Ixekizumab Study Patients Achieved Significant Levels of Skin Clearance after 12 Weeks of Treatment

Eli Lilly and Company (NYSE:LLY) announced that detailed results from two pivotal Phase III clinical studies of the ixekizumab treatment were published by The Lancet and which met all primary and secondary objectives and demonstrated superiority to etanercept and placebo after 12 weeks of treatment for moderate-to-severe plaque psoriasis.

As quoted in the press release:

The UNCOVER-2 and UNCOVER-3 clinical studies of more than 2,500 patients found ixekizumab to be statistically superior to etanercept and placebo on all measures of skin clearance. Patients treated with ixekizumab also demonstrated significant and meaningful improvements in health-related quality-of-life measures. Ixekizumab is the company’s investigational medicine for the treatment of moderate-to-severe plaque psoriasis.

In each study, co-primary efficacy objectives assessed whether ixekizumab administered once every two weeks or once every four weeks was superior to etanercept and placebo after twelve weeks, as measured by a Psoriasis Area and Severity Index reduction of at least 75 percent (PASI 75) and a Static Physician Global Assessment score of clear or minimal (sPGA 0/1).

PASI is a measure used by healthcare professionals to determine the severity of psoriasis, including redness, thickness, scaling and the extent of psoriasis coverage. A PASI 75 score signals at least a 75 percent reduction in a patient’s psoriasis from their baseline assessment. The sPGA is the physician’s assessment of severity of a patient’s psoriasis lesions overall at a specific point in time.

Christopher Griffiths, M.D., FRCP, professor of dermatology at The University of Manchester and primary study investigator, commented:

These studies show ixekizumab – at two different dosing regimens – performed significantly better than etanercept or placebo, inducing a rapid and high level of psoriasis plaque resolution for patients with moderate-to-severe disease. Importantly, these clinical results were accompanied by significant improvements to patient quality of life, and were achieved with a safety profile comparable to etanercept in these studies.

Brian J. Nickoloff, M.D., senior medical fellow at Lilly Bio-Medicines, commented:

The results of UNCOVER-2 and UNCOVER-3 provide a strong reason to believe that, if approved, ixekizumab may help patients treat their moderate-to-severe psoriasis quickly and effectively. We saw clinically-meaningful improvements in skin clearance as early as week one of treatment with ixekizumab, and with approximately 40 percent of patients achieving complete skin clearance at 12 weeks, we’re hopeful clear skin may be attainable for more people living with this hard-to-treat disease.

Click here to read the full Eli Lilly and Company (NYSE:LLY) press release.