ABSTRACT
Background: Vedolizumab (VDZ) is effective in inducing and maintaining remission in patients with Inflammatory bowel disease (IBD), but limited data exists in the youngest patients diagnosed <6, known as very early onset (VEO)-IBD. We aimed to evaluate the efficacy and safety of VDZ in this cohort. Methods: This was a retrospective study of patients with VEO-IBD followed at the Children's Hospital of Philadelphia, treated with VDZ for >6 months. Data collected included demographics, disease characteristics, medications, hospitalizations, growth, surgeries, and labs. Disease activity was measured using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and Pediatric Crohn Disease Activity Index (PCDAI) at baseline and 6 months. Primary outcome was clinical response defined as a decrease in PUCAI>20 or PCDAI>15 at 6 months. Secondary outcomes included improvement in growth, labs, steroid use and hospitalizations. Continuous variables were analyzed using the Friedman test followed by the Wilcoxon signed-rank test. Nominal data was analyzed using McNemar's test. Results: Thirty-three children with VEO-IBD, 66% male, treated with VDZ were included. Median age of diagnosis was 3.7 years (range 1.2-6 years), with a median baseline disease duration of 3 years (range 0.1-18.5 years). IBDU was classified in 61%, and CD in 39%. Disease location was 70% colonic, 27% ileocolonic and 3% small bowel. Seven patients had prior surgeries, including diverting ileostomies (n=6) and subtotal colectomy (n=1). Nineteen (58%) patients were biologic naïve. VDZ was used as combination therapy in 6 (18%) patients (methotrexate n=4, rapamycin n=1, tacrolimus n=1). Bridge therapy was initiated in 78% of patients, with steroids (n=8) and antibiotics (n=18). Clinical response at 6 months was achieved in 19 patients (58%) with improvement in median PUCAI from 25 to 5 (p<0.01) and median PCDAI from 18.75 to 5 (p<0.05). BMI for age Z-score improved from -0.325 to 0.65 (p<0.001). Steroids and antibiotics were tapered off in 6/8 (75%) and 14/18 (78%, p<0.001) respectively. Hospital length of stay decreased significantly during the 12 months after initiating VDZ compared to 3 months prior to initiation (p<0.05). 2 patients underwent surgery including a subtotal colectomy for colonic stricture and diverting ileostomy within 2 months of starting VDZ. Adverse effects included COVID-19 infection (n=2), influenza (n=2), upper respiratory infection (n=2), pneumonia (n=1), tracheitis (n= 1), cellulitis (n=1), molluscum (n=1), and pityriasis rosea (n=1). Conclusion: VDZ is effective at inducing clinical remission in a subset of children with VEO-IBD primarily with colonic disease. It has a favorable safety profile with minimal reported adverse events observed in this study. This study is limited by small sample size and retrospective design. Larger prospective studies are warranted.
ABSTRACT
Background: In September 2019 Sláintecare helped establish an Integrated Care team for Older People. The aim of this service was to provide a Comprehensive Geriatric Assessment (CGA) to older people within a community network. Service user experience/feedback are critically important for development of a team and a service. To give service users a platform to evaluate the service a patient experience survey was conducted. Methods: The survey was designed by the multidisciplinary team, consisting of 13 closed/3 open questions. A Likert scale was utilised for closed questions and thematic analysis for open questions. A question on impact of COVID-19 was also included. 150 of the 950 service users who received a CGA from June 2020 to June 2021 were selected randomly and invited to participate in the postal survey. All participants received a covering letter, questionnaire and a stamped address envelope to return their completed surveys. Results: 47% response rate (71/150). 77% were aged ≥75. 52% completed the survey themselves, 48% required assistance. 61% attendedmore than twice and most would prefer to attend a local spoke clinic. 96% agreed/strongly agreed that they were satisfied with the service. 99% felt they were treated with dignity/respect and had confidence in the service. 93% agreed that they were involved in care decisions. 82% reported their carers had the opportunity to discuss concerns. Themes emerging included importance of care close to home, avoiding acute hospital, difficulty parking at tertiary centres. 42% highlighted isolation and loneliness due to COVID-19 as a major issue. Conclusion: Service users had an overwhelmingly positive experience especially when care was delivered in clinics close to their homes. Development of the hub and spoke model is acceptable and feasible to older people and their carers' in this region and will be the focus for expansion of this service.