Tildrakizumab Gets FDA Nod for Moderate to Severe Plaque Psoriasis

The FDA has approved Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, announced Sun Pharmaceuticals in a press release.

Ilumya selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor, which leads to inhibition of the release of pro-inflammatory cytokines and chemokines. Ilumya is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. Ilumya is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

The FDA approval of Ilumya for the treatment of adults with moderate to severe plaque psoriasis was supported by data from the pivotal phase 3 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). Results from these studies were published in The Lancet in July 2017, with primary endpoints presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress.

Both phase 3 studies met the primary efficacy endpoints, demonstrating significant clinical improvement with Ilumya 100 mg compared with placebo when measured by at least 75% 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% (229 patients) achieved 75% 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 with 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 with 14% of patients who were re-randomized to placebo.

The most common (≥ 1%) adverse reactions associated with Ilumya include upper respiratory infections, injection site reactions, and diarrhea. Adverse reactions that occurred at rates less than 1% but greater than 0.1% in the Ilumya group and at a higher rate than in the placebo group included dizziness and pain in extremity.

Cases of angioedema and urticaria occurred in patients who received Ilumya in clinical trials. If a serious hypersensitivity reaction occurs, Ilumya should be discontinued immediately and appropriate therapy initiated.

Ilumya may increase the risk of infection, and treatment should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. The risks and benefits of treatment should be considered before Ilumya is prescribed for patients with a chronic infection or a history of recurrent infection.

Patients should be assessed for tuberculosis infection before, during, and after treatment with Ilumya. The use of live vaccines should be avoided in patients treated with Ilumya.

Full prescribing information is available online.