Ustekinumab Helps Joints and Skin in Psoriatic Arthritis

Kate Johnson

June 09, 2012

June 9, 2012 (Berlin, Germany) — The interleukin 12/23 inhibitor ustekinumab (Stelara, Janssen) significantly improved signs and symptoms of joint and skin involvement in patients with active psoriatic arthritis that was unresponsive to other therapies, according to results of a phase 3 trial reported here at the European League Against Rheumatism (EULAR) Congress 2012.

"There is still considerable unmet need in the treatment of psoriatic arthritis," said Iain B. McInnes, PhD, professor, experimental medicine and rheumatology, and director of the Institute of Infection, Immunity, and Inflammation at the University of Glasgow, United Kingdom, during a press conference.

"Ustekinumab is already licensed and in regular clinical use in the treatment of skin psoriasis, and the real issue in this trial was does it also work in the joints," he added. "The benefits were achieved across skin, joints, and quality of life."

The 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) trial included 615 adults with active psoriatic arthritis, despite treatment with disease-modifying antirheumatic drugs and/or nonsteroidal anti-inflammatory drugs.

Patients were randomly assigned to receive either subcutaneous ustekinumab 45 mg (n = 205) or 90 mg (n = 204) or placebo (n = 206) at baseline and week 4, and then every 12 weeks for 24 weeks.

At 24 weeks, patients in both the low- and high-dose groups were about twice as likely as those receiving placebo to achieve the study's primary endpoint of a ACR20 (20% improvement in tender/swollen joint counts, according to American College of Rheumatology criteria) response (42.4% and 49.5% vs 22.8%, respectively; P < .001).

Similar responses with low-dose and high-dose ustekinumab and placebo were seen on the secondary endpoints of ACR50 (24.9% and 27.9% vs 8.7%, respectively; P < .001) and ACR70 (12.2% and 14.2% vs 2.4%, respectively; P < .001) responses.

In addition, compared with placebo-treated participants, more participants receiving ustekinumab achieved clinically relevant improvements in physical function, measured by the Health Assessment Questionnaire Disability Index (47.8% and 47.5% vs 28.2%, respectively), said Dr. McInnes.

Skin benefits measured by at least a 75% improvement on the Psoriasis Area Severity Index were seen in 57.2% of patients receiving low-dose ustekinumab and 62.4% of those receiving high-dose ustekinumab compared with 11.0% of the patients receiving placebo (P < .001).

"This is unsurprising because ustekinumab is already widely used in skin psoriasis," Dr. McInnes noted.

"From the clinical perspective, we have very few options in the treatment of psoriatic arthritis.... Our understanding of pathology suggests this is a plausible target pathway."

Asked to comment on the findings, Christopher Buckley, MD, PhD, professor of rheumatology at the University of Birmingham, United Kingdom, and chairperson of the EULAR abstract selection committee, told Medscape Medical News that, "This is a first-in-kind [study].... They can get 2 for the price of 1 here, because if you can help the skin and the joints, that's a good outcome, and [anti–tumor necrosis factor agents] haven't been as successful in psoriatic arthritis as they have in rheumatoid arthritis or ankylosing spondylitis."

Janssen Research & Development LLC sponsored the study. Dr. McInnes and several of his coinvestigators receive grants and research support from the company. Dr. Buckley has disclosed no relevant financial relationships.

European League Against Rheumatism (EULAR) Congress 2012: Abstract OP0158. Presented June 8, 2012.

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