Clinical outcomes and cost savings of a nonmedical switch to a biosimilar in children/young adults with inflammatory bowel disease.

OBJECTIVES: The safety, efficacy, and cost savings associated with biosimilar medications are well established. However, a lack of pediatric data exists surrounding clinical outcomes when switching from an originator to a biosimilar. Our primary aim is to evaluate clinical outcomes following a nonmedical switch from the infliximab originator to a biosimilar in children and young adults with inflammatory bowel disease (IBD). Our secondary aim is to estimate cost savings associated with this switch. METHODS: A quality improvement project was implemented to establish safe switching protocols, then those patients who underwent a nonmedical switch from the infliximab originator to the biosimilar were retrospectively reviewed. Demographic data, physician global assessments (PGAs), and laboratory values were recorded 1 year pre- and post-switch. Continuation rates on the biosimilar were reported at 6 and 12 months. Cost savings were estimated using two different pricing models. RESULTS: Fifty-three patients underwent a nonmedical switch. Laboratory values including inflammatory markers, infliximab levels, and PGA scores remained similar when assessed pre- and post-switch. No infusion reactions or antidrug antibody development occurred. Two patients reported psoriasis-like rashes. Five patients switched back to the originator during the study period. There were 379 biosimilar infusions completed with an estimated total cost savings of $11,260 (average sales price) and $566,223 (wholesale acquisition cost). CONCLUSIONS: Clinical remission rates, inflammatory laboratory markers, serious adverse events, infliximab levels, and antidrug antibodies remained similar after a one-time nonmedical switch to an infliximab biosimilar. Nonmedical switching to biosimilars resulted in significant cost savings.

Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease.

OBJECTIVES: Therapeutic drug monitoring (TDM) and dose optimization have been shown to improve clinical outcomes with antitumor necrosis factor and recent studies in adults suggest an exposure-response relationship with drug levels associated with improved clinical outcomes. However, these levels are not universally recognized as therapeutic targets for vedolizumab dosing. We aimed to assess the impact of a TDM quality improvement (QI) initiative on 52-week clinical outcomes and describe proactively obtained vedolizumab levels during the induction period in children with inflammatory bowel disease (IBD). METHODS: A QI initiative to proactively obtain TDM levels at Week 6 was implemented in 2019. A retrospective review of pediatric patients with IBD treated with vedolizumab from 2018 to 2022 was performed. Baseline demographic data, medication dosing details, disease characteristics, lab results, and 12-month clinical outcomes were recorded. For this study, we defined therapeutic target levels (>20 µg/mL at Week 6 and >12 µg/mL during maintenance) based on existing data correlating these levels with improved clinical outcomes. RESULTS: Fifty-nine patients (31 Crohn disease [CD], 28 ulcerative colitis [UC]/indeterminate colitis [IC]) were included in the study. In total, 68% (40/59) of patients had vedolizumab levels at Week 6 and 90% (53/59) had levels drawn at Week 6 or 14. Thirty-five percent of Week 6 trough levels were below our defined target of 20 µg/mL. Fifty-two of 59 patients had available data at 52 weeks. Over 80% (42/52) of patients remained on vedolizumab 52 weeks after initiation (CD 79% [23/29], UC/IC 83% [19/23]). Sixty-two percent (26/42) of patients that remained on vedolizumab at 52 weeks were treated with an intensified dosing interval of <8 weeks. Thirty-one of these 42 (74%) were in clinical remission (CR) rate at 52 weeks with 29/42 (69%) in corticosteroid-free remission. The CR rate for the entire cohort including those who discontinued therapy due to a lack of efficacy before 52 weeks was 60% (31/52). CONCLUSION: Proactive TDM and early dose optimization with vedolizumab may improve drug durability and clinical outcomes in pediatric patients with IBD.

Progression of Pediatric Crohn's Disease Is Associated With Anti-Tumor Necrosis Factor Timing and Body Mass Index Z-Score Normalization.

