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A NEJM study of three clinical trials for ixekizumab to treat mild to moderate psoriasis, shows that the IL-17A inhibitor performs well through 60 weeks.
Ixekizumab (Taltz, Eli Lilly and Co.), a monoclonal antibody against interleukin-17A (IL-17A), is effective through 60 weeks of treatment for moderate to severe psoriasis, according to three phase 3 trials, involving 3,736 patients. More than a third of patients on active treatment had complete resolution of their psoriasis plaques, according to a study published July 28 in the New England Journal of Medicine.
The researchers reported on the UNCOVER -1, UNCOVER-2 and UNCOVER-3 trials, representing 21 countries and 100 sites. Eli Lilly funded and designed these trials on the injectable drug, which selectively binds and neutralizes IL-17a.
There were three groups in the trials: the placebo group, which received subcutaneous placebo injections; a 2-week dosing group, which received 80 mg of ixekizumab every two weeks after an initial dose of 160 mg; and a 4-week dosing group, which received 80 mg of monoclonal antibody every four weeks after a starting 160 mg dose. Other groups in the UNCOVER 2 and 3 trials randomly received 50 mg of etanercept twice weekly. In UNCOVER-3, subjects entered a long-term extension period starting at week 12 through week 60, during which they received 80 mg ixekizumab every four weeks. And in UNCOVER 1 and 2, patients on ixekizumab who at week 12 had a static Physicians Global Assessment (sPGA) score of clear (0) or minimal psoriasis (1) were randomly assigned to placebo, 80 mg of ixekizumab every four weeks or 80 mg of ixekizumab every 12 weeks through week 60, according to the study.
Among the findings: At 12 weeks, in UNCOVER-1, for 34-37 percent of patients, ixekizumab was effective in the “complete resolution” of psoriasis plaques.
“The high levels of clinical response were maintained with continued exposure to ixekizumab every 4 weeks through week 60, with at least 50% of patients maintaining or attaining complete resolution of their psoriasis (PASI 100). Among the patients in the 2-wk dosing group and the 4-wk dosing group who had an sPGA score of 0 or 1 at week 12 and were randomly reassigned to receive ixekizumab every 4 weeks during the randomized withdrawal period, 78.3% and 68.7%, respectively, maintained an sPGA score of 0 or 1 through week 60, with no exacerbation of their disease that resulted in an sPGA score of 3 or higher at any visit,” the authors wrote.
These high levels of clinical response came at a price for some. And the authors noted in the conclusion that benefits of ixekizumab treatment for moderate to severe plaque psoriasis need to be weighed against adverse event risks, including neutropenia, candidal infections and inflammatory bowel disease. Eleven patients in the trials reported inflammatory bowel disease while receiving the drug during the trials, and three others reported the disease while on placebo, after receiving ixekizumab.
Ixekizumab has not been studied beyond 60 weeks, the authors wrote.
Gordon KB, Blauvelt A, et al. “Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis,” New England Journal of Medicine. July 28, 2016. DOI: 10.1056/NEJMoa1512711