Tremfya for psoriatic arthritis phase 3b data

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Tremfya (guselkumab) provides sustained improvements across all minimal disease activity domains for adults living with active psoriatic arthritis in phase 3b trial.

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The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 3b 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 3 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 being 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 3b 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)c (66.8/81.5 percent), Leeds Enthesitis Index (LEI)d (74.5/79.8 percent), swollen joint count (SJC)e (46.2/63.0 percent), patient GA (24.5/39.9 percent), Health Assessment Questionnaire – Disability Index (HAQ-DI)f (26.1/37.0 percent), patient pain (14.7/30.6 percent) and tender joint count (TJC)e (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.g “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 3 DISCOVER-1 and DISCOVER-2 studies, which identified differences between patient GA and physician GA. 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 24.2 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.”

Source: jnj.com

Tremfya (guselkumab)