Anti-TNF-induced vasculitis: analysis of data from the French national pharmacovigilance database.
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OBJECTIVES: The increasing use of tumor necrosis factor (TNF) inhibitors poses new challenges in terms of drug iatrogenicity and diagnosis. In this study, we focus on the description of the TNF-inhibitors-induced vasculitis. METHODS: We conducted a retrospective descriptive study using the French national pharmacovigilance database to study cases of vasculitis attributable to TNF-inhibitor treatment. RESULTS: A total of 164 cases were analyzed, patients' mean age was 49.1 years, and 61.4% were women. The indications for TNF-inhibitor therapy were Crohn's disease (27%), rheumatoid arthritis (27%) and ankylosing spondylitis (21%). The median time to onset of vasculitis was 390 days [120-1095]. Clinical manifestations included cutaneous manifestations (88%), mainly purpura, rheumatic manifestations (27%), general symptoms (15%), renal manifestations (14%) and gastrointestinal and neurological manifestations (8% each). Skin biopsy was the most important diagnostic test, with 67.7% of cases showing vasculitis. Our study found mainly nonspecific vasculitis (54.9%), IgA vasculitis (28%) and ANCA vasculitis (7.9%). A possible association was observed between IgA vasculitis and TNF-inhibitors treatment for Crohn's disease, compared with other indications. CONCLUSION: Our study, based on national pharmacovigilance data, provides a better characterization of TNF-inhibitor-induced vasculitis. Resolution of vasculitis upon TNF inhibitor discontinuation, followed by recurrence upon reintroduction, confirms the drug's causative role and suggests that treatment should be stopped if possible. Clinicians should exercise heightened vigilance for symptom onset within the first 500 days of therapy. The atypical features of certain vasculitis, particularly from an epidemiological perspective given the unusual age at presentation, should prompt consideration of an iatrogenic etiology, including potential anti-TNF involvement.