Mucosal healing, determined by endoscopic evaluation, is one of the most important prognostic markers for patients with inflammatory bowel diseases.
Findings from histologic evaluation, however, could complement findings from endoscopy in assessing mucosal responses to treatment.
Dr Marzia Lazzerini and colleagues analyzed long-term results of children treated with thalidomide to determine the association between clinical response and histology and endoscopy findings.
The team collected data from 2 multicenter trials of 70 children with refractory Crohn’s disease (CD) or ulcerative colitis (UC) given thalidomide or placebo.
Clinical remission and clinical response at 8 weeks were defined as a pediatric CD activity index scores 10 points or lower and a decrease of at least 50% from baseline, respectively, for patients with CD.
The researchers defined clinical remission and clinical response at 8 weeks as a pediatric UC activity index score below 10, and a decrease of at least 20 points from baseline, respectively, for patients with UC.
|The team observed clinical remission in 60% at Week 8|
|Clinical Gastroenterology & Hepatology|
Patients with a clinical response to 8 weeks’ treatment with thalidomide underwent endoscopic examination with biopsy collection at study weeks 12 and 52.
Severity of inflammation in patients with UC was assessed by Mayo score and in patients with CD by 4-grade system.
The research team assessed biopsies for signs of active inflammation, erosion or ulceration, and crypt abscesses and assigned a histologic score.
The team observed clinical remission in 60%, and clinical response in 64% at Week 8.
At Week 52, a total of 54% of patients were still in clinical remission or still had a clinical response.
The researchers observed that 41% of patients had mucosal healing, defined as complete healing of erosions or ulcerations, and 28% had histologic healing, defined as complete absence of markers of inflammation.
Of patients with clinical remission or clinical response, 75% also had mucosal healing and 53% also had histologic healing.
The team noted that the probability of achieving mucosal healing decreased significantly with increasing values of erythrocyte sedimentation rate.
Dr Lazzerini's team concludes, "In a long-term analysis of data from 2 clinical trials of pediatric patients with CD or UC, 52 weeks’ treatment with thalidomide led to clinical remission in 54% of patients with ileocolonic or colonic disease.
"Of these patients, 75% had mucosal healing and 53% also had histologic healing."
"Further studies are needed to determine how thalidomide therapy affects long-term progression of inflammatory bowel diseases."