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Abstract Number: 1641

When Can Biological Therapy Be Resumed in Patients with Rheumatic Conditions Who Develop Tuberculosis Infection During Tumour Necrosis Factors Antagonists Therapy? Study Based On the Biobadaser Data Registry

Maria Victoria Hernández1, Miguel A. Descalzo2, Juan D. Cañete1, Raimon Sanmarti3 and BIOBADASER Study Group4, 1Rheumatology, Hospital Clínic of Barcelona. IDIBAPS. University of Barcelona, Barcelona, Spain, 2Research Unit, Spanish Society of Rheumatology, Madrid, Spain, 3Arthritis Unit. Rheumatology Department, Hospital Clínic of Barcelona, Barcelona, Spain, 4Research Unit. Spanish Society of Rheumatology, Madrid, Spain

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Adalimumab, etanercept, infliximab, rheumatoid arthritis (RA) and tuberculosis

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Safety I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Tuberculosis infection (TI) is one of the most serious adverse events related to tumour necrosis factor (TNF) antagonists. According to the current treatment guidelines (1), biological therapy may be resumed after completion of the treatment of active TI. However, during TI therapy, some patients undergo a relapse of the underlying inflammatory condition due to the prolonged duration of therapy. Our objective was to analyse whether patients suffering TI during biological therapy could reinitiate the biological therapy before completion of TI therapy with no relapse of TI.

Methods: Retrospective study based on data from the Spanish Biological Therapy registry (BIOBADASER), which has included 6479 patients from the beginning of the registry (February 2000) until November 2011. During this time, 52 cases of active TI requiring the withdrawals of biologicals were reported. We selected patients on TNF blockers who reinitiated biological treatment after development of TI. We analysed: demographic characteristics; diagnosis and disease duration; type of biological agent at TI diagnosis and mean time received; type of TI; mean time from TI diagnosis until biological therapy was resumed; type of biological agent reinitiated, and  outcomes. To assess differences in the outcome of TI, we divided patients into 2 groups according to reinitiation of biological treatment before (group 1) or after (group 2) TI treatment completion. 

Results: Twenty-seven patients (15 female, mean age 56.7 ± 15.1 years) reinitiated biological therapy after withdrawal due to TI. Diagnoses were: 14 rheumatoid arthritis; 6 ankylosing spondylitis; 3 psoriatic arthritis; 2 juvenile idiopathic arthritis; 1 undifferentiated spondyloarthropathy and 1 Behçet’s disease. Mean disease duration was 18.8 ± 9.4 years. The type of TI was: pulmonary in 14 patients; disseminated tuberculosis in 12; cutaneous in 1. The TNF blocker received at TI diagnosis was: 6 patients infliximab, 2 etanercept and 1 adalimumab in group 1; and 14 infliximab, 3 adalimumab and 1 etanercept in group 2; with a median of treatment of 13 months. Biological therapy was reinitiated while patients were receiving TI treatment in 9 out of 28 patients (group 1), with a mean TI treatment of 2.25 ± 0.9 months. Fifty-six percent of group 1 patients reinitiated with the same biological agent, whereas in group 2 only 27.7% resumed the previous treatment. The underlying inflammatory condition improved in all patients. No patient of both groups had a relapse of TI after a follow-up of 49.2 ± 28.8 months (42 ± 30.7 in group 1 and 53.2 ± 27.8 in group 2). 

Conclusion: Active TI in patients receiving TNF antagonists may not be a contraindication for the reinitiation of biological therapy before completion of TI treatment, especially in patients who experience a relapse of the underlying inflammatory disease, who have a favourable outcome of TI and who have received at least 2 months of tuberculostatic therapy.

Reference: 1. Singh JA et al. Arthritis Care Res 2012; 64: 625–39.


Disclosure:

M. V. Hernández,
None;

M. A. Descalzo,
None;

J. D. Cañete,
None;

R. Sanmarti,
None;

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