Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study)

Solberg, Inger Camilla; Lygren, Idar; Jahnsen, Jørgen; Aadland, E; Høie, Ole; Cvancarova, Milada; Bernklev, Tomm; Henriksen, Magne; Sauar, Jostein; Vatn, Morten H.; Moum, Bjørn

doi:10.1080/00365520802600961

Cited by 639 publications

(531 citation statements)

References 27 publications

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“…Choice of treatment may be influenced by the severity of symptoms, the extent and location of inflammation, and is based on clinical expertise and individual patient choice. Patients who fail both conventional and TNF-inhibitor therapy typically have no other medical therapeutic options available to them and up to 40% [11] may progress to surgery [12]. However, people may be reluctant to consider surgery due to the potential serious post-surgery complications such as bleeding, faecal incontinence, depression, distorted body image, sexual dysfunction, female infertility, pouchitis, pouch leakage, pelvic abscesses, pouch fistulae, small bowel obstruction and anastomotic stricture [13].…”

Section: Current Treatmentmentioning

confidence: 99%

Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2015

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As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of vedolizumab (Takeda UK) to submit evidence of the clinical effectiveness and cost-effectiveness of vedolizumab for the treatment of patients with moderate-to-severe active ulcerative colitis (UC). The Evidence Review Group (ERG) produced a critical review of the evidence for the clinical effectiveness and cost-effectiveness of the technology, based upon the company's submission to NICE. The evidence was derived mainly from the GEMINI1 trial, which is a Phase III, multicentre, randomised, doubleblind, placebo-controlled trial designed to evaluate the efficacy and safety of vedolizumab as an induction and maintenance treatment in patients with moderate-to-severe active UC who had an inadequate response to, loss of response to, or intolerance to conventional therapy or anti-Tumour necrosis factor-alpha (TNF-). The clinical evidence showed that vedolizumab performed significantly better than placebo in both the induction and maintenance phases. In the post-hoc subgroup analyses, patients with or without prior anti-TNF-therapy, vedolizumab performed better then placebo (p-value not reported). In addition, a greater improvement in health-related quality of life was observed in patients treated with vedolizumab and the frequency and types of adverse events were similar between the vedolizumab and placebo group but the evidence was limited to shortterm follow-up. There were a number of limitations and uncertainties in the clinical evidence base which warrant caution in its interpretation. In particular, the post-hoc subgroup analyses and high dropout rates in the maintenance phase of the GEMINI1 trial. The company also presented a network meta-analysis of vedolizumab versus other biologics therapies indicated for moderate-to-severe UC. However, the ERG considered that the results presented may have underestimated the uncertainty in treatment effects since fixed effects models were Key Points for Decision Makers Vedolizumab appears to be more effective in both the induction and maintenance phase compared with placebo in patients with moderate-to-severe active ulcerative colitis who have had an inadequate response to, loss of response to, or intolerance to conventional therapy or TNF-inhibitor. However, the subgroup analyses for patients with or without prior TNF-inhibitor therapy were post-hoc and the study was not powered for these assessments.  The findings of the network meta-analysis of vedolizumab versus TNF-inhibitor are limited due to a number of uncertainties in treatment effects. In addition, there is currently no head-to-head randomised 3 controlled trial comparing vedolizumab to other biologic therapies indicated for moderate-to-severe ulcerative colitis.  The National Institute for Health and Care Excellence (NICE) Appraisal Committee recommended vedolizumab within its licence indication but only if the company provides vedolizumab with the discount agr...

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Section: Current Treatmentmentioning

confidence: 99%

Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2015

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“…At diagnosis, UC patients presented with the following disease extent: proctitis [199 patients (21.7%)], left-sided colitis [338 patients (36.8%)] and extensive colitis/pancolitis [381 (41.5%)]. During a median disease duration of 9 [4][5][6][7][8][9][10][11][12][13][14][15][16] years, progression and regression was documented in 145 patients (15.8%) and 149 patients (16.2%) respectively. In addition, 624 patients (68.0%) had a stable disease extent.…”

Section: Resultsmentioning

confidence: 99%

Systematic analysis of factors associated with progression and regression of ulcerative colitis in 918 patients

Safroneeva

Vavricka

Fournier

et al. 2015

Aliment Pharmacol Ther

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“…Risk factors in CD include young age at diagnosis, current tobacco use, perianal disease, small bowel involvement and multiple extraintestinal manifestations [17][18][19]. Combination therapy is the preferred strategy in ulcerative colitis patients requiring hospitalization at diagnosis, younger age at diagnosis, with derangements in laboratories such as sedimentation rate, and extensive colitis [20,21]. In young men, MTX can be substituted for AZA to decrease the risk of HSTCL.…”

Section: Withdrawal Of Is or Anti-tnf In Patients On Combination Therapymentioning

confidence: 99%

Which patients with inflammatory bowel disease should receive combination therapy?

Cross

2015

Expert Review of Gastroenterology & Hepatology

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Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study)

Abstract: The prognosis for UC during the first 10 years was generally good. The colectomy rate was low, and a large proportion of patients were in remission as time progressed. Patients with initially extensive colitis and elevated ESR could benefit from an early potent medical treatment strategy.

Cited by 639 publications

References 27 publications

Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Systematic analysis of factors associated with progression and regression of ulcerative colitis in 918 patients

Which patients with inflammatory bowel disease should receive combination therapy?

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