Mucosal healing linked to long-term clinical benefits in ulcerative colitis

Mucosal healing in ulcerative colitis significantly improves the chances of long-term clinical remission without the need for corticosteroids or colectomy, according to a systematic review and meta-analysis of 13 prospective studies that included more than 2,000 patients reported in the September issue of Clinical Gastroenterology and Hepatology.

“On the basis of our findings, and in the absence of published prospective randomized clinical trials, it seems reasonable that achieving mucosal healing should be the goal of ulcerative colitis treatment, and interval endoscopic assessment should be performed after initiating new therapies to evaluate response and guide further therapeutic management,” wrote Shailja Shah, MD, of the Icahn School of Medicine at Mount Sinai, New York, together with her associates there and at McMaster University Medical Centre in Hamilton, Ont. “Whether this treat-to-target strategy alters the natural disease course of ulcerative colitis, including prevention of dysplasia and colorectal carcinoma, or whether such a strategy is favorable from a risk versus benefit and cost-effectiveness standpoint remains to be evaluated with well-designed prospective clinical trials,” they said.

Published trials of ulcerative colitis have focused on clinical response and remission instead of specific endoscopic endpoints, and as a result there were only indirect data to suggest that mucosal healing improved outcomes and justified the costs of interval endoscopy, the researchers noted.

To further elucidate the issue, they systematically searched Pubmed, EMBASE, and Cochrane Library CENTRAL for prospective studies that compared ulcerative colitis patients with and without mucosal healing at the first endoscopy after starting treatment. The resulting 13 studies included 2,073 patients with active ulcerative colitis, including both “hospitalized and ambulatory patients, varying disease severities, and achievement of mucosal healing by different therapeutic modalities, which make the results widely applicable,” the researchers said (Clin Gastroenterol Hepatol. 2016 Jan 29. doi: 10.1016/j.cgh.2016.01.015).Mucosal healing significantly improved the odds of several clinically meaningful outcomes, Dr. Shah and her associates stressed. Compared with patients who did not have mucosal healing, those with mucosal healing had 4.5-fold greater odds of achieving clinical remission for at least 52 weeks (95% confidence interval for pooled odds ratio, 2.1-9.5), about fourfold greater odds of avoiding colectomy (95% CI, 2.5-6.8), and more than eightfold greater odds of long-term mucosal healing (95% CI, 3.1-22.5). Patients who achieved mucosal healing also were more likely to achieve long-term remission without needing corticosteroids, with a 95% CI that trended toward statistical significance (pooled OR, 9.7; 95% CI, 0.9-99.7).

The studies were mostly observational, with varying times to first endoscopic assessment, and also were limited by the lack of a consensus definition for mucosal healing in ulcerative colitis. Nonetheless, the findings “clearly support the paradigm shift toward tailoring therapeutic decision-making to achieve mucosal healing,” Dr. Shah and her associates added. “Although endoscopy is currently the best way to assess for mucosal healing, routine implementation may be limited by cost, inconvenience, procedural risk, and endoscopy unit resources. Increasing data support nonendoscopic markers as surrogates for mucosal healing, including fecal biomarkers such as fecal calprotectin and fecal immunohistochemical testing, the latter of which may be a more sensitive predictor of complete [mucosal healing].”

The investigators reported no funding sources or conflicts of interest.

Mucosal healing in ulcerative colitis significantly improves the chances of long-term clinical remission without the need for corticosteroids or colectomy, according to a systematic review and meta-analysis of 13 prospective studies that included more than 2,000 patients reported in the September issue of Clinical Gastroenterology and Hepatology.

“On the basis of our findings, and in the absence of published prospective randomized clinical trials, it seems reasonable that achieving mucosal healing should be the goal of ulcerative colitis treatment, and interval endoscopic assessment should be performed after initiating new therapies to evaluate response and guide further therapeutic management,” wrote Shailja Shah, MD, of the Icahn School of Medicine at Mount Sinai, New York, together with her associates there and at McMaster University Medical Centre in Hamilton, Ont. “Whether this treat-to-target strategy alters the natural disease course of ulcerative colitis, including prevention of dysplasia and colorectal carcinoma, or whether such a strategy is favorable from a risk versus benefit and cost-effectiveness standpoint remains to be evaluated with well-designed prospective clinical trials,” they said.

Published trials of ulcerative colitis have focused on clinical response and remission instead of specific endoscopic endpoints, and as a result there were only indirect data to suggest that mucosal healing improved outcomes and justified the costs of interval endoscopy, the researchers noted.

