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  1. Book: Inflammatory bowel disease

    Lichtiger, Simon

    (Gastrointestinal endoscopy clinics of North America ; volume 29, number 3 (July 2019))

    2019  

    Author's details editor Simon Lichtiger
    Series title Gastrointestinal endoscopy clinics of North America ; volume 29, number 3 (July 2019)
    Collection
    Language English
    Size xvi Seiten, Seite 382-576, Illustrationen
    Publisher Elsevier
    Publishing place Philadelphia, Pennsylvania
    Publishing country United States
    Document type Book
    HBZ-ID HT020127591
    ISBN 978-0-323-67795-0 ; 0-323-67795-9
    Database Catalogue ZB MED Medicine, Health

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  2. Article ; Online: Inflammatory Bowel Disease.

    Lichtiger, Simon

    Gastrointestinal endoscopy clinics of North America

    2019  Volume 29, Issue 3, Page(s) xv–xvi

    MeSH term(s) Anti-Inflammatory Agents/therapeutic use ; Antibodies, Monoclonal/therapeutic use ; Combined Modality Therapy ; Endoscopy, Gastrointestinal/methods ; Humans ; Inflammatory Bowel Diseases/diagnostic imaging ; Inflammatory Bowel Diseases/microbiology ; Inflammatory Bowel Diseases/therapy ; Laparoscopy/methods ; Tumor Necrosis Factor-alpha/antagonists & inhibitors
    Chemical Substances Anti-Inflammatory Agents ; Antibodies, Monoclonal ; Tumor Necrosis Factor-alpha
    Language English
    Publishing date 2019-04-12
    Publishing country United States
    Document type Editorial ; Introductory Journal Article
    ZDB-ID 1313994-0
    ISSN 1558-1950 ; 1052-5157
    ISSN (online) 1558-1950
    ISSN 1052-5157
    DOI 10.1016/j.giec.2019.03.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: The Role of Cyclosporine Therapy in Ulcerative Colitis Treatment.

    Lichtiger, Simon

    Gastroenterology & hepatology

    2016  Volume 2, Issue 9, Page(s) 624–626

    Language English
    Publishing date 2016-12-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2386402-3
    ISSN 1554-7914
    ISSN 1554-7914
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Correction to: Efficacy, Safety, and Tolerability of 
Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Ulcerative Colitis.

    Leber, Andrew / Hontecillas, Raquel / Tubau-Juni, Nuria / Lichtiger, Simon / Bassaganya-Riera, Josep

    Inflammatory bowel diseases

    2022  Volume 28, Issue 12, Page(s) 1938

    Language English
    Publishing date 2022-04-29
    Publishing country England
    Document type Published Erratum
    ZDB-ID 1340971-2
    ISSN 1536-4844 ; 1078-0998
    ISSN (online) 1536-4844
    ISSN 1078-0998
    DOI 10.1093/ibd/izac055
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  5. Article ; Online: WITHDRAWN: EFFICACY, SAFETY, AND TOLERABILITY OF OMILANCOR IN A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF PATIENTS WITH ULCERATIVE COLITIS.

    Leber, Andrew / Hontecillas, Raquel / Tubau-Juni, Nuria / Lichtiger, Simon / Bassaganya-Riera, Josep

    Inflammatory bowel diseases

    2022  Volume 28, Issue Supplement_1, Page(s) S112

    Abstract: Background: Omilancor is an oral, once-daily, gut-restricted, small molecule, first-in-class therapeutic for Crohn's disease (CD) and ulcerative colitis (UC) that targets the novel LANCL2 pathway. Through LANCL2 activation, omilancor increases the ... ...

