Upcoming Trial to Evaluate Safety, Efficacy of Guselkumab for Treatment of Axial PsA

Recent data revealed that treatment with guselkumab improved axial symptoms in patients with psoriatic arthritis (PsA) who had investigator and imaging-confirmed sacroiliitis. As a result, STAR, the phase 4, prospective, multicenter, randomized, clinical trial will evaluate the safety and efficacy of selectively utilizing guselkumab to inhibit the interleukin-23 p19 peptide (IL-23p19) subunit in patients with MRI-confirmed axial psoriatic arthritis (axPsA). Terence Rooney, MD, discusses the upcoming study in depth and the potential of treatment with guselkumab to improve axPsA. Rooney is Vice President, Rheumatology and Maternal-Fetal Immunology Disease Area Leader at Janssen.

Terence Rooney, MD

Guselkumab is a monoclonal antibody and injectable therapy that interrupts cytokine, or chemical messenger, called IL-23, which is important in the pathogenesis of many inflammatory diseases. The drug was previously approved for the treatment of moderate-to-severe plaque psoriasis as well as psoriatic arthritis (PsA).

“Psoriatic arthritis is a complex disorder for patients to deal with. It involves inflammation and all of the features of inflammation, including pain, swelling, stiffness, and redness in multiple parts of a patient's body,” Rooney explained. “Many patients with PsA also deal have to deal with troublesome symptoms in their spine.”

Motivated by previous studies in which large proportions of patients were struggling with symptoms relating to the spine, investigators decided to conduct a new clinical trial to better understand the benefits and risks of treating these patients with guselkumab. The trial is actively enrolling eligible patients and is expected to continue to enroll through 2023.

“It’s an important part of our mission, as drug developers, to fully explore the benefits and risks of our of our medicines,” Rooney emphasized. “What's important about diseases like PsA, though, is that that soft tissue inflammation can lead to irreversible damage of the structural elements of the joint, the bones, and the cartilage. So, it's [imperative] that we show that medications can not only reverse the soft tissue inflammation of the joints, but that by doing so they can prevent long term progressive, irreversible damage to the structure of the joints. In this study, we reevaluate data in a very dedicated way. We look forward to seeing results and sharing in due course.”

View the interview in its entirety below: