Ilumya is not approved by the FDA to treat psoriatic arthritis, but studies for this use are ongoing. Illumya is only approved to treat plaque psoriasis at this time. Your doctor may decide, based on their medical judgement, to prescribe Ilumya off-label for other conditions.

"Off-label" use of a drug refers to prescribing a medication for a different purpose than those formally approved by the FDA and found in the package labeling of the drug.

Ilumya (tildrakizumab-asmn) is a prescription injection used to treat moderate-to-severe plaque psoriasis in adults. Ilumya is an injection given under the skin (subcutaneously).

• Ilumya is used in patients who may benefit from receiving injections, pills, or treatment with ultraviolet (UV) light phototherapy.
• It is classified as a humanized, anti-IL-23p19 monoclonal antibody and works by blocking inflammatory proteins (cytokines and chemokines) in the body.
• Sun Pharma is the manufacturer of Ilumya.

Psoriatic arthritis is an inflammatory form of arthritis also associated with psoriasis plaques of the skin. Psoriatic arthritis can affect over 40% of patients with plaque psoriasis. Symptoms include joint pain, swelling and stiffness, fatigue and loss of ability to fully use the joint.

Common treatments approved by the FDA to treat both psoriatic arthritis and plaque psoriasis include:

• Cosentyx (secukinumab)
• Enbrel (etanercept)
• Humira (adalimumab)

Studies of Ilumya for psoriatic arthritis

In a Phase 2b, 52-week study of 391 adult patients, researchers reported that 71.4% to
79.5% of patients treated with Ilumya had a 20% improvement in symptoms of psoriatic arthritis (ACR20) at week 24, compared to 50.6% of patients on placebo, a significant outcome.

Patients achieved similar results with either the 100 mg or 200 mg dose given every 12 weeks (quarterly) in the 24 week analysis. Some patients using the 100 mg dose had significant improvement as early as 8 weeks.

Ilumya was well-tolerated through 52-weeks of treatment and there was a low rate of serious side effects (3.3%) comparable to placebo. The most common side effects reported included the common cold (nasopharyngitis), upper respiratory tract infections, high blood pressure and headaches. Side effects of any type were reported in 64% of patients.

By week 52, 76 (19.4%) patients discontinued the study, primarily due to lack of efficacy (9.5%) or withdrawn consent (3.3%). The main study limitation was a high rate of placebo response, yet results remained statistically significant.

Learn More: Off-Label or Off-Limits: Should You Use a Drug for An Unapproved Use?

This is not all the information you need to know about Ilumya (tildrakizumab-asmn) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full product information here, and discuss this information and any questions you have with your doctor or other health care provider.