Tildrakizumab Shows Long-term Safety, Efficacy in Patients With Plaque Psoriasis in Japan

The long-term findings come from a subgroup analysis of 120 patients in Japan taking part in an extension of the 3-part, double-blind, randomized, controlled reSURFACE 1 trial.

Tildrakizumab maintained efficacy in patients with moderate to severe plaque psoriasis over 5 years, according to new study findings, which also show that 2 different doses of the treatment resulted in a low frequency of adverse events.

The long-term findings come from a subgroup analysis of 120 patients in Japan taking part in an extension of the 3-part, double-blind, randomized, controlled reSURFACE 1 trial. Efficacy was determined using 2 measures, including the Psoriasis Area and Severity Index, which measures the severity and extent of disease.

By 192 weeks, 80% of the patients receiving tildrakizumab 100 mg had a 75% reduction in PASI score (PASI 75), 48% had a 90% reduction (PASI 90), and 25% achieved a complete resolution of disease. At the same time point, 76% of the patients receiving tildrakizumab 200 mg had a PASI 75, 45% had a PASI 90, and 16% achieved a complete resolution.

The 192-week extension period followed the 64-week base study. According to the researchers, 85% of the 39 patients receiving tildrakizumab 100 mg who had a PASI 75 following the base study maintained their response through the 192 weeks. Among the 41 patients receiving tildrakizumab 200 mg who achieved PASI 75 during the base period, 88% maintained their response through the same period.

Meanwhile, 70% of the 27 patients receiving tildrakizumab 100 mg who achieved PASI 90 following the baseline study maintained their response through the end of the extension period, and 96% of the 23 patients treated with tildrakizumab 200 mg who achieved PASI 90 during the base period maintained their response.

For patients who demonstrated a complete resolution of disease at the end of the baseline period, 63% of the 16 patients receiving tildrakizumab 100 mg and 67% of the 9 patients receiving tildrakizumab 200 mg maintained their response through 192 weeks.

Efficacy was also based on how many patients maintained their Physical Global Assessment clear or minimal with ≥2-grade reduction from baseline (PGA 0/1) through week 192. At 192 weeks, 59% of patients receiving tildrakizumab 100 mg and 62% of patients had PGA 0/1.

“In the current study, tildrakizumab treatment was generally well tolerated, with low rates of discontinuations, SAEs, and AEs of special interest,” wrote the researchers, reflecting on the safety profile observed in the study. “Consistent with other clinical trials for the treatment of psoriasis with biologic agents, nasopharyngitis was the most common AE observed in this study. Other frequent AEs observed in this and other studies include eczema, hypertension, influenza, arthralgia, pruritis, and contact dermatitis.”

The reported AEs resulted in treatment discontinuation for 1.7 patients per 100 patient-years among patients receiving tildrakizumab 100 mg and in 0.8 patients per 100 patient-years among patients receiving tildrakizumab 200 mg.

Reference

Imafuku S, Nakagawa H, Igarashi A, et al. Long-term efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 5-year extension of a phase 3 study (reSURFACE 1). J Dermatol. Published online February 1, 2021. doi:10.1111/1346-8138.15763.