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Methotrexate and TNF inhibitors affect long-term immunogenicity to COVID-19 vaccination in patients with immune-mediated inflammatory disease

Haberman, Rebecca H; Um, Seungha; Axelrad, Jordan E; Blank, Rebecca B; Uddin, Zakwan; Catron, Sydney; Neimann, Andrea L; Mulligan, Mark J; Herat, Ramin Sedaghat; Hong, Simon J; Chang, Shannon; Myrtaj, Arnold; Ghiasian, Ghoncheh; Izmirly, Peter M; Saxena, Amit; Solomon, Gary; Azar, Natalie; Samuels, Jonathan; Golden, Brian D; Rackoff, Paula; Adhikari, Samrachana; Hudesman, David P; Scher, Jose U
PMCID:8975261
PMID: 35403000
ISSN: 2665-9913
CID: 5218902

Indications, functional and quality of life outcomes of new pouch creation during re-do ileal pouch anal anastomosis: A comparative study with existing pouch salvage

Esen, Eren; Kirat, Hasan T; Erkan, Arman; Aytac, Erman; Esterow, Joanna; Kani, H Tarik; Grieco, Michael J; Chang, Shannon; Remzi, Feza H
BACKGROUND:Salvage of the existing ileal pouch is favored during re-do ileal pouch anal anastomosis if the pouch is not damaged after pelvic dissection and there are no other mechanical reasons that may necessitate construction of a new pouch. Excision of the existing pouch may be associated with some concerns for short-bowel syndrome and poor functional outcomes. This study aimed to report indications and compare functional and quality of life outcomes of new pouch creation versus salvage of the existing pouch during re-do ileal pouch anal anastomosis. METHODS:Patients who underwent re-do ileal pouch anal anastomosis between September 2016 and June 2020 were included. The reasons for pouch excision and new pouch creation were reported. Perioperative, functional outcomes and quality of life were compared between patients who had creation of a new pouch versus salvage of existing pouch. RESULTS:A total of 105 patients with re-do ileal pouch anal anastomosis (new pouch, n = 63) were included. Most common indications for a new pouch creation were chronic pelvic infection that compromised the integrity and viability of the existing pouch (n = 32) and small pouch (n = 21). No patient developed short-bowel syndrome. The number of bowel movements, daily restrictions and Cleveland Global Quality of Life score scores were similar between 2 groups. Day-time seepage, day-time and night-time pad usage were more common after new pouch creation. Two-year pouch survival rates were comparable (new pouch: 92% versus existing pouch: 85%, P = .31). CONCLUSION/CONCLUSIONS:New pouch creation can be safely performed at the time of re-do ileal pouch anal anastomosis. It provides acceptable functional and quality of life outcomes if existing pouch salvage is not feasible.
PMID: 34272046
ISSN: 1532-7361
CID: 4947622

Treatment of pouchitis, Crohn's disease, cuffitis, and other inflammatory disorders of the pouch: consensus guidelines from the International Ileal Pouch Consortium

Shen, Bo; Kochhar, Gursimran S; Rubin, David T; Kane, Sunanda V; Navaneethan, Udayakumar; Bernstein, Charles N; Cross, Raymond K; Sugita, Akira; Schairer, Jason; Kiran, Ravi P; Fleshner, Philip; McCormick, James T; D'Hoore, André; Shah, Samir A; Farraye, Francis A; Kariv, Revital; Liu, Xiuli; Rosh, Joel; Chang, Shannon; Scherl, Ellen; Schwartz, David A; Kotze, Paulo Gustavo; Bruining, David H; Philpott, Jessica; Abraham, Bincy; Segal, Jonathan; Sedano, Rocio; Kayal, Maia; Bentley-Hibbert, Stuart; Tarabar, Dino; El-Hachem, Sandra; Sehgal, Priya; Picoraro, Joseph A; Vermeire, Séverine; Sandborn, William J; Silverberg, Mark S; Pardi, Darrell S
Pouchitis, Crohn's disease of the pouch, cuffitis, polyps, and extraintestinal manifestations of inflammatory bowel disease are common inflammatory disorders of the ileal pouch. Acute pouchitis is treated with oral antibiotics and chronic pouchitis often requires anti-inflammatory therapy, including the use of biologics. Aetiological factors for secondary pouchitis should be evaluated and managed accordingly. Crohn's disease of the pouch is usually treated with biologics and its stricturing and fistulising complications can be treated with endoscopy or surgery. The underlying cause of cuffitis determines treatment strategies. Endoscopic polypectomy is recommended for large, symptomatic inflammatory polyps and polyps in the cuff. The management principles of extraintestinal manifestations of inflammatory bowel disease in patients with pouches are similar to those in patients without pouches.
PMID: 34774224
ISSN: 2468-1253
CID: 5048812

Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

Lukin, Dana; Faleck, David; Xu, Ronghui; Zhang, Yiran; Weiss, Aaron; Aniwan, Satimai; Kadire, Siri; Tran, Gloria; Rahal, Mahmoud; Winters, Adam; Chablaney, Shreya; Koliani-Pace, Jenna L; Meserve, Joseph; Campbell, James P; Kochhar, Gursimran; Bohm, Matthew; Varma, Sashidhar; Fischer, Monika; Boland, Brigid; Singh, Siddharth; Hirten, Robert; Ungaro, Ryan; Lasch, Karen; Shmidt, Eugenia; Jairath, Vipul; Hudesman, David; Chang, Shannon; Swaminath, Arun; Shen, Bo; Kane, Sunanda; Loftus, Edward V; Sands, Bruce E; Colombel, Jean-Frederic; Siegel, Corey A; Sandborn, William J; Dulai, Parambir S
BACKGROUND & AIMS:We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. METHODS:A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist-naïve and -exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. RESULTS:A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist-naïve and -exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist-treated patients. However, in TNF-antagonist-naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). CONCLUSIONS:Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist-naïve patients.
PMCID:8026779
PMID: 33039584
ISSN: 1542-7714
CID: 5271582

COVID-19 is not associated with worse long-term inflammatory bowel disease outcomes: a multicenter case-control study

Hong, Simon J; Bhattacharya, Sumona; Aboubakr, Aiya; Nadkarni, Devika; Lech, Diana; Ungaro, Ryan C; Agrawal, Manasi; Hirten, Robert P; Greywoode, Ruby; Mone, Anjali; Chang, Shannon; Hudesman, David P; Ullman, Thomas; Sultan, Keith; Lukin, Dana J; Colombel, Jean-Frederic; Axelrad, Jordan E
Background/UNASSIGNED:Inflammatory bowel disease (IBD) is not associated with worse coronavirus disease 2019 (COVID-19) outcomes. However, data are lacking regarding the long-term impact of severe acute respiratory syndrome coronavirus 2 infection on the disease course of IBD. Objectives/UNASSIGNED:We aimed to investigate the effect of COVID-19 on long-term outcomes of IBD. Design/UNASSIGNED:We performed a multicenter case-control study of patients with IBD and COVID-19 between February 2020 and December 2020. Methods/UNASSIGNED:Cases and controls were individuals with IBD with presence or absence, respectively, of COVID-19-related symptoms and confirmatory testing. The primary composite outcome was IBD-related hospitalization or surgery. Results/UNASSIGNED: = 0.24) and on multivariate Cox regression, COVID-19 was not associated with increased risk of adverse IBD outcomes [adjusted hazard ratio (aHR): 0.84, 95% confidence interval [CI]: 0.44-1.42]. When stratified by infection severity, severe COVID-19 was associated with a numerically increased risk of adverse IBD outcomes (aHR: 2.43, 95% CI: 1.00-5.86), whereas mild-to-moderate COVID-19 was not (aHR: 0.68, 95% CI: 0.38-1.23). Conclusion/UNASSIGNED:In this case-control study, COVID-19 did not have a long-term impact on the disease course of IBD. However, severe COVID-19 was numerically associated with worse IBD outcomes, underscoring the continued importance of risk mitigation and prevention strategies for patients with IBD during the ongoing COVID-19 pandemic.
PMCID:9637830
PMID: 36348637
ISSN: 1756-283x
CID: 5357292