BACKGROUND & AIMS: The evolution of complicated pediatric Crohn's disease (CD) in the era of anti-tumor necrosis factor (aTNF) therapy continues to be described. Because CD progresses from inflammatory to stricturing (B2) and penetrating (B3) disease behaviors in a subset of patients, we aimed to understand the risk of developing complicated disease behavior or undergoing surgery in relation to aTNF timing and body mass index z-score (BMIz) normalization. METHODS: Multicenter, 5-year longitudinal data from 1075 newly diagnosed CD patients were analyzed. Descriptive statistics, univariate and stepwise multivariate Cox proportional hazard regression (CPHR), and log-rank analyses were performed for risk of surgery and complicated disease behaviors. Differential gene expression from ileal bulk RNA sequencing was correlated with outcomes. RESULTS: Stricturing complications had the largest increase: from 2.98% to 10.60% over 5 years. Multivariate CPHR showed aTNF exposure within 3 months from diagnosis (hazard ratio [HR], 0.33; 95% CI, 0.15-0.71) and baseline L2 disease (HR, 0.29; 95% CI, 0.09-0.92) to be associated with reduced B1 to B2 progression. For children with a low BMIz at diagnosis (n = 294), multivariate CPHR showed BMIz normalization within 6 months of diagnosis (HR, 0.47; 95% CI, 0.26-0.85) and 5-aminosalicyclic acid exposure (HR, 0.32; 95% CI, 0.13-0.81) were associated with a decreased risk for surgery while B2 (HR, 4.20; 95% CI, 1.66-10.65) and B2+B3 (HR, 8.24; 95% CI, 1.08-62.83) at diagnosis increased surgery risk. Patients without BMIz normalization were enriched for genes in cytokine production and inflammation. CONCLUSIONS: aTNF exposure up to 3 months from diagnosis may reduce B2 progression. In addition, lack of BMIz normalization within 6 months of diagnosis is associated with increased surgery risk and a proinflammatory transcriptomic profile.

Patient, Parent, and Provider Perceptions of Barriers to Pediatric Inflammatory Bowel Disease Care.

Objectives: Children with inflammatory bowel disease (IBD) have a significant life-long burden as a result of disease, impacted by environmental and individual barriers. Successful health system interventions require a comprehensive approach, informed by various stakeholders. The main objective was to identify health system barriers and potential solutions from existing patients, families, and providers via focus groups. Methods: Participants for the focus groups were existing English-speaking patients (ages 9-18) with IBD, their caregiver(s), and providers including multiple professions (eg, physician, nurse, pediatrician, social worker, care coordinator, scheduler, and psychologist). Separate focus groups were led by experienced personnel for parents, children, and providers, using a standardized interview guide. Sessions were recorded, transcribed, and verified. Using content analysis, we systematically classified data through coding and identified themes. Results: Focus groups comprised (a) 3 patient groups (n = 20, 50% female, including 2 younger; mean age = 11.4 ± 1.5 years) and 1 older group (mean age = 15.6 ± 1.3 years), (b) 3 parent groups (n = 24, 83% female), and (c) 2 multidisciplinary provider groups (n = 19). Families shared several common concerns with providers (eg, school, care delay, psychosocial, and financial) but varied on specifics. Some barriers may be addressable through family or staff education, improved communication (eg, care delay/ access, transition), or training (eg, labs and diet), while others may require change at an institutional or policy level (eg, insurance). Conclusions: This qualitative analysis identified several barriers to IBD care, some shared, some unique to patients, parents, and providers, highlighting the importance of obtaining multiple stakeholder perspectives when exploring barriers to care.

Impact of Telemedicine on Delivery of Pediatric Inflammatory Bowel Disease Care.

