Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib and Statins vs TNF Inhibitors: TOFSTAT CLINICAL TRIAL

This study is a prospective non randomized Clinical Trial Phase-4 aimed at observing the incidence of MACE in RA patients who have moderate to severe disease activity (as determined by the DAS-28 score) and one or more cardiovascular disease (CVD) risks. The patients included in the study will have non-responsiveness to standard cDMARDs treatment and will be prescribed tofacitinib 5 mg twice daily along with statins 20 mg daily as risk modification versus TNF Inhibitor as standard treatment will be the control group.

METHODOLOGY

• Initial Assessment:

• Baseline evaluation including DAS-28 score, lipid profile, and assessment of CVD risk factors (hypertension, diabetes, smoking, cholesterol levels, etc.).
• Recruitment of patients based on inclusion and exclusion criteria.
• Intervention:

• In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients.
• In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment.
• Patients will be followed up monthly for a period of 6 months.
• Monthly assessments during follow up: Lipid profile Total cholesterol, LDL, HDL, triglycerides, DAS-28 score, Recording of any CVD events (MACE), Monitoring of any other related complications.
• Tofacitinib Discontinuation:

o If a patient experiences a CVD event, tofacitinib will be stopped and documented.

• Follow up:

• Monthly visits for a 6 month, during which patient progress and any adverse events will be recorded.
• If a MACE occurs, treatment with tofacitinib will be discontinued, and the event will be thoroughly documented.

Inclusion criteria

• • RA diagnosis with moderate to severe disease activity, based on DAS-28 despite on > 2 conventional DMARDs.

• One or more CVD risk factors, such as hypertension, diabetes, smoking, high cholesterol, etc.
• Age 50 or older.

Exclusion criteria

• Known contraindications to statins.

• History of major adverse CV events (e.g., recent myocardial infarction or stroke).
• Pregnancy or breastfeeding.