Janssen Submits Guselkumab sBLA for Active Psoriatic Arthritis

September 19, 2019
FDAJanssen Pharmaceuticals has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for guselkumab (TREMFYA), for the treatment of adult patients with active psoriatic arthritis.

The submission for guselkumab is based on the results of the phase 3 DISCOVER-1 and DISCOVER-2 trials, in which the selective interleukin 23 (IL-23) inhibitor showed patient response over 24 weeks of therapy.

The human monoclonal antibody was previously approved by the FDA in July 2017 for the treatment of adult patients with moderate to severe plaque psoriasis—becoming the first marketed selective IL-23 inhibitor.

In DISCOVER-1 and DISCOVER-2, investigators assessed for a primary endpoint of patients achieving American College of Rheumatology 20% improvement (ACR20) response following 24 weeks of therapy. They also sought secondary endpoints including ACR50/70, soft tissue inflammation resolution, reduced disease activity, improvement in physical activity and skin clearance, and others.

Both trials were randomized, double-blind, multicenter assessments of guselkumab subcutaneous injection in patients with active psoriatic arthritis compared to placebo. DISCOVER-1 included 381 patients, including those previously treated with anti-TNF therapy, over 52 weeks. In DISCOVER-2, 739 patients naïve to biologic therapy are planned for assessment expanding 100 weeks.

Both DISCOVER trials were randomized, double-blind, multicenter Phase 3 studies designed to evaluate the efficacy and safety of TREMFYA administered by subcutaneous injection in patients with active PsA compared to placebo. DISCOVER-1 evaluated 381 participants, including those previously treated with anti-TNF therapy, and continued through 52 weeks. DISCOVER-2 included 739 biologic-naïve participants and is planned to continue through 100 weeks.

Along with achieving the primary outcome, patients treated with guselkumab also reported a safety profile consistent with that observed in previous studies and the current prescribing information for the therapy.

With the DISCOVER program serving as the first phase 3 studies to observe a human monoclonal antibody inhibiting IL-23 action for active psoriatic arthritis, investigators intend to share the results at an upcoming medical meeting.

"We're excited about the DISCOVER data and the potential of TREMFYA as a treatment option given the unmet needs of patients living with psoriatic arthritis, a chronic lifelong disease," Newman Yeilding, MD, head of Immunology Development, Janssen Research & Development, said in a statement.

Andrew Greenspan, MD, vice president of Immunology Medical Affairs for Janssen, said the offering of a novel biologic for active psoriatic arthritis will benefit the field.

"Psoriatic arthritis is a complex disease involving both the skin and the joints with a heterogeneous range of clinical manifestations, and it requires treatment options with different mechanisms of action,” he said in a statement.
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