Mark T Osterman

Mark T Osterman
University of Pennsylvania | UP · Division of Gastroenterology

About

116
Publications
4,021
Reads
How we measure 'reads'
A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. Learn more
2,409
Citations

Publications

Publications (116)
Article
Full-text available
Background and Aims ERELATE was a phase 4, multinational, retrospective, observational study evaluating the relationship between intravenous vedolizumab exposure and treatment outcomes over 52 weeks in adults with ulcerative colitis (UC) or Crohn’s disease (CD). Methods Real‐world data from patients with UC or CD treated with intravenous vedolizum...
Article
Background: It is uncertain if higher infliximab trough levels (TLs) confer a greater risk of infectious/noninfectious complications (IC/NIC). We aimed to assess the risk of IC and NIC in patients with different TLs. Methods: We retrospectively evaluated a cohort of Crohn's disease (CD) patients treated with infliximab who underwent therapeutic...
Article
Therapeutic drug monitoring (TDM) of biologics is a rapidly evolving field. We aimed to provide a consensus statement regarding the clinical utility of TDM for biologics in inflammatory bowel disease (IBD). A modified Delphi method was applied to develop consensus statements. A comprehensive literature review was performed regarding TDM of biologic...
Article
Introduction: There are only limited data regarding the role of therapeutic drug monitoring in fistulizing Crohn's disease (CD). We investigated the association between both induction and maintenance serum infliximab concentrations and favorable therapeutic outcomes in patients with fistulizing CD. Methods: This was a post hoc analysis of the AC...
Article
Full-text available
Serum vedolizumab concentrations are associated with clinical response although, it is unknown if vedolizumab concentrations predict response to dose escalation. The aim of this study was to identify if vedolizumab trough concentrations predicted the response to vedolizumab dose escalation. We assessed a retrospective cohort of patients on maintena...
Article
Background: Therapeutic efficacy of biologics has remained at about 50% for 2 decades. In Crohn's disease (CD) patients, we examined the predictive value of an epithelial cell biomarker, ileal microvillar length (MVL), for clinical response to ustekinumab (UST) and vedolizumab (VDZ) and its relationship to another biomarker, intestinal epithelial...
Preprint
Full-text available
Objective Therapeutic efficacy of biologics has remained at about 50% for 2 decades. In Crohn’s disease (CD) patients, we examined the predictive value of an epithelial cell biomarker, ileal microvillar length (MVL), for clinical response to ustekinumab (UST) and vedolizumab (VDZ), and its relationship to another biomarker, intestinal epithelial ce...
Article
Objective It is difficult to predict relapse in quiescent ulcerative colitis (UC), but newer endoscopic and histological indices could improve this. This study aimed to determine in UC patients in clinical remission (1) the prevalence of active endoscopic and histological disease; (2) the correlation between endoscopic and histological scores; and...
Article
Background & aims: It is not clear what factors affect risk of chronic kidney disease (CKD) in patients with inflammatory bowel disease (IBD); increased risk has been inconsistently associated with use of 5-aminosalicylates (5-ASAs). We aimed to calculate the relative hazard of CKD among patients with IBD, adjusted for CKD risk factors, and to det...
Article
Objective Mucosal barrier dysfunction plays a crucial role in intestinal inflammation in Crohn’s disease (CD). Intestinal epithelial cell (IEC) death resulting from innate immune activation, termed pyroptosis, was recently found to be a cause of this barrier defect. The aim of this study was to determine the predictive value of pretreatment ileal b...
Article
Full-text available
Background and Aims Treatment pathways for ulcerative colitis (UC) and Crohn’s disease (CD) are shifting to a more individualized, risk-stratified approach. The perception is that insurance policies may not have implemented this paradigm shift, particularly regarding access to newer agents. We evaluated patient access to advanced therapies by analy...
Article
Background: Therapeutic drug monitoring (TDM) is increasingly performed for Infliximab (IFX) in patients with Crohn's disease (CD). Reactive TDM is a cost-effective strategy to empiric IFX dose escalation. The cost-effectiveness of proactive TDM is unknown. The aim of this study is to assess the cost-effectiveness of proactive vs reactive TDM in a...
Article
Background Many patients with ulcerative colitis (UC) fear the potential side effects of immunosuppressive therapies. However, those with medically refractory disease often require total proctocolectomy (TPC) with a permanent ostomy or pouch, which may reduce quality of life. Prior studies have identified TPC predictors; however, no clinically usef...
Article
Full-text available
Background Prospectively designed studies assessing the exposure‐response profile of vedolizumab are lacking. Observational exposure‐response data for vedolizumab are limited and have not been adjusted for potential confounding factors, particularly those that may affect vedolizumab clearance. Aims This analysis aimed to: (a) investigate the vedol...
Article
Background Therapeutic drug monitoring is used in clinical practice to optimise infliximab (IFX) therapy in patients with Crohn’s disease (CD). However, IFX induction concentration cut-points associated with early post-induction complete response in patients with fistulizing CD are unknown. We aimed to investigate the association of IFX serum conce...
Article
Background Corticosteroids (CS) and anti-TNF drugs are used to treat Crohn’s disease (CD). In this study, we assessed the net health benefit of initiating anti-TNF therapy relative to additional CS use in CD using a novel combination of a retrospective cohort study and a simulation model. Methods Using Medicaid data from 2001 to 2005 and Medicare...
Article
Background & aims: Parenteral methotrexate induces clinical remission but not endoscopic improvement of mucosal inflammation in patients with ulcerative colitis (UC). We performed a randomized, placebo-controlled trial to assess the efficacy of parenteral methotrexate in maintaining steroid-free response or remission in patients with UC following...
Article
