Vedolizumab: A Review of Its Use in Adult Patients with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease

BioDrugs ◽  
2014 ◽  
Vol 29 (1) ◽  
pp. 57-67 ◽  
Author(s):  
K. P. Garnock-Jones
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adult Patients ◽  
Active Ulcerative Colitis

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.

The Effect of Mesalamine and Nicotine in the Treatment of Inflammatory Bowel Disease

1997 ◽  
Vol 31 (7-8) ◽  
pp. 907-913 ◽  
Author(s):  
Charles R. Bonapace ◽  
David A. Mays
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Relapse Rate ◽  
Bowel Disease ◽  
Therapeutic Agent ◽  
Active Ulcerative Colitis ◽  
Steroid Dependence ◽  
Inflammatory Bowel

OBJECTIVE: To characterize the usefulness of mesalamine and nicotine in the treatment of active ulcerative colitis and inactive Crohn's disease. DATA SOURCES: Citations were selected from the MEDLINE database. Only those involving human subjects, inflammatory bowel disease, and available in English were selected. STUDY SELECTION: Selection criteria consisted of clinical trials and review articles assessing the effects of mesalamine and nicotine in active ulcerative colitis or inactive Crohn's disease and the utility of reducing steroid dependence or relapse rate. Less than 20% of the articles identified met the selection criteria. DATA SYNTHESIS: In patients with inactive Crohn's disease, mesalamine 2 g/d significantly reduced the risk of relapse in high-relapse-risk patients compared with placebo, reducing the relapse rate from 71% to 55%, but was ineffective in preventing recurrence of inactive Crohn's disease following surgical resection. Mesalamine 4 g/d was effective in decreasing weaning failure due to steroid dependence by 67%, although the relapse rate was not significant compared with placebo at the end of 12 months. Following surgical resection, mesalamine was unable to significantly reduce the incidence of recurrence compared with placebo at the end of 1 year. In patients with active ulcerative colitis, oral mesalamine 2 and 4 g/d was superior to placebo in inducing remission compared with placebo. Among patients with prior steroid or sulfasalazine treatment, rectal mesalamine 4 g hs achieved a remission rate of 78% in more than 12 weeks of therapy. Other studies have not found a dose—response relationship with lower dosages of mesalamine. Whereas nicotine 15–25 mg/d administered as a transdermal patch produced greater symptomatic improvement in active ulcerative colitis compared with placebo, nicotine 15 mg/16 h produced results no different from those with placebo in maintaining remission in inactive ulcerative colitis. Nicotine appears to have an adverse effect on the course of Crohn's disease and is not recommended. CONCLUSIONS: Mesalamine has demonstrated clinical effectiveness as a therapeutic agent in the treatment of active ulcerative colitis and inactive Crohn's disease. Although its relationship to inflammatory bowel disease has been known for many years, the usefulness of nicotine for the treatment of active ulcerative colitis requires further exploration before it can be recommended as a therapeutic agent.

A New Type of Perinuclear Anti-Neutrophil Cytoplasmic Antibody (p-ANCA) in Active Ulcerative Colitis but not in Crohn's Disease

Immunobiology ◽  
1990 ◽  
Vol 181 (4-5) ◽  
pp. 406-413 ◽  
Author(s):  
Jörg A. Rump ◽  
Jürgen Schölmerich ◽  
Volker Gross ◽  
Michael Roth ◽  
Renate Helfesrieder ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Active Ulcerative Colitis ◽  
New Type

Polyunsaturated fatty acids (PUFA) profile in patients with active ulcerative colitis (UC) and Crohn's disease (CD)

1990 ◽  
Vol 9 ◽  
pp. 62
Author(s):  
M. Esteve ◽  
M. Ramirez ◽  
F. Fdez-Bañares ◽  
E. Cabré ◽  
F. Glez-Huix ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Fatty Acids ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Polyunsaturated Fatty Acids ◽  
Active Ulcerative Colitis

62 CAN ULTRASOUND OF THE DISTAL ILEUM DISCRIMINATE BETWEEN ACTIVE CROHN'S DISEASE AND ACTIVE ULCERATIVE COLITIS?

1996 ◽  
Vol 22 (4) ◽  
pp. 424
Author(s):  
M. A. Bali ◽  
A. Campanozzi ◽  
G. Vallone ◽  
B. De Vizia ◽  
C. Bruno ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Distal Ileum ◽  
Active Ulcerative Colitis

Tu1969 Elevated Expression of the Cytosolic DNA Sensors AIM2 and ZBP1/DAI in Active Ulcerative Colitis but Not Crohn's Disease Colonic Tissue

2012 ◽  
Vol 142 (5) ◽  
pp. S-889
Author(s):  
Aine Fanning ◽  
Gerard Moloney ◽  
John MacSharry ◽  
Monica Ambrose ◽  
Eamonn M. Quigley ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Active Ulcerative Colitis ◽  
Dna Sensors ◽  
Colonic Tissue ◽  
Elevated Expression
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