scispace - formally typeset
Search or ask a question

Showing papers by "William J. Tremaine published in 2012"


Journal ArticleDOI
TL;DR: The cumulative probability of major abdominal surgery in this population-based cohort of Crohn's disease approached 60% after 20 years of disease, and many patients required second or third surgeries.

244 citations


Journal ArticleDOI
TL;DR: CTE is a clinically useful examination, altering management plans in nearly half of patients with CD, while increasing physician LOC for the detection of small bowel inflammation and penetrating disease, further support the use of CTE in CD management algorithms.
Abstract: Background: Computed tomographic enterography (CTE) has been shown to have a high sensitivity and specificity for active small bowel inflammation. There are only sparse data on the effect of CTE results on Crohn's disease (CD) patient care. Methods: We prospectively assessed 273 patients with established or suspected CD undergoing a clinically indicated CTE. Providers were asked to complete pre- and postimaging questionnaires regarding proposed clinical management plans and physician level of confidence (LOC) for the presence or absence of active small bowel disease, fistula(s), abscess(es), or stricturing disease. Correlative clinical, serologic, and histologic data were recorded. Following revelation of CTE results, providers were questioned if CTE altered their management plans, and whether LOC changes were due to CTE findings (on a 5-point scale). Results: CTE altered management plans in 139 cases (51%). CTE changed management in 70 (48%) of those with established disease, prompting medication changes in 35 (24%). Management changes were made post-CTE in 69 (54%) of those with suspected CD, predominantly due to excluding CD (36%). CTE-perceived changes in management were independent of clinical, serologic, and histologic findings (P < 0.0001). Clinically meaningful LOC changes (2 or more points) were observed in 212 (78%). Conclusions: CTE is a clinically useful examination, altering management plans in nearly half of patients with CD, while increasing physician LOC for the detection of small bowel inflammation and penetrating disease. These findings further support the use of CTE in CD management algorithms. (Inflamm Bowel Dis 2011;)

69 citations


Journal ArticleDOI
TL;DR: In the experience with natalizumab in clinical practice, adverse events were manageable and did not result in treatment cessation, and clinical response was similar to that in clinical trials.
Abstract: Background: Not all patients with Crohn's disease (CD) respond or maintain response to anti-tumor necrosis factor (TNF) agents and alternative treatment is necessary. Natalizumab, a monoclonal antibody to alpha-4 integrin approved for CD, has demonstrated efficacy in randomized clinical trials. We describe our experience with natalizumab in clinical practice at Mayo Clinic Rochester. Methods: Consecutive patients prescribed natalizumab for active CD were invited to participate and were followed prospectively. Incidence of infection, hospitalization, neoplasm, or other adverse events were recorded. Clinical activity was assessed using the Harvey–Bradshaw Index at each 30-day infusion visit. Results: Between April 2008 and September 2010, 36 patients were prescribed natalizumab and 30 (83.3%) agreed to participate. Median disease duration was 9 years (range, 3–43). Twenty-three patients had prior exposure to two anti-TNF agents, seven to one agent. All patients experienced at least one adverse event; none of the 13 patients in whom natalizumab was stopped (43%) discontinued due to adverse events. Five patients had infusions held for infection. No patient developed progressive multifocal leukoencephalopathy (PML). Fourteen patients (46%) had clinical response. The cumulative probability of achieving complete response within 1 year was 56% (28%–73%). Four of seven patients were weaned off corticosteroids. Conclusions: In our experience with natalizumab in clinical practice, adverse events were manageable and did not result in treatment cessation. No PML cases were seen and clinical response was similar to that in clinical trials. Natalizumab results in clinical benefit in patients who have active disease and have failed anti-TNF therapy (Inflamm Bowel Dis 2012;)

39 citations


Journal ArticleDOI
William J. Tremaine1
TL;DR: Current serologic and genetic studies, as well as endoscopic and imaging studies lack sufficient positive predictive values to make a definite diagnosis of Crohn’s colitis or ulcerative colitis.
Abstract: About 10% of patients with colitis due to inflammatory bowel disease have indeterminate colitis. Despite newer diagnostic tools, the frequency has not diminished over the past 33 years. The current preferred term among academicians is colonic inflammatory bowel disease unclassified (IBDU), although indeterminate colitis is the term endorsed for inclusion in the ICD-10 coding system. Indeterminate colitis is more frequent among children. The anti-Saccharomyces cerevisiae (ASCA) and perinuclear anti-cytoplasmic antibody (pANCA) are useful in distinguishing IBDU from ulcerative colitis and Crohn’s disease. However, current serologic and genetic studies, as well as endoscopic and imaging studies lack sufficient positive predictive values to make a definite diagnosis of Crohn’s colitis or ulcerative colitis. Patients with IBDU who undergo proctocolectomy with ileal pouch-anal anastomosis have more complications than patients with ulcerative colitis. Although some patients with indeterminate colitis eventually develop characteristic ulcerative colitis or Crohn’s disease, a subgroup are durably indeterminate.