OBJECTIVES: Outpatient inflammatory bowel disease (IBD) care shifted from office visits (OVs) to a model with integrated telemedicine during the 2020 COVID-19 pandemic. We describe the impact of this shift on delivery of pediatric IBD care. METHODS: We collected electronic medical record data from office and telemedicine visits for pediatric patients with IBD at a single center from April 2019 to December 2020. We compared visit volume, duration, and test ordering between 2019 and 2020, and between OV and telemedicine, and assessed for differences in telemedicine adoption by sociodemographic factors. RESULTS: Visit volume was maintained between 2019 and 2020. Median overall appointment time was shorter for telemedicine versus OV [46 (interquartile range, IQR 35-72) vs 62 (IQR 51-80) minutes; P < 0.001] with no significant difference in time spent with provider [28 (IQR 21-41) vs OV 30 (IQR 24-39) minutes; P = 0.08]. Accounting for drive time, telemedicine visits were 2.6 times shorter than office visits in 2020 ( P < 0.001). In univariate analyses, there was no difference in telemedicine utilization by race or gender. Variables significantly associated with telemedicine were older age, English as primary language, being non-Hispanic, commercial insurance, living in an area of very high opportunity, and having a longer drive time to the office ( P < 0.05 for all comparisons). In multivariate analyses, visits among patients with commercial insurance were significantly more likely to be conducted via telemedicine ( P = 0.02). Among those with a telemedicine visit, multivariate analyses demonstrated multiracial patients were significantly more likely to have video visits (vs audio-only; P = 0.02), while patients with public insurance, no or missing insurance, and whose primary language was Arabic were significantly less likely to have video visits ( P < 0.05 for all comparisons). CONCLUSIONS: Integrated telemedicine allowed for continued delivery of pediatric IBD care and significantly decreased appointment time. While telemedicine may improve access for those who live further from the office, concerns remain about the introduction of disparities.

Outcomes for Standardized Home and Hospital-Based Infusions of Infliximab for Children With Inflammatory Bowel Disease.

BACKGROUND: Pediatric inflammatory bowel disease (IBD) is commonly treated with infliximab in a hospital setting. Utilization of home infusions (HI) is increasing due to insurance mandates, travel time savings, and convenience. We evaluated adverse outcomes (AOs) of infliximab infusions in children with IBD receiving HI compared to hospital-based infusions. METHODS: Children receiving HI between September 2016 and September 2018 were retrospectively matched based on age, race, ethnicity, sex, and disease type to a cohort receiving infliximab at a hospital-based center. A survival analysis evaluated the hazard ratio for AOs in HI relative to hospital-infused children over 2 years. AOs were defined as discontinuation of therapy for clinically relevant reasons, IBD-related hospitalizations, and emergency department visits. RESULTS: We included 102 children (51 pairs) (63% male, 91% White, 92% Crohn disease). Disease location, behavior, growth status, and disease severity were similar between the 2 cohorts. Quiescent disease increased from 3% to 93% after 2 years without cohort differences. At baseline, 94% of HI patients and 88% of controls were on 5 mg/kg every 8 weeks as standard maintenance therapy. Within 2 years, only 19% remained on 5 mg/kg and the remainder required increased dosing or decreased interval. The HI cohort had fewer labs obtained ( P < 0.001), though laboratory values, number of clinic visits, and frequency of AOs were similar. CONCLUSION: Drug durability, AOs, and laboratory values were similar between HI and hospital-based infusions. These findings suggest HI may be as effective as hospital-based infusions, provided a standardized care approach is utilized.

Diagnosis and Treatment of Iron Deficiency and Anemia in Youth With Inflammatory Bowel Disease.

OBJECTIVES: Iron deficiency (ID) with and without anemia is prevalent in children and adults diagnosed with inflammatory bowel disease (IBD), but often goes unrecognized. We hypothesized, quality improvement (QI) methodology could increase the screening for and treatment of ID in children newly diagnosed with IBD. METHODS: We developed and implemented an easy-to-follow algorithm to facilitate screening for and treatment of ID for patients diagnosed with IBD. Through a series of Plan-Do-Study-Act cycles, the approach was modified to increase screening and treatment of ID. Data between January 2019 and July 2021 were assessed using statistical process control. RESULTS: Among patients newly diagnosed with IBD, 298 patients were included (67% Crohn disease, 29% ulcerative colitis, 4% indeterminate colitis, and 56% males). Rates of ID screening increased significantly from a baseline of 20% to >90%. Of the 232 patients screened for ID during the improvement period, 205 (88%) met criteria for either iron deficiency anemia (IDA) or ID at diagnosis, specifically, 151 (65%) met criteria for IDA and 54 (23%) met criteria for ID. CONCLUSIONS: Use of QI methodology to standardize screening assessments for ID among children newly diagnosed with IBD improved screening rates from a baseline of 20% to >90%, with 88% of patients found to have IDA or ID.

Treatment and biologic maintenance-dosing patterns among pediatric patients with ulcerative colitis or Crohn's disease.

