Risk of adverse events, such as infection and lymphoma, were found to be higher in patients with Rheumatoid Arthritis (RA) treated with biological Disease-modifying antirheumatic drugs, according to a study, entitled, “Risk of tuberculosis, serious infection and lymphoma with disease-modifying biologic drugs in rheumatoid arthritis patients in Taiwan,” recently published in the International Journal of Rheumatic Diseases.
Disease-modifying antirheumatic drugs (DMARDs) are widely used as first-line treatment for rheumatoid arthritis (RA). The primary goal of RA pharmacotherapy is to improve clinical symptoms and to reduce the progression to structural joint damage. The most widely used drugs are traditional DMARD (tDMARD), such as methotrexate. When the patient does not respond to tDMARDs guidelines recommend the use of biologic anti-tumor necrosis factor (anti-TNF) agents, or biological DMARDs (bDMARD). Evidence from clinical trials showed that three anti-TNF agents, adalimumab, etanercept and infliximab, are effective.
Patients with RA are at higher risk of infections and lymphoma, however this may be caused not only by the condition itself, but may depend on one’s response to medication. It was then entirely unexplored how much RA may increase infection risk independent of related factors, such as treatment with DMARDs.
In this regard, Ying-Ming Chiu from the Division of Allergy Immunology & Rheumatology, Changhua Christian Hospital, Changhua, Taiwan, and colleagues determined the risk of adverse events in a sample of 2,150 patients with Rheumatoid Arthritis that were treated with biological (N=3459 bDMARD), versus traditional (N=7888 tDMARD) Disease-modifying antirheumatic drugs.
The retrospective study obtained patient data from Taiwan’s National Health Insurance Research Database to find potential cases of patients with RA that received biological (bDMARD) and traditional (tDMARD) Disease-modifying antirheumatic drugs between 1999 and 2009. They aimed to detect the cases of patients that had serious bacterial infection (SBI), diagnosis of tuberculosis (TB) or lymphoma. Within the bDMARD cohort, individual bDMARDS with adequate data were also compared (adalimumab and etanercept).
From the total sample, 1,711 patients had SBI, 406 TB and 33 had lymphoma. The incidence ration of TB and lymphoma was higher for the patients treated with bDMARD versus tDMARD. Moreover, results revealed that patients under treatment with adnalimumab had higher incidences of SBI and TB compared to those under etanercept.
The team of researchers conlcued that treatment with bDMARDS in patients with RA created a higher risk of adverse events such as tuberculosis (TB) and incident lymphoma, when comparing to tDMARDS. Additionally, this study provided evidence that the risk of adverse events is dependent on the bMARD type, with a higher risk associated with the monoclonal antibody therapy adalimumab, compared to etanercept, a soluble receptor fusion protein.