P024 Anorectal Manometry in Patients with Fecal Incontinence After Ileal Pouch-Anal Anastomosis for Inflammatory Bowel Disease: A Cohort Study

Young, Sigrid; Smukalla, Scott; Chang, Shannon
BACKGROUND:Fecal incontinence (FI) affects up to 1 in 4 patients with inflammatory bowel disease (IBD) and is associated with inflammation, surgeries, and altered rectal sensitivity. Ileal pouch-anal anastomosis (IPAA) is a surgical intervention for select IBD patients to avoid a permanent stoma. High-resolution anorectal manometry (HRAM) studies in IBD patients with FI demonstrate lower resting pressures and rectal sensory dysfunction. However, HRAM data in IBD patients with FI post-IPAA remains limited. We hypothesized patients with FI would have lower resting and squeeze pressures and rectal hypersensitivity compared to healthy controls and that these changes would be similar after IPAA. METHODS:Retrospective review of prospectively collected data was conducted on patients undergoing HRAM from 2017-2021 at a single urban academic medical center. Patient characteristics (age, gender, BMI, stool frequency, diabetes, pregnancy history) and surgical history (prior perianal surgery, index vs. re-do IPAA) were obtained. HRAM variables included rectoanal inhibitory reflex (RAIR), sphincter length, resting, squeeze, cough, and push pressures, sensation thresholds (first sensation, constant sensation, desire to defecate, urgency to defecate, max tolerable volume), and balloon expulsion test (BET). HRAM outcomes in IPAA patients with FI (IPAA-FI) were compared to non-IBD patients with FI (non-IBD-FI). HRAM data for both patient cohorts were also compared to existing normative data of healthy controls. Non-IBD patients with constipation and FI were excluded from analysis. An independent samples t-test was performed (p < 0.05) for continuous variables, and chi-square test was used for categorical variables. RESULTS:Fifty-six patients (66% female) were in the non-IBD-FI group. Eighteen patients (67% female) were in the IPAA-FI group. Average age in the IPAA-FI cohort was 44.8 ± 13.6 vs. 66.3 ± 14.4 in the non-IBD-FI group (p< 0.01). Sphincter length in the IPAA-FI group was 2.7 ± 1.1cm vs. 3.2 ± 0.6cm in the non-IBD-FI group (p=0.03). There was no significant difference in sensation thresholds or resting, squeeze, cough, and push pressures between the two groups. Urinary incontinence was observed in 5.6% of IPAA-FI patients vs. 44.6% of non-IBD-FI patients (p < 0.01). RAIR was present in 38.5% of IPAA-FI patients vs. 100% of non-IBD-FI patients (p < 0.01). Both patient cohorts had significantly shorter sphincter length, lower squeeze and push pressures, and lower sensation thresholds compared to normative data. Resting pressures for the IPAA-FI group was not significantly different compared to healthy controls. CONCLUSION/CONCLUSIONS:Overall, anorectal pressures and sensation are similar between IPAA-FI and non-IBD-FI patients. However, the underlying FI mechanism seems to differ. Higher rates of urinary incontinence in the non-IBD-FI cohort suggests global pelvic floor dysfunction compared to IPAA-FI patients who are younger and have post-operative neuromuscular dysfunction, as evidenced by shorter sphincter length and absent RAIR. Though rectal hypersensitivity and lower squeeze/push pressures are observed in both patient groups compared to healthy controls, normal resting pressure in IPAA-FI suggests that potentially different normative ranges are needed for this cohort to accurately assess post-surgical changes and guide pre-operative counseling.
PMID: 35006153
ISSN: 1572-0241
CID: 5118352

P024 Anorectal Manometry in Patients with Fecal Incontinence After Ileal Pouch-Anal Anastomosis for Inflammatory Bowel Disease: A Cohort Study

