This is the second approved indication for ixekizumab in the EU; it was authorized for the treatment of adult patients with moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy in Europe in April 2016.
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines.
The European Commission Marketing Authorisation for ixekizumab in PsA was based on findings from a Phase 3 clinical trial programme.
The efficacy and safety of ixekizumab was determined from findings from two randomized, double-blind, placebo-controlled Phase 3 studies, SPIRIT-P1 and SPIRIT-P2 which included 780 adult patients with active PsA.
In both studies, patients treated with ixekizumab achieved significant improvement in joint symptoms and skin symptoms compared with placebo.
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