Background The Canadian Rheumatology Association1 recommends that addition of corticosteroids (CS) should be considered only for the shortest period possible in rheumatoid arthritis (RA) patients treated with a traditional or biologic DMARD based on the patient’s clinical status.
Objectives Examine the effect of chronic systemic CS treatment at different doses on the incidence of infections in RA patients treated with IFX in a real-life setting. The impact of CS use on the sustainability of remission was also assessed.
Methods BioTRAC is an ongoing, Canadian, prospective, registry of rheumatology patients initiating treatment with IFX or golimumab as first biologics or after having been treated with a biologic for less than 6 mos. RA patients treated with IFX who were enrolled between 2002 and 2012 were included. Cox regression was used to examine the time-dependent association between systemic CS dose (no CS, ≤5 mg, >5 mg) and the incidence of first infection, while adjusting for possible confounders, and to assess the sustainability of remission.
Results 838 RA patients were included in the analyses. Mean (SD) age of the patient cohort was 56.6 (13.5) yrs and mean (SD) duration since diagnosis was 10.5 (9.8) yrs. At initiation of treatment, 38.2% of patients were treated with a systemic CS. After a mean (SE) follow-up of 51.3 (1.7) mos, 310 infections were reported for 19.7% of patients (19.6 /100 PYs). Among these, the majority (90.0%) were non-serious infections. Multivariate survival analysis using Cox regression showed that, upon adjusting for enrolment period, age, disease duration, number of steroid administrations, and HAQ-DI, the hazard ratio (HR) (95%CI) for acquiring an infection was 2.48 (1.24-4.98) in patients treated with high dose (>5 mg) CS compared to patients not receiving CS. Treatment with low dose CS was also associated with an increased hazard for infection (HR (95%CI) = 2.12 (0.97-4.66)) which did not reach statistical significance. Consistent with previous studies, increased HAQ-DI (HR (95%CI) = 1.51 (1.15-1.92)) and disease duration (HR (95%CI) = 1.01 (1.00-1.03)) were also identified as significant predictors. CS use was continued in 15% of cases despite the achievement of remission (DAS28-CRP: 15.2%; CDAI: 15.7%). Survival analysis did not show a significant positive effect of steroid use on sustainability of remission [HRDAS28-CRP (95%CI) = 1.40 (0.95-2.06); HRCDAI (95%CI) = 1.19 (0.75-1.88)].
Conclusions Treatment with systemic CS was associated with an increased hazard ratio for acquiring an infection upon adjusting for possible confounders. Despite the achievement of remission, steroid use was continued in 15% of cases without having an impact on sustainability of remission. We show that treatment with systemic CS is an independent predictor of infection in patients treated with anti-TNF agents and suggest that the use of concomitant medications should be considered in the interpretation of safety data.
J Rheumatol 2012;39;1559-1582
Disclosure of Interest B. Haraoui: None Declared, A. Jovaisas: None Declared, W. Bensen: None Declared, R. Faraawi: None Declared, J. Kelsall: None Declared, S. Dixit: None Declared, E. Rampakakis Employee of: JSS Medical Research, J. Sampalis Employee of: JSS Medical Research, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen, M. Shawi Employee of: Janssen
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