Both tumor necrosis factor (TNF) inhibitors and non-TNFi biologic DMARDs increase the risk of serious infection in rheumatoid arthritis patients compared to conventional synthetic DMARDs. Despite the risk, the treatments are effective in reducing disease activity, researchers report in the the August 6 issue of ACR Open Rheumatology.
Rheumatoid arthritis in general is associated with an increased risk of infection, which contributes to an increased risk of mortality for patients who suffer from ths condition. The risk of infection depends on a number of issues including the specific treatment, dose and duration, but also patient-specific characteristics, such as age, sex, extra-articular manifestations, comorbidities, and medications taken in combination with the DMARDs, especially, glucocorticoids.
The authors of this study, which was led by Kaleb Michaud, Ph.D., of the University of Nebraska Medical Center in Omaha, concluded that despite the efficacy of biologic DMARDs in reducing disease activity and disability, and to possibly reduced use of glucocorticoids, the risk/benefit ratio should be carefully considered when treating patients with rheumatoid arthritis. This is especially true for patients who are older and who have multiple comorbidities and disability. Patients should be monitored closely for any signs of infection, and their risk factors for serious infection should assessed and managed while they are being treated with these medications.
"Our study both strengthens the evidence of increased serious infection risk with biologic DMARDs and indicates that patient characteristics also determine serious infection risk. Therefore, despite the efficacy of biologic DMARDs in reducing disease activity, disability, and, potentially, glucocorticoids exposure, the risk/benefit ratio should be weighed carefully when treating patients with rheumatoid arthritis, particularly older individuals with multiple comorbidities and disability, with biologic DMARDs. Patients should be monitored closely for symptoms and signs of infection, and assessment and possible modification of risk factors should be continued throughout the biologic DMARD treatment," the authors wrote.
This was an observational study that included 694 rheumatoid arthritis patients who reported having their first serious infection. The data is from FORWARD–The National Databank for Rheumatic Diseases. The study included patients who had to have started a new course of treatment of either biologic DMARDs—either tumor necrosis factor α inhibitors or non- tumor necrosis factor α inhibitors—or conventional synthetic disease-modifying antirheumatic drugs in the period from 2001 through 2016. The study included 11,623 patients, of whom 2,737 were treated with conventional synthetic drugs, 7,210 were treated with tumor necrosis factor α inhibitors, and 1,676 were treated with non- tumor necrosis factor α inhibitors.
The incidence rate for serious infection per 1,000 patient-years was 22.4 (95% confidence interval 19.2-26.1) for conventional synthetic drugs, 26.9 (95% CI 24.5-29.6) for tumor necrosis factor α inhibitors, and 23.3 (95% CI 19.0-28.5) for non-tumor necrosis factor α inhibitors drugs.
There was no difference seen in serious infection rates between patients treated with TNF α inhibitors and those treated with non-TNFα inhibitors.
Serious infections were defined as any infection that required treatment with an intravenous antibiotic or hospitalization, or which resulted in death.
Gulsen Ozen, Sofia Pedro, Bryant R. England, et al. "Risk of Serious Infection in Patients With Rheumatoid Arthritis Treated With Biologic Versus Nonbiologic Disease-Modifying Antirheumatic Drugs," ACR Open Rheumatology. Aug. 6, 2019. DOI:10.1002/acr2.11064