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Crohn Disease: HELP
Articles by Jan C. Preiss
Based on 13 articles published since 2010
(Why 13 articles?)
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Between 2010 and 2020, J. Preiß wrote the following 13 articles about Crohn Disease.
 
+ Citations + Abstracts
1 Guideline [Updated German clinical practice guideline on "Diagnosis and treatment of Crohn's disease" 2014]. 2014

Preiß, J C / Bokemeyer, B / Buhr, H J / Dignaß, A / Häuser, W / Hartmann, F / Herrlinger, K R / Kaltz, B / Kienle, P / Kruis, W / Kucharzik, T / Langhorst, J / Schreiber, S / Siegmund, B / Stallmach, A / Stange, E F / Stein, J / Hoffmann, J C / Anonymous2240814. ·Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin. · Gastroenterologische Gemeinschaftspraxis Minden. · Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie, Berlin. · Medizinische Klinik I, Agaplesion Markus-Krankenhaus, Frankfurt/Main. · Klinik Innere Medizin I, Klinikum Saarbrücken. · Agaplesion MVZ, Frankfurt/Main. · Innere Medizin I, Asklepios Klinik Nord, Hamburg. · Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung (DCCV) e. V., Berlin. · Chirurgische Klinik, Universitätsmedizin Mannheim. · Abteilung für Innere Medizin, Evangelisches Krankenhaus Kalk, Köln. · Klinik für Allgemeine Innere Medizin & Gastroenterologie, Klinikum Lüneburg. · Integrative Gastroenterologie, Klinik für Naturheilkunde und Integrative Medizin, Kliniken Essen-Mitte. · Medizinische Klinik I, Universitätsklinikum Schleswig-Holstein, Campus Kiel. · Klinik für Innere Medizin IV, Universitätsklinikum Jena. · Abteilung für Gastroenterologie, Hepatologie und Endokrinologie, Robert-Bosch-Krankenhaus, Stuttgart. · Abteilung Gastroenterologie/Ernährungsmedizin, DGD Kliniken Frankfurt Sachsenhausen, Frankfurt/Main. · Medizinische Klinik I, St. Marien- und St. Annastiftskrankenhaus, Ludwigshafen. ·Z Gastroenterol · Pubmed #25474283.

ABSTRACT: -- No abstract --

2 Guideline [Updated S3 guideline on diagnosis and treatment of Crohn's disease: up to date or new?]. 2014

Stallmach, A / Hoffmann, J / Preiß, J C / Anonymous2220814. ·Klinik für Innere Medizin IV (Gastroenterologie, Hepatologie und Infektiologie), Universitätsklinikum Jena. · Medizinische Klinik I, St. Marien- und St. Annastiftskrankenhaus, Ludwigshafen. · Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin. ·Z Gastroenterol · Pubmed #25474276.

ABSTRACT: -- No abstract --

3 Review Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. 2015

Khanna, Reena / Preiss, Jan C / MacDonald, John K / Timmer, Antje. ·Robarts Clinical Trials, Robarts Research Institute, P.O. Box 5015, 100 Perth Drive, London, ON, Canada, N6A 5K8. ·Cochrane Database Syst Rev · Pubmed #25942580.

