Caldera, Freddy

Abstract Background Data describing the incidence and clinical outcomes of respiratory syncytial virus (RSV) infection among patients with inflammatory bowel disease (IBD) are limited. Methods We conducted a nationwide retrospective cohort study using the Veterans Health Administration (VHA) database. Adults with IBD were identified using a previously validated algorithm and matched 1:2 to non-IBD controls using propensity score matching. Laboratory-confirmed RSV infections that occurred between January 1, 2021, and December 31, 2024, were identified using standardized laboratory codes and confirmed by manual chart adjudication. Primary outcomes included RSV incidence and hospitalizations. Secondary outcomes included intensive care unit (ICU) admission and patient outcomes stratified by IBD medication class. Results After propensity score matching, 52 740 IBD patients and 104 997 non-IBD controls were included. Infection with RSV occurred in 219 patients with IBD and 426 non-IBD patients. Incidence rates of RSV were similar between cohorts across all years in our study period. Hospitalization related to RSV occurred in 18.26% of IBD-RSV patients compared with 13.15% of non-IBD patients (P = .08). ICU admission was rare in both groups (<1%). Among patients with IBD, RSV-related hospitalization did not differ significantly by medication class, when comparing biologic therapy (8.93%) with 5-aminosalicylic acid monotherapy (17.58%) (P = .15). Conclusions In this nationwide cohort, patients with IBD, with predominantly lower exposure to advanced therapies, did not have higher rates of RSV infection or worse clinical outcomes compared with matched non-IBD controls. RSV outcomes were similar across IBD medication classes. These findings support current vaccination recommendations and provide reassurance regarding RSV risk among patients with IBD.

Abstract Background Patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapies are at increased risk of vaccine-preventable diseases, including influenza. Despite recommendations for annual influenza vaccination, uptake remains suboptimal. The COVID-19 pandemic prompted a surge in telemedicine (Tele-M) use, raising concerns about its impact on vaccination rates due to reduced in-person interactions. This study aimed to assess the impact of IBD-specific Tele-M on influenza vaccine uptake and identify predictors of vaccination in patients with IBD. Methods This single-center retrospective study evaluated influenza vaccine uptake among adult patients with IBD seen between September 2021 and April 2022. Patients were categorized into two groups: Tele-M only and ≥1 in-person visit. Vaccination status was confirmed using the Wisconsin Immunization Registry. Primary outcome was influenza vaccination frequency by visit type, while secondary outcomes evaluated the impact of Tele-M on other vaccinations and predictors of influenza vaccine uptake. Results Among 547 patients, 53.2% received Tele-M only and 46.8% had ≥1 in-person visit. Influenza vaccine uptake was similar between the Tele-M only and ≥1 in-person visit groups (69.0% vs. 75.1%, respectively, p = 0.11). The uptake of pneumococcal, hepatitis B, and zoster vaccines was also comparable. Predictors of higher influenza vaccine uptake included age ≥65, female sex, receipt of ≥ 3 COVID-19 vaccines, and previous influenza vaccination. Conclusions IBD-specific Tele-M did not adversely affect influenza vaccine uptake among patients with IBD. These findings highlight the importance of ensuring vaccination compliance irrespective of healthcare delivery modes. Collaboration among healthcare providers is crucial to improve vaccination rates in patients with IBD.

