Indication: Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Mechanism: Monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23).
Dosage: 100 mg SC at weeks 0 and 4 and every 12 weeks thereafter.
Approval was based on two phase 3 trials (reSURFACE 1 and 2). The 2 multicenter, randomized, double-blind, placebo-controlled trials involved 926 adults with moderate-to-severe plaque psoriasis with 616 treated with tildrakizumab and 310 with placebo. Both studies met the primary efficacy endpoints, demonstrating significant clinical improvement with tildrakizumab compared with placebo when measured by at least a 75% reduction in Psoriasis Area and Severity Index score (PASI 75) and Physician Global Assessment (PGA) score of "clear" or "minimal" at week 12 after 2 doses.
In the reSURFACE 1 study, 74% of patients achieved PASI 75 at week 28 after 3 doses of tildrakizumab. In patients who continued on the drug, 84% maintained PASI 75 at week 64, compared to 22% of patients who were re-randomized to placebo. In reSURFACE 2, 66% of the 200-mg group and 61% of the 100-mg group achieved PASI 75, compared to 6% of the placebo group and 48% of the etanercept group at week 12.
Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017 Jul 15;390(10091):276-288. https://www.ncbi.nlm.nih.gov/pubmed/28596043
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.