    Abstract Background: Omilancor is an oral, once-daily, gut-restricted, small molecule, first-in-class therapeutic for Crohn's disease (CD) and ulcerative colitis (UC) that targets the novel LANCL2 pathway. Through LANCL2 activation, omilancor increases the suppressive capacity of regulatory immune cells, including regulatory CD4+ T cells (Tregs), locally within the intestinal mucosa. In a Phase I study in normal healthy volunteers no changes in AEs or trends in safety laboratory trends were observed up to daily oral doses of 7500 mg/day.
    Methods: In a Phase 2, proof of concept, double blind, parallel-group study, adult patients with Mayo Clinic scores (MCS) of 4 - 10 and endoscopic subscores of 2 or more were randomly assigned to groups given omilancor 440 mg QD (n=66), omilancor 880 mg QD (n=66) or placebo (n=66) for 12 weeks. The primary endpoint was clinical remission after 12 weeks as defined by rectal bleeding (RB) equal to 0, stool frequency (SF) equal to 0 or 1 and endoscopic appearance (MES) equal to 0 or 1. A modified intent to treat (mITT) population was defined by patients with RB > 0, histological activity and elevated fecal calprotectin (FCP) at baseline. Secondary endpoints included histological remission as defined by a Geboes score < 3.1 with absence of neutrophils in the lamina propria, endoscopic remission as defined by a MES < 2, normalization of FCP and pharmacokinetics (PK) of omilancor in stool, tissue and plasma.
    Results: Oral omilancor was well tolerated with no trends in AE profile observed and most AEs of mild severity and no dose-limiting toxicities. In the mITT population, clinical remission was induced in 30.4% of omilancor treated patients relative to 3.7% of patients given placebo (Δ = 26.7, p = 0.01), thereby meeting the primary endpoint. Endoscopic remission was induced in 41.7% of patients treated with omilancor relative to 18.6% of patients given placebo (Δ = 23.1, p = 0.07). Histological remission was induced in 41.7% of patients treated with omilancor relative to 22.2% of patients given placebo (Δ = 19.5, p = 0.14). In patients with elevated baseline FCP, normalization occurred in 43.8% of the omilancor 880 mg group and 40.6% of the omilancor 440 mg group relative to 21.4% of the placebo group after 2 weeks (p = 0.048). PK analysis validated a gut-restricted profile with stable drug levels in stool over the 12-week treatment period and penetration into colonic biopsy tissue with limited systemic exposure. Reduction of patient reported outcomes occurred during the OLE with nearly 90% of patients reaching SF ≤ 1 and RB = 0 after 36 weeks of open-label treatment.
    Conclusions: Once a day oral dosing with omilancor was well-tolerated and induced clinical remission in a Phase II mild to moderate UC population. A Phase II study in CD and a Phase III program in UC (PACIFY) were initiated in 2021 and are currently recruiting.
    Language English
    Publishing date 2022-02-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 1340971-2
    ISSN 1536-4844 ; 1078-0998
    ISSN (online) 1536-4844
    ISSN 1078-0998
    DOI 10.1093/ibd/izac015.180
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  6. Article ; Online: Clostridium difficile Infection: A Rarity in Patients Receiving Chronic Antibiotic Treatment for Crohn's Disease.

    Roy, Abhik / Lichtiger, Simon

    Inflammatory bowel diseases

    2015  Volume 22, Issue 3, Page(s) 648–653

    Abstract: Background: Prolonged antibiotic use is limited by several adverse effects, one of which is Clostridium difficile infection (CDI). The aim of this study was to determine the incidence of CDI in patients receiving chronic antibiotic treatment for Crohn's ...

