Eli Lilly’s Taltz (ixekizumab) met its endpoints in a head-to-head study against AbbVie’s Humira in the treatment of patients with active psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drug (DMARD)-naïve.
At 24 weeks, the study met its primary endpoint. Taltz demonstrated superiority against Humira, the best-selling drug in the world, in improving the signs and symptoms of active PsA. That superiority against Humira was measured by the proportion of patients simultaneously achieving at least a 50-percent reduction in disease activity, as well as complete skin clearance.
Lilly’s Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. Taltz was first approved in 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis and then received an additional indication last year for the treatment of adults with active psoriatic arthritis.
Lotus Mallbris, vice president of immunology development at Indianapolis-based Eli Lilly, said the positive results from the Phase IIIb/IV SPIRIT-H2H study reinforces the data that “Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance.» Mallbris added that the results from the late-stage trial provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis.
The SPIRIT-H2H study is the first completed large head-to-head superiority study in active PsA, Eli Lilly said this morning. This is the only head-to-head study that used on-label dosing for both Taltz and Humira and includes concomitant conventional DMARDs.
“In the SPIRIT-H2H trial, Taltz demonstrated superiority in improving active psoriatic arthritis compared to Humira. This study will help raise awareness and better inform conversations between patients and their healthcare providers about treatment options for active psoriatic arthritis,” Philip Mease, of the Swedish Medical Center/Providence St. Joseph Health and University of Washington said in a statement.
In the trial, a total of 566 active PsA patients were enrolled in the study to evaluate the safety and efficacy of Taltz compared to Humira. The patients were randomized to receive with Taltz or Humira for a total of 52 weeks, with the primary analysis conducted at 24 weeks.
Lilly plans to submit detailed data from the SPIRIT-H2H study for disclosure at scientific meetings and in peer-reviewed journals in 2019.
In addition to the Taltz news, Eli Lilly was also busy flexing its M&A muscle. On Friday, Eli Lilly announced that it had acquired Hydra Biosciences and its pre-clinical program of TRPA1 antagonists for treatment of chronic pain syndromes. Financial terms of the acquisition were not disclosed.
Mark Mintun, vice president of pain and neurodegeneration research at Lilly, said the acquisition of Hydra will advance the company’s understanding of the Transient Receptor Potential TRP pathway in pain signaling. Mintun said the company plans to initiate clinical studies in the near term for the TRPA1 antagonists.
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