Background Romania fully reimburses through the National Insurance Health House (NIHH) six biological products for patients with active rheumatoid arthritis (RA), non-responders to at least 2 conventional remissive drugs: infliximab (IFX) original and biosimilars: inflectra (IFN), remsima (REM), etanercept (ETA), adalimumab (ADA), rituximab (RTX). All RA patients treated with biologics are registered in the national electronic database of the Romanian Registry of Rheumatic Diseases (RRBR) - application developed in 2013. Currently, 39.000 cases of RA are treated in Romania, according to NIHH data.

Objectives Characteristics of RA population treated with biological agents in Romania, efficacy and safety data from RRBR, after 2 years of initiation.

Methods Observational cross sectional study, which included all RA patients treated with biologics.

Results 4470 RA patients were included, mean age 57.11 years (±12.02), 85.5% women, mean RA duration 13.51 years (±7.97), 64.8% living in urban areas, 77.4% retired (50% of them permanently work disabled due to RA), 33% with elementary education; mean body mass index (BMI) 26.09 (±4.60). Current treatment: 7.27% IFX, 0.08% IFN, 0.23% REM, 20,74% ADA, 27.21% ETA, 39.91% RTX. Methotrexate is used in 56.3% cases, leflunomide in 41.2%, sulphasalasine in 12.6% and hydroxychloroquine in 9.4%. 23% patients use steroids (20.8% <10mg prednisone daily). The current mean DAS28 is 2.86 (±1.32) and SDAI 6.88 (±7.98); 52.4% cases are in remission (according to DAS28), but only 41.4% according to SDAI; 21.5% cases are in LDA (according to DAS28) and 41.8% (SDAI). Mean EuroQoL 5D (EQ-5D) is 0.73 (±0.26). There is a strong negative association between EQ-5D and DAS28 (r = - 0.7, p<0.01). DAS28 levels correlate positively with BMI (r =0.2, p<0.05). On safety issues, 105 severe adverse events have been reported (2.34%), 21 infections, other than tuberculosis (TB), 21 cases of TB, 15 solid malignancies, 1 case of Hodgkin lymphoma, 11 major cardiovascular events; 13 cases were fatal.

Conclusions In Romania, the use of biologics in RA is on a positive trend (11.5% of all RA treated cases). 1/3 of patients have low education and 38.7% are permanently work disabled. Overall treatment efficacy of biological class in terms of T2T strategy (remission) reaches 52.4% (DAS28) and 41.4% (SDAI). Compared with other patients Registries from Europe or USA (1) in Romania there is a higher proportion of women treated and the percentage of steroids use is lower; DAS28 value is significantly lower (near-remission) compared to literature data (1), probably due to the strict evaluations imposed by the NIHH, while the adverse events seem less common (perhaps a lack of registration of all clinical situations). The impact of active disease on quality of life (EQ-5D) is major.

References

1. Curtis JR, Jain A, AsklingJ et al. A Comparison of Patient Characteristics and Outcomes in Selected European and U.S. Rheumatoid Arthritis Registries, Semin Arthritis Rheum. Aug 2010; 40(1): 2–14.e1., doi: 10.1016/j.semarthrit.2010.03.003, PMCID: PMC2958101, NIHMSID: NIHMS234142

Disclosure of Interest None declared