FDA Approves Taltz for Active Psoriatic Arthritis

Ixekizumab Injection 80 Mg/Ml (Taltz, Eli Lilly, And Company), FDA has approved for the treatment of adults with active psoriatic arthritis (PsA). Ixekizumab was first approved by the FDA in March 2016 for the treatment of adults with moderate-to-severe plaque psoriasis who are the possibility for systemic treatment or phototherapy. PsA is a chronic, painful, and progressive form of inflammatory arthritis that affects approximately 1.6 million Americans.

Ixekizumab might be administered alone or in combination with a conventional disease-modifying antirheumatic drug, for example, methotrexate. It should not be used for patients with a past history of serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Ixekizumab may reduce the risk of infection. Other warnings and safety precautions for ixekizumab include pre-treatment assessment for tuberculosis, immunizations, hypersensitivity reactions, and inflammatory bowel disease

The safety and efficacy of ixekizumab were resolved in 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 efficacy and safety of ixekizumab compared with placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug. SPIRIT-P2 assessed the efficacy and safety of ixekizumab compared with placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed maybe a couple TNF inhibitors.

Across both studies, patients were required to have an analysis of dynamic PsA for no less than a half year and no less than three tender and three swollen joints. Nonresponder imputation (NRI) methods were utilized. Inadequate responders (defined by blinded tender and swollen joint count criteria) at week 16 received rescue treatment and were analyzed as nonresponders.

In studies of biologic- naïve and TNFi-experienced patients, patients at 24 weeks accomplishing ACR20 response the essential efficacy endpoint was the proportion, which represents to a 20% decrease in a composite measure of disease activity as characterized by the American College of Rheumatology (ACR).

Outcomes from the two studies showed that patients treated with ixekizumab achieved significant improvement in joint symptoms, as measured by ACR20, compared with placebo. Patients treated with ixekizumab at 24 weeks achieved ACR20 at the following response rates versus patients receiving placebo: SPIRIT-P1, 58% versus 30%; and SPIRIT-P2, 53% versus 20%.

Philip Mease, MD, Swedish Medical Center and the University of Washington said, “For patients with PsA, treatment goals often include improvement in joint symptoms. In view of the study outcomes, Taltz provides a significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug and also patients who had an inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors.”


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