ABSTRACT: BACKGROUND: Ustekinumab (CNTO 1275) and briakinumab (ABT-874) are monoclonal antibodies that target the standard p40 subunit of the cytokines interleukin-12 and interleukin-23 (IL-12/23p40), which are involved in the pathogenesis of Crohn's disease. OBJECTIVES: The objectives of this review were to assess the efficacy and safety of anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. SEARCH METHODS: The following databases were searched from inception to September 16, 2014: PubMed, MEDLINE, EMBASE, and the Cochrane Library (CENTRAL). References and conference abstracts were searched to identify additional studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) trials in which monoclonal antibodies against IL-12/23p40 were compared to placebo or another active comparator in patients with active Crohn's disease were included.  DATA COLLECTION AND ANALYSIS: Two authors independently screened  studies for inclusion and extracted data. Methodological quality was assessed using the Cochrane risk of bias tool. The primary outcome was failure to induce clinical remission, defined as a Crohn's disease activity index (CDAI) of < 150 points. Secondary outcomes included failure to induce clinical improvement, serious adverse events, and withdrawals due to adverse events. Clinical improvement was defined as decreases of > 70 or > 100 points in the CDAI from baseline. We calculated the risk ratio (RR) and 95% confidence intervals (95% CI) for each outcome. A fixed-effect model was used to pool data. Data were analyzed on an intention-to-treat basis. The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria. MAIN RESULTS: Four randomized controlled trials (n = 955 patients) met the inclusion criteria. A low risk of bias was assigned to all studies. The two briakinumab trials were not pooled due to differences in doses and time points for analysis. In both studies there was no statistically significant difference in remission rates. One study (n = 79) compared doses of 1 mg/kg and 3 mg/kg to placebo. In the briakinumab group 70% (44/63) of patients failed to enter clinical remission at 6 or 9 weeks compared to 81% (13/16) of placebo patients (RR 0.86, 95% CI 0.65 to 1.14). Subgroup analysis revealed no significant differences by dose. The other briakinumab study (n = 230) compared intravenous doses of 200 mg, 400 mg and 700 mg with placebo. Eighty-four per cent (154/184) of briakinumab patients failed to enter clinical remission at six weeks compared to 91% (42/46) of placebo patients (RR 0.92, 95% CI 0.83 to 1.03). Subgroup analysis revealed no significant differences by dose. GRADE analyses of the briakinumab studies rated the overall quality of the evidence for the outcome clinical remission as low due. Based on the results of these two studies the manufacturers of briakinumab stopped production of this medication. The two ustekinumab studies (630 patients) were pooled despite differences in intravenous doses (i.e. 1mg/kg, 3 mg/kg, 4.5 mg/kg, and 6 mg/kg), however the subcutaneous dose group was not included in the analysis, as it was unclear if subcutaneous was equivalent to intravenous dosing. There was no statistically significant difference in remission rates. At week six, 85% (356/420) of ustekinumab patients failed to enter remission compared to 89% (142/159) of placebo patients (RR 0.94, 95% CI 0.88 to 1.01). Subgroup analysis showed no statistically significant difference by dose. There were statistically significant differences in clinical improvement between ustekinumab and placebo-treated patients. In the ustekinumab group, 55% (230/420) of patients failed to improve clinically (i.e. 70-point decline in CDAI score), compared to 72% (115/159) of placebo patients (RR 0.75, 95% CI 0.66 to 0.86). Subgroup analysis revealed significant differences compared to placebo for the 1 mg/kg, 4.5 mg/kg and 6 mg/kg dosage subgroups. Similarly for a 100-point decline in CDAI, 62% (262/420) of patients in the ustekinumab group failed to improve clinically compared to 78% (124/159) of placebo patients (RR 0.79, 95% CI 0.71 to 0.89). Subgroup analysis showed a significant difference compared to placebo for the 4.5 mg/kg dose group. GRADE analyses of the ustekinumab studies rated the overall quality of the evidence for the outcomes clinical remission and clinical response as moderate. There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events. Sixty-seven per cent (316/473) of ustekinumab patients developed at least one adverse event compared to 73% (135/184) of placebo patients (RR 0.92, 95% CI 0.83 to 1.03). A GRADE analysis indicated that the overall quality of the evidence for this outcome was high. Six per cent (29/473) of ustekinumab patients had a serious adverse event compared to 8% (14/184) of placebo patients (RR 0.81, 95% CI 0.44 to 1.49). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low. The most common adverse events in briakinumab patients were injection site reactions and infections. Infections were the most common adverse event in ustekinumab patients. Worsening of Crohn's disease and serious infections were the most common serious adverse events. AUTHORS' CONCLUSIONS: Although we are uncertain about the efficacy of ustekinumab for induction of remission, moderate quality evidence suggests that ustekinumab may be effective for induction of clinical improvement in patients with moderate to severe CD. Due to small numbers of patients in dose subgroups the optimal dosage of ustekinumab is unclear. Briakinumab and ustekinumab appear to be safe. Due to sparse data we were unable to determine the risk of serious adverse events. Further studies are required to determine the efficacy and safety of ustekinumab in patients with moderate to severe CD. The results of three phase III trials that are currently underway will provide important new information.

