Ixekizumab meets primary endpoint in phase 3 psoriatic arthritis trial
Ixekizumab met its primary endpoint of showing superiority to placebo in a phase 3 trial of patients with psoriatic arthritis, according to a press release from Eli Lilly and Company.
Around 400 patients with active psoriatic arthritis (PsA) were randomly assigned to treatment with one of two ixekizumab regimens administered subcutaneously or placebo during the 24-week study, titled SPIRIT-P1. Patients in the treatment group received a loading dose of 160 mg followed by either 80 mg once every 2 weeks of 80 mg once every 4 weeks, whereas patients in the placebo group received 40 mg of adalimumab subcutaneously every other week. All patients were naïve to biologic disease-modifying antirheumatic drugs and were required to have had active disease for at least 6 months before enrollment.
Results showed the targeted proportion of patients met the primary endpoint of a 20% reduction in symptoms based on the American College of Rheumatology criteria (ACR20). According to the company, many patients responded to treatment with both dosing regimens compared with placebo.
Lilly intends to release more information on the study at upcoming scientific meetings, according to a company spokesperson.
Ixekizumab is a monoclonal antibody that targets the cytokine interleukin-17A (IL-17A) and does not bind to other forms of IL-17. The drug is also in clinical study to explore the treatment of moderate-to-severe plaque psoriasis. Common adverse reactions included nasopharyngitis and mild irritation at the site of injection.
Reference: www.lilly.com.