TY - JOUR
T1 - Treatment and biologic maintenance-dosing patterns among pediatric patients with ulcerative colitis or Crohn’s disease
AU - for the ImproveCareNow Network
AU - Hunter, Theresa
AU - Komocsar, Wendy J.
AU - Colletti, Richard B.
AU - Liu, Chunyan
AU - Benkov, Keith J.
AU - Dotson, Jennifer L.
AU - Steiner, Steven J.
AU - Zhang, Nanhua
AU - Crandall, Wallace
N1 - Funding Information:
Theresa Hunter is employee and stockholder of Eli Lilly and Company. Wendy J. Komocsar is employee and stockholder of Eli Lilly and Company and worked on contract with ImproveCareNow to support the data queries used in this manuscript. Richard B. Colletti declares to have received consulting fee from Janssen Biotech. Chunyan Liu and Nahua Zhang are employees of Cincinnati Children’s Hospital Medical Center and have received funding from Eli Lilly and Company through their organization for this study. Keith Benkov and Steven J. Steiner declare no conflicts. Jennifer L. Dotson received registration and stipend as faculty participation by Crohn’s and Colitis Foundation for the Crohn’s and Colitis Congress meeting in January 2020; volunteers on local CMAC, regional Board, and National Scientific Advisory Committee as a committee co-chair for Crohn’s and Colitis Foundation. Wallace Crandall is an employee of Eli Lilly and Company. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Funding Information:
Suchita Dubey, an employee of Eli Lilly Services India Pvt. Ltd. provided writing support. Meena Ravuri, an employee of Eli Lilly Services India Pvt. Ltd., provided support in addressing peer reviewer comments from the journal.
Funding Information:
The study was funded by Eli Lilly and Company.
Publisher Copyright:
© 2022 Eli Lilly and Company. Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - Crohn’s disease
KW - Pediatrics
KW - bDMARDs
KW - children
KW - inflammatory bowel disease
KW - ulcerative colitis
UR - http://www.scopus.com/inward/record.url?scp=85141676853&partnerID=8YFLogxK
U2 - 10.1080/03007995.2022.2135836
DO - 10.1080/03007995.2022.2135836
M3 - Article
C2 - 36263735
AN - SCOPUS:85141676853
VL - 39
SP - 63
EP - 69
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
SN - 0300-7995
IS - 1
ER -