FDA approves first anti-IL-12/23 psoriatic arthritis drug

September 25, 2013

FDA has approved ustekinumab (Stelara, Janssen Biotech) alone or in combination with methotrexate for active psoriatic arthritis in adult patients aged 18 years and older.

FDA has approved ustekinumab (Stelara, Janssen Biotech) alone or in combination with methotrexate for active psoriatic arthritis in adult patients aged 18 years and older.

The approval marks the first treatment approved for psoriatic arthritis since the introduction of anti-TNF biologic drugs more than 10 years ago. It is currently the only therapy on the market that targets the cytokines interleukin-12 and interleukin-23, 2 naturally occurring proteins that could play a role in the development of psoriatic arthritis.

"It is critical for dermatologists and rheumatologists to be able to offer new and novel treatment options to our adult patients living with psoriatic arthritis, a disease where additional biologic options are very much needed," said investigator and Steering Committee member Alice B. Gottlieb, triple board certified in dermatology, rheumatology and internal medicine, MD, PhD, chief and dermatologist-in-chief, department of dermatology, Tufts Medical Center, said in a company press release.

The approval is based on findings from 2 pivotal Phase 3 Multicenter, Randomised, Double-blind, Placebo-controlled trials of Ustekinumab, a Fully Human anti–IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously administered ustekinumab 45 mg or 90 mg at weeks 0, 4, and then every 12 weeks. The trials included 927 patients diagnosed with active psoriatic arthritis who had at least 5 tender and 5 swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dL despite previous treatment with conventional therapy. PSUMMIT II also included 180 patients with previous exposure to 1-5 tumor necrosis factor (TNF) inhibitors. Results from PSUMMIT 1 showed that at week 24, 42% and 50% of patients receiving ustekinumab 45 mg and 90 mg, respectively, achieved at least 20% improvement in signs and symptoms according to the American College of Rheumatology criteria (ACR 20), the primary end point for both studies. In PSUMMIT II, 44% of patients receiving ustekinumab 45 mg and 44% of patients receiving ustekinumab 90 mg achieved ACR 20 at week 24. Additionally, ustekinumab is said to have improved soft tissue components of the disease, including dactylitis (inflammation of the finger or toe), enthesitis (inflammation of the entheses, the sites where tendons or ligaments attach to bone), and skin component as measured by Psoriasis Area and Severity Index score (PASI) 75.

Ustekinumab is administered as a 45-mg subcutaneous injection in psoriatic arthritis patients at weeks 0 and 4, and then every 12 weeks, thereafter. For those with co-existent moderate-to-severe plaque psoriasis weighing more than 220 lbs. (100 kg), the dose recommendation is a 90-mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks, thereafter.

It is estimated that more than 2 million people in the United States are living with psoriatic arthritis.