To further elucidate the issue, they systematically searched Pubmed, EMBASE, and Cochrane Library CENTRAL for prospective studies that compared ulcerative colitis patients with and without mucosal healing at the first endoscopy after starting treatment. The resulting 13 studies included 2,073 patients with active ulcerative colitis, including both “hospitalized and ambulatory patients, varying disease severities, and achievement of mucosal healing by different therapeutic modalities, which make the results widely applicable,” the researchers said (Clin Gastroenterol Hepatol. 2016 Jan 29. doi: 10.1016/j.cgh.2016.01.015).Mucosal healing significantly improved the odds of several clinically meaningful outcomes, Dr. Shah and her associates stressed. Compared with patients who did not have mucosal healing, those with mucosal healing had 4.5-fold greater odds of achieving clinical remission for at least 52 weeks (95% confidence interval for pooled odds ratio, 2.1-9.5), about fourfold greater odds of avoiding colectomy (95% CI, 2.5-6.8), and more than eightfold greater odds of long-term mucosal healing (95% CI, 3.1-22.5). Patients who achieved mucosal healing also were more likely to achieve long-term remission without needing corticosteroids, with a 95% CI that trended toward statistical significance (pooled OR, 9.7; 95% CI, 0.9-99.7).

The studies were mostly observational, with varying times to first endoscopic assessment, and also were limited by the lack of a consensus definition for mucosal healing in ulcerative colitis. Nonetheless, the findings “clearly support the paradigm shift toward tailoring therapeutic decision-making to achieve mucosal healing,” Dr. Shah and her associates added. “Although endoscopy is currently the best way to assess for mucosal healing, routine implementation may be limited by cost, inconvenience, procedural risk, and endoscopy unit resources. Increasing data support nonendoscopic markers as surrogates for mucosal healing, including fecal biomarkers such as fecal calprotectin and fecal immunohistochemical testing, the latter of which may be a more sensitive predictor of complete [mucosal healing].”

The investigators reported no funding sources or conflicts of interest.

Mucosal healing in ulcerative colitis significantly improves the chances of long-term clinical remission without the need for corticosteroids or colectomy, according to a systematic review and meta-analysis of 13 prospective studies that included more than 2,000 patients reported in the September issue of Clinical Gastroenterology and Hepatology.

“On the basis of our findings, and in the absence of published prospective randomized clinical trials, it seems reasonable that achieving mucosal healing should be the goal of ulcerative colitis treatment, and interval endoscopic assessment should be performed after initiating new therapies to evaluate response and guide further therapeutic management,” wrote Shailja Shah, MD, of the Icahn School of Medicine at Mount Sinai, New York, together with her associates there and at McMaster University Medical Centre in Hamilton, Ont. “Whether this treat-to-target strategy alters the natural disease course of ulcerative colitis, including prevention of dysplasia and colorectal carcinoma, or whether such a strategy is favorable from a risk versus benefit and cost-effectiveness standpoint remains to be evaluated with well-designed prospective clinical trials,” they said.

Published trials of ulcerative colitis have focused on clinical response and remission instead of specific endoscopic endpoints, and as a result there were only indirect data to suggest that mucosal healing improved outcomes and justified the costs of interval endoscopy, the researchers noted.

To further elucidate the issue, they systematically searched Pubmed, EMBASE, and Cochrane Library CENTRAL for prospective studies that compared ulcerative colitis patients with and without mucosal healing at the first endoscopy after starting treatment. The resulting 13 studies included 2,073 patients with active ulcerative colitis, including both “hospitalized and ambulatory patients, varying disease severities, and achievement of mucosal healing by different therapeutic modalities, which make the results widely applicable,” the researchers said (Clin Gastroenterol Hepatol. 2016 Jan 29. doi: 10.1016/j.cgh.2016.01.015).Mucosal healing significantly improved the odds of several clinically meaningful outcomes, Dr. Shah and her associates stressed. Compared with patients who did not have mucosal healing, those with mucosal healing had 4.5-fold greater odds of achieving clinical remission for at least 52 weeks (95% confidence interval for pooled odds ratio, 2.1-9.5), about fourfold greater odds of avoiding colectomy (95% CI, 2.5-6.8), and more than eightfold greater odds of long-term mucosal healing (95% CI, 3.1-22.5). Patients who achieved mucosal healing also were more likely to achieve long-term remission without needing corticosteroids, with a 95% CI that trended toward statistical significance (pooled OR, 9.7; 95% CI, 0.9-99.7).

The studies were mostly observational, with varying times to first endoscopic assessment, and also were limited by the lack of a consensus definition for mucosal healing in ulcerative colitis. Nonetheless, the findings “clearly support the paradigm shift toward tailoring therapeutic decision-making to achieve mucosal healing,” Dr. Shah and her associates added. “Although endoscopy is currently the best way to assess for mucosal healing, routine implementation may be limited by cost, inconvenience, procedural risk, and endoscopy unit resources. Increasing data support nonendoscopic markers as surrogates for mucosal healing, including fecal biomarkers such as fecal calprotectin and fecal immunohistochemical testing, the latter of which may be a more sensitive predictor of complete [mucosal healing].”

The investigators reported no funding sources or conflicts of interest.