4 Review Psychological interventions for treatment of inflammatory bowel disease. 2011

Timmer, Antje / Preiss, Jan C / Motschall, Edith / Rücker, Gerta / Jantschek, Günther / Moser, Gabriele. ·Clinical Epidemiology, Bremen Institute for Prevention Research and Social Medicine, Achterstrasse 30, Bremen, Germany, 28359. ·Cochrane Database Syst Rev · Pubmed #21328288.

ABSTRACT: BACKGROUND: The effect of psychological interventions in inflammatory bowel diseases (IBD) is controversial. OBJECTIVES: To assess the effects of psychological interventions (psychotherapy, patient education, relaxation techniques) on health related quality of life, coping, emotional state and disease activity in IBD. SEARCH STRATEGY: We searched the specialized register of the IBD/FBD Group, CENTRAL (Issue 5, 2010) and from inception to April 2010: Medline, Embase, LILACS, Psyndex, CINAHL, PsyInfo, CCMed, SOMED and Social SciSearch. Conference abstracts and reference lists were also checked. SELECTION CRITERIA: Randomized, quasi-randomized and non randomized controlled trials of psychological interventions in children or adults with IBD with a minimum follow up time of 2 months. DATA COLLECTION AND ANALYSIS: Data were extracted and study quality was independently assessed by two raters. Pooled standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated using a random effects model. MAIN RESULTS: Twenty-one studies were eligible for inclusion (1745 participants, 8 RCT, 4 QRCT, 8 NRCT; 19 in adults, 2 in adolescents). Most studies used multimodular approaches. The risk of bias was high for all studies.In adults, psychotherapy had no effect on quality of life at around 12 months (3 studies, 235 patients, SMD -0.07; 95% CI -0.33 to 0.19), emotional status (depression, 4 studies, 266 patients, SMD 0.03; 95% CI -0.22 to 0.27) or proportion of patients not in remission (5 studies, 287 patients, OR 0.85; 95% CI 0.48 to 1.48). Results were similar at 3 to 8 months. There was no evidence for statistical heterogeneity or subgroup effects based on type of disease or intensity of the therapy. In adolescents, there were positive short term effects of psychotherapy on most outcomes assessed including quality of life (2 studies, 71 patients, SMD 0.70; 95% CI 0.21 to 1.18) and depression (1 study, 41 patients, SMD -0.62; 95% CI -1.25 to 0.01).Educational interventions were ineffective with respect to quality of life at 12 months (5 studies, 947 patients, SMD 0.11; 95% CI -0.02 to 0.24), depression (3 studies, 378 patients, SMD -0.08; 95% CI -0.29 to 0.12) and proportion of patients not in remission (3 studies, 434 patients, OR 1.00; 95% CI 0.65 to 1.53). AUTHORS' CONCLUSIONS: There is no evidence for efficacy of psychological therapy in adult patients with IBD in general. In adolescents, psychological interventions may be beneficial, but the evidence is limited. Further evidence is needed to assess the efficacy of these therapies in subgroups identified as being in need of psychological interventions, and to identify what type of therapy maybe most useful.

5 Review [What has been confirmed in the treatment of inflammatory bowel disease?]. 2010

Siegmund, B / Preiss, J C / Zeitz, M. ·Medizinische Klinik I, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, Germany. britta.siegmund@charite.de ·Internist (Berl) · Pubmed #21069274.

