Safety and Durability of Accelerated Infliximab Dosing Strategies in Pediatric IBD: A Single Center, Retrospective Study.

OBJECTIVES: Infliximab (IFX) is commonly used to treat children with inflammatory bowel disease (IBD). We previously reported that patients with extensive disease started on IFX at a dose of 10 mg/kg had greater treatment durability at year one. The aim of this follow-up study is to assess the long-term safety and durability of this dosing strategy in pediatric IBD. METHODS: We performed a retrospective single-center study of pediatric IBD patients started on IFX over a 10-year period. RESULTS: Two hundred ninety-one patients were included (mean age = 12.61, 38% female) with a follow-up range of 0.1-9.7 years from IFX induction. One hundred fifty-five (53%) were started at a dose of 10 mg/kg. Only 35 patients (12%) discontinued IFX. The median duration of treatment was 2.9 years. Patients with ulcerative colitis ( P ≤ 0.01) and patients with extensive disease ( P = 0.01) had lower durability, despite a higher starting dose of IFX ( P = 0.03). Adverse events (AEs) were observed to occur at a rate of 234 per 1000 patient-years. Patients with a higher serum IFX trough level (≥20 µg/mL) had a higher rate of AEs ( P = 0.01). Use of combination therapy had no impact on risk of AEs ( P = 0.78). CONCLUSIONS: We observed an excellent IFX treatment durability, with only 12% of patients discontinuing therapy over the observed timeframe. The overall rate of AEs was low, the majority being infusion reactions and dermatologic conditions. Higher IFX dose and serum trough level> 20 µg/mL were associated with higher risk of AEs, the majority being mild and not resulting in cessation of therapy.

Personalized Technologies in Chronic Gastrointestinal Disorders: Self-monitoring and Remote Sensor Technologies.

With increased access to high-speed Internet and smartphone devices, patients have started to use mobile applications (apps) for various health needs. These mobile apps are now increasingly used in integration with telemedicine and wearables to support fitness, health education, symptom tracking, and collaborative disease management and care coordination. More recently, evidence (especially around remote patient monitoring) has started to build in some chronic diseases, and some of the digital health technologies have received approval from the Food and Drug Administration. With the changing healthcare landscape and push for value-based care, adoption of these digital health initiatives among providers is bound to increase. Although so far there is a dearth of published evidence about effectiveness of these apps in gastroenterology care, there are ongoing trials to determine whether remote patient monitoring can lead to improvement in process metrics or outcome metrics for patients with chronic gastrointestinal diseases.

Ustekinumab for anti-tumor necrosis factor refractory pediatric ulcerative colitis: a promising approach towards endoscopic healing.

BACKGROUND/AIMS: To describe the role of ustekinumab in inducing remission and endoscopic healing in anti-tumor necrosis factor α nonresponsive pediatric ulcerative colitis patients at a tertiary care inflammatory bowel disease center. METHODS: A retrospective chart review was performed on patients with ulcerative colitis receiving ustekinumab. Primary outcome was steroidfree clinical remission at follow-up. Secondary outcomes were biochemical remission and endoscopic healing. RESULTS: Ten children were analyzed; 7 (70%) had ulcerative colitis, and 3 (30%) had inflammatory bowel disease unspecified with colitis. Median follow-up period was 56 weeks. Nine patients (90%) achieved steroid-free clinical remission and biochemical remission. Seven patients had follow-up colonoscopies, out of which 6 (86%) achieved endoscopic remission, while 1 (14%) underwent colectomy. Out of the 3 patients without a follow-up colonoscopy, fecal calprotectin levels downtrended to < 150 mg/kg in 2 patients and < 400 mg/kg in 1 patient from baseline level of > 2,000 mg/kg. CONCLUSIONS: Ustekinumab appears efficacious in achieving not only clinical and biochemical remission but also has promising role in inducing endoscopic healing end point in patients who fail other biologics.

Frequency of beta-thalassemia trait in families of thalassemia major patients, Lahore.

