New Psoriasis Drug Taltz Shows Benefit Through 60 Weeks

06/07/2016

Three new studies demonstrate the efficacy and safety of Eli Lilly's Taltz® (ixekizumab) through 60 weeks among patients with moderate-to-severe plaque psoriasis.

The findings appear in the New England Journal of Medicine.

In all three pivotal Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3, Taltz responders through 12 weeks demonstrated high levels of skin clearance through 60 weeks.

"This group of studies show that patients on Taltz are able to achieve high levels of efficacy, and that the majority of patients are able to maintain or continue to improve their response with continued treatment through 60 weeks," says study author Kenneth Gordon, MD  professor of dermatology at Northwestern University Feinberg School of Medicine in Chicago.


All three studies evaluated the safety and efficacy of Taltz (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks. All three studies also evaluated response rates with Taltz every four weeks through 60 weeks. In UNCOVER-1 and UNCOVER-2, patients treated with Taltz who achieved clinical response (static Physician's Global Assessment score [sPGA] 0 or 1) at 12 weeks were re-randomized to receive Taltz (80 mg every four weeks) or placebo through 60 weeks. In UNCOVER-3, all patients completing 12 weeks continued the study receiving Taltz (80 mg every four weeks) through 60 weeks.

In all three studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index score (PASI) 75 and sPGA 0 or 1.  In all three studies, sPGA and PASI were also assessed through 60 weeks.


In UNCOVER-1, Taltz given every two weeks was statistically superior to placebo, with high levels of clearance achieved at 12 weeks among patients treated with Taltz, the majority of whom achieved virtually clear (PASI 90) or completely clear skin (PASI 100, sPGA 0).

  • 81.8 percent of patients treated with Taltz achieved sPGA 0 or 1 compared to 3.2 percent of those treated with placebo (p<0.001).
  • 89.1 percent of patients treated with Taltz achieved PASI 75 compared to 3.9 percent of patients treated with placebo (p<0.001).
  • 70.9 percent of patients treated with Taltz achieved PASI 90 compared to 0.5 percent treated with placebo (p<0.001).
  • 35.3 percent of patients treated with Taltz achieved complete resolution of psoriasis plaques (PASI 100) compared to zero patients treated with placebo (p<0.001).

In UNCOVER-1 and UNCOVER-2, high levels of clearance also were achieved through 60 weeks among patients treated with Taltz every two weeks who achieved clinically meaningful response (sPGA 0 or 1) at 12 weeks, the majority of whom achieved virtually clear or completely clear skin through 60 weeks when treated with Taltz every four weeks. 

In UNCOVER-1 and UNCOVER-2 through 60 weeks:

  • 78.3 percent of patients maintained sPGA 0 or 1.
  • 83.3 percent of patients achieved PASI 75.
  • 76.5 percent of patients achieved PASI 90.
  • More than half of patients (57.5 percent) achieved complete resolution of skin plaques (PASI 100).

In UNCOVER-3, high levels of clearance were also achieved with Taltz given every four weeks through 60 weeks among patients initially treated with Taltz every two weeks:

  • 74.5 percent of patients achieved sPGA 0 or 1.
  • 83.4 percent of patients achieved PASI 75.
  • 73.2 percent of patients achieved PASI 90.
  • More than half of patients (55.3 percent) achieved complete resolution of skin plaques (PASI 100).

Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27 percent vs. 23 percent). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. Serious infections have occurred.

Results from 12-week data in UNCOVER-2 and UNCOVER-3 were published in The Lancet in June 2015. Results from the UNCOVER-3 long-term extension study were also recently presented at the American Academy of Dermatology (AAD) Annual Meeting, March 4-8, 2016.

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