Guselkumab Demonstrates Efficacy in Phase 3b Study

COSMOS phase 3b study data demonstrated the effectiveness of guselkumab in patients diagnosed with psoriatic arthritis.

Janssen Pharmaceutical Companies of Johnson & Johnson announced new safety and efficacy data for guselkumab (Tremfya) from a phase 3b study (COSMOS; NCT03796858)

evaluating the drug in adult patients with active psoriatic arthritis (PsA) who also demonstrated an inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).1

Guselkumab is the first selective interleukin (IL)-23 inhibitor approved by the FDA for treatment of active PsA in adults

In the study, patients treated with guselkumab experienced at least a 20% improvement in joint symptom relief at week 24 compared to placebo (44% vs 19.8%). This improvement was measured using the American College of Rheumatology (ACR20). 

The response rate increased at year 1, with the guselkumab arm seeing a 57.7% improvement, and was superior to placebo in patients achieving ACR50 improvement in symptoms, general health outcomes, and physical function.

The proportion of patients with a greater than 3% body surface area (BSA) of psoriasis, an Investigator’s Global Assessment (IGA) score of greater than or equal to 2 at baseline and achieving a Psoriasis Area Severity Index (PASI) 100 was 30.8% in the guselkumab arm vs 3.8% in the placebo arm. At year 1, the patients treated with guselkumab complete skin clearance rate increased to 53.4%.

"The diverse manifestations, varying natural history, and potential severity of PsA mean that delivering treatments that are safe and have long-term effectiveness is challenging. A number of patients do not reach treatment targets of remission or low inflammation with available therapies. In particular, patients may either not respond well to TNFi, or respond but have a loss of response over time," said study investigator Laure Gossec, MD, PhD, professor of rheumatology in Pitie-Salpetriere Hospital and Pierre & Marie Curie University in Paris, France. "These COSMOS data reinforce TREMFYA as a therapeutic option with an alternative mechanism of action for adult patients with PsA when their disease management is complex because they have not responded to one or more therapies." 

Read more about the past results of the DISCOVER-1 and DISCOVER-1 trials and established safety profile here. 

Another study, APEX (NCT04882098) a long-term 3-year trial to access the efficacy of guselkumab on the inhibition of radiographic progression of joint structural damage in patients diagnosed with active PsA, will begin soon.

Reference:

1. Johnson JPC of J&. New phase 3b psoriatic arthritis (PsA) data show first-in-class tremfya® (Guselkumab) achieved robust joint symptom improvement and complete skin clearance in patients with inadequate response to tumor necrosis factor inhibition (Tnfi-ir). Published June 2, 2021. Accessed June 23, 2021. https://www.prnewswire.com/news-releases/new-phase-3b-psoriatic-arthritis-psa-data-show-first-in-class-tremfya-guselkumab-achieved-robust-joint-symptom-improvement-and-complete-skin-clearance-in-patients-with-inadequate-response-to-tumor-necrosis-factor-inhibition--301303807.html