Background/Purpose: Currently, the available evidence about tocilizumab (TCZ) use for the treatment of rheumatoid arthritis (RA) in daily clinical practice is scarce. This study was devised to describe usage patterns of TCZ and reasons for dosage modification (reduction/interruption/discontinuation) in the routine clinical practice, as well as its effectiveness and safety profile under real conditions of use.

Methods: This is a 12-month prospective observational study in 40 Spanish centers. Patients with moderate or severe RA of ≥6 months duration initiated on treatment with TCZ after failure of at least one previous DMARD or TNF inhibitor were included. We present preliminary results at 6-month follow-up

Results: A total of 390 patients were evaluable with a median age of 57 years (47-66) and 83% female. At baseline, patients had mean RA duration of 11.4±8.3 years, 70% were positive for rheumatoid factor and 68% for anti-CCP. Mean DAS28, SDAI, HAQ scores and CRP levels were 5.4±1.2, 22.4±14.9, 1.6±0.7 and 5.8±12.9 mg/dL, respectively. Patients had previously received a mean of 3±1.5 DMARDs and a mean of 2.3±1.2 biological agents, and 97.7% of them initiated TCZ at dose of 8 mg/kg.  At the 6-month follow-up, the mean DAS28 decreased significantly from baseline (5.5±1.2 vs 2.9±1.4; p<0.001, paired t-test, n=143), and disease remission (DAS28<2.6) was achieved in 48% of patients. Based on EULAR response criteria, 59.4% of patients were good responders, 31.5% moderate responders and 9.1% non-responders. Of all patients, premature withdrawal from the study during the first 6 months was reported in 34 (9%), 14 (41.2%) as a result of adverse events and 12 (35.3%) due to inadequate response. Grade 3/4 neutropenia occurred in 14 (3.6%) patients and grade 3/4 elevation of liver transaminases in 12 (3.1%). No cases of grade 3/4 thrombocytopenia were observed. One hundred and one (25.9%) patients required at least 1 dose reduction and 56 (14.4%) at least 1 temporary dose interruption. In patients intolerant or non-responders to DMARDs, delta DAS28 was significantly higher than in those previously treated with biological agents (3.2±1.2 vs 2.4±1.2; p<0.001). No differences in delta-DAS28 were found when TCZ was administered as monotherapy or in combination with DMARDs. Patients with intolerance or inadequate response to DMARDs showed significantly higher percentage of dose reduction than those intolerant or non-responders to biologic agents (36.7% vs23.9%; p<0.05).

Conclusion: These results show 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 approximately 50% of patients. Tocilizumab appears more effective when administered as a first-line biological agent. Additionally, TCZ proves to have a similar safety profile regardless of the use pattern as monotherapy or in combination, and the line-biological option may be used.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patterns-of-tocilizumab-use-and-dosing-among-patients-with-rheumatoid-arthritis-in-the-clinical-practice-preliminary-analyses-of-act-life-study/