OBJECTIVES: To assess treatment patterns and initial and maintenance dosing of biologics over 3 years in pediatric patients with ulcerative colitis (UC) or Crohn's disease (CD), utilizing data from the ImproveCareNow registry. METHODS: Pediatric patients diagnosed with UC or CD and aged 2-17 years were included in the study. Descriptive statistics were employed to summarize baseline demographics. The proportion of patients on medication for UC or CD were analyzed at the baseline visit, 1-year, and 3-year time points (Cohort 1). Biologic maintenance dosage was calculated only for patients who had data for dose and weight at all-time points (Cohort 2). RESULTS: In Cohort 1 (UC = 1784; CD = 4720), baseline treatment in UC included corticosteroid, 5-ASA, and 6-MP/AZA; at 1-year and 3-year time points, treatment with 5-ASA and corticosteroid decreased, whereas 6-MP/AZA and anti-TNFs increased. In CD, baseline treatment included corticosteroid, anti-TNF, 6-MP/AZA, and methotrexate; use of corticosteroids decreased, whereas the use of methotrexate and anti-TNFs increased over 3 years. In Cohort 2 (UC = 350; CD = 1537), at first maintenance dose, UC patients on infliximab received a mean dose of 10.5 mg/kg/8 wk, adalimumab (weight < 40 kg and ≥40 kg) 1.3 mg/kg/2 wk and 0.8 mg/kg/2 wk, and vedolizumab 6.9 mg/kg/8 wks. At the first maintenance dose, CD patients on infliximab received a mean dose of 8.1 mg/kg/8 wk, adalimumab (weight < 40 kg) 1.1 mg/kg/2 wk, adalimumab (weight ≥ 40 kg) 0.8 mg/kg/2 wk, and vedolizumab 10.5 mg/kg/8 wks. CONCLUSION: The use of corticosteroids was common at the initial visit in patients. Anti-TNFs remain the most used class of biologics, however, reported doses in our study were substantially higher than the standard dosing guidelines.

Improving Hepatitis B Vaccination Rates among At-risk Children and Adolescents with Inflammatory Bowel Disease.

Patients with inflammatory bowel disease (IBD) receiving tumor necrosis factor alpha inhibitors (TNFai) may be at higher risk for hepatitis B virus (HBV) infection. We conducted a quality improvement (QI) initiative to improve HBV vaccination rates in seronegative children with IBD. Methods: This QI initiative implemented an HBV vaccination strategy from September 2018 to March 2020 in patients with newly diagnosed IBD with hepatitis B surface antibody (HBsAb) <10 mIU/mL. The project aimed to (1) increase HBV vaccination rates in seronegative patients and (2) document immunogenicity after completing a three-dose vaccine series. Outcome measures included the percentage of seronegative patients who received HBV vaccines (dose 1 and three-dose series). Interventions included applying a standardized vaccination protocol, and creating a vaccine workflow in two clinical areas, previsit planning and stakeholder engagement. Results: One hundred seventy-four children and adolescents with IBD were evaluated during the study period, and 132 (76%) were HBsAb negative. After plan-do-study-act (PDSA) 1, the proportion of eligible patients who received HBV vaccine dose 1 increased from a baseline of 7% to 100% and was sustained for over 12 months. During PDSA 2, the proportion of patients completing the three-dose vaccine series improved from a baseline of 0% to 82% (n = 100); among 93 children in this subgroup who had repeat serology performed, 86 (92%) demonstrated serologic evidence of HBV protection. Conclusions: A multidisciplinary approach applying QI methodology allowed for improved and sustained HBV vaccination rates in at-risk seronegative children and adolescents with IBD. A three-dose HBV vaccine series proved immunogenic in 92% of eligible patients.

ACR Appropriateness Criteria® Crohn Disease-Child.

Crohn disease is an inflammatory condition of the gastrointestinal tract with episodes of exacerbation and remission occurring in children, adolescents, and adults. Crohn disease diagnosis and treatment depend upon a combination of clinical, laboratory, endoscopic, histological, and imaging findings. Appropriate use of imaging provides critical information in the settings of diagnosis, assessment of acute symptoms, disease surveillance, and therapy monitoring. Four variants are discussed. The first variant discusses the initial imaging for suspected Crohn disease before established diagnosis. The second variant pertains to appropriateness of imaging modalities during suspected acute exacerbation. The third variant is a substantial discussion of recommendations related to disease surveillance and monitoring of Crohn disease. Finally, panel recommendations and discussion of perianal fistulizing disease imaging completes the document. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

6- and 12-Month Outcomes after 90:10 Enteral Nutrition Induction Therapy in Pediatric Crohn's Disease.