    Abstract Background: Prolonged antibiotic use is limited by several adverse effects, one of which is Clostridium difficile infection (CDI). The aim of this study was to determine the incidence of CDI in patients receiving chronic antibiotic treatment for Crohn's disease (CD).
    Methods: We conducted a retrospective review of 100 patients with CD for which ≥6 months of outpatient antibiotic therapy was prescribed. Data were collected regarding demographics, CD phenotype, treatment history, and CDI. The incidence of CDI in our patient population was calculated and compared with historical controls.
    Results: 100 patients were studied-60% of men, mean age 23.9 years at CD diagnosis. Eighty-two percent had disease involving the ileum, and 33% had disease involving the colon. The mean duration of antibiotic therapy was 39.6 months (range, 6-217 months). The most commonly prescribed classes of antibiotics were fluoroquinolones (84%), penicillins (57%), and cephalosporins (32%). Forty-nine percent of patients were treated with concomitant thiopurines, 45% with budesonide, and 41% with biologics. The overall incidence of CDI was 2%. This incidence of CDI was lower than previously reported for non-CD patients receiving chronic antibiotics for continuous-flow left ventricular assist device infections (12.5%) and orthopedic prosthesis infections (22.2%).
    Conclusions: The incidence of CDI is rare in patients receiving chronic antibiotic treatment for CD, and it seems significantly lower than for non-CD populations reported in the literature.
    MeSH term(s) Adolescent ; Adult ; Aged ; Anti-Bacterial Agents/pharmacology ; Child ; Clostridium Infections/drug therapy ; Clostridium Infections/epidemiology ; Clostridium Infections/microbiology ; Clostridium difficile/drug effects ; Crohn Disease/drug therapy ; Crohn Disease/microbiology ; Female ; Follow-Up Studies ; Humans ; Incidence ; Male ; Middle Aged ; New York ; Prognosis ; Retrospective Studies ; Risk Factors ; Young Adult
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2015-11-20
    Publishing country England
    Document type Journal Article
    ZDB-ID 1340971-2
    ISSN 1536-4844 ; 1078-0998
    ISSN (online) 1536-4844
    ISSN 1078-0998
    DOI 10.1097/MIB.0000000000000641
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  7. Article ; Online: Treatment of Crohn's Disease Anastomotic Stricture With a Lumen-apposing Metal Stent.

    Axelrad, Jordan E / Lichtiger, Simon / Sethi, Amrita

    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

    2017  Volume 16, Issue 3, Page(s) A25–A26

    MeSH term(s) Colonic Diseases/diagnosis ; Colonic Diseases/surgery ; Colonoscopy ; Constriction, Pathologic/diagnosis ; Constriction, Pathologic/surgery ; Crohn Disease/complications ; Female ; Humans ; Middle Aged ; Stents
    Language English
    Publishing date 2017-05-18
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 2119789-1
    ISSN 1542-7714 ; 1542-3565
    ISSN (online) 1542-7714
    ISSN 1542-3565
    DOI 10.1016/j.cgh.2017.05.016
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  8. Article ; Online: The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study.

    Verstockt, Bram / Vermeire, Severine / Peyrin-Biroulet, Laurent / Mosig, Rebecca / Feagan, Brian G / Colombel, Jean-Frederic / Siegmund, Britta / Rieder, Florian / Schreiber, Stefan / Yarur, Andres / Panaccione, Remo / Dubinsky, Marla / Lichtiger, Simon / Cataldi, Fabio / Danese, Silvio

    Journal of Crohn's & colitis

    2023  

    Abstract: Background and aims: NX-13 activation of NLRX1 reduces intracellular reactive oxygen species and decreases inflammation in animal models of colitis. A phase 1a trial demonstrated a gut-selective pharmacokinetic (PK) profile with good tolerability. This ... ...

    Abstract Background and aims: NX-13 activation of NLRX1 reduces intracellular reactive oxygen species and decreases inflammation in animal models of colitis. A phase 1a trial demonstrated a gut-selective pharmacokinetic (PK) profile with good tolerability. This phase Ib study aimed to evaluate the safety, tolerability, and PK of NX-13 in patients with active ulcerative colitis (UC).
    Methods: We conducted a multicenter, randomized, double-blinded, placebo-controlled trial of NX-13 in patients with active UC. Patients with a Mayo Clinic Score of 4-10 were randomly assigned (3:3:3:1 ratio) to three NX-13 oral dose groups (250mg Immediate Release (IR), 500mg IR, or 500mg Delayed Release (DR) or placebo) once daily for 4 weeks. Safety and PK were the primary and secondary objectives, respectively.
    Results: Thirty-eight patients (11 females) were recruited and randomized to placebo (5), NX-13 250mg IR (11), NX-13 500mg IR (11), or NX-13 500mg DR (11) and received at least one dose. There were no Serious Adverse Events (SAEs) or deaths during the trial. One patient (500mg DR, 1/11) withdrew for worsening of UC and a second (500mg IR, 1/11) on the last day of treatment after a panic attack associated with atrial fibrillation. In the efficacy population (36 patients), clinical improvement in rectal bleeding and stool frequency scores relative to placebo were seen as early as week 2 and endoscopic response was seen at week 4.
    Conclusions: NX-13 was generally safe and well tolerated with early signs of rapid symptom and endoscopic improvement. This novel mechanism of action warrants further investigation. ClinicalTrials.gov: NCT04862741.
    Language English
    Publishing date 2023-11-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 2390120-2
    ISSN 1876-4479 ; 1873-9946
    ISSN (online) 1876-4479
    ISSN 1873-9946
    DOI 10.1093/ecco-jcc/jjad192
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  9. Article ; Online: Inflammatory bowel disease and cancer: The role of inflammation, immunosuppression, and cancer treatment.

