FDA Approves Ixekizumab for Psoriatic Arthritis
DECEMBER 04, 2017
The US Food and Drug Administration (FDA) has approved ixekizumab (Taltz) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis, announced Eli Lilly and Company.
Taltz, first approved by the FDA in Marc 2016 for treatment of adult patients with moderate-to-severe plaque psoriasis that are candidates for systemic therapy or phototherapy, is now approved for its second indication.
“For patients with psoriatic arthritis, treatment goals often include improvement in joint symptoms,” Philip Mease, MD, Swedish Medical Center and University of Washington, said in a statement. “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 1 or 2 TNF inhibitors or were intolerant to TNF inhibitors.”
The safety and efficacy of Taltz was determined from the findings of 2 randomized, phase 3 studies, SPIRIT-P1 and SPIRIT-P2, which studied more than 670 adult patients diagnosed with active psoriatic arthritis for at least 6 months and had at least 3 tender and 3 swollen joints.
The results from both of the studies displayed that patients treated with Taltz achieved a significant improvement in joint symptoms versus those patients given the placebo.
The SPIRIT-P1 trial evaluated the safety and efficacy of Taltz compared to the placebo in patients with active psoriatic arthritis who have never been treated with a biologic disease-modifying antirheumatic drug.
The SPIRIT-P2 study evaluated the safety and efficacy of Taltz compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active psoriatic arthritis who failed 1 or 2 TNFi.
The primary efficacy endpoint of the studies was the proportion of patients at 24 weeks achieving an ACR20 response — a 20% reduction in a composite measure of disease activity defined by the American College of Rheumatology (ACR).
In the SPIRIT-P1 trial, 58% of patients treated with Taltz achieved ACR20 versus 30% of those treated with the placebo, while 53% of patients in the SPIRIT-P2 trial treated with Taltz achieved ACR20 versus 20% of those treated with the placebo.
Inadequate responders at week 16 received rescue therapy and were analyzed as non-responders.
The most common adverse effects associated with treatment greater than 1% are injection site reactions, upper respiratory tract infections, nausea and tinea infections.
The safety profile observed in patients with psoriatic arthritis is consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.
Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug like methotrexate, and is not recommended for patients with a previous serious hypersensitivity reaction like anaphylaxis to ixekizumab or any excipients.
Precautions include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations.
A press release was made available.
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