Ilumya From Sun Pharmaceutical Industries

The FDA has approved Ilumya (tildrakizum- ab-asmn) from Sun Pharmaceutical Industries Ltd to treat moderate to severe plaque psoriasis.

The medication is indicated for adults who are candidates for phototherapy or systemic therapy.¹ Psoriasis is a chronic immune disease that speeds the growth cycle of skin cells, leading to scaly, thick areas. Plaque psoriasis is the most common form, comprising 80% to 90% of cases. It is characterized by raised red areas of skin that are covered with flaky white scales that may bleed, crack, and itch.²

PHARMACOLOGY AND PHARMACOKINETICS

Ilumya is an IL-23 antagonist. It selectively binds to the p19 subunit of IL-23 and inhibits its inter- action with the IL-23 receptor, causing inhibition of the release of proinflammatory cytokines and chemokines.^1,2 Ilumya reaches peak concentration about 6 days after subcutaneous administration. Its half-life is about 23 days. The effect of hepatic or renal impairment on the pharmacokinetics of Ilumya has not been studied.¹

DOSAGE AND ADMINISTRATION

The recommended dose of Ilumya is 100 mg given as a subcutaneous injection at weeks 0 and 4 and every 12 weeks thereafter. It is supplied as a 100-mg/mL solution in a single-dose, prefilled syringe. The medication should be stored in the refrigerator until 30 minutes prior to use. Ilumya should be administered by a health care provider.¹

CLINICAL TRIALS

Data from 2 double-blind, multicenter, placebo-controlled, randomized trials supported the approval of Ilumya. The trials consisted of 926 adult patients with moderate to severe plaque psoriasis who were randomized to receive either Ilumya or a placebo. The primary efficacy end points of both trials evaluated the changes after the first 12 weeks of the studies. Both trials met both end points, which were the proportion of patients who had at least a 75% reduction in their Psoriasis Area and Severity Index (PASI 75) composite score and the proportion of patients with a Physician Global Assessment (PGA) score of “clear” or “minimal” after 2 doses. At week 28, patients in the Ilumya group of trial 2 who responded to treatment were rerandomized to either continue treatment with Ilumya or receive a placebo. Among this group, 84% of patients who continued receiving Ilumya maintained their PASI 75 at week 64 compared with 22% of those who were rerandomized to receive a placebo. In addition, 69% of the patients receiving Ilumya who had a PGA score of “clear” or “minimal” at week 28 maintained this response at week 64 compared with 14% of those rerandomized to a placebo.^1,2

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

Treatment with Ilumya is contraindicated in patients with a previous serious hypersensitivity reaction to the medication or any of its components.

In clinical trials, some patients using Ilumya experienced angioedema and urticaria. If a serious allergic reaction occurs during treatment, the medication should be discontinued immediately and appropriate care should be administrated. Treatment with Ilumya may increase the risk of infection. Advise patients using Ilumya to seek medical help if signs or symptoms of a clinically important acute or chronic infection develop. If such an infection occurs or is not responding to standard therapy, discontinuation of Ilumya may be warranted until the infection resolves.

Patients should be evaluated for tuberculosis before beginning treatment with Ilumya and monitored for active tuberculosis during and after treatment. Patients with active tuberculosis should not receive Ilumya. The use of live vaccines should be avoided during treatment with Ilumya. There are not enough data available regarding the use of Ilumya in pregnancy to establish the associated risk of adverse developmental outcomes. There are no data available regarding the presence of Ilumya in human breast milk, its effects on a breast-fed infant, or its effects on milk production. The use of Ilumya in patients younger than 18 years has not been evaluated.

The most common adverse reactions (incidence ≥1%) are diarrhea, injection site reactions, and upper respiratory infections.¹

Monica Holmberg, PharmD, BCPS, earned her PharmD at the University of Connecticut in Storrs and completed an ambulatory care residency at the Phoenix VA Health Care System in Arizona. Her practice has also included pediatrics and inpatient mental health. She lives in Phoenix.

References

• Ilumya [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; 2018. ilumyapro.com/assets/pdf/Sun_Pharma_ILUMYA_US_Prescribing_Information.pdf. Accessed September 27, 2018.
• Sun Pharma announces U.S. FDA approval of Ilumya (tildrakizumab-asmn) for the treatment of moderate-to-severe plaque psoriasis [news release]. Mumbai, India, and Princeton, NJ: Sun Pharmaceutical Industries Ltd; March 21, 2018. sunpharma.com/media/press-releases. Accessed September 27, 2018.