- Results from the extension period of a Phase 3 clinical trial, SPIRIT-P1, assessing Eli Lilly's (LLY -0.2%) Taltz (ixekizumab) for the treatment of patients with active psoriatic arthritis (PsA) showed no or minimal progression of joint damage through 52 weeks of treatment. The data are being presented today at EULAR in Madrid.
- During the double-blind period of SPIRIT-P1, participants who had never received a biologic disease-modifying antirheumatic drug received 80 mg of Taltz every two or four weeks or AbbVie's HUMIRA (adalimumab) or placebo. After the treatment period, patients were re-randomized to receive 80 mg of Taltz every two or four weeks for another 28 weeks.
- Patients treated with both doses of Taltz showed no or minimal progression of structural joint damage through week 52 as measured by the change from baseline in a scale called van der Heijde modified Total Sharp Score for PsA. The same treatment benefit was also observed in patients who switched from HUMIRA or placebo after the 24-week treatment period.
- Lilly has filed a marketing application in the U.S. seeking approval for the use of Taltz in PsA. It was approved by the FDA in March 2016 for the treatment of plaque psoriasis. Regulatory submissions will be made later this year. Taltz is already approved in Japan for PsA.
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