Abstract
BackgroundThe risk of serious infectious events (SIEs) is increased in patients with rheumatoid arthritis (RA). The aim of this study was to develop an age-adjusted comorbidity index (AACI) to predict, using baseline characteristics, the SIE risk in patients with RA treated with certolizumab pegol (CZP).MethodsData of CZP-treated patients with RA were pooled from the RAPID1/RAPID2 randomized controlled trials (RCT CZP) and their open-label extensions (All CZP). Predictors of the first SIE were examined using multivariate Cox models. The AACI was developed by assigning specific weights to patient age and comorbidities on the basis of relative SIE risk. SIE rates were predicted using AACI score and baseline glucocorticoid use, and they were compared with observed rates. The percentage of patients in each SIE risk group achieving low disease activity (LDA)/remission was examined at 1 year of treatment.ResultsAmong 1224 RCT CZP patients, 40 reported ≥ 1 SIE (incidence rate [IR] 5.09/100 patient-years [PY]), and 201 of 1506 All CZP patients reported ≥ 1 SIE (IR 3.66/100 PY). Age ≥ 70 years, diabetes mellitus, and chronic obstructive pulmonary disease/asthma made the greatest contributions to AACI score. SIE rates predicted using AACI and glucocorticoid use at baseline showed good agreement with observed SIE rates across low-risk and high-risk groups. At 1 year, more high-risk All CZP patients than low-risk All CZP patients reported SIEs (IR 8.4/100 PY vs. IR 3.4/100 PY). Rates of LDA/remission were similar between groups.ConclusionsAACI and glucocorticoid use were strong baseline predictors of SIE risk in CZP-treated patients with RA. Predicted SIE risk was not associated with patients’ likelihood of clinical response. This SIE risk score may provide a valuable tool for clinicians when considering the risk of infection in individual patients with RA.Trial registrationClinicalTrials.gov, NCT00152386 (registered 7 September 2005); NCT00160602 (registered 8 September 2005); NCT00175877 (registered 9 September 2005); and NCT00160641 (registered 8 September 2005).
Highlights
The risk of serious infectious events (SIEs) is increased in patients with rheumatoid arthritis (RA)
Patient population and overall incidence of Serious infectious event (SIE) The anti-Tumor necrosis factor (TNF) naive RA population pooled from Rheumatoid Arthritis PreventIon of structural Damage 1 (RAPID1) and RAPID2 comprised 1224 patients in the Randomized controlled trial (RCT) certolizumab pegol (CZP) group, with a total CZP exposure of 798.5 PY and median exposure per patient of 0.5 PY
Observed rates of low disease activity (LDA) and remission in different SIE risk groups We investigated if the predicted SIE risk influenced the achievement of LDA and remission at 1 year of CZP treatment according to DAS28(CRP), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI) criteria (Fig. 4)
Summary
The risk of serious infectious events (SIEs) is increased in patients with rheumatoid arthritis (RA). Anti-tumor necrosis factor (anti-TNF) agents are often the first class of biologic drugs prescribed to patients with rheumatoid arthritis (RA), providing an effective therapeutic option that improves clinical, radiographic, and functional outcomes [1]. Owing to their immunomodulatory action, anti-TNFs have been linked to an increased risk of serious infectious events (SIEs), the strength of this association remains a topic of debate [2,3,4,5]. Infection risk scores, which summarize the relative contributions of various patient characteristics in a single composite measure, may help clinicians to anticipate the potential risk of SIEs in individual patients and make better-informed treatment decisions when balancing the expected therapeutic risks and benefits for an individual patient [11, 16, 17]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
