Positive Results Announced for Investigational Psoriatic Arthritis Biologic

Janssen Research & Development recently announced positive results from a phase 2 clinical trial of the investigational biologic drug, guselkumab.

Guselkumab is an injected anti-interleukin (IL)-23 monoclonal antibody for the treatment of patients with psoriatic arthritis.

In the trial, 58% of patients taking guselkumab showed an improvement in the signs and symptoms of the disease by at least 20% at week 24, which was the study’s endpoint, according to a press release from Janssen. Only 18.4% of patients taking the placebo achieved this level of symptom relief.

Findings from the study also demonstrated significant improvements in secondary endpoints, such as physical function, skin lesions, and health-related outcomes, in patients taking guselkumab compared with patients taking the placebo.

These findings follow positive findings from a phase 3 clinical trial of guselkumab in patients with moderate-to-severe plaque psoriasis, according to Janssen.

“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 study lead author Atul Deodhar, MD, MRCP, FACP, FACR, professor of Medicine at Oregon Health & Science University. “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 4, and in other health-related quality of life outcomes, including measures of physical and mental health.”

Secondary endpoints also included improvement in the signs and symptoms of disease by at least 20% at 16 weeks, and reduction by at least 50%, which was achieved by 60% and 34% of patients taking guselkumab, respectively.

Also evaluated as secondary endpoints were the amount of patients with 75% of more improvement from baseline in skin lesions measured by the Psoriasis Area Severity Index at 24 weeks. This was achieved by 78.6% of patients taking guselkumab, compared with 12.5% of patients taking placebo, according to Janssen.

Change in baseline measures of patient-reported physical and mental health was 0.43 in patients taking guselkumab, compared with 0.06 for patients taking the placebo.

Other secondary endpoints included percent change from baseline in Leeds Enthesitis Index at 24 weeks, the amount of patients reaching Minimal Disease Activity at 24 weeks, and percent change from baseline in dactylitis score at 24 weeks, Janssen reported.

Patients who were taking guselkumab showed improvements in enthesitis, dactylitis, and health-related quality of life, as determined by the Medical Outcomes Study Short Form-36 questionnaire physical and mental component summary scores.

Approximately 23% of patients taking guselkumab achieved Minimal Disease Activity, which measures disease aspects such as arthritis, psoriasis, enthesitis, pain, global disease activity, and physical function, according to the press release. Only 2% of patients taking the placebo achieved this goal.

Safety data indicated that 36% of patients taking guselkumab and 32.7% of patients taking placebo experienced adverse events. The most common adverse event reported was infection, and serious adverse events included a knee injury and a myocardial infarction.

Janssen said 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, MD, 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.”