Background Anti-TNF drugs (AD)s have been a major advance in the control of chronic rheumatic diseases, however they sometime have important adverse drug effects (ADEs).
Purpose To assess the frequency of AD and disease-modifying antirheumatic drug (DMARD) combinations leading to withdrawal of biological treatment (BT) due to ADEs.
Material and methods Observational study in a tertiary hospital (1,350 beds). Outpatients on BT followed in a rheumatic disease unit were included. We evaluated patients who had been prescribed infliximab, etanercept or adalimumab concomitantly with DMARDs (between November 1999 and March 2013). The primary end point was BT withdrawal due to ADEs.
Results 444 patients out of 531 took DMARDs at the same time as ADs. 52 (11.7%) discontinued treatment due to ADEs as did 10 patients receiving anti-TNF monotherapy (11.5%) (OR = 0.27; p > 0.05). 160 patients took leflunomide, 28 of them (17.5%) discontinued AD due to ADEs. This risk of discontinuation was significantly higher than in patients receiving other concomitant DMARDs (OR = 1.984; p < 0.05). However, methotrexate seemed to have a protective effect regarding the risk of stopping ADs (OR = 0.567; CI95%: 0.319–1.010; p > 0.05). The frequency of AD withdrawal was similar when comparing patients on monotherapy versus polytherapy (anti-TNF and DMARDs) regardless of drug or diagnoses. Only leflunomide showed significantly higher ADEs which led to BT interruption (OR = 1.984; p < 0.05). We did not detect a significant increase in ADEs when other DMARDs were used concomitantly with BT. We found less probability of withdrawal for patients treated with anti-TNF in combination with methotrexate (OR = 0.567; IC95% (0.319–1.010); p > 0.05). There was an increase in discontinuations with each additional number of concomitant DMARDs up to a maximum of three.
Conclusion Association of anti-TNF with different DMARDs did not modify the risk of BT withdrawal as a consequence of ADEs. As a DMARD was added to any AD, the number of its discontinuations increased. The addition of BT treatment concomitantly with leflunomide significantly increased the risk of anti-TNF discontinuation due to ADEs, while patients taking methotrexate with BT were less likely to develop ADEs.
References and/or acknowledgements Rheumatology Department
No conflict of interest.
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