OBJECTIVES: Studies describing longer-term outcomes after EEN induction are limited. We describe clinical outcomes during 90:10 EN induction, and 6- and 12- month outcomes among patients that successfully completed EN induction and then continued either EN or immunomodulator (IM) maintenance therapy. METHODS: All children with CD treated with 90:10 EN induction protocol (90% formula:10% regular diet) at our IBD Center from 2013 to 2018 were retrospectively reviewed. Demographic, clinical, and laboratory data were recorded at baseline, 6, and 12 months (± 3 months at each timepoint). Therapy changes after initiation of EN induction through 12 months were recorded. Among patients that successfully completed 90:10 induction, outcomes between EN and IM maintenance groups were compared. RESULTS: In total, 44/105 (42%) patients completed 8-12 weeks of 90:10 EN induction. Sixty-one patients had incomplete EN induction, with 52% requiring corticosteroids and 25% anti-TNF therapy as alternate induction approaches. Forty-four patients completed EN induction (18 continued EN maintenance and 26 IM maintenance therapy). Twenty-seven of these 44 (61%) remained on initial maintenance therapy at 6 months (10/18 (56%) EN and 17/26 (65%) IM). In total, 16/44 (36%) remained on their initial maintenance therapy at 12 months. By 12 months, 10 patients required anti-TNF and 11 corticosteroids after successful completion of induction. CONCLUSIONS: In this retrospective study of short and longer-term outcomes after 90:10 EN induction, the need for an alternate induction therapy was common, most frequently to anti-TNF or corticosteroid therapy. Future studies are needed to evaluate for predictors of long-term success after EN induction.

Overweight and Obese Status Is Not Associated With Disease Activity for Children and Adolescents With Newly Diagnosed Inflammatory Bowel Disease.

INTRODUCTION: Despite the high prevalence of pediatric obesity, its impact on Crohn's disease (CD) and ulcerative colitis (UC) activity remains poorly characterized. The aim of this study was to evaluate disease-related outcomes in overweight and obese children with CD and UC. METHODS: We conducted a retrospective cohort study using the ImproveCareNow Network, a multicenter registry of children with inflammatory bowel disease. We included children with newly diagnosed CD and UC enrolled in ImproveCareNow Network from September 2006 to December 2018 who had at least 1 follow-up visit 12-18 months after diagnosis. Patients were stratified into normal weight, overweight, or obese categories. Primary outcome was remission at 1 year based on physician's global assessment (PGA); key secondary outcomes included short pediatric CD activity index and pediatric UC activity index. RESULTS: There were 4,972 children included (70% CD). Compared with normal weight, obese and overweight children with CD did not have worse disease activity at 1 year based on PGA. However, obese children did have modestly worse disease activity based on short pediatric CD activity index (inactive 43% vs 58%, mild 48% vs 36%, and moderate-severe 9% vs 7% for obese vs normal weight, P < 0.01). For children with UC, there were no differences in disease activity at 1 year based on PGA or pediatric UC activity index. Logistic regression mirrored these findings. DISCUSSION: Obese and overweight children with newly diagnosed inflammatory bowel disease do not seem to have worsened disease activity at 1 year after diagnosis compared with normal weight children.

Patient and Caregivers' Perspectives on Biosimilar Use in Pediatric Inflammatory Bowel Disease.

BACKGROUND: Studies assessing adult inflammatory bowel disease (IBD) patient perspectives on biosimilar use revealed that most were unfamiliar with biosimilars and had a negative perception. The objective of this study was to evaluate the perspectives of pediatric patients with IBD and their caregivers regarding biosimilar use and non-medical switches. METHODS: A survey was given to a cross section of patients with IBD ages 11-21 years receiving the intravenous anti-tumor necrosis factor originator and caregivers of patients with IBD ages 3-21 years receiving the originator. Recruitment occurred via mail, during clinic visits, and infusions. Fisher exact tests were used to test for statistically significant differences. RESULTS: Response rate amongst caregivers was 49% (n = 98) and among patients was 35% (n = 67). Sixty-four percent of caregivers and 79% of patients had never heard of biosimilars. There was increased discomfort surrounding the use of biosimilars and switching to a biosimilar amongst caregivers who had previously heard of biosimilars compared to caregivers who had not previously heard of biosimilars ( P < 0.05). Similar concerns were not seen in patient respondents. The length of time on the originator had no effect on patient or caregiver concerns related to biosimilar efficacy, adverse effects, or switches. CONCLUSION: The majority of pediatric patients and caregivers had never heard of biosimilars. Caregivers that had heard of biosimilars before the study were more likely to have a negative perception of them. This study highlights the importance of providing thorough and accurate education to pediatric patients and families regarding the safety and efficacy of biosimilars.

