Cutaneous Leishmaniasis in Patients under Biologic Therapies: A Spanish CLINI-AEDV Multicentre Study

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Abstract
Anti-TNFα agents have been associated with the reactivation of granulomatous infections, including leishmaniasis. Cases of atypical or recurrent cutaneous (CL) or mucocutaneous leishmaniasis (MCL) have been reported in patients on biologics. We conducted a retrospective analysis of a multicenter database to describe the clinical characteristics and management of CL and MCL in patients receiving biological therapy in an endemic area. Clinical features, diagnostics, therapies, and outcomes were analyzed. Seventy-one patients were included (63 CL and 8 MCL). The most common underlying condition was inflammatory bowel disease (33.8%). Lesions were multifocal in 40% and larger than 1 cm in 94.4%. Treatment failures were more frequent in MCL (50%) than CL (8.1%). Biologic therapy was discontinued in 53.5%, leading to worsening of the underlying disease in 44.7%. No significant difference in cure rates was observed between patients who continued vs. discontinued biologics (p=0.868). These findings highlight the clinical burden of CL and MCL in patients undergoing anti-TNFα therapy and suggest that discontinuation of biologic therapy did not significantly impact cure rates, emphasizing the need for standardized strategies balancing infection control and underlying inflammatory disease management.

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