Trials Show Positive Results for Psoriasis Drug

The results of three Phase III trials indicate that ixekizumab is a safe and effective short term treatment for people with moderate-to-severe plaque-type psoriasis, according to a recent review of the existing literature. The review, conducted by Benjamin Farahnik, of UCSF Psoriasis & Skin Treatment Center in Los Angeles, CA and colleagues, was published in Dermatology and Therapy on February 24, 2016.

The reviewers looked at the results from 3 trials: UNCOVER-1, UNCOVER-2, and UNCOVER-3. Each compared ixekizumab to a placebo, and UNCOVER-2 and UNCOVER-3 also compared it to etanercept. The reviewers considered week 12 the endpoint.

The reviewers describe UNCOVER-1 as being “a prospective, double-blind, multicenter trial that consisted of 1296 patients randomly distributed in a 1:1:1 ratio to receive 80 mg ixekizumab every two weeks (Q2W), 80 mg ixekizumab every 4 weeks (Q4W), or placebo.”

At week 12, patients receiving ixekizumab experienced a statistically significant improvement over those taking the placebo. The dosage regimens, according to the reviewers, “were similarly statistically superior to placebo.” However, the patients receiving ixekizumab also experienced more adverse events, most commonly nasopharyngitis and a reaction at the injection site.

UNCOVER-2 was “a prospective, double-blind, multicenter study that consisted of 1224 patients randomly distributed in 2:2:2:1 ratio to receive 80 mg ixekizumab Q2W, 80 mg ixekizumab Q4W, etanercept 50 mg twice weekly, or placebo,” according to the reviewers.

In this study, ixekizumab was superior to both etanercept and placebo. Again, though, the patients receiving ixekizumab experienced more adverse events than those taking placebo, however, the researchers add, “It is important to note that comparisons in adverse events are not statistically significant, as the studies are powered to detect differences in efficacy rather than rates of adverse events.”

The third trial, UNCOVER-3, followed the same design and protocols as UNCOVER-2, but included 1346 people. The reviewers report, “Like the previous trials, UNCOVER-3 also showed statistically significant superiority of ixekizumab 80 mg Q2W and ixekizumab 80 mg Q4W over placebo.”

The reviewers conclude, “the results of Phase III clinical trials reinforce the theory that ixekizumab is an effective agent in the treatment of plaque-type psoriasis.” They do add that “further data from open -label extension studies are necessary to confirm the favorable efficacy and safety profile of this agent.”