ORAL Surveillance trial findings report increased infections in RA patients receiving tofacitinib

According to the ORAL Surveillance trial findings, published in the recent issue of Annals of Rheumatic Diseases, the incidences of infections are higher in patients receiving tofacitinib than tumor necrosis factor inhibitor (TNFi).

Previous literature studies have shown that multiple factors namely disease activity, age, comorbidities, and RA treatments are linked to increasing the likelihood of infection. The open-label randomized study has shown that in RA patients aged≥50 years and with ≥1 additional cardiovascular risk factor, the dose-dependent incidence of risk of all infections, serious infection events (SIEs), and non-serious infections (NSIs) was found to be significantly high with tofacitinib when compared to TNFi.

Moreover, the incidence of all infections and SIEs were found to be higher in the age group ≥65 as opposed to 50–<65 years, and this was found to be more predominant in the group receiving tofacitinib 10 mg two times per day. The study has identified increasing age, history of chronic lung disease, baseline opioid use, and time-dependent oral corticosteroid as the factors linked to SIEs. Whereas, female gender, history of chronic lung disease/infections, history of smoking, and time-dependent higher DAS 28 and C-reactive protein scores were found to be predictive of NSIs.

However, a pooled analysis by Kivitz et al. has reported a lower incidence of herpes zoster and serious infections in patients receiving tofacitinib monotherapy compared to combination therapy. Moreover, the study has noted a favorable risk-benefit profile in active RA patients receiving tofacitinib monotherapy and intolerant to csDMARDs.

It is paramount to consider the risk factors of infections identified by the present study as part of the shared decision-making between clinicians and patients.


  1. Balanescu AR, Citera G, Pascual-Ramos V, et al. Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumor necrosis factor inhibitors: results from the open-label, randomized controlled ORAL Surveillance trial [published online ahead of print, 2022 Aug 3]. Ann Rheum Dis. 2022;annrheumdis-2022-222405.
  2. Kivitz AJ, Cohen S, Keystone E, et al. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018;48(3):406-415.