While the inhibition of
TNF-alpha has been shown to improve
vasculitis in vitro and in animal models, the clinical evidence for the efficacy of
TNF-alpha blockade in most forms of
vasculitis is mainly based on case reports and case series. Randomised controlled studies have so far not shown superiority of anti-
TNF-alpha agents for
Wegener's granulomatosis and
giant cell arteritis. Moreover, in the context of
Wegener's granulomatosis, a higher frequency and severity of
infections are to be expected. In refractory cases of Behçet's disease
therapy of
uveitis and other organ manifestations is promising.
Rituximab has achieved good effects in case reports of
vasculitis. Results from controlled trials are not available. Observational studies indicate that in refractory
systemic lupus erythematosus, and possibly also in several instances of small vessel
vasculitis,
rituximab can achieve good responses. The increased frequency of severe
infections under
TNF-alpha blockade requires a stringent benefit and risk assessment in addition to a multidisciplinary analysis of follow-up parameters. A detailed information of the patient regarding symptoms and signs of a possible
infection are a prerequisite. Due to the complexity of the field and the danger of morbidity and mortality as a consequence of
vasculitis or
systemic lupus erythematosus on the one hand, and of the
therapy on the other, biologics should only be used to treat these disorders in institutions fully equipped and staffed for this purpose.