Eli Lilly said Monday that a Phase III trial of the experimental drug ixekizumab in patients with active psoriatic arthritis (PsA) met its primary endpoint, demonstrating superiority versus placebo as measured by the proportion of patients achieving an ACR 20 response. J. Anthony Ware, senior vice president of Lilly Bio-Medicines Product Development, remarked "these results strengthen our belief that ixekizumab may have the potential to help people confronting this challenging disease."
The SPIRIT-P1 study included patients who were naïve to biologic disease-modifying antirheumatic drugs and were treated with one of two different ixekizumab dosing regimens or placebo. Eli Lilly noted that all patients involved in the study were required to have a confirmed diagnosis of PsA and active disease for at least six months. Moreover, patients in the ixekizumab arm were first treated with a starting dose of the drug followed by one of two dosing regimens, while AbbVie's Humira (adalimumab) was selected as the active control for comparison with placebo.
The drugmaker indicated that for both dosing regimens, patients treated with ixekizumab exhibited significant improvements in the signs and symptoms of PsA versus the placebo group. Eli Lilly added that the incidence of treatment-emergent adverse events was more frequent with ixekizumab compared with placebo, but that the most common adverse events associated with ixekizumab were consistent with findings in previous late-stage studies, while the rates of serious adverse events and discontinuations due to adverse events were balanced across the study arms.
The company said that detailed results from the trial will be submitted for presentation at future scientific meetings and publication in peer-reviewed journals. The drugmaker further noted that the SPIRIT-P1 will also evaluate the long-term efficacy and safety of ixekizumab in patients with PsA for up to three years.