Efficacy of Hepatitis B Vaccination with a Novel Immunostimulatory Sequence Adjuvant (Heplisav-B) in Patients With Inflammatory Bowel Disease.

BACKGROUND: Owing to the use of immunosuppressive agents, patients with inflammatory bowel disease (IBD) have an increased risk of vaccine preventable diseases, including infection with hepatitis B virus (HBV). Heplisav-B, an FDA-approved vaccine, is more effective (90% to 100%) than Engerix-B (70.5% to 90.2%) at inducing immunity to HBV in clinical studies. Available data on efficacy of Heplisav-B vaccine in patients with IBD are limited. METHODS: This retrospective observational study included patients age 18 years and older with ulcerative colitis (UC) or Crohn's disease (CD) who received 1 or 2 doses of Heplisav-B vaccine and had postvaccination serologic testing. Prior to immunization, all participants were seronegative for HBsAb antibodies (HBsAb) measured as <10 IU/mL. Postvaccination HBsAb of ≥10 IU/mL was considered successful vaccination. Patient demographics, disease characteristics, and medications were abstracted. RESULTS: One hundred six patients were included in the analysis. Median age was 43 years, and 44 (42%) were female. Thirty-nine patients (37%) had UC, whereas 67 (63%) had CD. Eighty-three patients (78.3%) had active immunity after vaccination with Heplisav-B, with median postvaccination HBsAb levels of 114 IU/L. Patients with chronic obstructive pulmonary disease, chronic kidney disease, diabetes mellitus, immunomodulator use, or those on 2 or more of immunosuppressive medications were less likely to respond to Heplisav-B, though these findings were not statistically significant on a multivariate analysis aside from chronic kidney disease. CONCLUSIONS: Heplisav-B, a 2-dose vaccine, is an effective vaccine for HBV in patients with IBD. In our study, its overall efficacy (78.3%) is greater than that reported for the presently available 3-dose vaccination (Engerix) in patients with IBD.

Heplisav-B, a 2-dose vaccine, is an effective vaccine for HBV in patients with IBD. In our study, it had an overall efficacy of 78.3%. Patients on an immunomodulator and/or 2 or more immunosuppressants had decreased response rate to vaccination.

Higher Cell-Mediated Immune Responses in Patients With Inflammatory Bowel Disease on Anti-TNF Therapy After COVID-19 Vaccination.

BACKGROUND: Some patients with inflammatory bowel disease (IBD) on immunosuppressive therapies may have a blunted response to certain vaccines, including the messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines. However, few studies have evaluated the cell-mediated immune response (CMIR), which is critical to host defense after COVID-19 infection. The aim of this study was to evaluate the humoral immune response and CMIR after mRNA COVID-19 vaccination in patients with IBD. METHODS: This prospective study (HERCULES [HumoRal and CellULar initial and Sustained immunogenicity in patients with IBD] study) evaluated humoral immune response and CMIR after completion of 2 doses of mRNA COVID-19 vaccines in 158 IBD patients and 20 healthy control (HC) subjects. The primary outcome was the CMIR to mRNA COVID-19 vaccines in patients with IBD. The secondary outcomes were a comparison of (1) the CMIR in patients with IBD and HC subjects, (2) CMIR and humoral immune response in all participants, and (3) correlation between CMIR and humoral immune response. RESULTS: The majority (89%) of patients with IBD developed a CMIR, which was not different vs HC subjects (94%) (P = .6667). There was no significant difference (P = .5488) in CMIR between immunocompetent (median 255 [interquartile range, 146-958] spike T cells per million peripheral blood mononuclear cells) and immunosuppressed patients (median 377 [interquartile range, 123-1440]). There was no correlation between humoral and cell-mediated immunity after vaccination (P = .5215). In univariable analysis, anti-tumor necrosis factor therapy was associated with a higher CMIRs (P = .02) and confirmed in a multivariable model (P = .02). No other variables were associated with CMIR. CONCLUSIONS: Most patients with IBD achieved CMIR to a COVID-19 vaccine. Future studies are needed evaluating sustained CMIR and clinical outcomes.

Antibody and T cell responses to coronavirus disease 2019 vaccines in patients with inflammatory bowel disease do not correlate. Most patients with inflammatory bowel disease mount a T cell response despite being on biologic therapies, those on anti-tumor necrosis factor may have a higher T cell response. Anti-tumor necrosis factor therapy has been associated with a lower antibody response to coronavirus disease 2019 vaccines, but the T cell response is augmented.

A Cohort Study of the Age at Menopause in Female Patients With and Without Inflammatory Bowel Disease.

