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New 5-year data shows psoriasis improvement was similar among patients with and without metabolic syndrome, regardless of which dose they received.
A new study indicated that tildrakizumab appeared to be safe and effective over the long term in patients with psoriasis, regardless of whether they also had metabolic syndrome (MetS).
The new 5-year data provided clarity for a group of patients—those with MetS—for whom the long-term efficacy of the therapy remained in question.
A team of investigators led by Nehal N. Mehta, MD, MSCE, of the National Institutes of Health, , noted that patients with MetS have a higher risk of a number of comorbidities, such as cardiovascular events and death, diabetes, and psoriasis.
Previous research had suggested that patients who have MetS and psoriasis were less responsive to certain psoriasis therapies, such as tumor necrosis factor inhibitors and anti-interleukin 17A agents.
However, Mehta and colleagues said no long-term data regarding the safety and efficacy of psoriasis-targeted biologics were currently available.
Tildrakizumab is a monoclonal antibody designed to treat moderate to severe plaque psoriasis. The therapy was the subject of 2 placebo-controlled phase 3 trials (reSURFACE 1 and reSURFACE 2), both of which were published in 2018.
Patients from those studies who had a greater than 50% improvement in their Psoriasis Area and Severity Index (PASI) scores during the original studies were given the option of joining extension trials.
In the new report, Mehta and colleagues examine what that extension data show about the therapy’s long-term performance.
Patients in the original study received tildrakizumab at either a 100mg or 200 mg dose. Among those receiving the lower dose, 70 patients with MetS and 265 without MetS were included in the new analysis.
Among those receiving the higher dose, 64 patients with MetS and 241 without MetS were included. The patients took the therapy continuously and were followed for 244 weeks.
The authors found no significant difference among PASI score changes from baseline through Week 244 between the cohorts with MetS and the cohorts without MetS.
Among those in the reSURFACE 1 trial, 53.8% of patients taking the 100mg dose with MetS and 69.4% of patients without MetS achieved a PASI score of under 3 by week 244.
Among reSURFACE 2 patients, 77.3% of patients with MetS and 80.8% of patients without MetS who took the 100mg dose reached the same benchmark.
For patients receiving 200mg doses of tildrakizumab, 58.8% of patients with MetS and 72.1% of patients without MetS achieved PASI scores below 3 among those from reSURFACE 1, and for patients in reSURFACE 2 who took the higher dose, the percentages that reached PASI scores below 3 were 63.3% and 72.3%, among patients with and without MetS, respectively.
Regarding adverse events, the authors said safety data were similarly favorable among patients with and without MetS, suggesting the therapy is similarly safe for both groups. The most common Tier 1 treatment-emergent adverse events were serious infections/infestations and malignancies excluding melanoma and nonmelanoma skin cancer.
Mehta and colleagues cautioned that their study was limited by a relatively small sample size. They also noted that they treated patients with MetS as one group, without accounting for whether their MetS was controlled or not.
Still, the investigators concluded that MetS does not appear to affect tildrakizumab’s impact on patients with psoriasis.
“Our findings extend previously reported findings demonstrating numerically similar efficacy of tildrakizumab in patients with psoriasis with or without MetS based on PASI responses and median PASI score, improvement through up to 5 years, the longest duration of follow-up to our knowledge in this subgroup of patients,” the team concluded.
The study, "Tildrakizumab efficacy and safety in patients with psoriasis and concomitant metabolic syndrome: post hoc analysis of 5-year data from reSURFACE 1 and reSURFACE 2," was published online in the Journal of The European Academy of Dermatology.