Lilly’s Taltz cleared to treat psoriatic arthritis


US regulators have expanded the scope of Eli Lilly’s plaque psoriasis drug Taltz to include the treatment patients with psoriatic arthritis.

Taltz (ixekizumab) is an antibody that binds to interleukin-17A, a protein that causes inflammation and plays a role in the development of these conditions.

The drug is administered as an injection, either alone or in combination with a conventional disease-modifying antirheumatic drug such as methotrexate.

Its efficacy and safety in the psoriatic arthritis setting was demonstrated in two randomised, double-blind, placebo-controlled Phase III studies – SPIRIT-P1 and SPIRIT-P2 – which involved more than 670 adult patients with active disease.

In SPIRIT-P1, which 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, 58 percent of patients treated with the drug achieved an ACR20 response (a 20 percent reduction in a composite measure of disease activity) versus 30 percent for placebo.

In SPIRIT-P2, which pitted Taltz against placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors, the ACR20 responses were 53 percent and 20 percent, respectively.

"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."