Abstract
Ustekinumab is the first of a new class of biologic agents whose main mechanism of action involves the selective inhibition of IL-12 and IL-23. Although ustekinumab is the latest biologic to be approved for use in dermatology, its approval was based on the largest clinical development program conducted to date in psoriasis. Safety data accumulated during the clinical development phase showed the risk of infection to be similar in patients in the ustekinumab and placebo groups. The use of additional antibiotics and the rates of overall infection and serious infection in patients on ustekinumab and the general population were also comparable. Subsequent studies confirmed the safety of this drug in patients with moderate to severe psoriasis treated for 3 or 4 years. Despite its favorable safety profile, ustekinumab is a selective immunosuppressant. Clinicians should therefore closely monitor patients and apply screening measures similar to those used during anti-TNF therapy to detect de novo infections or the reactivation of latent infections.
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