What are the predic­ti­ve factors of response to treatment with tocilizumab in routine clinical practice? The ­experience of the Czech national registry ATTRA


Authors: K. Pavelka;  K. Hejduk;  H. Mann
Authors‘ workplace: Revmatologický ústav a Klinika revmatologie 1. LF UK
Published in: Čes. Revmatol., 21, 2013, No. 3, p. 132-139.
Category: Original Papers

Overview

Tocilizumab is a monoclonal antibody against IL-6R, which is registered for the treatment of moderately- and highly active rheumatoid arthritis in the first and second line of biological treatment. Tocilizumab has been registered on the basis of a series of randomized phase III clinical trials. Other valuable data have been obtained from registries of biological treatment. In the present paper the issue of predictive factors of efficacy of tocilizumab is discussed as well.

Methods:
An observational study of the effectiveness of tocilizumab (TCZ) in routine clinical practice has been performed. Patients enrolled in the study met the criteria of the Czech Society for Rheumatology for the application of biological treatment and were filed into the national registry ATTRA. The study monitored the following parameters: demographic characteristics of a patient, previous and current treatment, the presence of RF and anti-CCP antibodies (ACPA), DAS 28, serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), therapeutic response according to EULAR, achieving low disease activity (LDA) after 6 and 12 months (DAS 28 < 3.2) and achieving remission (DAS 28 < 2.6). Pre-treatment predictors of achievement of low disease activity at 6 and 12 months were evaluated.

Statistical analysis:
Univariate logistic regression evaluating the effect of all factors to achieve LDA was performed as the first step. The main factors were assessed by ROC analysis to identify the threshold value that divides the factor preferably in the sense of prediction of achieving LDA.

Results:
A total of 151 patients, whose test results were evaluated for safety, were enrolled into the registry. Data of 113 patients, who were newly started on TCZ at baseline, were used to assess the treatment efficacy. In the remaining 38 patients the efficacy was not evaluated because these were patients who continued therapy in the registry after the termination of clinical trials. Patients with advanced disease with a mean duration of 11 years and high disease activity (DAS 28 5.9, mean CRP 24.1 mg / l) were included in the analysis. The entire six-month monitoring was completed by 88% of patients treated concomitantly with disease-modifying antirheumatic drugs (DMARDs) and 85% of patients on monotherapy with TCZ. Therapeutic response according to EULAR at 6 months was reached by 88–89% of patients. After 12 months of treatment low disease activity was achieved by 67% of patients and 48% of patients were in remission. There were no differences found between the group treated with monotherapy or the group treated with combination of TCZ + DMARDs in achievement of LDA and remission. The only significant predictive indicator of achievement of low disease activity (LDA) after 12 months of treatment was the number of swollen joints. The incidence of adverse events was comparable between patients treated with monotherapy and combination of TCZ + DMARDs.

Conclusion:
The results of our study show good efficacy of TCZ in patients with rheumatoid arthritis in routine clinical practice. No significant difference was found between patients treated with monotherapy or with combination of TCZ+DMARDs in the efficacy or safety. The only predictive indicator of response to treatment with TCZ was the number of swollen joints.

Key words:
Rheumatoid arthritis, biological therapy, prediction of therapeutic response, tocilizumab


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Labels
Dermatology & STDs Paediatric rheumatology Rheumatology
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