INTRODUCTION: Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster and should receive the recombinant herpes zoster vaccine (RZV). We sought to assess the immunogenicity and safety of RZV series in patients receiving anti-tumor necrosis factor (TNF) therapy compared with those receiving vedolizumab. METHODS: This single-center prospective study enrolled patients with IBD on vedolizumab or anti-TNF monotherapy receiving RZV. Primary outcome assessed cell-mediated immunity (CMI) differences between groups postvaccination. Secondary outcomes included humoral response, sustained immunity, and safety monitoring for adverse events and IBD flares. Assessments occurred at baseline, 30, 240, and 425 days postvaccination. Statistical analyses included nonparametric Mann-Whitney U tests for between-group comparisons and Wilcoxon signed-rank tests for within-group changes, with significance set at P < 0.05. RESULTS: Thirty-three patients enrolled (16 vedolizumab, 17 anti-TNF). CMI responses increased postvaccination in both groups (median 56 cells/million [interquartile range {IQR} 21–102] vs 33 cells/million [IQR 11–73]; P = 0.13), with no significant difference between treatment groups. Both groups showed strong antibody responses to vaccination (preimmunization median: 349.9 mIU/mL [IQR 276.8–402.5] vs 90-day median: 605.0 mIU/mL [IQR 525.6–641.0]; P < 0.001). CMI responses remained elevated at both day 240 and 425 assessments. Antibody levels remained elevated through day 425 (549.1 mIU/mL, IQR 516.1–585.6), substantially higher than prevaccination levels. No IBD flares occurred; most adverse events were mild and transient. DISCUSSION: RZV demonstrated robust immunogenicity and favorable safety profile in patients with IBD receiving either vedolizumab or anti-TNF therapy. Both cellular and humoral immune responses persisted through 425 days postvaccination.

Abstract Background Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster (HZ) infection due to innate immune abnormalities and use of immunosuppressive therapy. The recombinant zoster vaccine (RZV) is recommended, but its efficacy in preventing recurrent HZ among patients with IBD is not well established. Methods Using data from the TriNetX Linked Network, we conducted a retrospective cohort study of adults (≥18 years) with IBD and a prior uncomplicated HZ episode. Patients with IBD who received RZV were propensity score-matched 1:1 with those who did not. The primary outcome was subsequent HZ complications. Secondary outcomes included subtypes of HZ complications and recurrent uncomplicated HZ. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated via Cox proportional hazards models. Results After matching, 1260 vaccinated and 1260 unvaccinated patients with IBD were included. Compared to the unvaccinated cohort, patients receiving RZV had a significantly reduced incidence of HZ complications (7.4% vs. 14.5%; HR, 0.75; 95% CI, 0.58–0.97; P = .028). Postherpetic neuralgia was notably decreased (5.8% vs. 12.5%; HR, 0.66; P = .010), and no central nervous system involvement occurred among vaccinated patients. Protective effects were more pronounced in patients with ulcerative colitis, females, and those not receiving immunosuppressive therapy. Conclusions RZV substantially lowers the risk of HZ complications in patients with IBD, offering significant clinical benefits to those at high risk due to immunosuppression. These findings underscore the importance of RZV as part of preventive care strategies in patients with IBD.

INTRODUCTION: Patients with inflammatory bowel disease (IBD) are at an increased risk of infections. Before the COVID-19 pandemic, respiratory syncytial virus (RSV) followed predictable seasonal patterns, which have been recently disrupted. This study aimed to investigate whether severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) infection is associated with an increased risk of RSV infection in patients with IBD compared with those without a history of SARS-CoV-2 infection. METHODS: This retrospective cohort study used the TriNetX database to identify patients aged 18 years and older with IBD and SARS-CoV-2 infection (IBD-SARS-CoV-2 cohort) during the 2022 and 2023 RSV seasons. A 1:1 propensity score matching was used to compare patients with IBD but no history of SARS-CoV-2 infection (IBD non-SARS-CoV-2 cohort). RESULTS: In the 2022 IBD-SARS-CoV-2 cohort (mean age: 53.7 ± 17.6 years; 59% female; 77% White), the RSV infection risk was 0.47%, higher than 0.19% in the matched IBD non-SARS-CoV-2 cohort (adjusted odds ratio [aOR]: 2.4; 95% CI: 1.5–3.6). The risk was highest 30–60 days after SARS-CoV-2 infection (aOR: 2.9; 95% CI: 1.7–4.9), particularly in those aged 60 years and older (aOR: 2.5; 95% CI: 1.3–4.5). The use of systemic corticosteroids (aOR: 2.3; 95% CI: 1.1–4.6) or immune-modifying therapies (aOR: 3.9; 95% CI: 2–7.1) was associated with higher RSV infection risk. Similar trends were observed during the 2023 RSV season, with no significant differences in RSV-related hospitalizations. DISCUSSION: Adults with IBD have a higher risk of RSV infection after SARS-CoV-2 infection, particularly those receiving steroids or immune therapies. SARS-CoV-2 infection may have contributed to the recent RSV infection surge in this population, warranting further research.

