ABSTRACT
UNLABELLED: Results of a multicenter, non-interventional, observational study assessing efficacy and safety of 1st course rituximab treatment with methotrexate in patients with rheumatoid arthritis and a history of inadequate response to anti-TNF-therapies, in the routine clinical settings in Poland (MIRACLE-POL 1). The aim of the study was to determine the efficacy and safety of treatment with rituximab and methotrexate in patients with active rheumatoid arthritis (RA) who had inadequate response to anti-TNF-therapies in routine clinical settings in Poland. MATERIAL AND METHODS: We evaluated effectiveness and safety of RTX and MTX therapy in 73 patients enrolled in the multicenter, non-interventional, observational study. Patients with active RA had a history of an inadequate response to 1 or more anti-TNF-alpha agents received 1st course of rituximab consisting of 2 intravenous infusions of 1000 mg each. The end points were: EULAR response criteria at 180 days, changes of Disease Activity Scores in 28 joints (DAS28) from the original baseline at 180 days, rate of remission, rate of low disease activity according to EULAR criteria and rate of adverse events (AEs) during treatment. RESULTS: At 180 days 22% of treated patients demonstrated good-to-moderate EULAR response and 12% of patients demonstrated moderate response. In 77% of cases DAS28 decreased > 1.2. 16% of patients achieved remission according to EULAR criteria and 23% of patients achieved low disease activity. After 180 days mean DAS28 score decreased from 6.33 to 4.06. In 16% of patients AEs occurred with the first rituximab infusion, in 12% of patients with the second rituximab one, and in 43% of patients afterwards. All AEs were mild or moderate in severity. There were no serious AEs including serious infections. Infusion-associated AEs occurred in a higher proportion during the first infusion. CONCLUSIONS: Results of this multicenter, non-interventional, observational study confirm efficacy and safety of 1st course rituximab treatment with concomitant methotrexate in patients with rheumatoid arthritis who had inadequate response to anti-TNF-therapies in the routine clinical settings in Poland.
