Endoscopic Outcomes In Patients Research Articles

Limitations of Fecal Calprotectin for Assessing Outcomes in Ulcerative Colitis

Fecal calprotectin is being used as a test to screen for inflammatory bowel disease and to follow disease activity. In an industry-funded, 8-week, phase II trial of a biologic agent, investigators conducted a post hoc analysis of the association between fecal calprotectin levels and clinical and endoscopic outcomes in patients with ulcerative colitis. Overall, the median fecal calprotectin concentration was …

Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial

Accurate biomarkers of disease activity and therapeutic response can be valuable for clinical trials. We performed a post hoc analysis of data from a phase 2trial to assess the relationship between the concentration of fecal calprotectin (FCP) and clinical and endoscopic outcomes of patients with moderate to severe ulcerative colitis receiving tofacitinib. In a double-blind, placebo-controlled, phase 2 trial, 194 patients were assigned randomly to groups given tofacitinib (0.5, 3, 10, or 15 mg twice daily) or placebo. Clinical and endoscopic outcomes were assessed at week 8 using the Mayo scoring system. Receiver operating characteristics were used to evaluate the relationships between FCP concentration and clinical and endoscopic outcomes, and to determine the FCP cut-off concentration that correlated with patient outcome. Week 8 median concentrations of FCP were significantly lower in responders than in nonresponders (P < .001): clinical response, 156 vs 725 mg/kg; clinical remission, 64 vs 617 mg/kg; endoscopic remission, 44vs 489 mg/kg; and mucosal healing, 127 vs 753 mg/kg. Area-under-the-curve values for FCP receiver operating characteristic models were 0.80 for clinical remission, 0.81 forendoscopic remission, and 0.78 for mucosal healing. An FCPcut-off value of 150 mg/kg achieved the highest summation of sensitivity and specificity for clinical remission (0.68 and 0.79, respectively; κ coefficient, 0.44) and endoscopic remission (0.79 and 0.75, respectively; κ coefficient, 0.38). Concentrations of FCP correlate with clinical and endoscopic outcomes of patients with moderate to severe ulcerative colitis receiving tofacitinib, although at an individual level the agreement was moderate. FCP concentration with a cut-off value of 150 mg/kg had only fair to good accuracy in classifying clinical and endoscopic outcomes in a clinical trial. ClinicalTrials.gov no: NCT00787202.

DOP040. Relationship between vedolizumab pharmacokinetics and endoscopic outcomes in patients with Ulcerative Colitis

DOP040. Relationship between vedolizumab pharmacokinetics and endoscopic outcomes in patients with Ulcerative Colitis

O-003 Relationship Between Vedolizumab Pharmacokinetics and Endoscopic Outcomes of Patients With Ulcerative Colitis

O-003 Relationship Between Vedolizumab Pharmacokinetics and Endoscopic Outcomes of Patients With Ulcerative Colitis

Outcomes in Bloodless Medicine Patients With Acute Gastrointestinal Bleeding

Introduction: Red blood cell transfusion is often indicated in acute gastrointestinal bleeding (GIB), but some patients refuse blood transfusion for personal or religious reasons. Limited data exists regarding the clinical management and outcomes in this population. We describe the in-hospital mortality and endoscopic outcomes of patients with overt GIB. Methods: A single center retrospective cohort study was performed using the clinical database of the Bloodless Medicine Referral Center at a university-affiliated hospital. Inclusion criteria were age 18 years or older, inpatient admission between January 2007 and January 2014, an ICD-9 diagnosis code for GIB, and documented refusal of blood transfusion. Results: Ninety-two patients (63% female, 37% male) met inclusion criteria. Mean age was 68 years (range 20-97) with a median length of stay of 5 days (range 0-48 days). A source of bleeding was documented in 86% of patients (35% upper, 51% lower, and 14% undetermined). For medical therapy, 76% received intravenous iron, 75% received erythropoietin, and 30% received aminocaproic acid. In-hospital mortality was 8.6%. Fifty-two patients (56%) underwent endoscopy (45% EGD, 30% colonoscopy, and 25% both). In the endoscopy group, mean admission hemoglobin was 9.2 g/dL (range 4.5-14.7), mean nadir hemoglobin was 7.8 g/dL (range 3.5-14.3) and in-hospital mortality was 1.9%. A source of bleeding was identified on endoscopy in 61% of patients. Of the 40 patients who did not undergo endoscopy, mean admission hemoglobin was 8.9 g/dL (range 3.5-14.9), mean nadir hemoglobin was 7.3 g/dL (range 3-13.2), and in-hospital mortality was 17.5%. Conclusion: In carefully selected Bloodless Medicine patients, endoscopy is safe and effective in the evaluation and treatment of acute GIB.

