Publications by authors named "David M Faleck"

11 Publications

  • Page 1 of 1

Reply.

Clin Gastroenterol Hepatol 2021 Apr 8. Epub 2021 Apr 8.

Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cgh.2021.04.010DOI Listing
April 2021

Effect of Concomitant Therapy With Steroids and Tumor Necrosis Factor Antagonists for Induction of Remission in Patients With Crohn's Disease: A Systematic Review and Pooled Meta-analysis.

Clin Gastroenterol Hepatol 2021 Feb 20;19(2):238-245.e4. Epub 2020 Jun 20.

Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

Background & Aims: It is not clear whether concomitant therapy with corticosteroids and anti-tumor necrosis factor (TNF) agents is more effective at inducing remission in patients with Crohn's disease (CD) than anti-TNF monotherapy. We aimed to determine whether patients with active CD receiving corticosteroids during induction therapy with anti-TNF agents had higher rates of clinical improvement than patients not receiving corticosteroids during induction therapy.

Methods: We systematically searched the MEDLINE, Embase, and CENTRAL databases, through January 20, 2016, for randomized trials of anti-TNF agents approved for treatment of CD and identified 14 trials (5 of adalimumab, 5 of certolizumab, and 4 of infliximab). We conducted a pooled meta-analysis of individual patient and aggregated data from these trials. We compared data from participants who continued oral corticosteroids during induction with anti-TNF therapy to those treated with anti-TNF agents alone. The endpoints were clinical remission (CD activity index [CDAI] scores <150) and clinical response (a decrease in CDAI of 100 points) at the end of induction (weeks 4-14 of treatment).

Results: We included 4354 patients who received induction therapy with anti-TNF agents, including 1653 [38.0%] who were receiving corticosteroids. The combination of corticosteroids and an anti-TNF agent induced clinical remission in 32.0% of patients, whereas anti-TNF monotherapy induced clinical remission in 35.5% of patients (odds ratio [OR], 0.93; 95% CI, 0.74-1.17). The combination of corticosteroids and an anti-TNF agent induced a clinical response in 42.7% of patients, whereas anti-TNF monotherapy induced a clinical response in 46.8% (OR 0.84; 95% CI, 0.73-0.96). These findings did not change with adjustment for baseline CDAI scores and concurrent use of immunomodulators.

Conclusions: Based on a meta-analysis of data from randomized trials of anti-TNF therapies in patients with active CD, patients receiving corticosteroids during induction therapy with anti-TNF agents did not have higher rates of clinical improvement compared with patients not receiving corticosteroids during induction therapy. Given these findings and the risks of corticosteroid use, clinicians should consider early weaning of corticosteroids during induction therapy with anti-TNF agents for patients with corticosteroid-refractory CD.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cgh.2020.06.036DOI Listing
February 2021

Reply to Y. Inagaki et al.

J Clin Oncol 2020 05 6;38(15):1749-1750. Epub 2020 Apr 6.

Hamzah Abu-Sbeih, MD, Department of Internal Medicine, The University of Missouri-Kansas City, Kansas City, MO; David M. Faleck, MD, Gastroenterology, Hepatology and Nutrition Service, Memorial Sloan Kettering Cancer Center, New York, NY; Michael Dougan, MD, PhD, Department of Medicine, Division of Gastroenterology, Massachusetts General Hospital, Boston, MA; and Yinghong Wang, MD, PhD, Department of Gastroenterology, Hepatology, and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1200/JCO.20.00295DOI Listing
May 2020

Immune Checkpoint Inhibitor Therapy in Patients With Preexisting Inflammatory Bowel Disease.

J Clin Oncol 2020 02 4;38(6):576-583. Epub 2019 Dec 4.

The University of Texas MD Anderson Cancer Center, Houston, TX.

Purpose: The risk of immune checkpoint inhibitor therapy-related GI adverse events in patients with cancer and inflammatory bowel disease (IBD) has not been well described. We characterized GI adverse events in patients with underlying IBD who received immune checkpoint inhibitors.

