General Information

Ilumya (tildrakizumab-asmn) is an interleukin-23 antagonist.

Ilumya is specifically indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Ilumya is supplied as a solution for subcutaneous injection. The recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.

Mechanism of Action

Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

Clinical Trial Results

The FDA approval of Ilumya for the treatment of adults with moderate-to-severe plaque psoriasis was based on data from the pivotal Phase III reSURFACE clinical development program. In the two multicenter, randomized, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 926 adult patients were treated with Ilumya (N=616) or placebo (N=310). Both studies met the primary efficacy endpoints, demonstrating significant clinical improvement with Ilumya 100 mg compared to placebo when measured by at least 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) and Physician's Global Assessment (PGA) score of "clear" or "minimal" at week 12 after two doses. Of the patients in the reSURFACE 1 study 74% (n=229) achieved 75 percent skin clearance at week 28 after three doses, and 84 % of patients who continued receiving Ilumya 100 mg maintained PASI 75 at week 64 compared to 22 % of patients who were re-randomized to placebo. In addition, 69% of the patients receiving Ilumya 100 mg who had a PGA score of "clear" or "minimal" at week 28 maintained this response at week 64 compared to 14% of patients who were re-randomized to placebo.