Trial results from an observational study investigating treatments for Rheumatoid Arthritis were posted on ClinicalTrials.gov on 2025-06-08, including data from 1972 enrolled participants.
Background
Rheumatoid Arthritis (RA) is a chronic autoimmune disease characterized by inflammation of the joints, leading to pain, swelling, and potential joint damage. Effective management aims to control disease activity and prevent long-term disability. The treatment landscape for RA includes various disease-modifying antirheumatic drugs (DMARDs), such as conventional synthetic DMARDs like methotrexate, biologic DMARDs including TNF inhibitors (TNFi) and non-TNFi biologics, and targeted synthetic DMARDs like tofacitinib. Understanding the safety profiles of these different treatments, particularly concerning cardiovascular events and infections, is critical for informed clinical decision-making and optimizing patient care.
Trial design
This completed secondary structured database observational study, conducted as part of the CorEvitas Japan RA Registry, enrolled 1972 participants with Arthritis, Rheumatoid. The study evaluated the safety and effects of various treatments, including tofacitinib and biologic and nonbiologic DMARDs. Data collected from March 2016 to the latest data cut in 2022 were used to assess effectiveness and safety outcomes across different treatment groups.
Key results
The study reported mean incidence rates for several key safety outcomes across different treatment groups:
- Mean Incidence Rate of Total Cardiovascular Disease (CVD) Events (Participants with event/100 Person years):
- Methotrexate: 0.51
- TNFi: 0.76
- Non-TNFi: 1.4
- Tofacitinib: 1.54
- Mean Incidence Rate of Serious Infections Events (Participants with event/100 Person years):
- Methotrexate: 1.94
- TNFi: 2.61
- Non-TNFi: 5.02
- Tofacitinib: 3.1
- Mean Incidence Rate of Total Herpes Zoster Events (Participants with event/100 Person years):
- Methotrexate: 0.9
- TNFi: 1.39
- Non-TNFi: 2.18
- Tofacitinib: 8.07
What this means
The observational data from this study provide insights into the comparative safety profiles of different Rheumatoid Arthritis treatments within the CorEvitas Japan RA Registry. Tofacitinib was associated with higher mean incidence rates of total cardiovascular disease events and total herpes zoster events compared to methotrexate and TNFi. For serious infections, tofacitinib showed a higher incidence rate than methotrexate and TNFi, but a lower rate than non-TNFi biologics. These findings suggest that clinicians should consider these observed differences in incidence rates when evaluating treatment options for RA patients, particularly regarding cardiovascular risk and the risk of herpes zoster. As an observational study, these results indicate associations rather than direct causation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05572567, titled "Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis", were posted on 2025-06-08 on clinicaltrials.gov.