New real- world data show Tremfya (guselkumab) was associated with clinically meaningful improvements in patient-reported outcomes for adults living with active psoriatic arthritis

that showed a substantial proportion of people living with treatment-resistant active PsA and using Tremfya (guselkumab) in real-world settings reported meaningful improvements in pain, physical function and fatigue through six months.

Additionally, across the DISCOVER-1, DISCOVER-2 and COSMOS clinical trials, treatment with 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 in the first assessment of the PsA 5-Thermometer Scale Domains (PsA-5T-Ds).

Tremfya is the first and only fully human selective interleukin (IL)-23p19-subunit inhibitor therapy approved for the treatment of adults living with active PsA. These study results are among 24 company-sponsored abstracts being presented by Janssen at the American College of Rheumatology (ACR) Convergence 2023 meeting taking place in San Diego, CA, November 10-15, 2023.

“People living with active psoriatic arthritis who are treatment-resistant need options that improve debilitating symptoms of their disease, like pain, physical function and fatigue,” said Philip Mease, M.D., Swedish Medical Center/Providence St. Joseph Health and University of Washington in Seattle, Washington.a “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.”

CorEvitas data showed patients characterized by longstanding, treatment-resistant, active disease reported meaningful improvements in pain, physical function and fatigue. In this analysis of the CorEvitas registry data, substantial proportions of on-label Tremfya persisters (n=90) reported clinically meaningful improvements from baseline (unadjusted nominal p values):i. Among these registry participants who reported moderate levels of PsA-related pain prior to starting Tremfya (n=89, mean baseline score of 57 on a 0-100 mm visual analog scale [VAS]), substantial proportions experienced clinically meaningful improvements in pain. Thirty-eight percent reported a greater than 30 percent reduction (n=33/86) and 40 percent reported a greater than 15-mm reduction (n=33/82). ii. Participants were evaluated for clinically meaningful improvements in overall joint and skin disease (n=84, mean baseline score of 50.3 VAS). Forty-seven percent had a greater than 15-mm reduction (n=36/77) in the patient global assessment of arthritis and psoriasis. iii. Participants’ physical function was also assessed (n=89, mean baseline score of 0.9 with Health Assessment Questionnaire Disability Index [HAQ-DI]). Thirty percent (n=21/69) showed clinically meaningful improvements in physical function with HAQ-DI improvement of greater than 0.35. iv. Up to one-quarter of patients achieved the more stringent thresholds of response, generally representing a major response or minimal disease activity, including 26 percent (n=18/69) with patient global assessment score less than 20-mm, 22 percent (n=19/86) with greater than 50 percent reduction in pain, 18 percent (n=14/80) with pain score less than 15 mm and 10 percent (n=6/58) with HAQ-DI ?0.5 (all nominal p<0.001). v. mean change (95 percent confidence interval [ci]) in psa-related fatigue from baseline at six months was -8.8 (-14.9, -2.7; nominal p="0.005;" based on component score of the bath ankylosing spondylitis disease activity index, 0-100 vas; with a 56.5 baseline score [n="89])." these aspects of psoriatic arthritis are often difficult to treat and are important contributors to health-related quality of life for people living with psa.

Analysis of DISCOVER-1, DISCOVER-2 and COSMOS clinical trials supports established Tremfya efficacy across key PsA patient-reported outcomes. In the first assessment of the PsA-5T-Dse longitudinal construct validity, in people living with PsA who were bio-naïve or who had an inadequate response to one or two tumor necrosis factor inhibitors (TNFis), this composite score of five patient-reported outcomes showed a strong correlation with the Psoriatic Arthritis Disease Activity Score (PASDAS), a validated instrument that encompasses most core PsA domains, and a good ability to discriminate between those with and without clinically meaningful improvements in disease activity and health-related quality of life.

i. PsA-5Ts is a simple multidimensional composite measure, assessing self-reported pain, fatigue, physical function, skin problems and depression, recently developed to measure overall health in people living with PsA and correlate with established composite measures. ii. Changes in PsA-5T-Ds score through week 24 correlated strongly with variations in PASDAS (r=0.7; p<0.0001) and moderately with variations in disease activity index for psa (dapsa), clinical dapsa and 36-item short form survey (sf-36) physical component summary (pcs) scores (r="0.5;" all p><0.0001). iii. achievement of clinically meaningful improvement in pasdas, dapsa, clinical dapsa and sf-36 pcs core through week 24 was associated with significantly greater improvements in psa-5t-ds score vs. nonachievement.

“These new Tremfya results demonstrate our commitment to addressing symptoms that impact people living with active psoriatic arthritis, including depression, pain, fatigue, physical function and skin problems,” said Terence Rooney, M.D., Vice President, Rheumatology, Immunology Disease Area Leader, Janssen Research & Development, LLC. “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.”