TNFi Reduces Risk of Infection Over Tofacitinib in RA Treatment
Patients with rheumatoid arthritis (RA) receiving tofacitinib were at a higher risk of developing infections than patients who were treated with tumor necrosis factor inhibitors (TNFi), according to a new open-label, randomized controlled ORAL surveillance trial. The findings are published in Annals of the Rheumatic Diseases.
“Incidence rates and hazard ratios for all infections, serious infection events (SIEs), and non-serious infections (NSIs) were higher with tofacitinib (for both 5mg and 10 mg two times per day) versus TNFi,” the researchers wrote. “Findings may inform future treatment decisions.”
Compared to the general population, patients with RA are at a greater risk of developing infections, with some resulting in rehospitalization. The team undertook the ORAL surveillance study to compare and characterize infections among patients who received tofacitinib either 5mg or 10 mg 2 times daily vs those who were treated with TNFis.
The team gathered data from patients who were older than 50 years of age with 1 or more additional cardiovascular risk factor. The study highlighted 3 sets of incidence rates and hazard ratios: overall totals, figures for patients between ages 50 and 65, and figures for patients who were older than 65 years of age.
The risk of all infections — serious infection events and nonserious infections — was universally higher among patients who received tofacitinib vs those on TNFi. The hazard ratio for SIEs was 1.17 (0.92 to 1.50) among the tofacitinib group vs 1.48 (1.17 to 1.87) among the TNFi group. The risk of infections increased substantially among patients in the older subgroup (more than 65 years of age) than in the 50-65 age group.
The data revealed that compared to those using TNFis, the tofacitinib group experienced higher rates of SIEs from month 18 onward, and the rates of NSI increased before the first 6 months.
“Across treatments, the most predictive risk factors for SIEs were increasing age, baseline opioid use, history of chronic lung disease and time-dependent oral corticosteroid use, and, for NSIs, female sex, history of chronic lung disease/infections, past smoking and time-dependent Disease Activity Score in 28 joints, C-reactive protein,” the investigators concluded.
Because patients with RA are at higher risk of developing infections due to factors including age, disease activity, comorbidities and RA treatments, the study pushes for increased shared decision-making on treatment choices between physicians and patients.
—Priyam Vora
Reference:
Balanescu A, Citera G, Ramos V et al. Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumour necrosis factor inhibitors: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. Published online August 3, 2022. DOI: 10.1136/ard-2022-222405