ABSTRACT: The therapy of inflammatory bowel diseases is currently guided by clinical variables. An escalation of immunosuppressive therapy is required in case of treatment failure. However, clinical remission does not necessarily imply mucosal healing. In parallel to the treatment of rheumatoid arthritis a novel concept is emerging suggesting that an early anti-inflammatory treatment can reduce structural changes in inflammatory bowel diseases. The studies supporting this novel therapeutic strategy that mucosal healing might build the future therapeutic goal will be discussed. In order to adjust the therapy, risk factors indicating a complicated disease course will be identified, resulting in the development of an individual disease course. The benefit of these strategies will be discussed together with therapy-associated complications.

6 Review Use of methotrexate in patients with inflammatory bowel diseases. 2010

Preiss, J C / Zeitz, M. ·Medizinische Klinik I, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany. jan.preiss@charite.de ·Clin Exp Rheumatol · Pubmed #21044450.

ABSTRACT: Methotrexate (MTX) is one of the immunosuppressants commonly used in inflammatory bowel diseases. There is very good evidence for its use in patients with steroid-dependent or steroid-refractory Crohn's disease for induction as well as maintenance of remission. Optimal dose as well as mode of application is still a matter of debate. The only large randomised controlled trials used 25 mg/wk for induction and 15 to 25 mg/wk for maintenance of remission, both applied intramuscularly. Current guidelines recommend methotrexate in patients with extensive disease, steroid-refractory, and steroid-dependent disease. They even suggest MTX for patients with infrequent relapses in the need of repetitive corticosteroid therapy. In clinical practice it is mainly used in patients who failed treatment with thiopurines (azathioprine or 6-mercaptopurine) or who are intolerant to these drugs. MTX can also be used in paediatric patients, whereas the evidence for its effectiveness in fistulising disease is very weak. Two small studies did not prove that MTX is efficacious in ulcerative colitis. Even though case series suggest otherwise, its use is not recommended by current guidelines for patients with ulcerative colitis.

7 Article Accuracy of diagnostic tests and a new algorithm for diagnosing cytomegalovirus colitis in inflammatory bowel diseases: a diagnostic study. 2019

Kredel, Lea I / Mundt, Pamela / van Riesen, Linda / Jöhrens, Korinna / Hofmann, Jörg / Loddenkemper, Christoph / Siegmund, Britta / Preiß, Jan C. ·Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany. · Praxis Jessen + Kollegen, Akademische Lehrpraxis der Charité - Universitätsmedizin Berlin, Berlin, Germany. · Klinik für Innere Medizin - Schwerpunkt Gastroenterologie, DRK Kliniken Westend, Berlin, Germany. · Institut für Pathologie, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. · Institut für Virologie, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. · Pathotres Gemeinschaftspraxis für Pathologie, Berlin, Germany. · Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany. jan.preiss@charite.de. · Klinik für Innere Medizin - Gastroenterologie, Diabetologie und Hepatologie, Vivantes Klinikum Neukölln, Berlin, Germany. jan.preiss@charite.de. ·Int J Colorectal Dis · Pubmed #30276706.

ABSTRACT: PURPOSE: The optimal method for detecting CMV colitis in patients with inflammatory bowel disease (IBD) has not been established. We wanted to investigate which diagnostic test would be most accurate when defining CMV colitis rather by the further clinical course than by using another diagnostic modality. METHODS: All consecutive patients with moderately or severely active IBD who had been tested for CMV by PCR, histology, or antigenemia assay at the two campuses CBF and CCM of the Charité - Universitätsmedizin Berlin between September 2006 and September 2009 were included in this retrospective study. During that time, in patients with a positive CMV test, immunosuppressive treatment of any kind was immediately reduced and antiviral treatment was started. This allowed identifying patients who responded to antiviral treatment and those who only responded to later escalation of immunosuppressive therapy. RESULTS: One hundred and nine patients were identified, out of whom nine were considered to have clinically relevant CMV colitis. Sensitivity and specificity were 1 and 0.94 for CMV PCR and 0.5 and 1 for pp65 antigen immunofluorescence assay from peripheral blood, 0.67 and 0.98 for immunohistochemistry, and 0.17 and 0.98 for hematoxylin-eosin staining. When using absence of leukocytosis, splenomegaly, and steroid refractory disease as clinical parameters to test for CMV colitis, blood CMV PCR and immunohistochemistry were able to exclude CMV colitis in negative patients with a 75% likelihood of positive patients to have clinically relevant CMV colitis. CONCLUSIONS: Blood-based CMV PCR together with simple clinical parameters can exclude clinically relevant CMV colitis at a high specificity.