Feasibility of Endoscopic Assessment and Treating to Target to Achieve Mucosal Healing in Ulcerative Colitis

Mucosal healing (MH) as a treatment target for ulcerative colitis is of growing interest because it is associated with improved clinical outcomes. However, the feasibility and probability of reaching MH in clinical practice is unknown. We therefore evaluated the feasibility of "treating to target" according to endoscopic findings to reach MH. All endoscopic outcomes of patients with ulcerative colitis followed in a single inflammatory bowel disease unit from 2011 to 2012 were reviewed and subsequent therapeutic management. Cumulative incidence of MH and histologic healing (HH) were estimated using a Kaplan-Meier method. A total of 60 patients underwent at least 2 consecutive endoscopic assessments, of whom 45 and 48 patients had endoscopic and histologic evidence of active disease, respectively. After a median follow-up of 76 weeks, 27 of 45 (60%) patients with endoscopic disease activity at baseline achieved MH and 24 (50%) of 48 patients with histologic disease activity at baseline had HH. The cumulative probabilities of MH were 26%, 52%, and 70% at 26, 52, and 76 weeks, respectively. The cumulative probabilities of HH at weeks 26, 52, and 76 from the time of initial procedure were 19%, 41%, and 57%, respectively. Any adjustment in medical therapy in case of persistent endoscopic activity was associated with both MH and HH. Repeated assessment of endoscopic disease activity with adjustment of medical therapy to the target of MH is feasible in clinical practice in patients with ulcerative colitis, and seems to be of benefit.

Association Between Plasma Concentrations of Certolizumab Pegol and Endoscopic Outcomes of Patients With Crohn's Disease

Monitoring plasma concentrations of anti-tumor necrosis factor agents could optimize treatment of patients with Crohn's Disease (CD). In a post hoc analysis of data from a clinical trial, we compared the relationship between plasma concentrations of certolizumab pegol (CZP) and endoscopic and clinical responses and remission with CZP therapy in patients with moderate to severe ileocolonic CD. We analyzed data from the Endoscopic Mucosal Improvement in Patients with Active CD Treated with CZP trial, from 89 adult patients with active endoscopic CD (ulceration in ≥ 2 intestinal segments and CD Endoscopic Index of Severity [CDEIS] scores of ≥ 8 points). Patients received subcutaneous CZP (400 mg) at weeks 0, 2, and 4 and then every 4 weeks until week 52. Endoscopic evaluations were performed at weeks 0, 10, and 54. Blood samples were collected to measure CZP plasma concentrations at weeks 8 and 54. CZP quartiles at weeks 8 (n = 80) and 54 (n = 45) were correlated with endoscopic response (>5-point decrease in CDEIS from baseline) and remission (CDEIS, <6) at weeks 10 and 54, respectively. Higher concentrations of CZP at week 8 were associated with endoscopic response (P = .0016) and remission (P = .0302) at week 10 (n = 45). At week 54, the rates of endoscopic remission correlated with plasma concentrations of CZP (P = .0206). There was a significant inverse relationship between plasma concentrations of CZP and baseline levels of C-reactive protein and body weight (P = .0014 and P = .0373, respectively). Endoscopic response and remission are associated with higher plasma concentrations of CZP in patients with moderate to severe ileocolonic CD. These results support the need to consider the pharmacokinetics of anti-tumor necrosis factor agents and therapeutic drug monitoring to optimize treatment. Clinicaltrials.gov Number, NCT00297648.

Altering the natural history of Crohn's disease?

With the medical advances achieved in Crohn's disease (CD) over the past several years, treatment goals have expanded to include not only improvement in clinical outcomes, but also potential alteration of underlying disease processes and modification of the clinical course. A reliable prospective predictive model for the clinical course of CD is presently lacking. However, preliminary evidence suggests that the clinical expression of CD may reflect at least in part transmural and superficial mucosal inflammatory changes. Treatments that induce healing of the intestinal mucosa and submucosa may therefore provide particular clinical benefits, including sustained response or remission. As a result, endoscopic outcomes in patients with CD are increasingly included as therapeutic efficacy end points in clinical studies. Corticosteroids have been shown to rapidly relieve symptoms in most patients but generally do not improve endoscopic lesions in parallel with clinical response and are ineffective as maintenance therapy. Open-label investigations suggest that azathioprine is associated with mucosal healing; in addition, placebo-controlled studies have demonstrated that this immunosuppressive agent can provide long-term suppression of disease activity, although initial onset of clinical action is slow. The antitumor necrosis factor-alpha monoclonal antibody infliximab provides endoscopic healing in parallel with clinical improvement and also effectively maintains remission with retreatment. As the relationship between endoscopic and clinical changes in disease activity is further explored and clarified, new treatment strategies will need to be developed to improve long-term prognosis in patients with CD.