Philip Mease, MD, Director of Rheumatology Research at Swedish Rheumatology Research Group, reflects upon new data and discusses where he sees guselkumab fitting into a PsA patient's current treatment plan.
Results of the phase 3 DISCOVER program are demonstrating the ability of guselkumab (Tremfya) to be a safe and efficacious treatment for adult patients with active psoriatic arthritis.
Presented at the 2019 American College of Rheumatology annual meeting, 24-week data highlighted guselkumab’s ability to achieve at least a 20% improvement in ACR 20 response compared to placebo in previously treated and biologic-naive patients.
Both the DISCOVER-1 and DISCOVER-2 trials were designed as randomized, double-blind, multicenter studies evaluating the safety of subcutaneously administered guselkumab in patients with active psoriatic arthritis. However, DISCOVER-1 was comprised of 381 patients who had previously been treated with a biologic anti-TNF agent and DISCOVER-2 consisted of 739 patients who were biologic-naive.
At 24 weeks in DISCOVER-1, 59% of patients receiving guselkumab every 4 weeks and 52% of patients receiving the treatment at weeks 0, 4, and every 8 weeks following met the primary endpoint of ACR20 response—in comparison, only 22% of patients receiving placebo met the primary endpoint.
Additionally, among patients who had a 3% or greater affected body surface area and an investigator Global Assessment score of 2 or more at baseline, 75% receiving guselkumab every 4 weeks and 57% receiving guselkumab every 8 weeks achieved an IGA score of 0 or 1 and a 2 grade or greater reduction from baseline. Conversely, only 15% of patients achieved this receiving placebo (both P<0.001).
In DISCOVER-2, 64% of patients taking guselkumab every 4 weeks or every 8 weeks achieved ACR20 response compared to 33% of patients receiving placebo(both P<0.001). Among patients who had a 3% or greater affected body surface area and an investigator Global Assessment score of 2 or more at baseline, 69% of patients receiving guselkumab every 4 weeks and 71% receiving it every 8 weeks achieved an IGA score of 0 or 1 and a 2 grade or greater reduction from baseline—compared to just 19% of patients receiving placebo. Additionally, patients receiving guselkumab every 4 weeks showed significantly reduced radiographic progression versus placebo at 24 weeks.
With data from the DISCOVER program being used to support Janssen’s supplemental Biologics License Application submission to the FDA, discussions about how guselkumab could fit into current treatment algorithms for psoriatic arthritis was a hot topic of discussion at ACR 2019.
For a better understanding of where guselkumab could fit among the gambit of approved psoriatic arthritis treatments, MD Magazine® sat down with Philip Mease, MD, director of rheumatology research at Swedish Rheumatology Research Group, for his thoughts.
MD Mag: How does guselkumab fit into treatment plans for patients with PsA?
Mease: So, it's going to be a drug that we use for patients who clearly have had an impact and effective result or loss of result to a TNF inhibitor, an IL-17 inhibitor, but because of its the safety profile of the drug, it could very easily be used earlier in the treatment ladder, because of the confidence that we're gaining around the safety profile. So, I think that it's going to be a meaningful addition to our armamentarium of drugs to use for psoriatic arthritis.