Ixekizumab Gets FDA Nod for Active Psoriatic Arthritis

Megan Brooks

December 06, 2017

The US Food and Drug Administration has approved ixekizumab (Taltz, Eli Lilly) to treat adults with active psoriatic arthritis (PsA).

Ixekizumab is a humanized monoclonal antibody that targets interleukin 17A, which drives inflammation in psoriasis. Ixekizumab is administered as an injection either alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.

Ixekizumab was first approved in the United States in March 2016 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The efficacy and safety of ixekizumab for active PsA was demonstrated in two randomized, double-blind, placebo-controlled phase 3 studies, which included more than 670 patients.

The SPIRIT-P1 study included active PsA patients who had never been treated with a biologic disease-modifying antirheumatic drug, while SPIRIT-P2 tested it in tumor necrosis factor inhibitor (TNFi)-experienced patients who failed one or two TNF inhibitors. Patients in both studies had active PsA for at least 6 months and at least three tender and three swollen joints.

In both studies, patients treated with ixekizumab (compared with placebo) achieved significant improvement in joint symptoms, as measured by American College of Rheumatology 20% response (ACR20).  In SPIRIT-P1, ACR20 response rates at 24 weeks were 58% with ixekizumab versus 30% with placebo and in SPIRIT-P2 ACR20 rates were 53% with ixekizumab versus 20% with placebo.

"For patients with PsA, treatment goals often include improvement in joint symptoms," Philip Mease, MD, Swedish Medical Center and University of Washington School of Medicine, Seattle, noted in a company news release.

"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,” he added.

Ixekizumab should not be used in patients with a previous serious hypersensitivity reaction to the drug or to any of the excipients. Ixekizumab may increase the risk for infection. Other warnings and precautions include pretreatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease, and immunizations.

Full prescribing information is available online.

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