Patients And Methods: We performed a multicenter, retrospective study of patients with documented IBD who received immune checkpoint inhibitor therapy between January 2010 and February 2019. Backward selection and multivariate logistic regression were conducted to assess risk of GI adverse events.

Results: Of the 102 included patients, 17 received therapy targeting cytotoxic T-lymphocyte antigen-4, and 85 received monotherapy targeting programmed cell death 1 or its ligand. Half of the patients had Crohn's disease, and half had ulcerative colitis. The median time from last active IBD episode to immunotherapy initiation was 5 years (interquartile range, 3-12 years). Forty-three patients were not receiving treatment of IBD. GI adverse events occurred in 42 patients (41%) after a median of 62 days (interquartile range, 33-123 days), a rate higher than that among similar patients without underlying IBD who were treated at centers participating in the study (11%; < .001). GI events among patients with IBD included grade 3 or 4 diarrhea in 21 patients (21%). Four patients experienced colonic perforation, 2 of whom required surgery. No GI adverse event-related deaths were recorded. Anti-cytotoxic T-lymphocyte antigen-4 therapy was associated with increased risk of GI adverse events on univariable but not multivariable analysis (odds ratio, 3.19; 95% CI, 1.8 to 9.48; = .037; and odds ratio, 4.72; 95% CI, 0.95 to 23.53; = .058, respectively).

Conclusion: Preexisting IBD increases the risk of severe GI adverse events in patients treated with immune checkpoint inhibitors.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1200/JCO.19.01674DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7030892PMC
February 2020

Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes.

Inflamm Bowel Dis 2019 10;25(11):1854-1861

Mayo Clinic, Rochester, Minnesota, USA.

Background: Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn's disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval.

Methods: We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014-June 2015 (Era 1) and July 2015-June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses.

Results: A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease-related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD.

Conclusion: Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ibd/izz071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6799947PMC
October 2019

Shorter Disease Duration Is Associated With Higher Rates of Response to Vedolizumab in Patients With Crohn's Disease But Not Ulcerative Colitis.

Clin Gastroenterol Hepatol 2019 11 6;17(12):2497-2505.e1. Epub 2019 Jan 6.

Mayo Clinic, Rochester, Minnesota.

Background & Aims: Patients with Crohn's disease (CD), but not ulcerative colitis (UC), of shorter duration have higher rates of response to tumor necrosis factor (TNF) antagonists than patients with longer disease duration. Little is known about the association between disease duration and response to other biologic agents. We aimed to evaluate response of patients with CD or UC to vedolizumab, stratified by disease duration.

Methods: We analyzed data from a retrospective, multicenter, consortium of patients with CD (n = 650) or UC (n = 437) treated with vedolizumab from May 2014 through December 2016. Using time to event analyses, we compared rates of clinical remission, corticosteroid-free remission (CSFR), and endoscopic remission between patients with early-stage (≤2 years duration) and later-stage (>2 years) CD or UC. We used Cox proportional hazards models to identify factors associated with outcomes.

Results: Within 6 months initiation of treatment with vedolizumab, significantly higher proportions of patients with early-stage CD, vs later-stage CD, achieved clinical remission (38% vs 23%), CSFR (43% vs 14%), and endoscopic remission (29% vs 13%) (P < .05 for all comparisons). After adjusting for disease-related factors including previous exposure to TNF antagonists, patients with early-stage CD were significantly more likely than patients with later-stage CD to achieve clinical remission (adjusted hazard ratio [aHR], 1.59; 95% CI, 1.02-2.49), CSFR (aHR, 3.39; 95% CI, 1.66-6.92), and endoscopic remission (aHR, 1.90; 95% CI, 1.06-3.39). In contrast, disease duration was not a significant predictor of response among patients with UC.

Conclusions: Patients with CD for 2 years or less are significantly more likely to achieve a complete response, CSFR, or endoscopic response to vedolizumab than patients with longer disease duration. Disease duration does not associate with response vedolizumab in patients with UC.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cgh.2018.12.040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7026826PMC
November 2019

Systematic Review and Meta-analysis: Optimal Salvage Therapy in Acute Severe Ulcerative Colitis.

