Objectives To evaluate interleukin 6 (IL-6) receptor inhibition with Tocilizumab (TCZ) in patient with moderate and severe RA in Russian Federation. Safety-related outcomes were analysed.
Methods A multicentre open-label phase IV study (LORNET: Local Open-label multicentre study qualite of life patients with moderate and severe RA having iNadEquaTely responded to DMARDs) was performed. A total 201 adult patients with active RA (DAS28>3,2) who had to be naïve to biologics were enrolled in the study. Patients remained on stable doses of DMARDs and recieved TCZ 8 mg/kg every 4 weeks for 24 weeks.
Results Overall AE rates were 129,99/100PY (per 100 patient-years). Serious AE were reported in 14,5% of patients (19,31/PY). 3 patients (1,5%) withdrew from the treatment because AE. The most common AE leading to treatment withdrawal were anaphylaxis event (n=1), pneumonia (n=1), ALT/AST elevations (n=1). Infections, laboratory abnormalities (33,46/PY and 39,9/PY, respectively) were the most common AEs: upper respiratory tract infection (n=17), herpes labialis (n=3), infection of foot (n=2), onychomycosis (n=1), acute urinary tract infection (n=1), postinjectional abscess (n=1). One patient had cervical myelopathy. Shifts in ALT/AST up to 1-3 ULN occurred in 7,5% of patients, had shifts to greater 3-5 ULN in 5,0% and 2,0% had shifts to greater than 5 ULN. The mean neutrophil count decreased from 5,71x109/l at baseline to 4,46x109/l at week 4 and 3,77x109/l at week 24. One patient had common toxity criteria grade 4 neutropenia <0,5x109/l. No serious infection were associated with neutrophil count. No death occurred during the study.
Most of AE were mild or moderate and resolved by the end of the study.
Conclusions Tocilizumab is effective in treatment moderate and severe RA and generally good tolerated and safe with DMARDs combinations.
Disclosure of Interest None declared
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