Background Recently registry data provide evidence about long-term safety and efficacy of TNF inhibitors. However, data on Rituximab (RTX) treatment in daily clinical practice is limited.
Objectives Our aim was to describe survival rate and effectiveness of RTX therapy in real-life practice conditions in a big cohort of patients with RA from Colombia
Methods We included patients with RA treated at Medicarte IPS from May 2008 and November 2015. Medicarte is a referral center for the integral medical care and pharmacosurveillance of patients under biologic therapies in 13 cities in Colombia. Only those patients with systemic rheumatic diseases were enrolled. We only included those patients with at least 1 complete cycle of RTX treatment. Clinical information was obtained from electronic clinical records and medical claims. We defined survival of RTX treatment only those cases who started RTX treatment before 2015 and persist on RTX during the last visit.
Results From a total of 1064 patients treated with Rituximab, 901 patients had a systemic rheumatic disease. 754 (86%) of patients had a diagnosis of RA. The majority of patients were female (87%); mean age was 55.0± 14.1 years and mean disease duration was 14.7±9.1 years. 57 patients were excluded as they had received less than 1 cycle, leaving 697 patients valid for full analysis. Of these, 80.2% received RTX as a first biological therapy. The mean number of cycles was 1.8 cycles (range 1–8). Adverse effect was reported in 85 (11.2%) patients. 318 patients received only 1 cycle, 185 patients 2 cycles, 91 patients 3 cycles, 30 patients 4 cycles, 18 patients 5 cycles and 8 patients 6 or more cycles. A total of 193 (25.5%) of patients remain on RTX treatment. At the last visit, mean DAS-28 score was 2.9± 1.4 and mean HAQ 0.97±0.71. 66% of patients had a low disease activity (DAS-28 <3.2) and 49% of patients were on remission (DAS-28<2.6). A 64% of patients had a good index of functionality (HAQ <1.0). We did not find differences in terms of clinical response or functionality among patients who used RTX as a first line therapy vs patients with previous biologic treatment (Table).
Conclusions In our cohort with more than 700 Colombian patients with RA treated with RTX, the rate of survival-on-drug in those with more than 1 cycle was 25%. Around half of patients under RTX treatment were on remission with an adequate physical function.
Disclosure of Interest J. A. Gόmez-Puerta Speakers bureau: Roche, Pfizer and BMS. Roche was not involved in the design, protocol, data collection or statistical analysis of this study, L. Uribe Botero: None declared, J. Urrego: None declared, L. A. González: None declared, C. Cerόn: None declared, C. Ochoa: None declared, M. A. Saldarriaga: None declared, A. Uribe Toro: None declared, O. J. Felipe Diaz: None declared