Young, Sigrid; Smukalla, Scott; Chang, Shannon
BACKGROUND:Fecal incontinence (FI) affects up to 1 in 4 patients with inflammatory bowel disease (IBD) and is associated with inflammation, surgeries, and altered rectal sensitivity. Ileal pouch-anal anastomosis (IPAA) is a surgical intervention for select IBD patients to avoid a permanent stoma. High-resolution anorectal manometry (HRAM) studies in IBD patients with FI demonstrate lower resting pressures and rectal sensory dysfunction. However, HRAM data in IBD patients with FI post-IPAA remains limited. We hypothesized patients with FI would have lower resting and squeeze pressures and rectal hypersensitivity compared to healthy controls and that these changes would be similar after IPAA. METHODS:Retrospective review of prospectively collected data was conducted on patients undergoing HRAM from 2017-2021 at a single urban academic medical center. Patient characteristics (age, gender, BMI, stool frequency, diabetes, pregnancy history) and surgical history (prior perianal surgery, index vs. re-do IPAA) were obtained. HRAM variables included rectoanal inhibitory reflex (RAIR), sphincter length, resting, squeeze, cough, and push pressures, sensation thresholds (first sensation, constant sensation, desire to defecate, urgency to defecate, max tolerable volume), and balloon expulsion test (BET). HRAM outcomes in IPAA patients with FI (IPAA-FI) were compared to non-IBD patients with FI (non-IBD-FI). HRAM data for both patient cohorts were also compared to existing normative data of healthy controls. Non-IBD patients with constipation and FI were excluded from analysis. An independent samples t-test was performed (p < 0.05) for continuous variables, and chi-square test was used for categorical variables. RESULTS:Fifty-six patients (66% female) were in the non-IBD-FI group. Eighteen patients (67% female) were in the IPAA-FI group. Average age in the IPAA-FI cohort was 44.8 ± 13.6 vs. 66.3 ± 14.4 in the non-IBD-FI group (p< 0.01). Sphincter length in the IPAA-FI group was 2.7 ± 1.1cm vs. 3.2 ± 0.6cm in the non-IBD-FI group (p=0.03). There was no significant difference in sensation thresholds or resting, squeeze, cough, and push pressures between the two groups. Urinary incontinence was observed in 5.6% of IPAA-FI patients vs. 44.6% of non-IBD-FI patients (p < 0.01). RAIR was present in 38.5% of IPAA-FI patients vs. 100% of non-IBD-FI patients (p < 0.01). Both patient cohorts had significantly shorter sphincter length, lower squeeze and push pressures, and lower sensation thresholds compared to normative data. Resting pressures for the IPAA-FI group was not significantly different compared to healthy controls. CONCLUSION/CONCLUSIONS:Overall, anorectal pressures and sensation are similar between IPAA-FI and non-IBD-FI patients. However, the underlying FI mechanism seems to differ. Higher rates of urinary incontinence in the non-IBD-FI cohort suggests global pelvic floor dysfunction compared to IPAA-FI patients who are younger and have post-operative neuromuscular dysfunction, as evidenced by shorter sphincter length and absent RAIR. Though rectal hypersensitivity and lower squeeze/push pressures are observed in both patient groups compared to healthy controls, normal resting pressure in IPAA-FI suggests that potentially different normative ranges are needed for this cohort to accurately assess post-surgical changes and guide pre-operative counseling.
PMID: 37461944
ISSN: 1572-0241
CID: 5650842

Implementation of an Inpatient IBD Service Is Associated with Improvement in Quality of Care and Long-Term Outcomes

