FDA approves Taltz for treating psoriasis in adults

The FDA has approved Taltz injection for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, according to a press release from Eli Lilly and Company.

Taltz (ixekizumab) 80 mg/mL injection specifically targets IL-17A, a protein that plays a role in the inflammation of psoriasis, according to the release. The FDA approval was based on results of a phase 3 trial program of more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries, the release reported.

Paul Yamauchi

“Moderate-to-severe plaque psoriasis is a serious disease that can be difficult-to-treat, and many patients are looking for a treatment that can provide higher levels of skin clearance,” Paul Yamauchi, MD, PhD, of the Dermatology Institute & Skin Care Center in Santa Monica, California, and an ixekizumab trial researcher, told Healio.com/Dermatology. “The approval of Taltz is an important advancement that provides dermatologists a new option that may help their patients achieve virtually clear or completely clear skin.”

“Complete clearance of skin plaques is an important treatment goal for psoriasis,” Craig Leonardi, MD, a study researcher and clinical professor of dermatology at St. Louis University School of Medicine, stated in the release. “With these study results, physicians can reassure patients that consistent results can be maintained with Taltz.”

Three phase 3 studies measured the safety and efficacy of ixekizumab of 80 mg every 2 weeks, following a 160-mg starting dose compared with placebo after 12 weeks. In the UNCOVER-2 and UNCOVER-3 trials, there was an additional comparator arm in which patients received U.S.-approved Enbrel (etanercept, Amgen; 50 mg twice a week) for 12 weeks.

Response rates with ixekizumab during the maintenance period through 60 weeks were also measured in the UNCOVER-1 and UNCOVER-2 trials.

Co-primary efficacy endpoints in the study at week 12 were a 75% improvement in composite Psoriasis Area Severity Index (PASI) score and static Physician’s Global Assessment (sPGA) 0 or 1 with at least a 2-point improvement from baseline, according to the release.

There were 87% to 90% of patients treated with ixekizumab at week 12 who saw significant improvement in PASI 75, and 81% to 83% of patients who achieved sPGA 0 or 1. There were 68% to 71% of patients who achieved PASI 90 (virtually clear skin) and 35% to 42% of patients who achieved PASI 100 (complete resolution), the release reported. Fewer than 10% of patients treated with placebo achieved PASI 75 or higher.

At 60-week endpoint in UNCOVER-1 and UNCOVER-2 trials, 75% of patients treated with ixekizumab maintained an sPGA 0 or 1 and at least a 2-point improvement from 12 weeks.

In the UNCOVER-2 and UNCOVER-3 trials, respective response rates for ixekizumab compared with etanercept were 87% vs. 41% for PASI 75 and 73% vs. 27% for sPGA 0 or 1 at 12 weeks, according to the release.

Adverse events reported with ixekizumab included risk of infection, with other warnings including pretreatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations, according to the release.

Lilly reports it expects ixekizumab to be available in the United States beginning in the second quarter of 2016.

Reference: www.lilly.com