FDA Clears Tildrakizumab (Ilumya) for Plaque Psoriasis

Megan Brooks

March 21, 2018

The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (Ilumya, Sun Pharmaceuticals) for adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy, the company has announced.

Tildrakizumab-asmn is a selective interleukin (IL)-23p19 inhibitor given by subcutaneous injection at a dose of 100 mg every 12 weeks, after the completion of initial doses at week 0 and week 4, the company said.

The efficacy of tildrakizumab-asmn for moderate-to-severe plaque psoriasis was demonstrated in the phase-3 reSURFACE clinical development program. The two multicenter, randomized, double-blind, placebo-controlled trials known as reSURFACE 1 and reSURFACE 2 involved 926 adults with moderate-to-severe plaque psoriasis with 616 treated with tildrakizumab-asmn and 310 with placebo.

Both studies met the primary efficacy endpoints, demonstrating significant clinical improvement with tildrakizumab-asmn 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 two doses.

In the reSURFACE 1 study, 74% of patients achieved PASI 75 at week 28 after three doses of tildrakizumab-asmn, and 84% of patients who continued on the drug maintained PASI 75 at week 64 compared with 22% of patients who were rerandomized to placebo.

In addition, according to the company, 69% of the patients receiving tildrakizumab-asmn who had a PGA score of "clear" or "minimal" at week 28 maintained this response at 64 weeks compared with 14% of patients who were rerandomized to placebo.

Results from the reSURFACE 1 and 2 studies were published last year in The Lancet, as reported by Medscape Medical News.

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

In the clinical trials, cases of angioedema and urticaria were reported with tildrakizumab-asmn. In the case of serious hypersensitivity reaction, the drug should be stopped immediately and appropriate therapy initiated, the company said. 

Tildrakizumab-asmn may increase the risk for 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 in patients with chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to starting treatment and throughout treatment.

Full prescribing information is available online.

For more news, join us on Facebook and Twitter

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....