    Axelrad, Jordan E / Lichtiger, Simon / Yajnik, Vijay

    World journal of gastroenterology

    2016  Volume 22, Issue 20, Page(s) 4794–4801

    Abstract: In patients with inflammatory bowel disease (IBD), chronic inflammation is a major risk factor for the development of gastrointestinal malignancies. The pathogenesis of colitis-associated cancer is distinct from sporadic colorectal carcinoma and the ... ...

    Abstract In patients with inflammatory bowel disease (IBD), chronic inflammation is a major risk factor for the development of gastrointestinal malignancies. The pathogenesis of colitis-associated cancer is distinct from sporadic colorectal carcinoma and the critical molecular mechanisms underlying this process have yet to be elucidated. Patients with IBD have also been shown to be at increased risk of developing extra-intestinal malignancies. Medical therapies that diminish the mucosal inflammatory response represent the foundation of treatment in IBD, and recent evidence supports their introduction earlier in the disease course. However, therapies that alter the immune system, often used for long durations, may also promote carcinogenesis. As the population of patients with IBD grows older, with longer duration of chronic inflammation and longer exposure to immunosuppression, there is an increasing risk of cancer development. Many of these patients will require cancer treatment, including chemotherapy, radiation, hormonal therapy, and surgery. Many patients will require further treatment for their IBD. This review seeks to explore the characteristics and risks of cancer in patients with IBD, and to evaluate the limited data on patients with IBD and cancer, including management of IBD after a diagnosis of cancer, the effects of cancer treatment on IBD, and the effect of IBD and medications for IBD on cancer outcomes.
    MeSH term(s) Animals ; Digestive System Neoplasms/chemically induced ; Digestive System Neoplasms/etiology ; Digestive System Neoplasms/immunology ; Digestive System Neoplasms/therapy ; Humans ; Immunocompromised Host ; Immunosuppressive Agents/adverse effects ; Inflammatory Bowel Diseases/complications ; Inflammatory Bowel Diseases/drug therapy ; Inflammatory Bowel Diseases/immunology ; Prognosis ; Risk Factors ; Time Factors
    Chemical Substances Immunosuppressive Agents
    Language English
    Publishing date 2016-05-28
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2185929-2
    ISSN 2219-2840 ; 1007-9327
    ISSN (online) 2219-2840
    ISSN 1007-9327
    DOI 10.3748/wjg.v22.i20.4794
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Treatment of choice for acute severe steroid-refractory ulcerative colitis is cyclosporine.

    Lichtiger, Simon

    Inflammatory bowel diseases

    2001  Volume 15, Issue 1, Page(s) 141–142

    MeSH term(s) Acute Disease ; Clinical Trials as Topic ; Colitis, Ulcerative/drug therapy ; Cyclosporine/therapeutic use ; Drug Resistance ; Glucocorticoids/therapeutic use ; Humans ; Immunosuppressive Agents/therapeutic use
    Chemical Substances Glucocorticoids ; Immunosuppressive Agents ; Cyclosporine (83HN0GTJ6D)
    Language English
    Publishing date 2001-04-04
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1340971-2
    ISSN 1536-4844 ; 1078-0998
    ISSN (online) 1536-4844
    ISSN 1078-0998
    DOI 10.1002/ibd.20363
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