Janssen’s Guselkumab found safe for treatment of psoriatic arthritis in phase 2 study

Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23. It is administered by subcutaneous injection.

The phase 2 study met its primary endpoint, where 58% of patients receiving guselkumab achieved at least a 20% improvement in signs and symptoms of disease (ACR 20) at week 24, compared with 18.4% of patients receiving placebo (P < 0.001).

Data from the trial also demonstrated statistically significant improvements in all secondary endpoints including physical function, psoriatic skin lesions and other health related outcomes, compared to placebo.

Patients treated with guselkumab had significantly greater improvements in enthesitis and dactylitis, 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.

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]).

Janssen head of immunology development Newman Yielding said: "The efficacy and safety results from this Phase 2 study show the potential of guselkumab in the treatment of active psoriatic arthritis.

"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."