8 Article Restless legs syndrome is a relevant comorbidity in patients with inflammatory bowel disease. 2018

Becker, Janek / Berger, Felix / Schindlbeck, Katharina A / Poddubnyy, Denis / Koch, Peter M / Preiß, Jan C / Siegmund, Britta / Marzinzik, Frank / Maul, Jochen. ·Department of Medicine (Gastroenterology, Infectious Diseases, Rheumatology), Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany. · Department of Neurology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany. · Center for Neurosciences, Feinstein Institute for Medical Research, Manhasset, NY, USA. · Gastroenterologie, Hepatologie und Diabetologie, Vivantes Klinikum Neukölln, Berlin, Germany. · Department of Medicine (Gastroenterology, Infectious Diseases, Rheumatology), Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany. jochen.maul@charite.de. · Gastroenterologie am Bayerischen Platz, Innsbrucker Str. 58, 10825, Berlin, Germany. jochen.maul@charite.de. ·Int J Colorectal Dis · Pubmed #29610943.

ABSTRACT: BACKGROUND AND AIMS: In patients with inflammatory bowel disease (IBD), restless legs syndrome (RLS) may occur as an extraintestinal disease manifestation. Iron deficiency (ID) or folate deficiency/vitamin B METHODS: Patients were screened for ID and RLS by a gastroenterologist. If RLS was suspected, a neurologist was consulted for definitive diagnosis and severity. Patients with RLS and ID, FD, or VB RESULTS: A total of 353 IBD patients were included. Prevalence for RLS was 9.4% in Crohn's disease (CD) and 8% in ulcerative colitis (UC). Prevalence for the subgroup of clinically relevant RLS (symptoms ≥ twice/week with at least moderate distress) was 7.1% (n = 16) for CD and 4.8% (n = 6) for UC. 38.7% of RLS patients presented with ID, FD, and/or VB CONCLUSION: Although the overall prevalence of RLS in IBD did not differ to the general population, clinically relevant RLS was more frequent in IBD patients and, therefore, it is important for clinicians to be aware of RLS symptoms. Though for definite diagnosis and proper treatment of RLS, a neurologist must be consulted. Additionally, iron supplementation of IBD patients with ID can improve RLS symptoms. TRIAL REGISTRATION: ClinicalTrials.gov No. NCT03457571.

9 Article Microbial Spectrum of Intra-Abdominal Abscesses in Perforating Crohn's Disease: Results from a Prospective German Registry. 2018

Reuken, P A / Kruis, W / Maaser, C / Teich, N / Büning, J / Preiß, J C / Schmelz, R / Bruns, T / Fichtner-Feigl, S / Stallmach, A / Anonymous6090935. ·Department of Internal Medicine IV [Gastroenterology, Hepatology, and Infectious Diseases], Jena University Hospital, Jena, Germany. · Klinik für Gastroenterologie, Pulmonologie und Allgemeine Innere Medizin, Evangelisches Krankenhaus Köln Kalk, University of Cologne, Cologne, Germany. · Ambulanzzentrum Gastroenterologie, University Teaching Hospital Lüneburg, Lüneburg, Germany. · Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten Leipzig und Schkeuditz, Leipzig, Germany. · Medical Faculty, Friedrich-Schiller University, Jena, Germany. · Department of Internal Medicine I [Gastroenterology], University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany. · Department of Medicine I [Gastroenterology, Infectious Diseases, Rheumatology], Charité-Universitätsmedizin Berlin, Berlin, Germany. · Department of Internal Medicine 1, University Hospital Carl Gustav Carus, Dresden, Germany. · Department of Surgery, University Medical Center Regensburg, Regensburg, Germany. ·J Crohns Colitis · Pubmed #29415186.

