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Your search keyword '"Schreiber, S"' showing total 22 results
Start Over Author "Schreiber, S" Journal alimentary pharmacology & therapeutics
22 results on '"Schreiber, S"'

4. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohnʼs disease: analyses from the 7-year PRECiSE 3 study

Author

Sandborn, W. J., Melmed, G. Y., McGovern, D. P. B., Loftus, E. V., Jr, Choi, J. M., Cho, J. H., Abraham, B., Gutierrez, A., Lichtenstein, G., Lee, S. D., Randall, C. W., Schwartz, D. A., Regueiro, M., Siegel, C. A., Spearman, M., Kosutic, G., Pierre-Louis, B., Coarse, J., and Schreiber, S.

Published
2015
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20. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECi SE 3 study.

Author

Sandborn, W. J., Lee, S. D., Randall, C., Gutierrez, A., Schwartz, D. A., Ambarkhane, S., Kayhan, C., Pierre‐Louis, B., Schreiber, S., and Lichtenstein, G. R.

Subjects
THERAPEUTIC use of monoclonal antibodies, INFLAMMATORY bowel disease treatment, TREATMENT effectiveness, TUMORS, DISEASE remission
Abstract

Background The efficacy and safety of certolizumab pegol ( CZP) in moderate-to-severe Crohn's disease were demonstrated in two 26-week double-blind studies ( PRECi SE 1 & 2). Aim To report the safety and efficacy outcomes of long-term, CZP therapy from PRECi SE 3, in which patients received treatment up to 7 years treatment. Methods Patients completing PRECi SE 1 or 2 were eligible to enter PRECi SE 3 in which they received CZP 400 mg, open-label, every 4 weeks (without additional induction therapy) for up to 7 years, for up to 91 doses from study start. Safety (adverse events, including infections and malignancies) and efficacy (Harvey-Bradshaw Index, faecal calprotectin, C-reactive protein) were prospectively monitored. Remission was analysed using observed cases, last observation carried forward imputation and nonresponder imputation. Results A total of 595 patients entered the study; 117 (20%) completed 7 years. Discontinuation rates were 29.2%, 13.6%, 16.1%, 7.9%, 5.0%, 4.5% and 3.9% (years 1-7 respectively). During 1920 patient-years of exposure to CZP, no new safety signals were observed. Incidence rates (new cases/100 patient-years) for serious infections and malignant neoplasms were 4.37 and 1.06 respectively. No lymphoproliferative malignancies were reported. Clinical remission rates were ≥68% at each year (observed cases); rates by last observation carried forward and nonresponder imputation were 58% and 45% at year 1, 56% and 26% at year 3 and 55% and 13% at year 7 respectively. Conclusion Certolizumab pegol was well tolerated in the long-term treatment of Crohn's disease, with sustained remission in some patients continuing in the study for up to 7 years. ClinicalTrials.gov identifier NCT00552058. [ABSTRACT FROM AUTHOR]

Published
2014
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22. Review article: the histological assessment of disease activity in ulcerative colitis

Author

Silvio Danese, Laurent Peyrin-Biroulet, A. Marchal Bressenot, Camille Boulagnon-Rombi, Walter Reinisch, Stefan Schreiber, Robert H. Riddell, Bressenot, Am, Riddell, Rh, Boulagnon-Rombi, C, Reinisch, W, Danese, S, Schreiber, S, and Peyrin-Biroulet, L

Subjects
medicine.medical_specialty, Pathology, Hepatology, medicine.diagnostic_test, business.industry, Gastroenterology, Rectum, Inflammation, Disease, medicine.disease, Ulcerative colitis, Review article, Clinical trial, medicine.anatomical_structure, Internal medicine, Biopsy, medicine, Pharmacology (medical), Colitis, medicine.symptom, business
Abstract

Backgound In patients with ulcerative colitis (UC), mucosal healing has emerged as a major therapeutic goal, and is usually assessed endoscopically. Histological healing does not correlate very well with endoscopic mucosal healing in UC and persistent histological inflammation might be a better predictor of future clinical relapse than the endoscopic appearance alone. Aim To define how histological assessment of disease activity should be best done in UC. Methods Electronic (PubMed/Embase) and manual search. Results At least 18 histological indices to assess disease activity in UC have been described, though none are fully validated. However, histological assessment is increasingly used as a secondary endpoint in clinical trials in UC. After reviewing and discussing existing histological scoring systems for UC activity, we describe features of histological response and define three grades of activity: (i) histological healing - complete resolution of abnormalities (ii) quiescent disease, - lack of mucosal neutrophils but chronic inflammation may remain (iii) active disease - presence of neutrophils plus possible epithelial damage. It is recommended that two biopsies are taken from each colonic segment which should include always biopsy of the rectum and the most affected segments. There is to date no agreed preferable scoring system but the Geboes Index is the best validated (kappa for interobserver variation 0.59-0.70). Conclusion Histological assessment of disease activity in UC is increasingly used, but needs to be carefully defined.

Published
2015

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