Use of the Crohn’s disease activity index in clinical trials of biological agents

Freeman, Hugh James

doi:10.3748/wjg.14.4127

Cited by 53 publications

(39 citation statements)

References 26 publications

(20 reference statements)

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“…The Crohn's disease activity index is a standard classification system that allows clinical evaluation by interpretation of the patients' symptoms. It is currently used in most clinical screenings to evaluate different effects on the symptoms of Crohn's disease activity (5) . The ulcerative colitis activity index has been proposed by several studies to help choosing the treatment and follow-up the long-term development, furthermore, it allows comparing patients in multicenter studies.…”

Section: Introductionmentioning

confidence: 99%

Assessment of quality of life of patients with inflammatory bowel disease residing in Southern Brazil

Cohen

Bin

Fayh

2010

Arq. Gastroenterol.

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-Context -Chronic diseases have an impact on the quality of life of the individuals. Objective -To evaluate the quality of life of adults with inflammatory bowel disease by the inflammatory bowel disease questionnaire certified for Portuguese language. Methods -We interviewed 50 individuals from both genders aged from 18 to 60 years old, with Crohn's disease and ulcerative colitis, regardless of disease activity. Results -The average age of the sample was 42.2 ± 13.6 years old, the disease length was 98.8 ± 74.3 months, and 72% of patients had Crohn's disease and 14% presented disease activity. There was no significant difference in questionnaire scores of patients with different inflammatory bowel disease when they are in the remission phase (172.0 ± 42.4 and 173.6 ± 28.2 for ulcerative colitis and Crohn's disease, respectively, P = 0.886). When compared to scores of patients who were in crisis, it was found that they have a lower quality of life that patients in remission (123.8 ± 44.5 and 173.3 ± 31.5 for patients in crisis and remission, respectively, P = 0.001). Conclusion -It was noticed that the quality of life of patients with inflammatory bowel disease did not differ among patients with Crohn's disease or ulcerative colitis, when patients are in remission. The main aspect which determines the loss of quality of life would be being at the stage of disease activity. HEADINGS -Inflammatory bowel diseases. Crohn disease. Proctocolitis. Quality of life.

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Section: Introductionmentioning

confidence: 99%

Assessment of quality of life of patients with inflammatory bowel disease residing in Southern Brazil

Cohen

Bin

Fayh

2010

Arq. Gastroenterol.

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“…A CDAI score of ≥ 150 points is indicative of an active form of the disease. 22 CDAI is also used in conjunction with additional parameters/markers such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). 23 …”

Section: Measurement Of Diseasementioning

confidence: 99%

“…severity) of CD is the Crohn's Disease Activity Index (CDAI). 8,22 Patients with a CDAI score of < 150 points are often classified as having a quiescent or non-active (i.e. in remission) form of disease.…”

Section: Measurement Of Diseasementioning

confidence: 99%

Clinical effectiveness and cost-effectiveness of elemental nutrition for the maintenance of remission in Crohn’s disease: a systematic review and meta-analysis

Tsertsvadze

Gurung

Court

et al. 2015

Health Technology Assessment

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BackgroundAlthough enteral nutrition has been shown to be a viable treatment option for the management of active Crohn’s disease (CD), the evidence regarding its clinical benefits compared with standard treatments (e.g. steroids) for maintaining remission in patients with CD has been inconsistent. If enteral nutrition was to be effective, the use of drugs such as steroids and immunosuppressive drugs could be reduced, thereby reducing the likelihood of adverse events associated with these medications.ObjectivesThis systematic review aimed to assess the clinical effectiveness and cost-effectiveness of elemental nutrition (a type of enteral nutrition) for maintenance of remission in patients with CD.Data sourcesMajor bibliographic databases (e.g. MEDLINE, EMBASE, Cochrane Database of Systematic Reviews) were searched from inception to August/September 2013. Searches were not limited by study design, language or publication date. Websites for relevant organisations and references of included studies were checked.MethodsExperimental randomised and non-randomised controlled trials (RCTs and nRCTs) reporting clinical effectiveness and cost-effectiveness of elemental nutrition in the maintenance of remission in patients with CD were eligible. Study selection, data extraction and risk of bias (RoB) assessment were performed independently. Risk ratios (RRs) and mean differences (MDs) were pooled using a random-effects model. Heterogeneity was assessed via forest plots, Cochran’sQand theI2statistics. Overall, quality of evidence for each outcome was rated using the Grading of Recommendations, Assessment, Development, and Evaluation approach.ResultsEight studies (three RCTs and five nRCTs) were included in the review. RCTs indicated a significant benefit of elemental nutrition vs. no intervention (an unrestricted diet) in maintaining remission at 24 months [one RCT; RR 2.06, 95% confidence interval (CI) 1.00 to 4.43; very low-grade evidence] and preventing relapse at 12–24 months post baseline (two RCTs; pooled RR 0.57, 95% CI 0.38 to 0.84;I2 = 0%; high-grade evidence). Similarly, three nRCTs showed significant benefits of elemental nutrition over no intervention in maintaining remission at 12–48 months and preventing relapse at 12 months post baseline (MD 1.20 months, 95% CI 0.35 to 2.04 months). The incidence of mucosal healing was not significantly different in the intervention and control groups (RR 2.70, 95% CI 0.62 to 11.72). Adherence to an elemental nutrition regime was significantly worse than adherence to polymeric nutrition (RR 0.68, 95% CI 0.50 to 0.92) and, when compared with other active treatments (medications, polymeric nutrition or a combination), elemental nutrition yielded non-significant results with wide 95% CIs, rendering these results inconclusive. Complications and adverse events were too sparse to allow meaningful comparisons. None of the studies reported cost-effectiveness of elemental nutrition. Owing to scarcity of data, subgroup and sensitivity analyses could not be performed to explore methodological and clinical sources of heterogeneity.LimitationsThe findings warrant cautious interpretation given the limitations of the evidence in methodological quality (small samples, short follow-up) and the RoB in individual studies (lack of blinding, confounding).ConclusionsLimited evidence indicates potential benefits of elemental nutrition against no intervention in the maintenance of remission and prevention of relapse in adult patients with CD. There was a lack or insufficient evidence on adverse events and complications. Future large and long-term randomised trials are warranted to draw more definitive conclusions regarding the effects of elemental nutrition in maintaining remission in CD.Trial registrationThis study is registered as PROSPERO CRD42013005134.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…There are eight factors involved in determining CDAI, which are assessed daily for 7 d, including: (1) frequency of watery stools; (2) wellbeing; (3) abdominal pain; (4) presence of any complications; (5) presence of abdominal mass; (6) usage of opioids; (7) low hematocrit < 0.47 and < 0.42 in men and women respectively, and lastly; and (8) standard weight percentage deviation [45] . A CDAI below 150 is defined as "in remission", while a CDAI > 450 is termed severe disease [46] .…”