Background: Menopause, defined by the complete cessation of menstrual cycles for 12 consecutive months, may occur at a younger age in women who have concomitant immune dysregulation. Our aim was to determine whether women with inflammatory bowel disease (IBD) experience an earlier onset of menopause compared to women without IBD. Methods: This was a retrospective cohort study using resources of the Rochester Epidemiology Project, a collaboration between clinics, hospitals, and medical facilities in Olmsted County, Minnesota. From these people, women who were diagnosed with IBD between 1970 and 2010 comprised the case cohort while the reference cohort included women with no diagnosis of IBD. Data including age, body mass index (BMI), ethnicity, smoking status, age at onset of menopause, and current use of hormone therapy were collected. Patients with history of hysterectomy or oophorectomy were excluded. Wilcoxon rank-sum test for numeric variables and Fisher's exact test for categorical variables were used to analyze the data. Results: A total of 171 women met criteria for inclusion (83 cases and 88 controls). Mean age of menopause in women with IBD was 50.0 years compared to 51.5 years in women with no IBD (P = .006). There was no difference in BMI of women with and without IBD (28.7 versus 28.2 kg m-2; P = .9), respectively. There were more former smokers (33.7%) and current (6%) smokers in the IBD group (P = .009) compared to the non-IBD group. Conclusions: IBD is associated with an earlier onset of menopause. Although it is unclear if this mean difference of 1.5 years is clinically relevant, it is known that early menopause is associated with an increased risk of osteoporosis and cardiovascular disease. Further research on the possible mechanisms is needed.

Endoscopic Management of Luminal Strictures: Beyond Dilation.

Luminal strictures can occur as part of many different gastrointestinal (GI) disorders anywhere along the GI tract and affect all age groups. The end goal of managing any stricture is to re-establish an adequate and durable luminal patency that is sufficient to resolve the presenting clinical symptoms. Treatment options can be generally categorized into medical, endoscopic, and surgical. However, within each of these categories, multiple different options are available. Therefore, choosing the best treatment modality is often challenging and depends on multiple factors including the type, location, and complexity of the stricture, as well as the preference of the treating physician. In this article, we will review the most current literature regarding foregut strictures, particularly esophageal and gastric, beyond dilation.

Oral Contraceptive Pills Are an Effective Method of Preventing Pregnancy in Women With Crohn's Disease.

Background: Oral contraceptive pill (OCP) use in the general population is associated with a failure rate as low as 0.3% with perfect use but as high as 9% with typical use. Women with Crohn's disease (CD) may have malabsorption in the setting of small bowel disease or resection, which could affect absorption of OCPs. Our aim was to determine the incidence of pregnancy in women with CD on OCPs. Methods: This is a retrospective study assessing the incidence rate of OCP failure in females between 18 and 45 years of age seen at the Mayo Clinic with a diagnosis of CD and provided a prescription for OCPs, between 2016 and 2020. Failure was defined as clear documentation of becoming pregnant while using OCPs or having an active prescription of OCP at the time of conception. Results: A total of 818 female patients with CD between 18 and 45 years of age with a prescription for an OCP were included in our study. Sixty-six patients (8%) conceived in this cohort. Of the 66 patients who became pregnant, 57 stopped the OCP before conceiving, 5 were excluded due to lack of data, and 4 women had active oral contraceptive prescriptions when they became pregnant (pregnancy rate of 0.5%). Conclusions: In female patients with CD who are using OCPs for contraception, we found a low rate of pregnancy (0.5%) similar to the rate of pregnancy with perfect use of OCPs in the general population. OCPs are an effective method of birth control in women with CD.

Faecal Calprotectin from Ileostomy Output Is Sensitive and Specific for the Prediction of Small Bowel Inflammation in Patients with Crohn's Disease.

BACKGROUND: Severe Crohn's disease [CD] can result in extensive bowel resections and need for creation of an ileostomy. Faecal calprotectin [FC] is well studied in CD management, though its role in patients who have an ileostomy is unclear. Our aim is to understand if FC is a useful adjunct to radiographic or endoscopic studies in identifying recurrent CD after surgery in patients with an ileostomy. METHODS: Between January 1, 2017, and September 30, 2020, we searched the Mayo Clinic electronic medical record retrospectively for adult patients with ICD-10 code for CD, and a surgical history of an ileostomy. Patients were included in the analysis if they had at least one FC measured and a concomitant radiographic imaging and/or endoscopic procedure. An abnormal FC was defined as greater than 60 µg/g. RESULTS: Of 51 patients who met our inclusion criteria, 17 had an FC level >60 µg/g. Of these 17 patients, 14 had imaging and/or an ileoscopy confirming the presence of small bowel inflammation, with a sensitivity of 87.5%. Of the remaining 34 patients with an FC level ≤60 µg/g, 32 patients had imaging and/or ileoscopy demonstrating no small bowel inflammation, with a specificity of 91.4%. FC from an ileostomy effluent had a positive predictive value of 82.3%, a negative predictive value of 94.1% and test diagnostic accuracy of 90.1%. CONCLUSION: FC from an ileostomy effluent is a highly sensitive and specific test for the assessment and monitoring of small bowel inflammation and disease recurrence in patients with CD.