scholarly journals Erratum to: Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice

2015 ◽  
Vol 34 (7) ◽  
pp. 1321-1321
Author(s):  
Vivian P. Bykerk ◽  
Andrew J. K. Östör ◽  
José Alvaro-Gracia ◽  
Karel Pavelka ◽  
José Andrés Román Ivorra ◽  
...  
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)


2012 ◽  
Vol 71 (12) ◽  
pp. 1950-1954 ◽  
Author(s):  
Vivian P Bykerk ◽  
Andrew J K Östör ◽  
José Alvaro-Gracia ◽  
Karel Pavelka ◽  
José Andrés Román Ivorra ◽  
...  

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