AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease.
AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease.
- # Maintenance Of Remission
- # American Gastroenterological Association
- # Active Crohn's Disease
- # Certolizumab Pegol
- # Use Of Certolizumab Pegol
- # Grading Of Recommendations Assessment
- # Grading Of Recommendations Assessment, Development And Evaluation
- # Advanced Therapies
- # Immunomodulators In Patients
- # Thiopurine Monotherapy
- Front Matter
577
- 10.1053/j.gastro.2020.01.006
- Jan 13, 2020
- Gastroenterology
AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis
- Front Matter
52
- 10.1053/j.gastro.2024.10.001
- Dec 1, 2024
- Gastroenterology
AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis
- Research Article
68
- 10.1016/j.cgh.2006.04.022
- Jun 22, 2006
- Clinical Gastroenterology and Hepatology
Onercept for Moderate-to-Severe Crohn’s Disease: A Randomized, Double-Blind, Placebo-Controlled Trial
- Research Article
38
- 10.1002/14651858.cd012774.pub3
- Apr 25, 2023
- Cochrane Database of Systematic Reviews
FMT may increase the proportion of people with active UC who achieve clinical and endoscopic remission. The evidence was very uncertain about whether use of FMT in people with active UC impacted the risk of serious adverse events or improvement in quality of life. The evidence was also very uncertain about the use of FMT for maintenance of remission in people with UC, as well as induction and maintenance of remission in people with CD, and no conclusive statements could be made in this regard. Further studies are needed to address the beneficial effects and safety profile of FMT in adults and children with active UC and CD, as well as its potential to promote longer-term maintenance of remission in UC and CD.
- Front Matter
- 10.1016/j.gie.2005.10.036
- Feb 22, 2006
- Gastrointestinal Endoscopy
Infliximab treatment of postoperative ulcers in Crohn's disease: to inject or not to inject—that is the question
- Research Article
1
- 10.1053/j.gastro.2025.08.032
- Dec 1, 2025
- Gastroenterology
Comparative Efficacy of Advanced Therapies for Management of Moderate-to-Severe Crohn's Disease: 2025 AGA Evidence Synthesis.
- Research Article
228
- 10.1053/j.gastro.2007.05.006
- Jul 1, 2007
- Gastroenterology
American Gastroenterological Association Consensus Development Conference on the Use of Biologics in the Treatment of Inflammatory Bowel Disease, June 21–23, 2006
- Research Article
282
- 10.1053/j.gastro.2020.03.072
- Apr 1, 2020
- Gastroenterology
AGA Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic
- Research Article
5
- 10.1053/j.gastro.2022.03.023
- Mar 23, 2022
- Gastroenterology
AGA Institute Quality Measure Development for the Management of Gastric Intestinal Metaplasia With Helicobacter pylori
- Front Matter
83
- 10.1053/j.gastro.2021.04.023
- May 26, 2021
- Gastroenterology
AGA Technical Review on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease
- Research Article
7
- 10.1002/14651858.cd013611.pub2
- Jul 17, 2023
- The Cochrane database of systematic reviews
Vedolizumab blocks inflammatory activity within the gastrointestinal tract. Systematic reviews have demonstrated the efficacy of vedolizumab in ulcerative colitis and inflammatory bowel disease in general. This systematic review and meta-analysis summarises the current evidence of vedolizumab in the induction and maintenance of remission in Crohn's disease. To evaluate the benefits and harms of vedolizumab versus placebo for the induction and maintenance of remission in people with Crohn's disease. We used standard, extensive Cochrane search methods. The latest search date was 30 November 2022. We included randomised controlled trials (RCTs) and quasi-RCTs comparing vedolizumab to placebo for the induction or maintenance of remission in people with Crohn's disease. We used standard Cochrane methods. For induction studies, the primary outcome was 1. clinical remission, and secondary outcomes were rates of 2. clinical response, 3. adverse events, 4. serious adverse events, 5. surgery, 6. endoscopic remission and 7. endoscopic response. For maintenance studies, the primary outcome was 1. maintenance of clinical remission, and secondary outcomes were rates of 2. adverse events, 3. serious adverse events, 4. surgery, 5. endoscopic remission and 6. endoscopic response. We used GRADE to assess certainty of evidence. We analysed induction (4 trials, 1126 participants) and maintenance (3 trials, 894 participants) studies representing people across North America, Europe, Asia and Australasia separately. One maintenance trial administered subcutaneous vedolizumab whilst the other studies used the intravenous form. The mean age ranged between 32.6 and 38.6 years. Vedolizumab was