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Taltz effective through 60 weeks in treating patients with psoriasis

Taltz was effective treatment for patients with moderate-to-severe plaque psoriasis through week 60, according to results from three phase 3 trials recently published in The New England Journal of Medicine.

“This group of studies not only shows very high and consistent levels of safety and efficacy, but also that the great majority of the responses persist at least 60 weeks,” Kenneth B. Gordon, MD, professor of dermatology at Northwestern University Feinberg School of Medicine, stated in a news release.

There were 1,296 patients in the UNCOVER-1 trial, 1,224 patients in the UNCOVER-2 trial and 1,346 patients in the UNCOVER-3 trial who received either injections of placebo, 8 mg of Taltz (ixekizumab, Eli Lilly and Company) every 2 weeks (2-week dosing group) or 80 mg of ixekizumab every 4 weeks (4-week dosing group), with the patients receiving ixekizumab receiving a starting dose of 160 mg. There were additional cohorts in the UNCOVER-2 and UNCOVER-3 trials who received 50 mg of Enbrel (etanercept, Amgen) twice weekly.

Patients in the UNCOVER-3 trial entered a long-term extension period at week 12 in which they received 80 mg of ixekizumab every 4 weeks through week 60, while patients in the UNCOVER-1 and UNCOVER-2 trials who had a response to ixekizumab at week 12 randomly received placebo, 80 mg of ixekizumab every 4 weeks or 80 mg of ixekizumab every 12 weeks through week 60.

At week 12, patients in the UNCOVER-1 trial had response rates of 81.8% with a static Physicians Global Assessment (sPGA) score of 0 or 1 and 89.1% had a Psoriasis Area and Severity Index (PASI) 75 response in the 2 week-dosing group, with the 4-week dosing group having scores of 76.4% and 82.6% and the placebo group having rates of 3.2% and 3.9%, respectively (P < .001 for all ixekizumab vs. placebo comparisons).

“In the UNCOVER-1 and UNCOVER-2 trials, among patients who were randomly reassigned at week 12 to received 80 mg of ixekizumab every 4 weeks, 80 mg every 12 weeks, or placebo, and sPGA score of 0 or 1 was maintained by 73.8%, 39% and 7% of the patients, respectively,” the researchers wrote.

There were 73% of patients in the UNCOVER-3 trial who at week 60 had an sPGA score of 0 or 1, with at least 80% of patient having a PASI 75 response.

Neutropenia, candida infections and inflammatory bowel disease were among the reported adverse events.

“Based on these findings, we expect that 80 percent of patients will have an extremely high response rate to ixekizumab, and about 40 percent will be completely cleared of psoriasis,” Gordon stated in the release. “Ten years ago, we thought complete clearance of this disease was impossible. It wasn’t something we would even try to do. Now with this drug, we’re obtaining response levels higher than we’ve ever seen before.” – by Bruce Thiel

Disclosure: The trials were supported by Eli Lilly and Company. Healio.com/Dermatology was unable to determine the researchers’ relevant financial disclosures at time of publication.