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FDA Approves Ilumya for Plaque Psoriasis

Clinical trial data show drug may help achieve clear skin.

Adults with moderate-to-severe plaque psoriasis will soon have access to a new treatment option. On March 21, 2018, the U.S. Food and Drug Administration approved Ilumya (tildrakizumab-asmn) for adults who are eligible for systemic therapy or phototherapy.

Dosage calls for an injection of 100 mg (pre-filled syringe) every 12 weeks, after two initial injections at weeks 0 and 4. Ilumya works by binding to interleukin-23, a key protein involved in inflammatory diseases.

“As we move to finding a cure for psoriasis, what we are looking for are high performance drugs that provide durable response in between treatments and that lend themselves to patient compliance – in this case 12 weeks. This lessens the need for multiple injections along the way,” says dermatologist George Martin, M.D., a member of NPF’s Medical Board. “It’s exciting that we have newer, very powerful choices.”

Results from two Phase 3 clinical trials showed significant improvement in patients who received Ilumya (100 mg) compared with the placebo. In one study, 74 percent (229 patients) achieved 75 percent skin clearance at week 28 after three doses. Meanwhile, 84 percent who continued receiving Ilumya (100 mg) maintained 75 percent skin clearance at week 64, compared with 22 percent who were randomly reassigned to placebo.

Additionally, of the patients on Ilumya (100 mg) who at week 28 had a physician’s global assessment score of "clear" or "minimal,” 69 percent maintained this response at week 64, compared with 14 percent who were randomly reassigned to placebo.

Since 1987, NPF has invested more than $17 million into psoriatic disease research, which has directly contributed to the wave of newly approved therapies in recent years. Furthermore, NPF connects patients with clinical trials so that more drugs may be tested and eventually approved. 

NPF understands that treating psoriasis has its challenges. The good news is that, thanks to scientific advancements, individuals living with psoriatic disease have more options than ever before to set and achieve treatment goals including clear or nearly clear skin. If you would like to learn more about your treatment options, such as Ilumya, contact our Patient Navigation Center. Our Patient Navigators offer free resources and personalized support to help you live your healthiest life with psoriatic disease.

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