Trial Results Show Tildrakizumab Is Safe, Effective for Psoriasis Across Ages

New analyses of 2 phase 3 trials found tildrakizumab is safe and effective for adults over age 55 with moderate to severe plaque psoriasis.

The pooled analyses of the reSURFACE 1 and reSURFACE 2 trials also showed the safety and efficacy of the treatment was comparable in those with moderate to severe plaque psoriasis across age quartiles. Nearly 600 patients were included in the trials. Tildrakizumab is an anti–interleukin-23 p19 monoclonal antibody approved by the FDA for adult treatment in 2018.

Because those with psoriasis and older individuals have a heightened risk of comorbidities, the researchers set out to determine the treatment’s efficacy in patients with moderate to severe forms of the disease across age groups. Around 3%, or over 7.5 million US adults aged 20 or older have psoriasis, and the condition is most common among non-Hispanic White individuals.

It’s also one of the most common immune-mediated diseases affecting American adults.

The phase 3 double-blind, placebo-controlled randomized trials were carried out over 28 weeks. Participants were treated with the labeled dose of tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter.

Participants were also divided into quartiles based on age: 146 patients were aged 18 to 35 years, 142 were aged 36 to 44 years, 156 were aged 45 to 54 years, and 150 were aged 55 through 82. Weight at baseline and body surface area affected were similar across quartiles.

Mean (SD) psoriasis area and severity index (PASI) score at baseline was 20.5 (8.1) for the youngest group and 19.4 (7.3) for those aged 55 to 82 years. The average patient age in the oldest quartile was approximately 63 years.

The researchers measured disease activity using PASI scores. Median scores substantially decreased for all age groups throughout the trials.

From week 0 to week 28. PASI scores decreased from 17.5 to 1.8 in the oldest group and from 18.1 to 1.1 in the youngest group. In all age quartiles, more than half of patients achieved PASI 75 by week 12, meaning they saw a 75% or greater reduction in PASI scores from baseline. The percentage of patients achieving PASI 90 and PASI 100 also increased over time and peaked at week 28 for all ages.

Data showed “the percentage of patients achieving PASI 100 response by week 28 was highest in the subgroup of patients aged 18 to 35 years,” at nearly 30%.

Clinical improvement was also assessed by measuring the proportions of patients achieving a Physician Global Assessment (PGA) score of 0 or 1 with at least a 2-grade reduction from baseline.

“Similar proportions of patients across age quartiles achieved PGA 0/1 with at least a 2-grade decrease from baseline by week 28,” the researchers noted. For patients with psoriasis, the PGA system measures treatment response based on lesion erythema, induration, and scale. The score assignments range is clear, almost clear, mild, moderate, and severe.

Treatment emergent adverse events (TEAEs) included infections and infestations like nasopharyngitis, diarrhea, arthralgia, and headache. Frequency of AEs throughout the trials was similar among all age quartiles. Severe TEAEs were reported in 5% or less of patients, with a slightly higher frequency seen among those aged 45 or older.

However, “the proportion of patients with any TEAE considered related to treatment trended down with age,” researchers wrote.

One death was reported in the 55 to 82 age group, but it was unrelated to treatment with tildrakizumab.

Reference

Elewski B, Han G, Gogineni R, Schenkel B, Guenthner S. Insights into the efficacy and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis across age quartiles: pooled analyses from the phase 3 reSURFACE 1 and reSURFACE 2 trials. Presented at: American Academy of Dermatology Annual Meeting; March 17-23, 2023; New Orleans, LA. Accessed April 12, 2023. https://bit.ly/3KU1vO1