Background/Purpose: Treatment with biologic disease-modifying antirheumatic drugs (DMARDs) and tofacitinib confer increased risk of life-threatening infections, including reactivation of latent tuberculosis infection (LTBI), hepatitis B virus (HBV), and hepatitis C virus (HCV). We aimed to assess gaps in patient safety measures such as LTBI and hepatitis screening prior to drug initiation among patients treated with biologic DMARDs or tofacitinib in a large health system across multiple specialties.

Methods: We analyzed electronic health record (EHR) data from a university center, including diagnosis codes, problem lists, medications, laboratories, procedures, clinical notes, and scanned documents. Patients included all new users of a biologic DMARD (abatacept, adalimumab, anakinra,  canakinumab, certolizumab, etanercept, golimumab, infliximab, secukinumab, tociluzimab,  or ustekinumab) or tofacitinib  between 7/1/13 and 10/1/17. We assessed screening for each infection: LTBI (fulfilled via tuberculin skin test, interferon gamma release assay, or prior treatment for TB); HBV (hepatitis B surface antigen); and HCV (Hepatitis C antibody) from 12 months preceding through 60 days after medication initiation.  Next, we calculated performance on a composite safety measure that required screening for all 3 infections. We then liberalized the screening window to include any time prior to medication initiation. Multivariable logistic regression was used to assess differences in screening across prescribing specialties, adjusting for race, sex, age, and comorbidities.

Results: We included 1,029 patients; mean age was 39.5 (SD 19.5), mean Charlson score 1.1 (SD 2.1), and 64% were White, 13% Hispanic, 12% Asian, 4% African American, and 22% other/not reported. Rheumatology was the most common prescribing specialty (Table) and the most common drugs prescribed were adalimumab (32%), etanercept (24%), infliximab (19%), and ustekinumab (9%). Overall, 62% of patients were screened for LTBI, 42% for HBV, 33% for HCV, and only 26% for all 3 infections within 12 months preceding through 60 days after initiation of an eligible drug. When we assessed screening at any time before drug initiation, the proportions screened were: 68% for LTBI, 55% for HBV, 46% for HCV, and 36% for all 3. Screening patterns differed by treating specialty (p<0.0001) (Table).

Conclusion:

Screening for LTBI and hepatitis B and C among patients initiating biologic DMARDs or tofacitinib in a large health system is suboptimal. More robust safety protocols are needed across specialties to ensure adequate screening and prevent adverse drug events in this high-risk population.