ABSTRACT: Background: Intra-abdominal abscesses [IAAs] are common life-threatening complications in patients with Crohn's disease [CD]. In addition to interventional drainage and surgical therapy, empirical antibiotic therapy represents a cornerstone of treatment, but contemporary data on microbial spectra and antimicrobial resistance are scarce. Methods: We recruited 105 patients with CD and IAAs from nine German centres for a prospective registry in order to characterize the microbiological spectrum, resistance profiles, antibiotic therapy and outcome. Results: In 92 of 105 patients, microbial investigations of abscess material revealed pathogenic microorganisms. A total of 174 pathogens were isolated, with a median of 2 pathogens per culture [range: 1-6]. Most frequently isolated pathogens were E. coli [45 patients], Streptococcus spp. [28 patients], Enterococci [27 patients], Candida [13 patients] and anaerobes [12 patients]. Resistance to third-generation cephalosporins, penicillins with beta-lactamase inhibitors and quinolones were observed in 51, 36 and 35 patients, respectively. Seven patients had multiple-drug-resistant bacteria. Thirty patients received inadequate empirical treatment, and this was more frequent in patients receiving steroids or immunosuppression [37%] than in patients without immunosuppression [10%: p = 0.001] and was associated with a longer hospital stay [21 days vs 13 days, p = 0.003]. Conclusion: Based on antimicrobial resistance profiles, we herein report a high rate of inadequate empirical first-line therapy for IAAs in CD, especially in patients receiving immunosuppression, and this is associated with prolonged hospitalization.

10 Article Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study. 2016

Stallmach, A / Langbein, C / Atreya, R / Bruns, T / Dignass, A / Ende, K / Hampe, J / Hartmann, F / Neurath, M F / Maul, J / Preiss, J C / Schmelz, R / Siegmund, B / Schulze, H / Teich, N / von Arnim, U / Baumgart, D C / Schmidt, C. ·Jena, Germany. · Erlangen, Germany. · Frankfurt/Main, Germany. · Erfurt, Germany. · Dresden, Germany. · Berlin, Germany. · Leipzig, Germany. · Magdeburg, Germany. ·Aliment Pharmacol Ther · Pubmed #27714831.

ABSTRACT: BACKGROUND: Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials. AIM: To determine the long-term effectiveness of vedolizumab in a real-world clinical setting. METHODS: This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60). Primary endpoint was clinical remission (HBI ≤ 4/pMayo ≤ 1) at week 54. Secondary endpoints included clinical response rates (HBI/pMayo score drop ≥3) and steroid-free clinical remission at weeks 30 and 54. RESULTS: Vedolizumab was stopped in 69/127 (56%) patients after a median time of 18 weeks (range 2-49) predominantly owing to lack or loss of response. Using nonresponder imputation analysis, clinical remission and steroid-free remission rates were 21% and 15% in Crohn's disease and 25% and 22% in ulcerative colitis, respectively. Lack of clinical remission was associated with prior treatment with anti-TNF or with steroids for more than 3 months in the last 6 months in ulcerative colitis. At week 14, the absence of remission in Crohn's disease or nonresponse in ulcerative colitis indicated a low likelihood of clinical remission at week 54 [2/31 (7%) in Crohn's disease, 4/41 (10%) in ulcerative colitis]. Accordingly, declining C-reactive protein in inflammatory bowel disease and/or lower faecal calprotectin in ulcerative colitis at week 14 predicted remission at week 54. CONCLUSION: Among patients who started vedolizumab for active inflammatory bowel disease, clinical remission rates are 21-25% after 54 weeks.

