Background Health-related quality of life (HR-QoL) in patients with rheumatoid arthritis (RA) is important part of patients status, and become main outcome measure in clinical practice and trials. Tocilizumab (TCZ), anti-interleukin-6 receptor monoclonal antibody was used in treatment of active rheumatoid arthritis (RA).
Objectives To evaluate efficacy of TCZ on HR-QoL as measured by 36-Item Short Form Health Survey (SF-36) subscales, Health Assessment Questionnaire Disability Index (HAQ-DI) and EuroQoL-5D (EQ-5D) in LORNET study and to show the influence of TCZ on the results of treatment.
Methods LORNET (Local Open-label multicentre study quality of life patients with moderate and severe RA having iNadEquaTely responded to DMARDs) is study in patients who initiated treatment with TCZ. Patient had to be naïve to biologics and have moderate to severe active RA (1987 ACR criteria) to be included in the 6-month trial. A total 201 adult patients with active RA (DAS>3,2) who remained on stable doses of DMARDs and received TCZ 8 mg/kg every 4 weeks for 24 weeks (total 6 infusions) were enrolled in the study. Patient completed the SF-36 and EQ-5D questionnaire at baseline and week 24. HAQ-DI evaluation was performed on every 4 weeks.
Results Baseline characteristics of 201 patients included: mean (SD) age 49 (12), disease duration 7,5 (6,5) years, HAQ-DI 1,93±0,6. Average disease activity score (DAS) 28 of all 201 patients significantly decreased from 6,75±0,85 (baseline) to 2,6±1,16 (week 24). DAS28 remission (DAS28<2,6) rate at week 24 being achieved by 51,3%, SDAI remission – 21,4%, CDAI remission – 22,0%. Significant mean improvement at week 24 from baseline weas seen in SF-36 subscales and EQ-5D outcomes. EQ-5D improvement was seen at week 24, delta EQ-5D was performed 0,41±0,33 (minimal clinical difference is - 0,01). Improvements in physical functioning measured by HAQ-DI and delta HAQ-DI -0,44 (minimal clinical difference is -0,22) were observed early at week 4, and were sustained for treatments duration. At week 24 delta HAQ-DI amount to 1,11±0.66.
Conclusions Tocilizumab in combination with DMARDs showed significant and clinically meaningful improvements in social and leisure activities in patient with moderate to severe RA. Rapid and sustained improvement was noted in quality of life.
Disclosure of Interest None declared