BACKGROUND: Thalassemia major is one of the most common genetic disorders in Pakistan and over five thousand new patients are added in the pool annually. This familial disease has both medical and social implications, and therefore there is a need to assess the magnitude of beta-Thalassemia trait amongst family members of Thalassemia major patients. METHODS: This cross-sectional descriptive study enrolled 674 blood samples from first degree relatives of registered patients of Thalassemia major at Sir Ganga Ram Hospital, Lahore. Peripheral blood smears were studied for abnormal morphology findings of microcytosis, hypochromia, poikilocytosis (tear drops, target cells) and Erythrocyte indices (haemoglobin, RBCs, mean corpuscular haemoglobin, mean corpuscular volume, mean corpuscular haemoglobin concentration) and Hb electrophoretic (HbA, HbA2, & HbF). RESULTS: Hb electrophoresis showed 61% of the study subjects had haemoglobinopathies. Frequency of beta-Thalassemia trait was highest followed by beta-Thalassemia major, HbE trait, HbD Punjab and Hb intermedia. CONCLUSION: Findings strongly suggest screening for beta-Thalassemia trait in families of Thalassemia major patients.

Diagnostic and Treatment Practices for Helicobacter Pylori Infection in an Academic Pediatric Hospital.

BACKGROUND: In 2016, ESPGHAN/NASPGHAN issued revised guidelines for the management of Helicobacter pylori (H. pylori) infection in children and adolescents. Recommendations include performing antibiotic susceptibility testing to tailor therapy. The aim of our study was to evaluate the H. pylori treatment landscape in pediatric patients at our institution. METHODS: We performed a retrospective study of patients diagnosed with H. pylori infection at a single academic children's hospital from 2015 to 2021. The frequency of each treatment regimen and their respective eradication rates were calculated. We compared trends in antibiotic prescriptions and eradication rates before and after 2016. RESULTS: One hundred and ninety-six patients were included. Triple therapy with amoxicillin, clarithromycin, and a proton pump inhibiter (PPI) was the most often prescribed regimen (46.5%), followed by amoxicillin, metronidazole, and PPI (33%). Eradication rates were 70% for amoxicillin, clarithromycin, and PPI and 64% for amoxicillin, metronidazole, and PPI. CONCLUSION: Our results show eradication rates for both regimens were comparable but suboptimal, highlighting the need to incorporate resistance testing into broader practice.

Unmet Communication and Information Needs for Patients with IBD: Implications for Mobile Health Technology.

AIMS: In order to develop an application that addresses the most significant challenges facing IBD patients, this qualitative study explored the major hurdles of living with IBD, the information needs of IBD patients, and how application technology may be used to improve quality of life. METHODS: 15 IBD patients participated in two focus groups of 120 minutes each. Data collection was achieved by combining focus groups with surveys and direct observation of patients looking at a patient-engaged app (HealthPROMISE) screenshots. The survey elicited information on demographics, health literacy and quality of life through the Short IBD Questionnaire (SIBDQ). RESULTS: The needs of IBD patients center around communication as it relates to both patient information needs and navigating the social impacts of IBD on patients' lives: Communication Challenges regarding Information Needs: Patients cited a doctor-patient communication divide where there is a continued lack of goal setting when discussing treatments and a lack of objectivity in disease control. When objectively compared with the SIBDQ, nearly half of the patients in the focus groups wrongly estimated their IBD control.Communication Challenges regarding Social Impacts of IBD: Patients strongly felt that while IBD disrupts routines, adds significant stress, and contributes to a sense of isolation, the impact of these issues would be significantly alleviated through more conversation and better support.Implication for Mobile Health Solutions: Patients want a tool that improves tracking of symptoms, medication adherence and provides education. Physician feedback to patient input on an application is required for long-term sustainability. CONCLUSIONS: IBD patients need mobile health technologies that evaluate disease control and the goals of care. Patients feel an objective assessment of their disease control, goal setting and physician feedback will greatly enhance utilization of all mobile health applications.