,
  • Sylvain Dubucquoi,
  • Myriam Labalette,
  • Bénédicte Neven,
  • Marion Malphettes,
  • Nicolas Schleinitz,
  • Lionel Galicier,
  • Jean-François Viallard,
  • Guy Gorochov,
  • Guillaume Lefèvre

摘要

Purpose

Despite well-conducted replacement therapy with polyvalent immunoglobulins (IgRT), some patients with primary immunodeficiencies (PID) continue to experience recurrent or chronic infections. IgA and IgM, essential for mucosal and complement-mediated immunity, are absent or minimal in standard immunoglobulin products. The aim of this study is to evaluate the safety and clinical evolution profiles in PID patients with undetectable IgA/IgM levels and persistent infections despite standard IgRT, after introduction of an IgA- and IgM-enriched immunoglobulin preparation (IgGAM, Pentaglobin®).

Methods

A compassionate use program (CUP) in France enrolled 20 PID patients with undetectable IgA/IgM levels, receiving IgGAM IV infusions every 7–14 days. Tolerance, infection frequency, hospitalizations, and biological markers (Ig levels, complement activation, salivary IgA) were analyzed prospectively.

Results

Twenty patients were included in the CUP at the time of analysis. No severe adverse event was reported. Half of the patients experienced mild to moderate hypersensitivity symptoms. Mean antibiotic courses dropped from 5.4 to 2.3/year (p = 0.0009) and mean number of hospitalizations decreased from 2.6 to 1.2/year (p = 0.01). Median serum IgA and IgM levels increased three months after IgGAM start. IgM and low levels of IgA were detected in saliva samples, suggesting at least a transient transfer of IgA/IgM from IgGAM into mucosal fluids.

Conclusion

In patients with severe PID and undetectable IgA/IgM, IgGAM was associated with reduced infections and hospitalizations. Controlled studies are needed to confirm the benefit of IgA/M enriched immunoglobulin preparations in PID patients with persistent and/or recurrent respiratory or digestive infections.