INTRODUCTION: Immune-modifying therapies in pediatric inflammatory bowel disease (IBD) increase infection risks, including varicella. METHODS: Using Optum's deidentified Clinformatics Data Mart Database, a nationwide US commercial insurance claims database (2007–2022), we conducted a retrospective study of 5,368 patients with IBD aged 21 years or younger matched to a non-IBD cohort. The primary outcome was incidence of varicella. RESULTS: Varicella incidence was low in both groups (IBD: 0.570 vs non-IBD: 0.297 per 1,000 person-years, P = 0.23). At year 4, cumulative varicella incidence was 0.27% for IBD and 0.18% for non-IBD ( P = 0.24). No hospitalizations or deaths occurred. DISCUSSION: Despite immune-modifying therapy, pediatric patients with IBD demonstrate low varicella incidence.

Objective: Patients with inflammatory bowel disease (IBD) are commonly treated with immunosuppressive therapies that increase the risk for infections, including hepatitis B (HepB) virus. Adult patients with IBD have suboptimal seroprotection rates after vaccination with a 3-dose recombinant recombinant HepB vaccine. Heplisav-B is an adjuvanted 2-dose HepB series that is more immunogenic in the general adult population. Herein, we evaluated the immunogenicity of Heplisav-B in adult patients with IBD. Patients and Methods: We conducted a prospective observational study of adult patients with IBD who were not seroprotected to HepB virus and received a Heplisav-B series with postimmunization HepB surface antibody (anti-HBs) serologic testing. Postimmunization anti-HBs ≥10 IU/mL was considered seroprotection. The primary outcome was the rate of seroprotection. Secondary outcomes were rates of seroprotection in different age groups, those on immunosuppressive therapy, and previous HepB vaccine nonresponders using a univariate analysis. Results: Eighty-five patients met the inclusion criteria with the majority (72%) achieving seroprotection with a median anti-HBs level of 48.7 IU/mL and 28 patients (33%) having an anti-HBs level >100 IU/mL. Those on immunosuppressive therapy [49 (58%), 18 nonresponders, odds ratio: 0.34, 95% CI: 0.12-0.99] and primary nonresponders to a previous HepB series [22 (26%), 11 nonresponders, odds ratio: 0.26, 95% CI: 0.09-0.73] were less likely to achieve seroprotection. Seven patients who did not respond received a third dose of Heplisav-B, and 2 achieved seroprotection. Conclusions: Heplisav-B achieved higher rates of seroprotection than those seen with 3-dose recombinant HepB vaccines in patients with IBD and may be the preferred option.

Abstract Background In infants that were exposed to biologics in utero, gastroenterology societal guidelines have either recommended against administration of the live rotavirus vaccine until 6-12 months of age or until serum biologic levels are undetectable. We performed a systematic review to evaluate the safety of rotavirus vaccination in biologic-exposed infants. Methods EMBASE, PubMed, Scopus, and Cochrane databases were searched from 2006 to 2024 for original data reporting on the safety of rotavirus vaccination in infants that were exposed to anti-tumor necrosis factors (TNFs) (ie, infliximab, adalimumab, golimumab, certolizumab) and non-TNF biologics (ie, vedolizumab, ustekinumab, rizankizumab, mirikizumab) in utero. Results A database search yielded 7185 screening results of which 10 studies met inclusion criteria. There were over 300 instances of rotavirus vaccination in biologic-exposed infants (n = 162 exposed to anti-TNFs, n = 142 exposed to non-TNF biologics). Biologic-exposed infants were not at an increased risk of severe adverse events or adverse events of any severity related to rotavirus vaccination. Conclusions Administration of the live rotavirus vaccine appears to be safe in biologic-exposed infants. As such, with careful examination of the risks and benefits, there may be a role for rotavirus vaccination in this population.