Hepatitis B serology and vaccinations are infrequently assessed in IBD patients receiving TNF-a inhibitors

Abstract

TNF-α inhibitors are important agents in the treatment of inflammatory bowel disease (IBD) patients. Individuals requiring TNF-α inhibitors are at increased risk for development of severe hepatitis B infection when immunosuppressed. There are numerous reports of significant morbidity and mortality associated with hepatitis B infections in patients receiving TNF-α inhibitors. It is recommended that all patients receiving TNF-α inhibitors have hepatitis B serology obtained and be immunized if appropriate. This study evaluated the frequency at which hepatitis B serology and vaccination status was obtained in IBD patients receiving TNF-α inhibitors at an urban university medical center. The medical records of all IBD patients on infliximab (Remicade), adalimumab (Humira), and certolizumab (Cemzia) at an IBD program in an urban university medical center were evaluated. There were no exclusion criteria. Patient age, race, gender, disease type (Crohn's Disease or Ulcerative Colitis), type of TNF-α inhibitor, hepatitis B antigen (HBsAg), hepatitis B antibody (HBsAb), and hepatitis B vaccination status were recorded. A database, maintaining patient confidentiality, was created using Microsoft Excel. Statistical analysis was performed using a Fisher Exact Test with significance set at P < 0.05. Medical records of 44 patients were reviewed. There were 21 females (48%) and 23 males (52%) with a mean age of 36 years (range 19-75 years). 35 patients were diagnosed with Crohn's disease (79.5%), 8 patients with ulcerative colitis (18.2%), and 1 indeterminate colitis (2.3%). 30 patients were on infliximab (68%), 14 on adalimumab (32%), and none were on certolizumab. Of the total study population 25 (57%) had documented HBsAg titer results prior to initiating therapy with no patients having positive results. There were no differences in screening based on gender (p = 0.76), disease type (p = 1.0), or drug therapy (p = 0.10). HBsAb serologies were documented in 12 patients (27%) of which 8 were positive (18%) and 4 were negative (9%). Only 1 patient had prior documentation of HBV vaccination, and no vaccinations were administered prior to or during TNF-α inhibitor therapy. The mean age for the HBsAb positive group was 24.7 years and 40.1 years for the negative group. There were no appreciable differences in HBsAb screening between gender (p = 1) or disease type (p = 0.617). There was however, significantly less HBsAb screening (p = 0.025) in patients on adalimumab with 93% undocumented compared to 67% of those on infliximab. Hepatitis B virus serologies and vaccination status are inconsistently checked before initiating treatment with TNF-α inhibitors. It is unclear why adalimumab compared to infliximab had even lower assessment frequencies. The small sample size, single-institution, and retrospective design of this study may limit the ability to extrapolate the results. However, the low incidence of hepatitis B virus serology documentation despite the known dangers suggests the need for increased awareness of virus risk and the administration of vaccination when appropriate in IBD patients on TNF-α inhibitors.