Patients with active psoriatic arthritis receiving the interleukin (IL)-12/23 inhibitor STELARA® (ustekinumab) experienced significant improvements in signs and symptoms of the disease, according to new findings presented today from a Janssen Research & Development, LLC, (Janssen)-sponsored investigational study. Data from the 615-patient Phase 3 trial presented at the European League Against Rheumatism (EULAR) Annual Congress showed patients receiving STELARA 45 mg and 90 mg achieved the primary endpoint of the study, a significant reduction in arthritis signs and symptoms at week 24. Investigators reported STELARA-treated patients also achieved significant improvements in physical function, including dactylitis and enthesitis (two common manifestations of psoriatic arthritis which cause pain and swelling), as well as in plaque psoriasis. STELARA is currently being investigated in a Phase 3 program for the treatment of active psoriatic arthritis and is approved for the treatment of moderate to severe plaque psoriasis in 65 countries. The EULAR press committee has selected the STELARA psoriatic arthritis study findings to be presented during the official EULAR press conference occurring Friday, June 8 from 9:00-9:45 CEST, which will take place in the Press Centre, Hall 6.3 at the congress.
"Some 15 percent of patients living with psoriasis of the skin will develop psoriatic arthritis. This is a challenging disease that causes great distress for those afflicted, for which we currently have too few treatment options. These new findings showing the efficacy of STELARA in improving the joint symptoms of the disease are therefore important for rheumatologists and dermatologists," said Iain B. McInnes, Ph.D., Professor, Experimental Medicine and Rheumatology, Director of the Institute of Infection, Immunity, and Inflammation, University of Glasgow, Scotland, and study investigator. "We look forward to additional data from the Phase 3 psoriatic arthritis clinical development program to allow us to more fully assess the efficacy and safety of STELARA in the treatment of this complex inflammatory disease."
In 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) study, patients with active psoriatic arthritis, despite treatment with disease-modifying antirheumatic drugs
) and/or nonsteroidal anti-inflammatory drugs (NSAIDs), were randomized to receive subcutaneous STELARA 45 mg or 90 mg or placebo at weeks 0, 4 and then every 12 weeks. At week 24 of the trial, 42 percent and 50 percent of patients receiving STELARA 45 mg and 90 mg, respectively, achieved at least a 20 percent improvement in signs and symptoms according to American College of Rheumatology (ACR) criteria (ACR 20), the primary endpoint, compared with 23 percent of patients receiving placebo (P
< 0.001). ACR responses were greater with STELARA than placebo regardless of methotrexate use. As measured by the ACR response criteria, significantly higher proportion of patients in the STELARA
45 mg and 90 mg groups also achieved approximately 50 percent improvement in signs and symptoms (ACR 50) and approximately 70 percent improvement in signs and symptoms (ACR 70) versus patients receiving placebo (P
< 0.001 for all comparisons).
Study participants receiving STELARA achieved clinically relevant
improvements in physical function, as measured by the Health Assessment
Questionnaire Disability Index (HAQ-DI) and enthesitis (inflammation of the
entheses, the sites where tendons or ligaments attach to bone) and dactylitis
(inflammation of the finger or toe) scores. Changes from baseline in HAQ-DI at
week 24 were significantly greater in the STELARA groups, and significantly
greater proportions of STELARA-treated patients had a clinically meaningful
change from baseline in HAQ-DI (defined as a change of at least 0.3) compared
with patients in the placebo group. Among study participants affected with
enthesitis (n=425) or dactylitis (n=286) at baseline, significantly greater
improvements in symptoms were observed in patients receiving STELARA 45 mg or 90
mg than in patients receiving placebo based on median percent changes in the
enthesitis score (-42.9 and -50.0 versus 0.0, respectively) and the dactylitis
score (-75.0 and -70.8 vs. 0.0) [P < 0.001].