Tags

Type your tag names separated by a space and hit enter

Endoscopic and Histologic Healing in Children With Inflammatory Bowel Diseases Treated With Thalidomide.
Clin Gastroenterol Hepatol 2017; 15(9):1382-1389.e1CG

Abstract

BACKGROUND & AIMS

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. We analyzed long-term results of children treated with thalidomide to determine the association between clinical response and histology and endoscopy findings.

METHODS

We collected data from 2 multicenter trials of 70 children with refractory Crohn's disease (CD) or ulcerative colitis (UC) (2-18 years old; ileocolonic or colonic disease) given thalidomide or placebo (NCT00720538). 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; and as a pediatric UC activity index score below 10 and a decrease of at least 20 points from baseline, respectively, for patients with UC. 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. Biopsies were assessed for signs of active inflammation, erosion or ulceration, and crypt abscesses and assigned a histologic score.

RESULTS

Clinical remission was observed in 42 patients (60.0%) and clinical response in 45 patients (64.2%) at Week 8. At Week 52, a total of 38 patients (54.3%) were still in clinical remission or still had a clinical response; 29 patients (41.4%) had mucosal healing, defined as complete healing of erosions or ulcerations, and 20 patients (27.7%) had histologic healing, defined as complete absence of markers of inflammation. Of patients with clinical remission or clinical response, 75.3% also had mucosal healing and 52.6% also had histologic healing. The probability of achieving mucosal healing decreased significantly with increasing values of erythrocyte sedimentation rate (adjusted odds ratio, 0.96; 95% CI, 0.93-0.98; P = .006).

CONCLUSIONS

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 54.3% of patients with ileocolonic or colonic disease; of these patients, 75.3% had mucosal healing and 52.6% also had histologic healing. Further studies are needed to determine how thalidomide therapy affects long-term progression of inflammatory bowel diseases. (ClinicalTrials.gov number NCT00720538).

Authors+Show Affiliations

Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy. Electronic address: marzia.lazzerini@burlo.trieste.it.Department of Pathology, Spedali Civili, Brescia, Italy.Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy; University of Trieste, Trieste, Italy.Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy.Paediatric Sciences, University of Messina, Messina, Italy.Paediatric Sciences, University of Messina, Messina, Italy.Paediatric Sciences, University of Messina, Messina, Italy.Paediatric Gastroenterology Unit, Institute Giannina Gaslini, Genoa, Italy.Paediatric Gastroenterology Unit, Institute Giannina Gaslini, Genoa, Italy.Paediatric Gastroenterology Unit, Institute Giannina Gaslini, Genoa, Italy.Department of Sciences for Woman and Child Health, University of Florence, Meyer Children's Hospital, Florence, Italy.Paediatric Department, Children's Hospital "V. Buzzi", Milan, Italy.Paediatric Department, Children's Hospital "V. Buzzi", Milan, Italy.Paediatric Gastroenterology, University of Pisa, Pisa, Italy.Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy; University of Trieste, Trieste, Italy.Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy.Department of Pathology, Spedali Civili, Brescia, Italy.Department of Pathology, Spedali Civili, Brescia, Italy.Department of Pathology, Spedali Civili, Brescia, Italy.University of Trieste, Trieste, Italy.Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy.Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy; University of Trieste, Trieste, Italy.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28286192

Citation

Lazzerini, Marzia, et al. "Endoscopic and Histologic Healing in Children With Inflammatory Bowel Diseases Treated With Thalidomide." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 15, no. 9, 2017, pp. 1382-1389.e1.
Lazzerini M, Villanacci V, Pellegrin MC, et al. Endoscopic and Histologic Healing in Children With Inflammatory Bowel Diseases Treated With Thalidomide. Clin Gastroenterol Hepatol. 2017;15(9):1382-1389.e1.
Lazzerini, M., Villanacci, V., Pellegrin, M. C., Martelossi, S., Magazzù, G., Pellegrino, S., ... Ventura, A. (2017). Endoscopic and Histologic Healing in Children With Inflammatory Bowel Diseases Treated With Thalidomide. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 15(9), pp. 1382-1389.e1. doi:10.1016/j.cgh.2017.02.029.
Lazzerini M, et al. Endoscopic and Histologic Healing in Children With Inflammatory Bowel Diseases Treated With Thalidomide. Clin Gastroenterol Hepatol. 2017;15(9):1382-1389.e1. PubMed PMID: 28286192.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Endoscopic and Histologic Healing in Children With Inflammatory Bowel Diseases Treated With Thalidomide. AU - Lazzerini,Marzia, AU - Villanacci,Vincenzo, AU - Pellegrin,Maria Chiara, AU - Martelossi,Stefano, AU - Magazzù,Giuseppe, AU - Pellegrino,Salvatore, AU - Lucanto,Maria Cristina, AU - Barabino,Arrigo, AU - Calvi,Angela, AU - Arrigo,Serena, AU - Lionetti,Paolo, AU - Fontana,Massimo, AU - Zuin,Giovanna, AU - Maggiore,Giuseppe, AU - Bramuzzo,Matteo, AU - Maschio,Massimo, AU - Salemme,Marianna, AU - Manenti,Stefania, AU - Lorenzi,Luisa, AU - Decorti,Giuliana, AU - Montico,Marcella, AU - Ventura,Alessandro, Y1 - 2017/03/07/ PY - 2016/12/20/received PY - 2017/02/23/revised PY - 2017/02/25/accepted PY - 2017/3/14/pubmed PY - 2018/5/1/medline PY - 2017/3/14/entrez KW - Drug KW - Efficacy KW - IBD KW - Intestinal Mucosa SP - 1382 EP - 1389.e1 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin. Gastroenterol. Hepatol. VL - 15 IS - 9 N2 - BACKGROUND & AIMS: 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. We analyzed long-term results of children treated with thalidomide to determine the association between clinical response and histology and endoscopy findings. METHODS: We collected data from 2 multicenter trials of 70 children with refractory Crohn's disease (CD) or ulcerative colitis (UC) (2-18 years old; ileocolonic or colonic disease) given thalidomide or placebo (NCT00720538). 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; and as a pediatric UC activity index score below 10 and a decrease of at least 20 points from baseline, respectively, for patients with UC. 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. Biopsies were assessed for signs of active inflammation, erosion or ulceration, and crypt abscesses and assigned a histologic score. RESULTS: Clinical remission was observed in 42 patients (60.0%) and clinical response in 45 patients (64.2%) at Week 8. At Week 52, a total of 38 patients (54.3%) were still in clinical remission or still had a clinical response; 29 patients (41.4%) had mucosal healing, defined as complete healing of erosions or ulcerations, and 20 patients (27.7%) had histologic healing, defined as complete absence of markers of inflammation. Of patients with clinical remission or clinical response, 75.3% also had mucosal healing and 52.6% also had histologic healing. The probability of achieving mucosal healing decreased significantly with increasing values of erythrocyte sedimentation rate (adjusted odds ratio, 0.96; 95% CI, 0.93-0.98; P = .006). CONCLUSIONS: 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 54.3% of patients with ileocolonic or colonic disease; of these patients, 75.3% had mucosal healing and 52.6% also had histologic healing. Further studies are needed to determine how thalidomide therapy affects long-term progression of inflammatory bowel diseases. (ClinicalTrials.gov number NCT00720538). SN - 1542-7714 UR - https://www.unboundmedicine.com/medline/citation/28286192/Endoscopic_and_Histologic_Healing_in_Children_With_Inflammatory_Bowel_Diseases_Treated_With_Thalidomide_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(17)30260-4 DB - PRIME DP - Unbound Medicine ER -