Risk of Post-Resection Recurrence in Pediatric Crohn Disease.

BACKGROUND: Ileocecectomy related to stricturing, fistula formation, or medically refractory disease is commonly required in patients with Crohn disease (CD). Limited research exists in endoscopic recurrence (ER) in pediatric inflammatory bowel disease (IBD). In this study, we sought to determine ER rates and the impact of therapy duration before surgery in pediatric patients with CD. METHODS: This was a single-center retrospective review of patients with CD between the ages of 2 to 20 years who required ileocecectomy between January 2015 and December 2019 at Nationwide Children's Hospital. Follow-up endoscopies, laboratory values, medications, and sPCDAI scores were recorded at 6, 12, 24, and 36 months post-resection wherever available. Modified Rutgeert scores (mRS) were independently assigned to post-resection colonoscopy images by 3 trained investigators. Post-resection outcomes were compared between patients on CD therapy >30 days before resection (late surgery) to those started on CD therapy <30 days before resection (early surgery). RESULTS: A total of 48 patients underwent ileocecectomy, with a mean age at time of resection of 17 years (+/-2.3). In total, 88% of patients had a post-resection endoscopy and 57% had an endoscopy within 12 months of resection. Twenty-nine percentage had ER with a mRS ≥i2. There was no statistical difference in endoscopic and clinical outcomes after resection between the early and late surgery groups. CONCLUSIONS: Post-resection endoscopic recurrence after ileocecectomy was found in 29% of our center's pediatric CD population based on mRS. Post-resection outcomes were not affected by therapy duration before resection.

Postcolectomy Enteritis in a Pediatric Patient With Ulcerative Colitis.

Postcolectomy enteritis is characterized by diffuse small bowel inflammatory changes following colectomy for medically refractory ulcerative colitis. Symptoms may include abdominal pain, massive intestinal bleeding, intestinal perforation, and high stoma output. While the exact pathogenesis is unknown, immune dysregulation with increased cytokine and inflammatory cell response is suspected to lead to the inflammatory response. Therefore, immunosuppressive medications are the mainstay for treatment. All cases to date have been described in adult patients. We present a case of postcolectomy enteritis in a pediatric patient who improved without significant intervention.

Clinical Outcome Assessments in Pediatric Patients With Ulcerative Colitis and Crohn's Disease Receiving Biologics: A Retrospective Cohort Study.

Background: To assess disease activity, steroid-free remission, and other clinical outcome assessments among pediatric patients with ulcerative colitis (UC) and Crohn's disease (CD) in the ImproveCareNow (ICN) registry. Methods: Patients aged 2-17 years diagnosed with UC or CD between June 1, 2013 and December 31, 2019 were enrolled if they initiated a biologic after enrollment in the ICN registry and completed at least 12 months follow-up after first maintenance dose. Baseline (at biologic initiation) demographics were summarized using descriptive statistics. Pediatric UC Activity Index (PUCAI), partial Mayo score, and Physician Global Assessment (PGA) were assessed for UC; and the Short Pediatric Crohn's Disease Activity Index (sPCDAI) and PGA were assessed for CD at first maintenance dose, 1- and 3-year time points. Kappa coefficients were used to assess the level of agreement between the outcome measures. Results: A total of 1887 patients (UC = 350; CD = 1537) were included. Baseline demographics were similar across groups. For UC patients, mean PUCAI scores decreased and the proportion of patients in steroid-free remission, quiescent state based on PGA, and remission based on partial Mayo score increased from first maintenance dose to 1 and 3 years. For CD patients, mean sPCDAI score of CD patients decreased and the proportion of patients in steroid-free remission by sPCDAI and in quiescent state based on PGA increased from first maintenance dose to 1 and 3 years. Kappa coefficients showed only modest correlation between disease activity assessments. Conclusions: Disease activity scores improved over time, with more pediatric patients with UC and CD achieving steroid-free remission at 1 and 3 years after first biologic maintenance dose.

