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Background <p>Escalation in the use of biologic agents including tumor necrosis factor (TNF)-α inhibitors to treat immune-mediated inflammatory diseases (IMID) is linked to higher susceptibility of severe infections caused by intracellular pathogens, including <i>Leishmania</i>.</p> Methods <p>This multicentric prospective study assessed the presence of <i>Leishmania</i> spp. infection among patients with IMID under treatment with biologic agents in two Italian clinical centers. We utilized a combination of diagnostic tests: real-time PCR for the detection of parasitic kinetoplast DNA in peripheral blood, Western blot for the identification of serum IgG antibodies, and a Whole blood assay to assess cytokine and chemokine responses following stimulation with parasitic antigen.</p> Results <p>A total of 126 patients residing in Italy were enrolled. Patients testing positive in at least one assay were classified as <i>Leishmania</i>-positive. Of the 125 asymptomatic individuals, 25 (20%) tested positive for <i>Leishmania</i> infection, revealing a significant rate of subclinical infection. The most frequent marker of infection was positive serology (15/126, 12%) followed by a detectable cell-mediated immune response (9/125, 7%). Parasitic DNA was detected in 3 patients (2%).</p> Conclusions <p>This study showed a high prevalence of asymptomatic <i>Leishmania</i> infection in Italian patients with IMID under treatment with biologic agents, with a north-to-south gradient. Given the risk of disease reactivation, these patients may benefit from close monitoring. Further research is warranted to clarify the clinical implications of these findings.</p>

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Screening for Leishmania spp. infection in patients treated with biologic agents for immune-mediated inflammatory diseases: results of an Italian multicentric prospective study

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  • 发表日期：

    2025年9月24日

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  • Emma Balducelli,
  • Ana Torres,
  • Sara Morselli,
  • Andrea Angheben,
  • Chiara Piubelli,
  • Francesca Perandin,
  • Salvatore Scarso,
  • Cinzia Scambi,
  • Alessandro Bartoloni,
  • Lorenzo Zammarchi,
  • Anna Barbiero,
  • Filippo Lagi,
  • Michele Spinicci,
  • Francesca Nacci,
  • Margherita Ortalli,
  • Simone Baiocchi,
  • Lorena Bernardo,
  • Javier Moreno,
  • Eugenia Carrillo,
  • Stefania Varani

摘要

Background

Escalation in the use of biologic agents including tumor necrosis factor (TNF)-α inhibitors to treat immune-mediated inflammatory diseases (IMID) is linked to higher susceptibility of severe infections caused by intracellular pathogens, including Leishmania.

Methods

This multicentric prospective study assessed the presence of Leishmania spp. infection among patients with IMID under treatment with biologic agents in two Italian clinical centers. We utilized a combination of diagnostic tests: real-time PCR for the detection of parasitic kinetoplast DNA in peripheral blood, Western blot for the identification of serum IgG antibodies, and a Whole blood assay to assess cytokine and chemokine responses following stimulation with parasitic antigen.

Results

A total of 126 patients residing in Italy were enrolled. Patients testing positive in at least one assay were classified as Leishmania-positive. Of the 125 asymptomatic individuals, 25 (20%) tested positive for Leishmania infection, revealing a significant rate of subclinical infection. The most frequent marker of infection was positive serology (15/126, 12%) followed by a detectable cell-mediated immune response (9/125, 7%). Parasitic DNA was detected in 3 patients (2%).

Conclusions

This study showed a high prevalence of asymptomatic Leishmania infection in Italian patients with IMID under treatment with biologic agents, with a north-to-south gradient. Given the risk of disease reactivation, these patients may benefit from close monitoring. Further research is warranted to clarify the clinical implications of these findings.