Damian McNamara

September 30, 2016

VIENNA — For patients with moderate to severe palmoplantar plaque psoriasis, improvements were significantly better at 2 weeks with ixekizumab (Taltz, Lilly) than with etanercept or placebo, according to a subanalysis of data from the phase 3, multicenter, UNCOVER-3 trial.

Ixekizumab, a monoclonal antibody with a high affinity for interleukin-17, is associated with a "persistent long-term response in the majority of patients, with no new side-effect issues," said Alan Menter, MD, from the Baylor University Medical Center in Dallas.

Palmoplantar psoriasis generally affects less than 5% of body surface area; however, the effect on the patient "is very significant," he told Medscape Medical News. The negative impact on quality of life "can equal that of patients with severe rheumatoid or osteoarthritis."

Dr Menter and his colleagues conducted a subanalysis of participants in the UNCOVER-3 population who had moderate to severe plaque psoriasis with substantial palmoplantar involvement (N Engl J Med. 2016;375:345-356).

He presented the results to a standing-room-only crowd here at the 25th European Academy of Dermatology and Venereology Congress.

In UNCOVER-3, all participants were randomized to one of four treatment groups for 12 weeks: ixekizumab 80 mg every 2 weeks after a starting dose of 160 mg; ixekizumab 80 mg every 4 weeks after a starting dose of 160 mg; etanercept 50 mg twice weekly; and subcutaneous placebo. During the subsequent 48 weeks, all participants received an injection of ixekizumab 80 mg every 4 weeks.

For their analysis, Dr Menter's team identified 115 participants with a baseline score of at least 8 on the Palmoplantar Psoriasis Area and Severity Index (PPASI). They assessed the degree of improvement in PPASI (50%, 75%, or 100%) at week 12 and week 60.

Table 1. Results at 12 Weeks by Treatment Group

Score 2-Week Ixekizumab (n = 38), % 4-Week Ixekizumab (n = 32), % Etanercept (n = 25), % Placebo (n = 20), %
PPASI 50 78.9* 87.5 72.0* 40.0
PPASI 75 68.4† 78.1† 44.0 20.0
PPASI 100 50.0* 46.9* 36.0 10.0

*P < .05 vs placebo
P < .001 vs placebo

"It's always nice to show early results in psoriasis. But we need to maintain that," Dr Menter explained. "What psoriasis patients fear most is that we clear them and they flare back up again. We need to maintain the PASI 75 scores."

At week 60, PPSAI improved by 75% in about 80% of the patients treated with ixekizumab, he reported.

Table 2. Results at Week 60 by Treatment Group, After 48 Weeks of Ixekizumab Therapy for All

Score 2-Week Ixekizumab (n = 36), % 4-Week Ixekizumab (n = 30), % Etanercept (n = 25), % Placebo (n = 19), %
PPASI 50 77.8 73.3 80.0 94.7
PPASI 75 75.0 73.3 80.0 84.2
PPASI 100 61.1 70.0 60.0 63.2

 

"Ixekizumab has a really fast action," said session cochair Christa de Cuyper, MD, from A.Z. Sint-Jan in Brugge, Belgium. "Patients reached high scores after 2 weeks."

"I have the impression that ixekizumab is more effective; it certainly has a faster onset of action," she explained. "But the etanercept results are also 80% at 60 weeks. That is a very good result for all palmoplantar patients. It shows high efficacy."

Safety Results

"There were no new safety issues in the palmoplantar psoriasis assessment," Dr Menter said.

The incidence of adverse events was similar for ixekizumab and placebo during the first 12 weeks of the study (4% vs 5%). During the subsequent 48 weeks, the incidence of adverse events was 13% for all patients combined.

The researchers did not assess treatment efficacy or safety for patients with the pustular form of palmoplantar psoriasis. That is a different disease, said Dr Menter.

"Hopefully, we will be studying these patients shortly," he added.

The UNCOVER-2 and UNCOVER-3 studies were sponsored by Eli Lilly. Dr Menter reports receiving research support from Eli Lilly. Dr de Cuyper has disclosed no relevant financial relationships.

25th European Academy of Dermatology and Venereology (EADV) Congress: Abstract FC03.08. Presented September 29, 2016.

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