Background Biologics are widely used for the treatment of rheumatic diseases because of the efficacy, but careful surveillance and prophylactic measures are necessary to reduce the incidence of adverse events, especially infections. Quality indicator (QI) has been received an increasing attention in rheumatology field and several guidelines for the prevention of biologic agents-related infections have been published. However, few studies have reported the status of the implementation as well as interventions to improve its adherence in clinical settings.
Objectives Herein, we repot the efficacy of QI monitoring for hepatitis, latent tuberculosis infection (LTBI), and pneumocystis pneumonia (PCP) in the use of biologic agents in the treatment of rheumatic diseases.
Methods We retrospectively studied all patients who had received biologic agents (TNF and non-TNF agents) from January 2007 to December 2013 in our department. To evaluate the adherence of a minimal standard of care for the pre-administration screening, we monitored 3 QI bundles as LTBI bundle: chest image, tuberculosis skin test (TST) or prophylaxis, and interferon-gamma-release assays (IGRAs), de novo hepatitis B and C infection bundle: HBs-Ag, HBs-Ab, HBc-Ab, and HCV-Ab, and PCP bundle: chest image, IgG, and β-D glucan. QI bundles were implemented in 2010 and data were compared before and after QI monitoring investigation. In addition, we also evaluated the results of follow-up IGRA tests for detection of latent and newly developing tuberculosis.
Results We identified 328 eligible patients (mean age 52.5 years; 73.8% female), and improved adherence to pre-administration screening was shown after QI implementation in 2010. The rates of following the QIs improved from 82% to 99% in LTBI bundle, from 74% to 84% in PCP bundle, and from 65% to 78% in hepatitis B and C infection bundle, respectively (Table 1). We also assessed 168 patients with a negative or indeterminant IGRA results in the initial LTBI screening and evaluated by follow-up IGRA test after starting biologic agents, which showed 7% of IGRA positive conversion (Table 2). Neither active tuberculosis, PCP, nor de novo hepatitis were reported in our study.
Conclusions Implementation of monitoring of quality indicators based on guidelines lead to the safety for the use of biologic agents in the treatment of rheumatic disease.Our results also indicate the importance of follow-up IGRA test for the patients with previous negative results to prevent the activation of newly acquired LTBI, especially in relatively endemic countries.
Disclosure of Interest None declared