Janssen Pharmaceuticals, a Johnson & Johnson company, has announced positive real-world data for its IL-23 inhibitor Tremfya (guselkumab) in adults with treatment-resistant active psoriatic arthritis (PsA).
Affecting approximately ten million people worldwide, psoriatic arthritis is a chronic immune-mediated inflammatory disease characterised by joint pain, stiffness and swelling.
Nearly half of patients with PsA experience moderate fatigue and about 30% suffer from severe fatigue, as measured by the modified fatigue severity scale. Comorbidities such as obesity, cardiovascular disease, anxiety and depression are also often present.
Tremfya, which already holds approvals to treat active PsA and moderate-to-severe plaque psoriasis, works by blocking IL-23 and inhibiting the release of cytokines and chemokines that cause inflammation.
New data from an observational registry of those with PsA or spondyloarthritis in the US has shown that a “substantial proportion” of treatment-resistant PsA patients using Tremfya reported meaningful improvements in pain, physical function and fatigue through six months, which Janssen notes as aspects that are “often difficult to treat and important contributors to health-related quality of life for people living with PsA”.
“People living with active PsA who are treatment-resistant need options that improve debilitating symptoms of their disease, like pain, physical function and fatigue,” said Philip Mease, Swedish Medical Center/Providence St Joseph Health and University of Washington.
“It is important that we assess patient-reported outcomes in a real-world setting, ensuring that we address unmet needs for people living with this challenging disease,” he added.
The company also reported that, across additional pooled data from three clinical trials, Tremfya was associated with higher rates of clinically meaningful improvements in a composite assessment of patient-reported pain, fatigue, physical function, skin problems and PsA-related depression than placebo.
Terence Rooney, vice president, rheumatology, immunology disease area leader, Janssen Research & Development, said: “It is critical that we evaluate patient-reported outcomes to truly understand the lived experiences of patients and better develop and provide treatments in psoriatic disease.”
The readout comes just a day after Janssen announced positive results from a mid-stage study of its investigational FcRn inhibitor nipocalimab in adults with moderate-to-severe rheumatoid arthritis who have tested positive for anti-citrullinated protein antibodies or rheumatoid factor and had an inadequate response or been intolerant to at least one anti-TNF therapy.