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September 01, 2020
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Long-term tildrakizumab beneficial in treating plaque psoriasis

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Tildrakizumab was efficacious and safe in treating plaque psoriasis over 4 years, according to a study presented at the American Academy of Dermatology virtual meeting.

The three-part double-blind, randomized, placebo-controlled, 64-week reSURFACE 1 trial included 772 subjects. The first part of the trial randomly assigned patients to receive tildrakizumab 100 mg, tildrakizumab 200 mg or placebo at weeks 0 and 4. Part two included patients who previously received placebo who were rerandomized to receive tildrakizumab 100 mg or tildrakizumab 200 mg at weeks 12 and 16 and every 12 weeks thereafter. Part three included patients who received tildrakizumab from the beginning of the study who were rerandomized to placebo, tildrakizumab 100 mg or tildrakizumab 200 mg based on their response to treatment.

An extension study started with 525 patients with at least a 50% improvement in Psoriasis Area and Severity Index score during the original study who received tildrakizumab within 12 weeks of the end of the study. The patients received the same tildrakizumab dose they had received in the base study once every 12 weeks.

The study found that 87% of those treated with tildrakizumab 100 mg had reached PASI 75, 54% reached PASI 90 and 31% reached PASI 100 at week 64. At week 208, 82% reached PASI 75, 56% reached PASI 90 and 28% reached PASI 100.

At week 64, PASI 75, PASI 90 and PASI 100 were achieved by 82%, 52% and 27%, respectively, of those in the tildrakizumab 200 mg group. At week 208, PASI 75, PASI 90 and PASI 100 were achieved by 82%, 55% and 27%, respectively.

A favorable Physician Global Assessment response at week 64 was recorded in 65% of patients who received the 100 mg dose and 63% of those who received the 200 mg dose. At week 208, those percentages were 58% and 60%.

“Over 4 years of treatment with tildrakizumab, PASI and PGA response rates were high and durable for tildrakizumab 100 mg and 200 mg,” the study authors wrote.

The number of patients reporting prespecified adverse events was low for both treatment groups at up to 5 years.