Background and aim Objective and more rigorous therapeutic outcomes are emerging as novel targets in Crohn’s disease (CD). We investigated the association between maintenance serum infliximab trough concentrations and biochemical, endoscopic, or histologic remission in CD. Methods This retrospective multicenter study involved consecutive CD patien...
Article
Background and aims: Reactive testing has emerged as the new standard of care for managing loss of response to infliximab in inflammatory bowel disease (IBD). Recent data suggest that proactive infliximab monitoring is associated with better therapeutic outcomes in IBD. Nevertheless, there are no data regarding the clinical utility of proactive in...
Article
Full-text available
Background: Preliminary data suggest that treatment optimization can reverse immunogenicity and regain response in patients with IBD and secondary loss of response (SLR) to anti-TNF therapy due to antidrug antibodies. However, data regarding the long-term outcome of these patients are scarce. Aims: We aimed to investigate drug retention in IBD p...
Article
Full-text available
Objectives: Crohn’s disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBD) that compromise quality of life and may increase mortality. This study compared the mortality risk with prolonged corticosteroid use vs. antitumor necrosis factor-α (anti-TNF) drugs in IBD. Methods: A retrospective cohort study was conducted among Me...
Chapter
Monoclonal antibodies directed against tumor necrosis factor (TNF)-α have markedly impacted the course of Crohn’s disease and ulcerative colitis. However, it was recognized early on that these complex compounds are also potentially immunogenic, prompting the host to develop an antibody response to these medications. Anti-drug antibodies can increas...
Article
Background QuantiFERON-TB Gold (QFTG) is a blood test used to diagnose latent tuberculosis infection (LTBI) prior to TNF-α inhibitor (anti-TNF) initiation. We sought to determine factors associated with indeterminate QFTG results in inflammatory bowel disease (IBD) patients and whether indeterminate results are associated with IBD-related morbidity...
Article
Background: Endoscopic and histologic healing are emerging as new therapeutic goals in ulcerative colitis (UC), as these endpoints are associated with less relapse, hospitalization and colectomy. Aim: To investigate the association of serum infliximab trough concentrations during maintenance therapy with endoscopic or histologic healing in UC....
Chapter
Inflammatory bowel disease can be characterized as inflammatory, stricturing, and penetrating/fistulizing disease. Perianal disease involving fistulae and abscess are common and important aspect of this disease, and require effective therapy. The treatment of perianal CD fistulae has improved greatly over the last 15 years as new medical therapies,...
Article
Investigator-initiated randomized clinical trials are the backbone of academic clinical research. Investigator-initiated trials (IITs) complement the large clinical studies sponsored by industry and address questions, which are usually not the main focus of a commercially directed research but have the purpose to confirm, improve, or refute clinica...
Article
Full-text available
Objectives: Anti-tumor necrosis factor (TNF) drugs are commonly used to treat moderate-to-severe Crohn's disease (CD). Both the activity of CD and the concomitant immunosuppressants (corticosteroids and immunomodulators) used with anti-TNF drugs could increase the risk of infection. We determined the relative risk of serious and opportunistic infe...
Article
Objective: Breast cancer recurrence may be promoted by immunosuppression due to decreased immune surveillance. Among patients with immune-mediated disease and treated breast cancer, we examined rates of breast cancer recurrence with use of methotrexate, thiopurines, and anti-TNF therapy. Methods: Three retrospective cohort studies within Medicar...
Article
Objectives To compare the coronary heart disease risk among patients with rheumatoid arthritis (RA) initiating common biologic disease-modifying antirheumatic drugs of different mechanisms. Methods We conducted a retrospective cohort study of patients with RA enrolled in Medicare, a public health plan covering >90% of US residents 65 years or older...
Article
Importance Immune dysfunction underlies the pathogenesis of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Immunosuppressive therapy is the standard of care for these diseases. Both immune dysfunction and therapy-related immunosuppression can inhibit cancer-related immune surveillance in this population. Drug-induced immunosuppres...
Article
Ulcerative colitis (UC) can be treated with surgery or medications. Patients often must choose between long-term immunosuppressant therapy or total colectomy. Whether one of these treatment approaches has a mortality benefit is uncertain. To determine whether patients with advanced UC treated with elective colectomy have improved survival compared...
Article
The Crohn's Disease Activity Index (CDAI) and Mayo score for ulcerative colitis (UC) require symptom recall and/or use of a symptom diary. We examined patients' abilities to recall their symptoms and the day-to-day variability of symptoms. Patients with UC or CD completed a questionnaire including items from the short CDAI (sCDAI) and the 6-point M...
Article
The benefit of continuing immunomodulators when "stepping up" to anti-tumor necrosis factor (anti-TNF) therapy for Crohn's disease (CD) is uncertain. This study assessed the effectiveness and safety of immunomodulators with anti-TNF therapy in CD. We conducted a retrospective cohort study of new users of anti-TNF therapy for CD in Medicare. Users o...
Chapter
Every day in the routine care of patients with ulcerative colitis, physicians are forced to consider the potential benefits and harms of a variety of medical therapies. There are numerous medications that have demonstrated efficacy for the treatment of ulcerative colitis, each of which has the potential to also cause unintended harm. Because most a...
Article
Full-text available
Among patients with quiescent ulcerative colitis (UC), lower fecal concentrations of calprotectin are associated with lower rates of relapse. We performed an open-label, randomized, controlled trial to investigate whether increasing doses mesalamine reduce concentrations of fecal calprotectin (FC) in patients with quiescent UC. We screened 119 pati...