Inflamm Bowel Dis 2019 06;25(7):1169-1186

Department of Gastroenterology, Austin Hospital, Melbourne, Australia.

Background: Infliximab is an effective salvage therapy in acute severe ulcerative colitis; however, the optimal dosing strategy is unknown. We performed a systematic review and meta-analysis to examine the impact of infliximab dosage and intensification on colectomy-free survival in acute severe ulcerative colitis.

Methods: Studies reporting outcomes of hospitalized steroid-refractory acute severe ulcerative colitis treated with infliximab salvage were identified. Infliximab use was categorized by dose, dose number, and schedule. The primary outcome was colectomy-free survival at 3 months. Pooled proportions and odds ratios with 95% confidence intervals were reported.

Results: Forty-one cohorts (n = 2158 cases) were included. Overall colectomy-free survival with infliximab salvage was 79.7% (95% confidence interval [CI], 75.48% to 83.6%) at 3 months and 69.8% (95% CI, 65.7% to 73.7%) at 12 months. Colectomy-free survival at 3 months was superior with 5-mg/kg multiple (≥2) doses compared with single-dose induction (odds ratio [OR], 4.24; 95% CI, 2.44 to 7.36; P < 0.001). However, dose intensification with either high-dose or accelerated strategies was not significantly different to 5-mg/kg standard induction at 3 months (OR, 0.70; 95% CI, 0.39 to 1.27; P = 0.24) despite being utilized in patients with a significantly higher mean C-reactive protein and lower albumin levels.

Conclusions: In acute severe ulcerative colitis, multiple 5-mg/kg infliximab doses are superior to single-dose salvage. Dose-intensified induction outcomes were not significantly different compared to standard induction and were more often used in patients with increased disease severity, which may have confounded the results. This meta-analysis highlights the marked variability in the management of infliximab salvage therapy and the need for further studies to determine the optimal dose strategy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ibd/izy383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6783899PMC
June 2019

Response to Goyal and Katner.

Am J Gastroenterol 2017 05;112(5):806

Division of Digestive and Liver Diseases, Columbia University Medical Center, New York City, New York, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/ajg.2017.65DOI Listing
May 2017

Proton Pump Inhibitors Do Not Increase Risk for Clostridium difficile Infection in the Intensive Care Unit.

Am J Gastroenterol 2016 11 30;111(11):1641-1648. Epub 2016 Aug 30.

Division of Digestive and Liver Diseases, Columbia University Medical Center, New York, New York, USA.

Objectives: Patients in the intensive care unit (ICU) frequently receive proton pump inhibitors (PPIs) and have high rates of Clostridium difficile infection (CDI). PPIs have been associated with CDI in hospitalized patients, but ICU patients differ fundamentally from non-ICU patients and few studies have focused on PPI use exclusively in the critical care setting. We performed a retrospective cohort study to determine the associations between PPIs and health-care facility-onset CDI in the ICU.

Methods: We analyzed data from all adult ICU patients at three affiliated hospitals (14 ICUs) between 2010 and 2013. Patients were excluded if they had recent CDI or an ICU stay of <3 days. We parsed electronic medical records for ICU exposures, focusing on PPIs and other potentially modifiable exposures that occurred during ICU stays. Health-care facility-onset CDI in the ICU was defined as a newly positive PCR for the C. difficile toxin B gene from an unformed stool, with subsequent receipt of anti-CDI therapy. We analyzed PPIs and other exposures as time-varying covariates and used Cox proportional hazards models to adjust for demographics, comorbidities, and other clinical factors.

Results: Of 18,134 patients who met the criteria for inclusion, 271 (1.5%) developed health-care facility-onset CDI in the ICU. Receipt of antibiotics was the strongest risk factor for CDI (adjusted HR (aHR) 2.79; 95% confidence interval (CI), 1.50-5.19). There was no significant increase in risk for CDI associated with PPIs in those who did not receive antibiotics (aHR 1.56; 95% CI, 0.72-3.35), and PPIs were actually associated with a decreased risk for CDI in those who received antibiotics (aHR 0.64; 95% CI, 0.48-0.83). There was also no evidence of increased risk for CDI in those who received higher doses of PPIs.

