Methods : A retrospective analysis of charts registered in the French National Pharmacovigilance Database (FNPVD) under the diagnosis of vasculitis in adults patients treated with approved Mabs or Fc-fusion proteins was performed between 1985 and 2015. After reviewing of the cases, the demographics and clinical data were recorded. Exposure to biologics proteins was searched to the observatory of drugs, medical devices and therapeutic innovation (OMEDIT) in order to estimate the incidence.

Results: During the study period, 434 423 AEs were registered in the BNPV leading to 143 clinical suspicions of vasculitis. Thus, the incidence of vasculitis is reported in table 1. Among the 143 vasculitis, 79 biopsy-proven vasculitis were analyzed showing a mean age at diagnosis of 51±17 years with a predominantly comprising women (65%). The therapeutic indications were autoimmune diseases in 69 patients, followed by solid cancers, with a significantly longer time to onset of vasculitis between patients with autoimmune diseases as compared with non-autoimmune diseases (244 vs 32 days, P = .01). TNF inhibitors were involved in 60 patients (76%). Rituximab, tocilizumab, cetuximab, trastuzumab, abatacept, and ranibizumab were less common. Indeed, patients undergoing anti-TNF biologics had a significantly later occurrence of the vasculitis as compared with the other drugs (318 vs 30 days, P = .0002). Cutaneous vasculitis (63%) was the most frequent as compared with systemic vasculitis. No difference was found between patients with cutaneous vasculitis and systemic vasculitis in terms of the age of onset (52 vs 48 years, P = .2806), the sex ratio (P = .1159), the median time to onset (196 vs 289 days; P = .258), and the therapeutic indications (P = .2482), except for higher extracutaneous manifestations in those with systemic vasculitis (P = .0022).

Table 1. Incidence of vasculitis under biologics treatment.

Conclusion: Vasculitis associated with Mabs and Fc-fusion proteins are rare and potentially challenging cases. TNF-inhibitors remain usual suspects, mostly etanercept and certolizumab in our study. However, our data report other biologics that should be kept in mind. Moreover, systemic vasculitis, IgA vasculitis being the most frequent, need a more specific recognition for a specific management, including immunosuppressant.