ABSTRACT
OBJECTIVES: Biologics are medications widely applied in the management of inflammatory rheumatic diseases. The drugs were found to be effective but their application is associated with some disadvantages. Medication with biologics is relatively expensive, and in Poland, it is carried out in specialized centers. The study was designed to evaluate various aspects of satisfaction and dissatisfaction of Polish patients treated with biologics. MATERIAL AND METHODS: An anonymous questionnaire was distributed in 23 Polish rheumatological centers involved in the treatment; 1212 returned questionnaires were used for analysis. Responses were received from 606 patients with rheumatoid arthritis, 427 with ankylosing spondylitis, 117 psoriatic arthritis, and 62 adult patients with juvenile idiopathic arthritis (in whom administration of the drugs had been introduced before they were 18 years old). The investigated group constituted about one-fifth of all rheumatic patients on biologics in Poland. RESULTS: A beneficial or very beneficial influence of the medication on the state of physical health was found mostly in patients with rheumatoid arthritis (51.3 and 30.5%) and ankylosing spondylitis (51.0 and 36.8%). Family life was improved by the treatment especially in patients with ankylosing spondylitis (40.7 and 35.6% beneficial and very beneficial, respectively), sleep quality and sexual life mostly in those with ankylosing spondylitis (beneficial/very beneficial influence 41.5/38.4, and 38.7/23.9, respectively). There was a rather small influence of biological treatment on the financial situation of the patients. In general, satisfaction with the treatment was evaluated as positive or very positive in 88% of all investigated patients.In a significant part of the patients, transportation to the medical center was considered as a disadvantage of the treatment. About one-third of the patients considered laboratory and imaging tests to be done before initiation of the medication as a difficulty, and for about 40% waiting time for qualification for the medication was a significant disadvantage. The route of drug administration was without importance for 4/5 of the patients. CONCLUSIONS: Summing up, the results were similar in the patients suffering from various diseases although those with psoriatic arthritis felt the highest satisfaction (possibly due to the positive aesthetic effect), and those with ankylosing spondylitis had significant improvement in sexual life (probably due to younger age). Relatively low satisfaction was found in patients with juvenile idiopathic arthritis. There was a small influence of medication on financial status of the patients. Application of biologics has few disadvantages and most of them are associated with the organization of health services (waiting time for the tests, transportation to the medical centers).
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.