Conclusions: Exposure to antibiotics was the most important risk factor for health-care facility-onset CDI in the ICU. PPIs did not increase risk for CDI in the ICU regardless of use of antibiotics.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/ajg.2016.343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5096970PMC
November 2016

Assessment of complication and functional outcome reporting in the minimally invasive prostatectomy literature from 2006 to the present.

BJU Int 2012 Jan 27;109(1):26-30; discussion 30. Epub 2011 Sep 27.

Department of Urology, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY 10467, USA.

To query the minimally invasive urological literature from 2006 to the middle of 2010, focusing on complications and functional outcome reporting in laparoscopic radical prostatectomy (LRP) and robot-assisted LRP (RALP), to see if there has been an improvement in the overall reporting of complications. We performed a Medline search using the Medical Subject Heading terms 'prostatectomy', 'laparoscopy', 'robotics', and 'minimally invasive'. We then applied the Martin criteria for complications reporting to the selected articles. We identified 51 studies for a total of 32,680 patients. When excluding functional outcomes the outpatient complications reporting was 20/51 (39.2%). In all, 35% and 43% of papers did not list any method for recording continence and potency, respectively. A complication grading system was only used in 30 studies (58.8%). Of the 16 papers using a grading scale in 2006-2007, only 31.3% used the Clavien system, compared with 69% from 2008 to the first half of 2010. In all, 27% of papers used some form of risk-factor analysis for complications. Multivariate analysis was used in 43% of papers, 29% looked at body mass index, while one looked at prostate weight, and another age. There has been an overall improvement in complications reporting in the minimally invasive RP literature since 2005. However, most studies still do not fulfil many of the criteria necessary for standardised complication reporting. Functional outcome reporting remains poor and unstandardised. Given our current reliance on observational studies, increased efforts should be made to standardise all complication outcomes reporting.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/j.1464-410X.2011.10591.xDOI Listing
January 2012

Preoperative and intraoperative measurements of urethral length as predictors of continence after robot-assisted radical prostatectomy.

J Endourol 2011 Jun 13;25(6):1025-30. Epub 2011 May 13.

Department of Urology, Montefiore Medical Center, Bronx, New York, USA.

Background And Purpose: Membranous urethral length is one of several factors that can influence return of continence after radical prostatectomy. Using our robot-assisted laparoscopic prostatectomy (RALP) database, we assessed which preoperative (with endorectal coil MRI [eMRI]) and intraoperative anatomic measurements correlate with return to urinary continence (no pads) and continence quality of life (CQOL) as determined by the International Consultation on Incontinence Questionnaire (ICIQ) score.

Patients And Methods: A total of 75 patients who underwent RALP and eMRI by a single surgeon were analyzed. To emulate the distal continence zone intraoperatively, stretched urethral length (distance from the perineal membrane to the prostate apex on stretch) and cut urethral length (urethral stump length) were individually measured and recorded after apical dissection. Preoperative International Prostate Symptom Scores (IPSS) were recorded. Univariate and multivariate Cox regression analysis were performed to determine the association between MRI-measured and intraoperative urethral lengths and return to continence as well as CQOL.

Results: None of the urethral measurements as determined by eMRI correlated with continence or ICIQ scores. On multivariate analysis, only membranous urethral length on eMRI approached significance with respect to ICIQ (P=0.07). On multivariate analysis controlling for preoperative age, body mass index, IPSS score, and gland size, both stretched and cut urethral length correlated with decreased time to continence (P=0.03 and P=0.04 respectively).

Conclusion: Longer stretched and cut urethral lengths appear to correlate with faster return to a pad-free state. Attention to maximal preservation of the distal continence mechanism is important for optimal continence outcomes after RALP.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1089/end.2010.0692DOI Listing
June 2011