The Pediatric Inflammatory Bowel Disease Medical Home: A Proposed Model.

Care for patients with inflammatory bowel disease (IBD) can be complex and costly. Care delivery models to address these challenges and improve care quality are essential. The patient-centered medical home (PCMH), which was developed in the primary care setting, has recently been applied successfully to the adult IBD population. Following the tenets of the PCMH, this specialty medical home (SMH) emphasizes team-based care that is accessible, comprehensive, patient/family-centered, coordinated, compassionate, and continuous and has demonstrated improved patient outcomes. Children and young adults with IBD have equally complex care needs, with additional challenges not faced by the adult population such as growth, physical and psychosocial development, and transition of care from pediatric to adult providers. Thus, we advocate that the components of the PCMH are equally-if not more-important in caring for the pediatric patient population. In this article, we review what is known about the application of the PCMH model in adult IBD care, describe care delivery within the Center for Pediatric and Adolescent IBD at Nationwide Children's Hospital as an example of a pediatric IBD medical home, and propose a research agenda to further the development and dissemination of comprehensive care delivery for children and adolescents with IBD.

This article summarizes the literature regarding the adult inflammatory bowel disease medical home, highlights the need for similar models in pediatrics using the Nationwide Children's Hospital program as an example, and outlines next steps to support research and development of the pediatric IBD medical home.

Applying Telemedicine to Multidisciplinary Pediatric Inflammatory Bowel Disease Care.

Multidisciplinary care is essential to the delivery of comprehensive, whole-person care for children and adolescents with inflammatory bowel disease (IBD). Team members may include medical, psychosocial, and ancillary providers as well as patient and family advocates. There is significant variability in how this care is delivered from center to center, though prior to the COVID-19 pandemic, most care occurred during in-person visits. At the onset of the pandemic, medical systems world-wide were challenged to continue delivering high quality, comprehensive care, requiring many centers to turn to telemedicine technology. The aim of this manuscript is to describe the process by which we converted our multidisciplinary pediatric and adolescent IBD visits to a telemedicine model by leveraging technology, a multidisciplinary team, and quality improvement (QI) methods. Finally, we put our experience into context by summarizing the literature on telemedicine in IBD care, with a focus on pediatrics and multidisciplinary care.

Predicting Suboptimal Transitions in Adolescents With Inflammatory Bowel Disease.

OBJECTIVES: Adolescents and young adults (AYAs) are at risk for disease exacerbations and increased health care utilization around the time of transition to adult care. Our aim was to identify risk factors predictive of a suboptimal transition for AYA with inflammatory bowel disease. MATERIALS AND METHODS: We performed a retrospective chart review of patients with pediatric inflammatory bowel disease transferred to adult care from our institution in 2016 and 2017, recording demographic, psychosocial, and disease-specific data. Post-transfer data were obtained via the health care information exchange from the adult provider within our electronic medical record. We defined suboptimal transition as either a return to pediatric care or requiring care escalation within 1 year of transfer. RESULTS: Out of 104 subjects 37 (36%) were found to have had a suboptimal transition. Our models suggest that a suboptimal transition is associated with several risk factors including any mental health diagnosis (odds ratio [OR] = 4.15; 95% confidence interval [95% CI]: 1.18-14.59), history of medication nonadherence (OR = 5.15 [95% CI: 1.52-17.42]), public insurance (OR = 6.60 [95% CI: 1.25-34.96]), higher Physician Global Assessment score at time of transition (OR = 6.64 [95% CI: 1.60-27.58], and short Pediatric Crohn Disease Activity Index scores (OR = 1.17 [95% CI: 1.03-1.33]). Higher hemoglobin levels at transition were protective (OR = 0.69 [95% CI: 0.48-0.98]). Age at time of transition, disease duration, and medication type at transition were not found to be associated with transition outcomes. CONCLUSION: AYA with public insurance, a mental health history, medication nonadherence, and evidence of active disease may be at greater risk for suboptimal and poor health outcomes at transition.