SPRING HOUSE, Pa.—Psoriatic arthritis (PsA) is a type of arthritis that affects individuals with the skin condition psoriasis; while it generally manifests after psoriasis, it can occasionally appear first. According to the Arthritis Foundation, roughly 30 percent of people diagnosed with psoriasis also end up developing PsA. Like other types of arthritis, PsA is characterized by pain, stiffness and swelling of the joints, and treatments include NSAIDs and anti-inflammatories.
And based on encouraging Phase 3 data, the Janssen Pharmaceutical Companies of Johnson & Johnson might be adding another option to that list. The company shared 24-week data at the recent 2019 American College of Rheumatology and Association of Rheumatology Professionals Annual Meeting regarding Tremfya (guselkumab) showing that adult PsA patients treated with Tremfya saw at least a 20-percent improvement in disease signs and symptoms compared to placebo. Tremfya was evaluated in two Phase 3 studies—DISCOVER-1 and DISCOVER-2—with the primary endpoints of efficacy and safety in adults with PsA and inadequate response to previous treatment.
Tremfya is a human monoclonal antibody against the p19 subunit of IL-23. As Janssen notes, “IL-23 is an important driver of the pathogenesis of inflammatory diseases such as psoriasis and psoriatic arthritis.”
"People living with psoriatic arthritis cope with symptoms like pain, joint swelling and irreversible joint damage that may interfere with their daily activities," said Dr. Atul Deodhar, Professor of Medicine, Oregon Health & Science University and study steering committee member. "These data show TREMFYA as a potential treatment option to help patients living with this serious disease."
At week 24 in the DISCOVER-1 trial, 59 percent of participants receiving TREMFYA every four weeks (q4w) and 52 percent of patients receiving TREMFYA at weeks 0, 4 and every eight weeks thereafter (q8w) saw an ACR20 response, compared to 22 percent of patients who received placebo. Of the participants who had a ≥3 percent body surface area (BSA) affected with psoriasis, and an Investigator Global Assessment (IGA) score of ≥2 at baseline, 75 percent of patients receiving TREMFYA q4w and 57 percent of patients receiving TREMFYA q8w saw an IGA score of 0 (cleared) or 1 (minimal) and a >2 grade reduction, compared to 15 percent of patients receiving placebo.
In DISCOVER-2, 64 percent of patients receiving TREMFYA q4w or q8w respectively, achieved an ACR20 response at week 24, compared to 33 percent of patients receiving placebo. Of those who had a ≥3 percent BSA affected with psoriasis, and an IGA score of ≥2 at baseline, 69 percent receiving TREMFYA q4w and 71 percent receiving TREMFYA q8w achieved an IGA score of 0 or 1, and a ≥2 grade reduction from baseline, compared to 19 percent of patients on placebo. In addition, individuals with active PsA receiving TREMFYA q4w showed a significant reduction in radiographic damage progression vs. placebo at week 24.
Based on these data, Janssen submitted a supplemental Biologics License Application to the FDA on Sept. 13 for Tremfya, and a validated filing on Oct. 11 to the European Medicines Agency for approval in the European Union in adults with PsA.
"We are passionate about the development of therapies, such as TREMFYA, since patients are still struggling with active psoriatic arthritis and need new treatment options," remarked Dr. Alyssa Johnsen, vice president, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. "These results from the DISCOVER program represent a major step in the development of Tremfya as a treatment for psoriatic arthritis."
In other Phase 3 news, Janssen also announced that in its Phase 3 CREDENCE study, Invokana (canagliflozin) proved capable of consistently reducing the risk of renal and cardiovascular events in patients with various levels of kidney function (or estimated glomerular filtration rates, eGFR). Greater renal absolute benefits were seen in participants with the most advanced renal insufficiency. Invokana gained FDA approval in September to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes and diabetic neuropathy (also known as diabetic kidney disease).