Background Targeting interleukin-6 receptor signal transduction by tocilizumab (TCZ) has been shown to be an effective treatment for patients with rheumatoid arthritis (RA).
Objectives This study aimed to describe safety and efficacy of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in routine clinical practice, based on prospectively registered observational data from a third-level hospital.
Methods Forty patients with RA who were started on TCZ at the Rheumatology Unit between April 2009 and July 2011 were included. Changes in tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR), haemoglobin (Hb), 28-joint Disease Activity Score (DAS28), European League Against Rheumatism (EULAR) response and remission rates with the 2011 American College of Rheumatology (ACR)/EULAR criteria after 4, 12, 24, 48, 72 and 96 weeks (W) were investigated. SPSS 17.0 program was used for statistical analysis. Adverse Events (AE) and withdrawals were also described.
Results Thirty-five women and five men were included. Median age was 52 years old (33-79). Median disease duration was 11 (2-39) years. Rheumatoid Factor was positive in 32 patients (80%), anti-citrullinated protein antibody in 34 (85%) and anti-nuclear antibodies were detected in 34 patients (85%). Thirty-four patients (85%) had previously received at least one biological treatment. Decrease of TJC, SJC, ESR and DAS28 was statistically significant in all the weeks. Increase of Hb was statistically significant until W48.
By analysing the response data the following results were obtained:
Regarding the use of concomitant treatments, the following information compares the first and the last data recorded in each patient: disease-modifying antirheumatic drugs in 60% to 48%; nonsteroidal anti-inflammatory drugs in 80% to 35%; the average dose of corticosteroids (adjusted to prednisone dose) was initially 6.1 mg/day and finally 4.2 mg/day. Regarding safety, 31 patients (77.5%) had at least one AE. The most frequent AE were infections (22 episodes), dyslipidaemia (present in 16 patients) and haematology abnormalities (detected in 14 patients). Three severe AEs were observed (community-acquired pneumonia, fever without source and acute toxic hepatitis). There was no mortality in the group. Fifteen patients (31%) withdrew from treatment for safety-related (25%) or non-safety-related (12.5%) reasons.
Conclusions In our serial TCZ had achieved a good-or-moderate EULAR response in patients with RA in routine clinical practice. An early and maintained response was observed. The most frequent AE were infections, dyslipidemia and haematological abnormalities. The main causes of withdrawal were AEs.
Disclosure of Interest None Declared
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