Success for ixekizumab in SPIRIT-P1 Phase III trial for Psoriatic Arthritis-Eli Lilly

Eli Lilly and Company has announced that the investigational medicine ixekizumab was statistically superior to placebo in the treatment of patients with active psoriatic arthritis (PsA), as demonstrated by the proportion of patients achieving an ACR 20 response. ACR 20 is a standard assessment that represents a 20 percent reduction in disease signs and symptoms as defined by the American College of Rheumatology response criteria.

During the 24-week, Phase III study, titled SPIRIT-P1 , patients who were na�ve to biologic disease-modifying antirheumatic drugs (bDMARD) were treated with one of two different ixekizumab dosing regimens or placebo. In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements versus placebo in signs and symptoms of active PsA.In SPIRIT-P1, the incidence of treatment-emergent adverse events was more frequent with ixekizumab compared with placebo. The most common adverse events observed were consistent with the Phase III studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis. The rates of serious adverse events with ixekizumab treatment were similar to placebo. Discontinuation rates due to adverse events were similar between treatment groups. Lilly plans to submit detailed data from the SPIRIT-P1 study for disclosure at scientific meetings and in peer-reviewed journals.

Comment: Ixekizumab (LY 2439821), an anti-IL-17 monoclonal antibody, has shown superiority over Enbrel (etanercept) in the Phase III UNCOVER studies for plaque psoriasis.