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Ustekinumab

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Adverse Events with Biomedicines

Abstract

Ustekinumab (Stelara®, Janssen-Cilag, Centocor Ortho) is a fully humanized IgG1k monoclonal antibody binding with high affinity to the p40 subunit shared by interleukin-12 (IL-12) and IL-23 heterodimeric cytokines, thus preventing their binding to the IL-12Rβ1 receptor expressed on the surface of immune cells and therefore neutralizing their biological activity. In December 2008, Health Canada authorized ustekinumab for the treatment of chronic moderate to severe plaque psoriasis (Ps) in adult patients suited for phototherapy or systemic therapy. EMEA granted first approval of ustekinumab in January 2009 for the treatment of adult patients with moderate to severe chronic plaque psoriasis, who are intolerant or have a contraindication, or failed to respond to systemic therapies including cyclosporine, methotrexate, and PUVA. Following the initial submission in November 2007, approval from FDA was granted in September 2009 for adult (≥18 years) patients with Ps, who are candidates to phototherapy or systemic therapy. In December 2012, the sponsor requested both Agencies to extend the treatment to patients with active psoriasic arthritis (PsA). The request was accepted in September 2013 by both Agencies.

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Authors and Affiliations

  1. University of Verona, Verona, Italy

    Giuseppe Tridente

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  1. Giuseppe Tridente
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Correspondence to Giuseppe Tridente .

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Tridente, G. (2014). Ustekinumab. In: Adverse Events with Biomedicines. Springer, Milano. https://doi.org/10.1007/978-88-470-5313-7_39

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