38 citations


Journal ArticleDOI
TL;DR: Female gender and extraintestinal manifestations were associated with increased risks for perianal lesions other than fistulas, while older age at diagnosis was associated with a slightly decreased risk.
Abstract: Background: The cumulative incidence of and risk factors for perianal Crohn's disease (CD) for findings other than fistulas are unknown. Methods: The medical records of 310 incident cases of CD from Olmsted County, Minnesota, diagnosed between 1970 and 2004, were reviewed for evidence of perianal disease findings other than fistulas. Cumulative incidence was estimated using the Kaplan–Meier method, and associations between baseline factors and time to first event were assessed using proportional hazards regression. Four types of lesions were studied: anorectal strictures, deep anal canal ulcers, anal fissures, and perianal skin tags. Results: The 10-year cumulative probability from time of diagnosis was 5.8% (95% confidence interval [CI], 2.6%–8.8%) for anorectal strictures, 6.6% (3.6%–9.6%) for deep anal canal ulcers, 10.5% (6.8%–14.1%) for anal fissures, and 18.7% (13.9%–23.3%) for perianal skin tags. The cumulative probability for any perianal lesion other than fistulas was 21.3% (16.5%–25.8%) at 5 years and 29.2% (23.5%–34.5%) at 10 years. Baseline factors associated with time to first perianal lesion other than fistulas were age (hazard ratio [HR] per 10 years, 0.9; 95% CI, 0.8–0.98; P = 0.026), female gender (HR, 1.7; 95% CI, 1.1–2.7; P = 0.013), and presence of extraintestinal manifestations (HR, 1.7; 95% CI, 1.03–2.8; P = 0.038). Conclusions: Perianal lesions other than fistulas occurred frequently during the clinical course of CD. Female gender and extraintestinal manifestations were associated with increased risks for perianal lesions other than fistulas, while older age at diagnosis was associated with a slightly decreased risk. (Inflamm Bowel Dis 2011)

36 citations


Journal ArticleDOI
TL;DR: The actual cumulative incidence of SpA in CD is defined for the first time using complete medical record information in a population-based cohort and the results emphasize the importance of maintaining a high level of suspicion for SpA when following patients with CD.
Abstract: Objective. Spondyloarthritis (SpA) is an extraintestinal manifestation of inflammatory bowel disease with significant clinical effects, although the frequency is uncertain. We assessed the cumulative incidence and clinical spectrum of SpA in patients with Crohn’s disease (CD) in a population-based cohort. Methods. The medical records of a population-based cohort of Olmsted County, Minnesota, residents diagnosed with CD between 1970 and 2004 were reviewed. Patients were followed longitudinally until migration, death, or December 31, 2010. We used the European Spondylarthropathy Study Group, Assessment of Spondyloarthritis international Society (ASAS) criteria and modified New York criteria to identify patients with SpA. The Kaplan-Meier method was used to estimate the cumulative incidence of SpA following diagnosis of CD. Results. The cohort included 311 patients with CD (49.8% females; median age 29.9 yrs, range 8–89). Thirty-two patients developed SpA based on ASAS criteria. The cumulative incidence of SpA after CD diagnosis was 6.7% (95% CI 2.5%–6.7%) at 10 years, 13.9% (95% CI 8.7%–18.8%) at 20 years, and 18.6% (95% CI 11.0%–25.5%) at 30 years. The 10-year cumulative incidence of ankylosing spondylitis was 0, while both the 20-year and 30-year cumulative incidences were 0.5% (95% CI 0–1.6%). Conclusion. We have for the first time defined the actual cumulative incidence of SpA in CD using complete medical record information in a population-based cohort. The cumulative incidence of all forms of SpA increased to approximately 19% by 30 years from diagnosis of CD. Our results emphasize the importance of maintaining a high level of suspicion for SpA when following patients with CD.

34 citations


Journal ArticleDOI
TL;DR: The principal methods and issues in the governance of clinical research: oversight of human research by federal offices, certification of clinical trial centers, management of conflict of interest in clinical research, and trial registration and reporting are reviewed.

5 citations


Book ChapterDOI
William J. Tremaine1
30 Jan 2012

2 citations