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Janssen Research & Development, LLC (Janssen) announced positive efficacy and safety results from a Phase 2 study investigating guselkumab, an anti-interleukin (IL)-23 monoclonal antibody administered by subcutaneous injection, for the treatment of active psoriatic arthritis. According to findings presented at the 2016 ACR/ARHP Annual Meeting, 58 percent of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at week 24, the study’s primary endpoint, compared with 18.4 percent of patients receiving placebo (P < 0.001).
Data from the trial also showed statistically significant improvements in all secondary endpoints including physical function, psoriatic skin lesions and other health related outcomes, compared with patients receiving placebo. The guselkumab Phase 2 results in active psoriatic arthritis follow positive Phase 3 study results in moderate to severe plaque psoriasis recently presented at the European Academy of Dermatology and Venereology Congress in Vienna.
“Guselkumab is the first biologic therapy targeting IL-23 specifically, and the Phase 2 results are promising as they demonstrate a significant improvement in the treatment of active psoriatic arthritis,” said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and lead study author.* “It’s encouraging to see how well patients responded to guselkumab in this study with respect to improvements in disease signs and symptoms, as early as week four, and in other health-related quality of life outcomes, including measures of physical and mental health.”
Patients treated with guselkumab had significantly greater improvements in enthesitis (inflammation of the entheses, the sites at which tendons or ligaments attach to bone) and dactylitis (inflammation of the fingers or toes), and in health-related quality of life as measured by SF-36 physical component summary (SF36-PCS) scores and mental component summary (SF36-MCS) scores compared with patients treated with placebo at week 24. In addition, a greater percentage of patients in the guselkumab group achieved MDA compared with the placebo group at week 24 (23 percent versus 2 percent, respectively, [P = 0.001]). MDA for psoriatic arthritis is a composite measure encompassing clinically important aspects of the disease, including arthritis, psoriasis, enthesitis, pain, patient-assessed global disease activity, and physical function.
Safety observations through week 24 showed that 36.0 percent versus 32.7 percent experienced adverse events (AEs), in the guselkumab and placebo groups, respectively.
The most common AEs were infections. Two serious AEs were reported including one knee injury and one myocardial infarction. Investigators remain blinded to individual treatment group assignments, as the study is ongoing. There were no serious infections, malignancies, or deaths through week 24.
“The efficacy and safety results from this Phase 2 study show the potential of guselkumab in the treatment of active psoriatic arthritis,” said Newman Yielding, M.D., Head of Immunology Development, Janssen. “We plan to advance guselkumab into a Phase 3 psoriatic arthritis development program next year to further characterize this novel monoclonal antibody’s profile in the treatment of this complex inflammatory disease.”