11 Article Cerebrovascular events in inflammatory bowel disease patients treated with anti-tumour necrosis factor alpha agents. 2015

Karmiris, Konstantinos / Bossuyt, Peter / Sorrentino, Dario / Moreels, Tom / Scarcelli, Antonella / Legido, Jesus / Dotan, Iris / Naismith, Graham D / Jussila, Airi / Preiss, Jan C / Kruis, Wolfgang / Li, Andy C Y / Bouguen, Guillaume / Yanai, Henit / Steinwurz, Flavio / Katsanos, Konstantinos H / Subramaniam, Kavitha / Tarabar, Dino / Zaganas, Ioannis V / Ben-Horin, Shomron / Anonymous5220822. ·Department of Gastroenterology, Venizeleio General Hospital, Heraklion, Crete, Greece kkarmiris@gmail.com. · Imelda GI Clinical Research Center, Bonheiden, Belgium. · IBD Center, Virginia Tech-Carilion School of Medicine, Roanoke, VA, USA and Department of Clinical and Experimental Medical Sciences, University of Udine School of Medicine, Udine, Italy. · Department of Hepato-gastroenterology, Cliniques Universitaires Saint-Luc, Brussels, Belgium. · Department of Gastroenterology, Azienda University Hospital, Policlinico di Modena, Italy. · Gastroenterology Unit, Segovia General Hospital, Segovia, Spain. · IBD Center, Department of Gastroenterology and Liver Diseases and the Sackler School of Medicine, Sourasky Medical Center, Tel Aviv, Israel. · Department of Gastroenterology, Paisley RAH, Glasgow, Scotland. · Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland. · Charité-Universitätsmedizin, Berlin, Germany. · Department of Gastroenterology, Western Sussex Hospitals NHSFT, Worthing, UK. · Department of Gastroenterology, University Hospital Pontchaillou, Rennes, France. · IBD Unit, Hospital Israelita Albert Einstein, Sao Paulo, Brazil. · Division of Gastroenterology, University Hospital of Ioannina, Greece. · Gastroenterology and Hepatology Unit, Canberra Hospital, Canberra, Australia. · Department of Gastroenterology, MMA Belgrade, Serbia. · Department of Neurology, University Hospital of Heraklion, Heraklion, Crete, Greece. · Department of Gastroenterology, Sheba Medical Center, Tel-Aviv University, Tel-Aviv, Israel. ·J Crohns Colitis · Pubmed #25740813.

ABSTRACT: BACKGROUND AND AIMS: Cerebrovascular accidents [CVA] have rarely been reported in inflammatory bowel disease [IBD] patients treated with anti-tumour necrosis alpha [anti-TNF alpha] agents. Our aim here was to describe the clinical course of CVA in these patients. METHODS: This was a European Crohn's and Colitis Organisation [ECCO] retrospective observational study, performed as part of the CONFER [COllaborative Network For Exceptionally Rare case reports] project. A call to all ECCO members was made to report on IBD patients afflicted with CVA during treatment with anti-TNF alpha agents. Clinical data were recorded in a standardised case report form and analysed for event association with anti-TNF alpha treatment. RESULTS: A total of 19 patients were identified from 16 centres: 14 had Crohn's disease, four ulcerative colitis and one IBD colitis unclassified [median age at diagnosis: 38.0 years, range: 18.6-62.5]. Patients received anti-TNF alpha for a median duration of 11.8 months [range: 0-62] at CVA onset; seven had previously been treated with at least one other anti-TNF alpha agent. Complete neurological recovery was observed in 16 patients. Anti-TNF alpha was discontinued in 16/19 patients. However, recurrent CVA or neurological deterioration was not observed in any of the 11 patients who received anti-TNF alpha after CVA [eight resumed after temporary cessation, three continued without interruption] for a median follow-up of 39.8 months [range: 5.6-98.2]. CONCLUSION: These preliminary findings do not unequivocally indicate a causal role of anti-TNF alpha in CVA complicating IBD. Resuming or continuing anti-TNF alpha in IBD patients with CVA may be feasible and safe in selected cases, but careful weighing of IBD activity versus neurological status is prudent.

12 Article Predictors for subsequent need for immunosuppressive therapy in early Crohn's disease. 2012

Wenger, Sandra / Nikolaus, Susanna / Howaldt, Stefanie / Bokemeyer, Bernd / Sturm, Andreas / Preiss, Jan C / Schoepfer, Alain M / Stallmach, Andreas / Schmidt, Carsten. ·University Clinic Jena, Clinic of Internal Medicine II, Jena, Germany. ·J Crohns Colitis · Pubmed #22261524.

