ABSTRACT
Introduction: Pivotal anti-SARS-CoV-2 vaccines clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease (IBD). We aimed to describe the implementation of anti-SARS-CoV-2 vaccines among IBD patients, patients' concerns before vaccination and side-effect profile of the anti-SARS-CoV-2 vaccines using real-world data. Methods: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of patients' characteristics, concerns, vaccination status and side-effect profile were analysed using descriptive statistics and logistic regression. Results: Among the 3272 IBD patients completing the survey (0.1% of the IBD European population), 79.6% had received at least one dose of anti-SARS-CoV- 2 vaccine, and 71.7% had completed the vaccination process. Most of the patients (70.6%) were vaccinated with the Pfizer-BioNTech (BNT162b2) vaccine. Patients over 60 years old had a significantly higher rate of vaccination (OR 2.98, 95% CI 2.20-4.03, p<0.001). Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD (24.6%), having an IBD flare after vaccination (21.1%) and reduced vaccine efficacy due to IBD or associated immunosuppression (17.6%). After the first dose of the vaccine, 72.4% had local symptoms at the injection site and 51.4% had systemic symptoms (5 patients had non-specified thrombosis). Adverse events were less frequent after the second dose of the vaccine and in older patients. When comparing with previous studies from the general population, the IBD patients answering the survey did not seem to have increased side effects (table 1). Only a minority of the patients were hospitalized (0.3%), needed a consultation (3.6%) or had to change IBD therapy (13.4%) after anti- SARS-CoV-2 vaccination. Conclusion: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD. (Table Presented)
ABSTRACT
Introduction: Inflammatory bowel disease (IBD) is a lifelong relapsingremitting condition. Education is one aspect of high quality care that empowers patients with knowledge, skills and confidence to manage their disease. Patient Activation Measure (PAM)1 is an objective tool designed to assess patient empowerment. A high PAM is associated with better clinical outcomes in chronic conditions including IBD.2 We aimed to measure the effect of education on PAM scores for newly diagnosed IBD patients over 12 months. Aims & Methods: A New Diagnosis of IBD clinic (NDC) was set-up whereby patients had a 45 minute consultation delivered jointly by an IBD physician, and nurse specialist. The topics covered were the natural history of IBD, triggers to relapse, self-management of mild relapses, and signposting to reliable information sources. PAM is a tool consisting of 13 questions, which generates a score from 1 (poor activation) to 4 (high activation). A patient with PAM score of ≥3 is considered 'activated'. 2 PAM scores were taken prior to NDC (T1), immediately following NDC (T2) and 12 months later (T3). The primary outcome was the proportion of activated patients at 12 months. A change in PAM score by ≥1 was a secondary outcome. Data on age, gender, ethnicity, smoking, IBD sub-type, and baseline disease activity were collected. An amendment to assess patient activation due to the COVID-19 pandemic was made. Data was collected on change in employment due to COVID-19, and/or having PCR proven COVID-19, and the use of healthcare resources. Median (IQR) and mean (±SD) described continuous variables. Unpaired and paired categorical variables were compared with Fischer's test and McNemar's test respectively. Results: 54 patients attended the NDC;38 completed the study (20 male);16 were lost to follow-up (LFU) and thus only had a baseline score recorded, and were excluded from 12 month analysis. Median age was 42(range 18-83) years. 24 patients had ulcerative colitis, 10 Crohn's disease, and 4 had IBD-unclassified. 25 had active disease at baseline. The mean time from symptom onset to NDC attendance was 3.26 (±2.89) months. At T1, the median PAM score for the 38 patients was 3 (IQR 2) in contrast to 1 (IQR 1) for the LFU group. 24 (63%) had a PAM score ≥3 (activated) at T1, and T2. 14 patients were PAM <3 (non-activated) at T1 of whom 8 (57%) had an increase PAM by ≥1 at T2, (p=0.0133). From this non-activated patient cohort at T1, 9/14 patients (64%) had an improved PAM at T3. At T3, 23/38 (60%) had a PAM score ≥3;11/38(29%) had an improvement in PAM of ≥1 and13/38 (34%) patients had no change. PAM score changes were independent of disease activity, age, gender, ethnicity or smoking. The COVID affected group included 6 patients with PCR proven COVID infection (1 death) and 9/38 patients with a change in employment due to COVID. This group was labelled the COVID group. 5/15 patients in the COVID group had a PAM score ≤2 at T1;an improvement in PAM by ≥1 was seen at T3 in all 5 cases. 6/9 (67%) activated patients in the COVID group at T1 in maintained activation at T3. 19/24 patients in the non-COVID group made use of healthcare resources compared to 8/14 in the COVID group (p=0.0027). Conclusion: Patient activation at baseline was sustained at 12 months. There was an improvement in PAM of ≥1 immediately after attendance at the NDC. This improvement is independent of the patient demographics, or disease status. The COVID-19 pandemic was not associated with a worsening in PAM, or an increase in demand on healthcare resources.