Background Currently, there is not substantial evidence about tocilizumab (TCZ) use for the treatment of rheumatoid arthritis (RA) outside of clinical trials.
Objectives To describe usage patterns and dosage of TCZ, as well as its effectiveness and safety profile under real conditions of use.
Methods This is a 12-month prospective, observational study carried out in 40 Spanish centers. The study population consisted of adult patients with moderate or severe RA and disease duration of ≥6 months who initiated treatment with TCZ after failure of at least one previous DMARD or TNF inhibitor. Final results are presented.
Results A total of 379 patients were evaluated (83% female) with a median age of 57 years (47-66). At baseline, patients had mean disease duration of 12.1±8.2 years, 70.5% were rheumatoid factor positive and 68% anti-CCP positive. Mean baseline DAS28, SDAI, HAQ scores and CRP levels were 5.6±1.0, 22.9±15, 1.6±0.7 and 5.6±11.6 mg/dl, respectively. 78.4% of patients received TCZ in combination and 84.4% after prior use of biological agents. 97.6% of patients initiated TCZ at dose of 8 mg/kg. During the follow-up period, 68 (17.9%) discontinued TCZ treatment due to inadequate response (35.3%) and as result of adverse events (33.8%). At the end of follow-up, the mean DAS28 decreased significantly from baseline (5.6±1.0 vs 2.8±1.4; p<0.001), and disease remission (DAS28<2.6) was achieved in 51.3% of patients. Patients who received TCZ as first biological agent did not show a mean change in DAS28 score from baseline to final visit (delta-DAS28) significantly higher than in those previously treated with biological agents. No differences in delta-DAS28 were found when TCZ was administered as monotherapy or in combination with DMARDs. Based on EULAR response criteria, 65.2% of patients were good responders and 25.2% moderate responders. The main adverse events were infections (33.5%), gastrointestinal disturbances (21.4%), neutropenia (5.8%), elevation of liver transaminases (4.7%), and thrombocytopenia (1.1%).
Conclusions Final results of this study indicate that in daily clinical practice, tocilizumab is a safe and effective treatment for moderate or severe RA, with the majority of patients having a good EULAR response and a disease remission being achieved in 51.3% of patients. Tocilizumab proves to have a similar efficacy profile regardless of the use pattern as monotherapy or in combination, and the line-biological option may be used.
Disclosure of Interest: None Declared