The rationale of our study is to observe the incidence of MACE in RA patients treated with tofacitinib along with statins with one or more cardiovascular disease risks.
PRIMARY OBJECTIVE
* To determine the incidence of MACE in Rheumatoid Arthritis patients with moderate to high disease activity and with one or more cardiovascular disease risks, which are non-responsive to standard conventional DMARDs (cDMARDs) treatment and are prescribed Tofacitinib 5 mg twice daily along with statin 20 mg daily versus TNF Inhibitors. * The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.
• 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.
Known contraindications to statins.
History of major adverse CV events (e.g., recent myocardial infarction or stroke).
Pregnancy or breastfeeding.
Parallel
Tofacitinib 5 MG
Drug* 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 will include Lipid profile Total cholesterol, LDL, HDL, triglycerides. DAS-28 score. Recording of any CVD events (MACE). Monitoring of any other related complications.
Major Adverse Cardiovascular Event
incidence of MACE in Rheumatoid Arthritis patients with moderate to high disease activity and with one or more cardiovascular disease risks, which are non-responsive to standard conventional DMARDs (cDMARDs) treatment and are prescribed Tofacitinib 5 mg twice daily along with statin 20 mg daily versus TNF Inhibitors.
Compare Incidence of MACE in two group
o The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.
effectiveness of tofacitinib in controlling disease activity
o To evaluate the effectiveness of tofacitinib in reducing RA disease activity as measured by the DAS-28 score.
lipid profile
o To assess the impact of statins on lipid profile in RA patients on tofacitinib
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