FDA approves ixekizumab for plaque psoriasis

The FDA approved Taltz (ixekizumab, Eli Lilly and Company) injection 80 mg/mL March 22 for treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Ixekizumab clinical trial investigator Paul Yamauchi, M.D., Ph.D., tells Dermatology Timesthat Taltz is the only biologic agent for psoriasis to have data for PASI 100 and sPGA 0 scores at week 12.

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“In the clinical trials that were conducted, 35 to 40% of patients attained PASI 100 response and 37 to 42% of patients were totally clear based on the sPGA response at week 12,” says Dr. Yamauchi, of the Dermatology Institute & Skin Care Center in Santa Monica, Calif., and assistant clinical professor of dermatology at the David Geffen School of Medicine at UCLA. “In addition, 87 to 90% of patients attained PASI 75 response and 68 to 71% of patients were PASI 90 responders at week 12.”

According to Dr. Yamauchi, comparator head-to-head trials demonstrated superior response rates for ixekizumab compared with etanercept (Enbrel, Amgen) (87% vs. 41% for PASI 75 and 73% vs. 27% for sPGA 0/1 at 12 weeks).

Dr. Yamauchi says that dermatologists can use ixekizumab as first-line therapy or for patients in which other biologic agents or other systemic agents have failed to induce or maintain adequate response.  

“The clinical trials have shown that Taltz demonstrates comparable efficacy when used in patients who have never been on a biologic agent before or those who have tried a biologic agent previously for their psoriasis,” he says. “It is the second IL-17A inhibitor to be approved for moderate-to-severe plaque psoriasis. The IL-17 pathway is important in the immunopathogenesis of psoriasis. By targeting IL-17A, Taltz prevents the hyperproliferation of keratinocytes which leads to significant reduction of psoriatic plaques.”

Helen M. Torok, M.D., medical director of Trillium Creek Dermatology, in Medina, Ohio, says ixekizumab joins secukinumab (Cosentyx, Novartis) in blocking IL-17 as its mechanism of action.

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“We now have Enbrel, Humira [adalimumab, Abbvie], Remicade [infliximab, Janssen], Stelara [ustekinumab, Janssen], Cosentyx [secukinumab, Novartis], Otezla [apremilast, Celgene] and, now, Taltz,” Dr. Torok says. “It appears that the IL-17 [inhibitors] have the best efficacy.”

According to Dr. Torok, IL-17 inhibitors have been shown to halt bone loss that plagues many with psoriasis.

“The side effects of this new IL-17 are no different than the others, however,” Dr. Torok says. “The occurrence of new inflammatory bowel disease is worrisome. It will become more evident whether this is a real concern as we enroll more patients. There were over 3,000 patients in the studies, which is a robust number. But inflammatory bowel disease is a concern.”

Disclosures: Dr. Yamauchi is a researcher, speaker, and consultant to Lilly, Abbvie, Amgen, Janssen, and Novartis. Dr. Torok reports no relevant disclosures.