ABSTRACT: BACKGROUND AND AIMS: The clinical course of Crohn's disease (CD) is highly variable with a subgroup of patients developing a progressive disease course necessitating immunosuppressive therapy (IT). However, reliable, stable and non-invasive individual clinical parameters in order to identify patients at risk for undergoing subsequent IT have not been sufficiently established. We therefore aimed to identify such clinical parameters. METHODS: A retrospective, multicenter analysis of CD patients from 6 German tertiary IBD centers was performed. Patients were classified into two groups depending on requiring IT or not. Personal data, clinical and laboratory parameters during the first 3 months after CD diagnosis and effects of initial medical therapy were compared between these two groups. RESULTS: In 218 (61.8%) of the 353 patients the CD course necessitated IT. Those patients were significantly younger at symptom onset and diagnosis, and required significantly more often a systemic corticosteroid therapy. Furthermore, significant differences in serological markers of inflammation were observed. Age, gender and the effect of initial steroid therapy were used to develop a prognostic model predicting the individual probability of necessitating IT. CONCLUSIONS: The simple clinical items age at diagnosis, gender, and need for systemic steroid therapy can predict a progressive disease course in early CD. Our model based on these parameters allows an individualized estimation of each patient's risk to develop a progressive disease course. Thereby, our model can help in deciding if patients will need immunosuppressive drugs early in the disease course or if a careful watch and wait strategy is justified.

13 Article Randomized, placebo-controlled, double-blind trial of Boswellia serrata in maintaining remission of Crohn's disease: good safety profile but lack of efficacy. 2011

Holtmeier, Wolfgang / Zeuzem, Stefan / Preiss, Jan / Kruis, Wolfgang / Böhm, Stephan / Maaser, Christian / Raedler, Andreas / Schmidt, Carsten / Schnitker, Jörg / Schwarz, Joachim / Zeitz, Martin / Caspary, Wolfgang. ·Department of Gastroenterology, Diabetes and Internal Medicine, Hospital Porz am Rhein, Cologne, Germany. W.Holtmeier@khporz.de ·Inflamm Bowel Dis · Pubmed #20848527.

ABSTRACT: BACKGROUND: Complementary therapies are frequently used by patients with inflammatory bowel disease (IBD). The aim of this study was to evaluate the efficacy and safety of long-term therapy with a new Boswellia serrata extract (Boswelan, PS0201Bo) in maintaining remission in patients with Crohn's disease (CD). METHODS: In 22 German centers a double-blind, placebo-controlled, randomized, parallel study was performed. In all, 108 outpatients with CD in clinical remission were included. Patients were randomized to Boswelan (3×2 capsules/day; 400 mg each) or placebo for 52 weeks. The primary endpoint was the proportion of patients in whom remission was maintained throughout the 52 weeks. Secondary endpoints were time to relapse, changes of Crohn's Disease Activity Index (CDAI), and IBD Questionnaire (IBDQ) scores. RESULTS: The trial was prematurely terminated due to insufficient discrimination of drug and placebo with regard to the primary efficacy endpoint. A total of 82 patients were randomized to Boswelan (n=42) or placebo (n=40). Sixty-six patients could be analyzed for efficacy. 59.9% of the actively treated patients and 55.3% of the placebo group stayed in remission (P=0.85). The mean time to diagnosis of relapse was 171 days for the active group and 185 days for the placebo group (P=0.69). With respect to CDAI, IBDQ, and laboratory measurements of inflammation, no advantages in favor of active treatment were detected. Regarding safety concerns, no disadvantages of taking the drug compared to placebo were observed. CONCLUSIONS: The trial confirmed good tolerability of a new Boswellia serrata extract, Boswelan, in long-term treatment of CD. However, superiority versus placebo in maintenance therapy of remission could not be demonstrated.