FDA Approves Stelara for Active Psoriatic Arthritis

VBCR - October 2013, Volume 2, No 5 - FDA Approvals, News & Updates

The US Food and Drug Administration (FDA) approved the first anti–interleukin (IL)-12 and anti–IL-23, ustekinumab (Stelara; Janssen Biotech), alone or in combination with methotrexate, for the treatment of adult patients aged ≥18 years with active 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 Alice B. Gottlieb, MD, PhD, Chief and Dermatologist-in-Chief, Department of Dermatology, Tufts Medical Center, who is also certified in rheumatology. “Therapy that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (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,” Dr Gottlieb said.

The FDA approval of Stelara is based on safety and efficacy results from 2 pivotal phase 3, multicenter, randomized, double-blind, placebo-controlled trials of ustekinumab, a fully human anti–IL-12 and IL-23p40 monoclonal antibody—PSUMMIT I and PSUMMIT II. In these trials, ustekinumab was administered subcutaneously in doses of 45 mg or 90 mg at weeks 0 and 4, and then every 12 weeks. A total of 927 patients with active psoriatic arthritis who had at least 5 tender and 5 swollen joints and C-reactive protein levels of ≥0.3 mg/dL despite previous treatment with conventional therapy, were included in these 2 trials. PSUMMIT II also included 180 patients who were previously exposed to 1 of 5 tumor necrosis factor inhibitors.

In PSUMMIT I, at week 24, 42% of patients receiving ustekinumab 45 mg and 50% of patients receiving 90 mg achieved at least a 20% improvement in the American College of Rheumatology criteria (ACR20), the primary end point for the 2 trials. In PSUMMIT II, 44% of patients receiving ustekinumab 45 mg and 44% of patients receiving 90 mg achieved ACR20 by week 24. In addition, ustekinumab improved soft-tissue components of the disease, including dactylitis, enthesitis, and skin component as measured by Psoriasis Area and Severity Index 75.

Ustekinumab was approved in 2009 by the FDA for the treatment of patients with moderate-to-severe plaque psoriasis. When used for the treatment of patients with psoriatic arthritis, ustekinumab is administered as a 45-mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks thereafter. (September 23, 2013)

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