The US Food and Drug Administration (FDA) and European Union (EU) have approved the interleukin (IL) 12/23 inhibitor ustekinumab (Stelara, Janssen Biotech) for adults with active psoriatic arthritis who have not responded adequately to previous nonbiological disease-modifying antirheumatic drug therapy, the company announced today.
Approval of ustekinumab for psoriatic arthritis is "significant for patients and physicians as it marks the first treatment approved for this devastating and complex disease since the introduction of anti-TNF biologic medicines more than a decade ago," Jerome A. Boscia, MD, vice president and head of immunology development, Janssen Research & Development, LLC, said in a statement.
The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of ustekinumab for active psoriatic arthritis in June, as reported by Medscape Medical News.
Ustekinumab is already approved in the US and EU for treatment of moderate to severe psoriatic plaques in adults. The drug, which can be used alone or in combination with methotrexate, is novel in that it targets both IL-12 and IL-23.
"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," added Alice B. Gottlieb, MD, PhD, chief of dermatology at Tufts Medical Center in Boston, Massachusetts, and lead investigator on the ustekinumab studies.
A drug that targets both IL-12 and IL-23, "2 naturally occurring proteins believed to play a role in the development of this debilitating immune-mediated inflammatory disease, could improve patient care," she said.
2 Pivotal Trials
For the treatment of psoriatic arthritis, ustekinumab is administered as a 45-mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks thereafter, the company said. For patients with coexistent moderate to severe plaque psoriasis who weigh more than 220 pounds (100 kg), the recommended dose is 90 mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks thereafter.
The approval of ustekinumab for active psoriatic arthritis was based on 2 pivotal phase 3 multicenter, randomized, double-blind, placebo-controlled trials known as Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I) and PSUMMIT II.
The trials included 927 patients diagnosed with active psoriatic arthritis who had at least 5 tender and 5 swollen joints and C-reactive protein 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 to 5 TNF inhibitors.
Results from PSUMMIT I, as previously reported by Medscape Medical News showed that at week 24, 42% and 50% of patients receiving ustekinumab 45 and 90 mg, respectively, achieved at least 20% improvement in signs and symptoms, according to the American College of Rheumatology criteria (ACR20), the primary outcome of both studies.
In PSUMMIT II, as reported by Medscape Medical News, the ACR20 response was sustained at week 52.
Ustekinumab also improved soft tissue components of the disease, including dactylitis, enthesitis, and skin component, as measured by Psoriasis Area and Severity Index score 75.
The safety results of the ustekinumab observed in the PSUMMIT studies were consistent with the known safety profile of the drug in the labeled moderate-to-severe plaque psoriasis indication, which has 5 years of safety experience in clinical trials, the company said.
The PSUMMIT studies "demonstrated the efficacy and safety of Stelara in one of the largest clinical development programs ever conducted for the treatment of active psoriatic arthritis," Dr. Boscia noted.
It is estimated that more than 2 million people in the United States and 4.2 million people across Europe have psoriatic arthritis.
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Cite this: Ustekinumab Approved for Psoriatic Arthritis in US, Europe - Medscape - Sep 23, 2013.