Taltz Receives FDA Approval for Active Psoriatic Arthritis

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA). Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

"PsA is a chronic, progressive and painful form of inflammatory arthritis that impacts approximately 1.6 million Americans living with the disease," said Christi Shaw, president, Lilly Bio-Medicines. "We are proud to offer a new treatment option that can provide improvements in joint symptoms for these patients, further demonstrating Lilly's overall commitment to immunology."

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate. Taltz should not be used in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations.

The efficacy and safety of Taltz was determined from findings from two randomized, double-blind, placebo-controlled Phase 3 studies – SPIRIT-P1 and SPIRIT-P2 – which included more than 670 adult patients with active PsA. SPIRIT-P1 evaluated the safety and efficacy of Taltz compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug. SPIRIT-P2 evaluated the safety and efficacy of Taltz compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors. Across both studies, patients were required to have a diagnosis of active PsA for at least six months and at least three tender and three swollen joints. Non-responder imputation (NRI) methods were used. Inadequate responders (defined by blinded tender and swollen joint count criteria) at Week 16 received rescue therapy and were analyzed as non-responders.

In studies of biologic-naïve and TNFi-experienced patients, the primary efficacy endpoint was the proportion of patients at 24 weeks achieving ACR20 response, which represents a 20 percent reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR). Results from both studies demonstrated that patients treated with Taltz achieved significant improvement in joint symptoms, as measured by ACR20, compared with placebo. At 24 weeks, patients achieved ACR20 at the following response rates:

• SPIRIT-P1: 58 percent of patients treated with Taltz vs. 30 percent for placebo
• SPIRIT-P2: 53 percent of patients treated with Taltz vs. 20 percent for placebo

"For patients with PsA, treatment goals often include improvement in joint symptoms," said Philip Mease, M.D., Swedish Medical Center and University of Washington. "Based on the study results, Taltz can provide significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug as well as patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors."