1164 EFFICACY, SAFETY, TOLERABILITY OF USTEKINUMAB IN PEDIATRIC PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: RESULTS FROM UNISTAR, A PHASE 1 STUDY

2020 ◽  
Vol 158 (6) ◽  
pp. S-235-S-236
Author(s):  
Joel R. Rosh ◽  
Dan Turner ◽  
Anne M. Griffiths ◽  
Douglas Jacobstein ◽  
Omoniyi J. Adedokun ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Pediatric Patients ◽  
Phase 1 ◽  
Phase 1 Study

615 PHARMACOKINETICS OF USTEKINUMAB IN CHILDREN AND ADOLESCENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: RESULTS FROM UNISTAR, A PHASE 1 STUDY

2020 ◽  
Vol 158 (6) ◽  
pp. S-131-S-132
Author(s):  
Omoniyi J. Adedokun ◽  
Jeffrey S. Hyams ◽  
Dan Turner ◽  
Anne M. Griffiths ◽  
Natalie A. Terry ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Children And Adolescents ◽  
Phase 1 ◽  
Phase 1 Study

scholarly journals Phase 1 study on the safety and efficacy of E6011, anti‐fractalkine antibody, in patients with Crohn’s disease

2021 ◽  
Author(s):  
Katsuyoshi Matsuoka ◽  
Makoto Naganuma ◽  
Toshifumi Hibi ◽  
Hirohito Tsubouchi ◽  
Kiyoshi Oketani ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Phase 1 ◽  
Phase 1 Study ◽  
Safety And Efficacy

Su1915 Prediction of Anti-TNF Antibody Responses in Crohn's Disease by Endoscopic Molecular Imaging In Vivo: A Clinical Phase 1 Study

2012 ◽  
Vol 142 (5) ◽  
pp. S-535 ◽  
Author(s):  
Raja Atreya ◽  
Helmut Neumann ◽  
Clemens Neufert ◽  
Yurdagül Zopf ◽  
Maximilian J. Waldner ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Molecular Imaging ◽  
Crohn's Disease ◽  
Phase 1 ◽  
Antibody Responses ◽  
Phase 1 Study ◽  
Clinical Phase

scholarly journals P023 CROHN'S DISEASE PRESENTATION IN PEDIATRIC PATIENTS

2009 ◽  
Vol 3 (1) ◽  
pp. 7-8
Author(s):  
C. Jung ◽  
J. Colombel ◽  
L. Beaugerie ◽  
M. Lemann ◽  
J. Cezard ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Pediatric Patients

A Treat to Target Strategy Using Panenteric Capsule Endoscopy in Pediatric Patients With Crohn’s Disease

2019 ◽  
Vol 17 (10) ◽  
pp. 2060-2067.e1 ◽  
Author(s):  
Salvatore Oliva ◽  
Marina Aloi ◽  
Franca Viola ◽  
Saverio Mallardo ◽  
Fortunata Civitelli ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Capsule Endoscopy ◽  
Pediatric Patients ◽  
Treat To Target ◽  
Target Strategy

PP2 SMALL INTESTINE CONTRAST ULTRASONOGRAPHY: A NEW NON-INVASIVE TOOL IN THE ASSESSMENT OF SMALL BOWEL IN PEDIATRIC PATIENTS WITH SUSPECTED OR KNOWN CROHN'S DISEASE

2009 ◽  
Vol 41 ◽  
pp. S204
Author(s):  
F. Civitelli ◽  
N. Pallotta ◽  
F. Viola ◽  
G. DiNardo ◽  
E. Romeo ◽  
...  
Keyword(s):  
Small Intestine ◽  
Crohn’S Disease ◽  
Small Bowel ◽  
Crohn's Disease ◽  
Pediatric Patients ◽  
Non Invasive ◽  
Contrast Ultrasonography

scholarly journals Infliximab treatment time and the mucosal healing effect in pediatric patients with severe Crohn’s disease – own experience

2012 ◽  
Vol 2 ◽  
pp. 87-93 ◽  
Author(s):  
Grażyna Czaja-Bulsa ◽  
Aneta Gębala ◽  
Anna Korlatowicz-Bilar
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Pediatric Patients ◽  
Treatment Time ◽  
Mucosal Healing ◽  
Infliximab Treatment ◽  
Healing Effect

scholarly journals Pharmacokinetics, Pharmacodynamics, and Safety of Etrolizumab in Children With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease: Results from a Phase 1 Randomized Trial

2021 ◽  
Author(s):  
Wenhui Zhang ◽  
Astrid Scalori ◽  
Franklin Fuh ◽  
Jacqueline McBride ◽  
Gaohong She ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Phase 1 ◽  
Receptor Occupancy ◽  
Clinical Activity ◽  
Active Ulcerative Colitis ◽  
Open Label ◽  
Proportional Increase ◽  
Dose Proportional

Abstract Background Etrolizumab, a humanized anti-β7 antibody, has not been studied in children. Here, we evaluate the pharmacokinetics, pharmacodynamics, and safety of etrolizumab in children with inflammatory bowel disease. Methods Patients age 4 to 17 years with moderately to severely active ulcerative colitis or Crohn’s disease were randomized 1:1 to receive 1.5mg/kg of etrolizumab subcutaneously every 4 weeks (q4w) or 3.0mg/kg every 8 weeks (q8w) for 16 weeks in this open-label phase 1 trial. Pharmacokinetics, pharmacodynamics, safety, and efficacy were assessed. Results Of the 24 patients treated, 21 completed the study. In the groups of 1.5mg/kg q4w and 3.0mg/kg q8w, respectively, mean (SD) maximum concentration (Cmax) was 9.8 (4.86) µg/mL and 18.1 (6.25) µg/mL; and mean (SD) area under the curve within a dosing interval (AUCtau) was 167 (86.9) and 521 (306) μg·day/mL after the last dose. The Cmax increased dose proportionally. The AUC over an 8-week period was slightly higher in the 3.0mg/kg q8w dose group. Median half-life was similar for both dosing regimens. Median numbers of free β7high gut-homing T and B cell subsets declined below 10% of baseline, confirming β7 target engagement and complete/near-complete receptor occupancy. Adverse events were consistent with the safety profile in adults. Approximately 60% of patients achieved a clinical response. Conclusions Etrolizumab showed a dose-proportional increase in Cmax and a slightly greater than dose-proportional increase in AUCtau. Both regimens achieved complete/near-complete β7 receptor occupancy, with a similar relationship to concentration as adults. Etrolizumab was well tolerated and demonstrated clinical activity in children.

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