scholarly journals Tofacitinib 5 mg Twice Daily in Patients with Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs

2019 ◽  
Vol 25 (3) ◽  
pp. 115-126 ◽  
Author(s):  
Paul Bird ◽  
William Bensen ◽  
Bassel El-Zorkany ◽  
Jeffrey Kaine ◽  
Bernadette Heizel Manapat-Reyes ◽  
...  
Author(s):  
Chung‐Yuan Hsu ◽  
Yu‐Jih Su ◽  
Jia‐Feng Chen ◽  
Chi‐Chin Sun ◽  
Tien‐Tsai Cheng ◽  
...  

Background Cardiovascular disease is the most common cause of death in patients with rheumatoid arthritis. It is believed that using disease‐modifying antirheumatic drugs (DMARDs) to control inflammation can reduce the risk of cardiovascular disease. In this study, we investigated whether patients who responded differently to DMARDs might sustain different cardiovascular events. Methods and Results We designed a cohort study using the Chang Gung Research Database. We identified 7114 patients diagnosed with rheumatoid arthritis. After strict exclusion criteria, we collected 663 individuals as an inadequate response to DMARDs group. Then, 2034 individuals were included as the control group. The end point was composite vascular outcomes, including acute coronary syndrome or ischemic stroke. We used the inverse probability of treatment weighting to keep the covariates between these 2 groups well balanced. We compared the risk of these outcomes using the Cox proportional hazards model. The mean follow‐up time was 4.7 years. During follow‐up, there were 7.5% and 6.4% of patients with composite vascular outcomes in the DMARD‐inadequate response and control groups, respectively. There was no significant difference in the risk of composite vascular outcomes (95% CI, 0.94–1.41) and ischemic stroke (95% CI, 0.84–1.36). The risk of acute coronary syndrome was significantly higher in the DMARD‐inadequate response group (hazard ratio, 1.45; 95% CI, 1.02–2.05). Conclusions Patients with DMARD‐inadequate response rheumatoid arthritis have a higher risk of developing acute coronary syndrome than those whose disease can be controlled by DMARDs.


2013 ◽  
Vol 40 (5) ◽  
pp. 599-604 ◽  
Author(s):  
William F.C. Rigby ◽  
Philip J. Mease ◽  
Ewa Olech ◽  
Mark Ashby ◽  
Swati Tole

Objective.To characterize the safety of rituximab (RTX) in combination with biologic disease-modifying antirheumatic drugs (DMARD) in patients with rheumatoid arthritis (RA).Methods.We did an open-label study of the safety and efficacy of RTX in adult patients with active RA and an inadequate response to ≥ 1 biologic for ≥ 12 weeks (stable dose ≥ 4 weeks). RTX (2 × 500 mg) was added to patients’ current biologic and nonbiologic DMARD treatment. After 24 weeks, patients with 28-joint Disease Activity Score ≥ 2.6 were eligible for RTX retreatment. The primary endpoint was the proportion of patients developing a serious adverse event (SAE) within 24 weeks of initiating RTX.Results.Patients (n = 176) received RTX with 18 different biologic/DMARD combinations. Adalimumab alone (n = 46; 26.1%) or etanercept alone (n = 37; 21.0%) plus RTX were the most common combinations. Overall, 90.9% and 76.1% of patients completed 24 and 48 weeks, respectively; 147 patients (83.5%) received a second course of RTX. Over 24 weeks, 9.1% of patients reported SAE (24.3 events/100 patient-yrs, 95% CI 15.5–38.1). The SAE rate was similar over 48 weeks (22.4 events/100 patient-yrs, 95% CI 15.9–31.5). Four serious infections were reported over 48 weeks (2.7 events/100 patient-yrs, 95% CI 1.0–7.2). No SAE occurred within 24 h of any RTX infusion. Efficacy responses improved numerically at Week 48 compared with Week 24.Conclusion.The overall safety profile of RTX in combination with 1 other biologic was consistent with that previously reported for RTX plus methotrexate or other nonbiologic DMARD. (Clinicaltrials.govNCT00443651)


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