Real-World Incidence and Determinants of Infection in Patients With Rheumatoid Arthritis Treated With Golimumab After a Median Follow-Up Time of 27 Months

Abstract

ObjectiveTo characterize the long-term incidence of infection in rheumatoid arthritis (RA) patients treated with subcutaneous golimumab (GLM) in Canadian routine care, assess the impact of infections on GLM retention, and explore factors associated with infection incidence.MethodsRA patients enrolled in the BioTRAC registry (NCT00741793) initiating GLM treatment were included. The incidence density rates (IDRs) of total (TI), serious (SI), and nonserious (NSI) infections were calculated for the overall follow-up (90 months) and by 6-month intervals. Determinants of infection over time or within the first 6 months were explored using generalized estimating equation models and logistic regression, respectively.Results530 patients were included; mean baseline age was 57.7 years and RA duration of 8.0 years. Over an average follow-up of 27.0 months, the IDR for TI was 35.1 events/100 person-years (PY), the majority occurring during the first 6 months; IDRs for NSI and SI were 32.9 and 2.2 events/100PY, respectively. No predictors were identified for infection incidence within 6 months. Comorbid pulmonary disease was associated with significantly higher odds of TI and NSI over time, while higher age and high corticosteroid dose (≥5mg/day) predicted higher odds of SI. Incidence of SI, but not NSI, was associated with significantly higher odds of GLM discontinuation.ConclusionLong-term GLM treatment was associated with relatively low infection rates, most being non-serious and occurring during the first 6 months. Pulmonary disease, higher age, and high corticosteroid dose were identified as significant predictors of infections. SIs, but not NSIs, predicted higher odds of GLM discontinuation.