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  • Tremfya provides sustained improvements across all...

Tremfya provides sustained improvements across all minimal disease activity domains for adults with active psoriatic arthritis in phase IIIb trial

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Published:6th Jun 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase IIIb COSMOS clinical trial showing that treatment with Tremfya (guselkumab) provided sustainable improvements in all minimal disease activity (MDA)a domains through week 48 in adults living with active psoriatic arthritis (PsA) who previously had an inadequate response to one to two tumor necrosis factor inhibitors (TNFi-IR)

In a separate post-hoc analysis of the Phase III DISCOVER-1 and DISCOVER-2b clinical trial findings, Tremfya was shown to be associated with prompt and sustained improvements in all identified determinants. This analysis also identified factors that influenced disagreement between patient and physician global assessments (GA), such as patient-reported pain, physical aspects of health-related quality of life and fatigue. Tremfya is the first and only fully human selective interleukin (IL)-23 inhibitor therapy approved for the treatment of adult patients living with active PsA.

These study results are among 41 company-sponsored abstracts were presented by Janssen at the 2023 Annual European Congress of Rheumatology (EULAR) meeting taking place in Milan, Italy, May 31 - June 3, 2023.

A previous study, has shown that sustained MDA is typically only achieved by a minority of patients receiving biologic therapy for active PsA. However, in a post-hoc analysis of the Phase IIIb COSMOS clinical trial, Tremfya provided sustained improvement in all MDA domains from baseline through week 48 in adult patients living with active PsA and who were inadequate responders to one to two TNFis (n=189).

Overall response rates at week 24 and week 48 were Psoriasis Area and Severity Index (PASI) (66.8/81.5 percent), Leeds Enthesitis Index (LEI) (74.5/79.8 percent), swollen joint count (SJC) (46.2/63.0 percent), patient GA (24.5/39.9 percent), Health Assessment Questionnaire – Disability Index (HAQ-DI) (26.1/37.0 percent), patient pain (14.7/30.6 percent) and tender joint count (TJC) (14.7/28.3 percent), respectively. Physician-reported domains (LEI, PASI and SJC) were achieved faster than patient-driven domains (patient GA, HAQ-DI, patient pain and TJC).

“Assessing patient-reported symptoms is a vital part of our research that helps us to address unmet needs and provide treatments that can improve outcomes,” said Laura Coates, M.D., Ph.D., Senior Clinical Research Fellow at the University of Oxford. “These results advance our understanding of the psoriatic arthritis patient experience and will help healthcare professionals develop individualized treatment plans that can target debilitating symptoms and, ultimately, aim to improve quality of life for people living with psoriatic arthritis.”

The importance of a personalized approach to PsA treatment that prioritizes shared decision-making and open dialogue is reinforced in a separate post-hoc analysis of the Phase III DISCOVER-1 and DISCOVER-2 studies, which identified differences between patient GA and physician GA (global assessment). The results showed that while scores were aligned across most factors, patients weighed pain, fatigue and physical health higher than physicians. Tremfya was associated with prompt and sustained improvements in all identified determinants, including those driving higher patient versus physician scores, such as patient-reported pain, physical aspects of health-related quality of life, and fatigue.

At baseline, patient GA and physician GA scores were similar in most instances (61.2 percent) with 23.2 percent of cases characterized by a patient GA score higher than a physician GA score. Higher patient scores meant the patient considered this aspect of their disease to be worse than the physician. 15.7 percent of cases had a physician GA score higher than patient GA.

The proportion of patients with higher patient GA score than physician GA score increased to 39.1 percent at week 24, while the proportion with higher physician GA scores decreased to 11.2 percent. The main determinant of higher patient scores was patient pain, with additional factors including worse physical health-related quality of life at baseline and worse fatigue at week 24. Conversely, physicians emphasized objective disease measures, including SJCs, TJCs and elevated C-reactive protein when assessing patient disease status.

“Our continued research underscores Janssen’s commitment to not only provide therapeutic options for psoriatic disease, but also to better understand and support the pressing needs of the patients we serve,” said Terence Rooney, M.D., Ph.D., Vice President, Rheumatology and Maternal-Fetal Immunology Disease Area Leader, Janssen Research & Development, LLC. “Active psoriatic arthritis is a challenging, chronic disease, so these findings have important implications for patients and their providers as they work together to address the full spectrum of disease symptoms, including patient-reported outcomes, with the goal of achieving long-term relief.”

Editor’s Notes:a. MDA was defined as fulfillment of five or more out of seven domains: tender entheses (LEI) <1, haq-di><0.5, patient pain less than 15, pasi><1, patient ga><20, sjc><1 and tjc><1.1. b. this analysis assessed agreement between patient ga and physician ga to potentially provide valuable insight into the differential importance of specific psa manifestations to patients and physicians. c. the pasi score grades the amount of surface area on each body region that is covered by psoriasis (pso) plaques and the severity of plaques for their redness, thickness, and scaliness. d. the lei index evaluates the absence or presence of entheseal tenderness at six anatomical sites: bilateral lateral epicondyles, medial femoral condyles, and achilles tendon insertion sites. e. the tjc and sjc are core outcome measures used to assess arthritis disease activity in the context of clinical trials and observational studies. f. the haq-di was designed to represent a model of patient-oriented outcome. patients complete the 20-item haq-di to assess their level of functional ability; the haq-di includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. g. acr20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient ga, physician ga, functional ability measure (haq-di), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or c-reactive protein.

Condition: Psoriatic Arthritis
Type: drug

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