superior to placebo for the induction of clinical remission (71 more per 1000 with clinical remission with vedolizumab; risk ratio (RR) 1.61, 95% confidence interval (CI) 1.20 to 2.17; number needed to treat for an additional beneficial outcome (NNTB) 13; 4 studies; high-certainty evidence) and superior to placebo for inducing clinical response (105 more per 1000 with clinical response with vedolizumab; RR 1.43, 95% CI 1.19 to 1.71; NNTB 8; 4 studies; high-certainty evidence). For the induction phase, vedolizumab may be equivalent to placebo for the development of serious adverse events (9 fewer serious adverse events per 1000 with vedolizumab; RR 0.91, 95% CI 0.62 to 1.33; 4 studies; low-certainty evidence) and probably equivalent to placebo for overall adverse events (6 fewer adverse events per 1000 with vedolizumab; RR 1.01, 95% CI 0.93 to 1.11; 4 studies; moderate-certainty evidence). Vedolizumab was superior to placebo for the maintenance of clinical remission (141 more per 1000 with maintenance of clinical remission with vedolizumab; RR 1.52, 95% CI 1.24 to 1.87; NNTB 7; 3 studies; high-certainty evidence). During the maintenance phase, vedolizumab may be equivalent to placebo for the development of serious adverse events (3 fewer serious adverse events per 1000 with vedolizumab; RR 0.98, 95% CI 0.68 to 1.39; 3 studies; low-certainty evidence) and probably equivalent to placebo for the development of overall adverse events (0 difference in adverse events per 1000; RR 1.00, 95% CI 0.94 to 1.07; 3 studies; moderate-certainty evidence). High-certainty data across four induction and three maintenance trials demonstrate that vedolizumab is superior to placebo in the induction and maintenance of remission in Crohn's disease. Overall adverse events are probably similar and serious adverse events may be similar between vedolizumab and placebo during both induction and maintenance phases of treatment. Head-to-head research comparing the efficacy and safety of vedolizumab to other biological therapies is required.
- Discussion
4
- 10.1016/s0016-5085(03)00569-9
- Jun 1, 2003
- Gastroenterology
Maintenance infliximab therapy in patients with crohn’s disease: how long, how much, how frequent?
- Research Article
4
- 10.1053/j.gastro.2020.11.039
- Nov 24, 2020
- Gastroenterology
AGA Institute Quality Measure Development for the Diagnosis and Management of COVID-19
- Research Article
38
- 10.1016/j.eclinm.2020.100271
- Feb 4, 2020
- EClinicalMedicine
Efficacy and safety of methotrexate in the management of inflammatory bowel disease: A systematic review and meta-analysis of randomized, controlled trials
- Research Article
- 10.1097/00054725-200705005-00100
- May 1, 2007
- Inflammatory Bowel Diseases
Certolizumab pegol is a PEGylated Fab' fragment of a humanized anti-tumor necrosis factor-α [TNFα] monoclonal antibody. In the PRECiSE 2 Phase III maintenance trial, certolizumab pegol demonstrated efficacy and safety in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of 220-450). The mean duration (standard deviation) of Crohn's disease in the certolizumab pegol group was 8.6 (7.1) years [range <1-33 years]). This analysis assessed the effect on efficacy of the duration of Crohn's disease. Patients received open-label induction treatment with certolizumab pegol 400 mg administered subcutaneously (sc) at Weeks 0, 2, and 4. Responding patients (≥100-point decrease from baseline in CDAI) at Week 6 were randomized to certolizumab pegol 400 mg sc or placebo every 4 weeks from Weeks 8-24. Rates of response (defined above) and remission (CDAI ≤150 points) at Week 26 by baseline disease duration (intent to treat [ITT] population) underwent exploratory analyses. Irrespective of disease duration, certolizumab pegol induced and maintained response and remission compared with placebo. Maintenance of response at Week 26 in patients with disease duration <3 years was 75.9% with certolizumab pegol (n=58) and 39.5% with placebo (n=81; p<0.001). In patients with disease duration <1 year, the certolizumab pegol long-term response rate increased to 89.5% (placebo 37.1%; p<0.01) (Table). This pattern was also seen in Week26 remission rates: 58.6% in <3-year group (placebo 33.3%; p<0.01); 68.4% in <1-year group (placebo 37.1%; p<0.05). Certolizumab pegol was effective in Crohn's disease irrespective of disease duration at baseline. Higher clinical response and remission rates at Week 26 were observed among patients who received treatment soon after developing Crohn's disease. These data suggest a benefit of early intervention with certolizumab pegol 400 mg sc every 4 weeks for long-term maintenance of response and remission in patients with active Crohn's disease.
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