Janssen announced the submission of a supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) for guselkumab for the treatment of adult patients with active psoriatic arthritis (PsA).
Guselkumab is a human monoclonal antibody that blocks the p19 subunit of interleukin (IL)-23. The sBLA is based on data from the phase 3 DISCOVER-1 (N=381) and DISCOVER-2 (N=739) trials that evaluated the efficacy and safety of subcutaneous guselkumab in patients with active PsA compared with placebo for 52 weeks and 100 weeks, respectively.
Results showed that both trials met the primary end point of American College of Rheumatology 20% improvement (ACR20) response after 24 weeks of treatment. Secondary end points included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and quality of life (SF-36 PCS and MCS); a key secondary end point from the DISCOVER-2 study also assessed effect on structural damage using the van der Heide-Sharp score (vdH-S).
The overall safety profile of guselkumab was similar to that observed in previous studies. Full detailed data from both studies have been submitted for presentation at an upcoming medical meeting.
“We’re excited about the DISCOVER data and the potential of [guselkumab] as a treatment option given the unmet needs of patients living with psoriatic arthritis, a chronic lifelong disease,” said Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC. “DISCOVER-1 and 2 are the ninth and tenth phase 3 studies Janssen has completed in PsA, across our portfolio of medicines.”
Guselkumab (Tremfya) is already approved for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The product is currently being investigated for the treatment of Crohn disease, ulcerative colitis and hidradenitis suppurativa.
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