Improving Hepatitis B Virus Vaccination Responses in Inflammatory Bowel Disease: Does Greater Dose and Greater Frequency Lead to Greater Protection?

Prevention of hepatitis B (HBV) infection is particularly important for patients with inflammatory bowel disease because of risks of HBV reactivation on immunosuppressive therapies. However, immune responses to standard HBV vaccination regimens are suboptimal. Chaparro et al. compared immune responses to 2 vaccines, an adjuvanted HBV vaccine (Fendrix) and double-dosed standard vaccine (Engerix-B) using an accelerated, 4-dose regimen (0, 1, 2, and 6 months). Although the study did not demonstrate superiority of one vaccine over another, several lessons can be derived regarding immune response to vaccinations among patients with inflammatory bowel disease, including the need to consider nonstandard regimens for patients on immunosuppression. These lessons can be translated broadly, including to a potential future severe acute respiratory syndrome coronavirus 2 vaccine when one becomes available.

Clinical Impact of Corrections to Infliximab and Adalimumab Monitoring Results with the Homogeneous Mobility Shift Assay.

An upward drift for both infliximab and adalimumab concentrations measured by the homogenous mobility shift assay (HMSA) was previously reported. We aimed to investigate the impact of this drift on clinical care of patients with inflammatory bowel disease. This was a retrospective, multicenter study. Providers reviewed the individual patient data and drug concentrations before and after the laboratory corrections and then documented whether a different clinical decision would have been made had the corrected drug concentration been originally reported. A multivariable Cox proportional hazards regression analysis was performed to investigate the association of a documented treatment change with treatment failure, defined as drug discontinuation for primary nonresponse, loss of response, or serious adverse event, adjusting for confounding factors. The study population consisted of 479 patients (infliximab, n = 219; adalimumab, n = 260). Upon review, 14.9% (71/479) patients would have had a different treatment decision made had the corrected drug concentration been initially reported. After a median follow-up of 10.6 months, 25.7% of patients (123/479) had treatment failure. A theoretical different clinical decision based on the corrected drug concentrations was not associated with treatment failure (adjusted hazard ratio (HR): 1.452; 95% confidence interval (CI): 0.805-2.618; p = 0.216), which was consistent for both infliximab (adjusted HR: 1.977; 95% CI: 0.695-5.627; p = 0.201) and adalimumab (adjusted HR: 1.484; 95% CI: 0.721-3.054; p = 0.284). The drift in infliximab and adalimumab concentrations in the HMSA assay affected treatment decisions in 15% of cases. However, this discrepancy was not associated with a higher cumulative probability for treatment failure.