Background Tocilizumab (T) is a new biological agent for the treatment of rheumatoid arthritis (RA).
Purpose Our purpose was to review the response to, and safety of, tocilizumab.
Materials and methods Retrospective and descriptive study in a University hospital. All patients with RA being treated with tocilizumab (since the drug was included in the hospital's formulary) were selected. Period of study: December 2009-May 2011. Data collected: demographics, diagnosis, previous treatments, duration of treatment with tocilizumab, concomitant treatment, response (Clinical criteria: pain, inflammation of the joints (DAS28), morning stiffness, as defined by the Spanish Society of Rheumatology (SSR), adverse events (AEs) and cost. All data were collected through the pharmaco-therapeutic profile and by reviewing the medical chart.
Results 12 patients (8 women) with seropositive rheumatoid arthritis were included, mean age: 53.42±14.93 years. Median time from diagnosis of RA: 9.17±6.23 years. Mean duration of treatment: 8.25±5.46 months. All patients received tocilizumab due to progression after other treatment. 41.67% of patients received tocilizumab as a second-line, 25% as a third-line, 33.33% as a fourth or more line. 25% of patients took T-MTX, T-Leflunomide (8.34%) and without concomitant disease-modifying antirheumatic drugs (66.67%). 75% of patients took corticosteroids concomitantly. Dosage: 8 mg/kg/ 4 weeks. 11 patients had any type of response to T after 3 cycles (their subjective symptoms improved). Only 2 patients had DAS28 data (3.04 and 2.08) after 3 cycles. In 2 patients the treatment was stopped: 1 lack of response and 1 AE. The most frequent AEs: 3 cases of hyperlipidaemia that required statin therapy (1 required to stop T and was notified to the National Pharmacovigilance Center),1 grade II neutropenia. T treatment has cost €97,167 since December 2009. Average cost/patient was €8,097. Annual cost of treatment/patient €12,087.
Conclusions T is a therapeutic alternative to use when conventional therapies have failed. T is well tolerated but cholesterol levels should be monitored during treatment. To assess the response with the available data is difficult because DAS28 was not collected according to SSR recommendations. Pharmacists should get involved in evaluating the tolerance and the cost-effectiveness of this type of drug.
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