Section: Disease Activity During Pregnancymentioning

confidence: 99%

“…The Crohn's Disease Activity Index (CDAI) is used in CD patients to evaluate baseline disease severity quantify cumulative symptoms and assess the changes of the disease in response to therapies in afflicted individuals [45] . There are eight factors involved in determining CDAI, which are assessed daily for 7 d, including: (1) frequency of watery stools; (2) wellbeing; (3) abdominal pain; (4) presence of any complications; (5) presence of abdominal mass; (6) usage of opioids; (7) low hematocrit < 0.47 and < 0.42 in men and women respectively, and lastly; and (8) standard weight percentage deviation [45] .…”

Section: Disease Activity During Pregnancymentioning

confidence: 99%

Pregnancy and inflammatory bowel diseases: Current perspectives, risks and patient management

Hosseini‐Carroll¹,

Mutyala²,

Seth³

et al. 2015

WJGPT

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Manas K made critical revisions of the manuscript; Becker F and Alexander JS contributed equally as senior authors. Conflict-of-interest statement:There are no known conflicts of interest. The authors (Pegah Hosseini-Carroll, Monica Mutyala, Abhishek Seth, Shaheen Nageeb, Demiana Soliman, Moheb Boktor, Ankur Sheth, Jonathon Chapman, James Morris, Paul Jordan, Kenneth Manas, Felix Becker, and J Steven Alexander) have no relevant financial considerations related to this proposal, and the study was not supported by any corporate entity. There is no known intellectual property associated with this report. AbstractInflammatory bowel diseases (IBD) are chronic idiopathic inflammatory conditions characterized by relapsing and remitting episodes of inflammation which can affect several different regions of the gastrointestinal tract, but also shows extra-intestinal manifestations. IBD is most frequently diagnosed during peak female reproductive years, with 25% of women with IBD conceiving after their diagnosis. While IBD therapy has improved dramatically with enhanced surveillance and more abundant and powerful treatment options, IBD disease can have important effects on pregnancy and presents several challenges for maintaining optimal outcomes for mothers with IBD and the developing fetus/neonate. Women with IBD, the medical team treating them (both gastroenterologists and obstetricians/gynecologists) must often make highly complicated choices regarding conception, pregnancy, and post-natal care (particularly breastfeeding) related to their choice of treatment options at different phases of pregnancy as well as post-partum. This current review discusses current concerns and recommendations for pregnancy during 157November 6, 2015|Volume 6|Issue 4| WJGPT|www.wjgnet.com Hosseini-Carroll P et al . Pregnancy and inflammatory bowel diseases IBD and is intended for gastroenterologists, general practitioners and IBD patients intending to become, (or already) pregnant, and their families. We have addressed patterns of IBD inheritance, effects of IBD on fertility and conception (in both men and women), the effects of IBD disease activity on maintenance of pregnancy and outcomes, risks of diagnostic procedures during pregnancy and potential risks and complications associated with different classes of IBD therapeutics. We also have evaluated the clinical experience using "top-down" care with biologics, which is currently the standard care at our institution. Post-partum care and breastfeeding recommendations are also addressed. Core tip: Inflammatory bowel diseases (IBD) are chronic inflammatory conditions characterized by relapsing and remitting episodes of intestinal inflammation. IBD is most frequently diagnosed during peak female reproductive years, with 25% of women with IBD conceiving after their diagnosis. While therapies have improved dramatically, IBDs have important effects on pregnancy and present challenges for maintaining optimal outcomes for mothers and their developing fetus/ neonate. Women with IBD and physician...

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Use of the Crohn’s disease activity index in clinical trials of biological agents

Cited by 53 publications

References 26 publications

Assessment of quality of life of patients with inflammatory bowel disease residing in Southern Brazil

Assessment of quality of life of patients with inflammatory bowel disease residing in Southern Brazil

Clinical effectiveness and cost-effectiveness of elemental nutrition for the maintenance of remission in Crohn’s disease: a systematic review and meta-analysis

Pregnancy and inflammatory bowel diseases: Current perspectives, risks and patient management

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