Eli Lilly and Co. (NYSE: LLY) has announced positive results from its late-stage active psoriatic arthritis (PsA) study. This trial is the first completed large head-to-head superiority study in active PsA.
Specifically, the company’s study of Taltz (ixekizumab) met the primary and all major secondary endpoints in the Phase 3b/4 SPIRIT-H2H study, which evaluated the efficacy and safety of Taltz versus Humira (adalimumab) in patients with active PsA who are biologic disease-modifying anti-rheumatic drug-naive.
At 24 weeks, patients treated with Taltz met the primary endpoint by demonstrating superiority in improving the signs and symptoms of active PsA compared to Humira, as measured by the proportion of patients simultaneously achieving at least a 50% reduction in disease activity, as defined by the American College of Rheumatology, as well as complete skin clearance as measured by the Psoriasis Area and Severity Index. Additionally, Taltz met the major secondary endpoints.
Overall, the safety profile of Taltz was consistent with previously reported results.
Looking ahead, Eli Lilly plans to submit detailed data from the SPIRIT-H2H study for disclosure at scientific meetings and in peer-reviewed journals in 2019.
Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Eli Lilly, commented:
The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance. These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis.
Shares of Eli Lilly were last seen down about 2% at $109.77, in a 52-week range of $73.69 to $119.84. The consensus analyst price target is $115.00.
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