Hong, Simon J; Jang, Janice; Berg, Dana; Kirat, Tarik; Remzi, Feza; Chang, Shannon; Malter, Lisa B; Axelrad, Jordan E; Hudesman, David P
BACKGROUND:There is wide variation in the quality of care of hospitalized patients with inflammatory bowel disease (IBD). Prior studies have demonstrated that a specialized inpatient IBD service improves short-term outcomes. In this study, we assessed the impact of a dedicated IBD service on the quality of care and long-term outcomes. METHODS:This retrospective cohort study included adult patients admitted for a complication of IBD between March 2017 and February 2019 to a tertiary referral center. In March 2018, a dedicated inpatient IBD service co-managed by IBD gastroenterologists and colorectal surgeons was implemented. Quality of care outcomes included C. difficile stool testing, confirmed VTE prophylaxis administration and opiate avoidance. Long-term outcomes were clinical remission, IBD-related surgery, ED visits, and hospital readmissions at 90 days and 12 months. RESULTS:In total, 143 patients were included; 66 pre- and 77 post-implementation of the IBD service. Fifty-two percent had ulcerative colitis and 48% had Crohn's disease. After implementation, there was improvement in C.difficile testing (90% vs. 76%, P = 0.04), early VTE prophylaxis (92% vs. 77%, P = 0.01) and decreases in narcotic use (14% vs. 30%, P = 0.02), IBD-related ED visits at 90 days (7% vs 18%, P = 0.03) and 12 months (16% vs 30%, P = 0.04), and IBD readmissions at 90 days (16% vs. 30%, P = 0.04). There were no differences in rates of clinical remission or surgery. CONCLUSIONS:The creation of a dedicated inpatient IBD service improved quality of IBD care and reduced post-discharge ED visits and readmissions and broader implementation of this strategy may help optimize care of hospitalized IBD patients.
PMID: 33474649
ISSN: 1573-2568
CID: 4760702

Inter-reader agreement of the Society of Abdominal Radiology-American Gastroenterological Association (SAR-AGA) consensus reporting for key phenotypes at MR enterography in adults with Crohn disease: impact of radiologist experience

Dane, Bari; Qian, Kun; Gauvin, Simon; Ji, Hoon; Karajgikar, Jay; Kim, Nancy; Chang, Shannon; Chandarana, Hersh; Kim, Sooah
PURPOSE/OBJECTIVE:To assess inter-reader agreement of key features from the SAR-AGA recommendations for the interpretation and reporting of MRE in adult patients with CD, focusing on the impact of radiologist experience on inter-reader agreement of CD phenotypes. METHODS:Two experienced and two less-experienced radiologists retrospectively evaluated 99 MRE in CD patients (50 initial MRE, 49 follow-up MRE) performed from 1/1/2019 to 3/20/2020 for the presence of active bowel inflammation (stomach, proximal small bowel, ileum, colon), stricture, probable stricture, penetrating disease, and perianal disease. The MRE protocol did not include dedicated perianal sequences. Inter-rater agreement was determined for each imaging feature using prevalence-adjusted bias-adjusted kappa and compared by experience level. RESULTS:All readers had almost-perfect inter-reader agreement (κ > 0.90) for penetrating disease, abscess, and perianal abscess in all 99 CD patients. All readers had strong inter-reader agreement (κ: 0.80-0.90) in 99 CD patients for active ileum inflammation, proximal small bowel inflammation, and stricture. Less-experienced readers had significantly lower inter-reader agreement for active ileum inflammation on initial than follow-up MRE (κ 0.68 versus 0.96, p = 0.018) and for strictures on follow-up than initial MRE (κ 0.76 versus 1.0, p = 0.027). Experienced readers had significantly lower agreement for perianal fistula on follow-up than initial MRE (κ: 0.55 versus 0.92, p = 0.008). CONCLUSION/CONCLUSIONS:There was strong to almost-perfect inter-reader agreement for key CD phenotypes described in the SAR-AGA consensus recommendations including active ileum and proximal small bowel inflammation, stricture, penetrating disease, abscess, and perianal abscess. Areas of lower inter-reader agreement could be targeted for future education efforts to further standardize CD MRE reporting. Dedicated perianal sequences should be included on follow-up MRE.
PMID: 34324038
ISSN: 2366-0058
CID: 4949952

Comparative Evaluation of Conventional Stool Testing and Multiplex Molecular Panel in Outpatients With Relapse of Inflammatory Bowel Disease

Hong, Soonwook; Zaki, Timothy A; Main, Michael; Hine, Ashley M; Chang, Shannon; Hudesman, David; Axelrad, Jordan E
BACKGROUND:Differentiating between enteric infection and relapse of inflammatory bowel disease (IBD) is a common clinical challenge. Few studies have evaluated the impact of multiplex gastrointestinal polymerase chain reaction (GI PCR) pathogen panels on clinical practice compared to stool culture. Our aim was to compare the impact of PCR stool testing to conventional stool testing in outpatients presenting with relapse of IBD. METHODS:In a retrospective cohort study of outpatients with IBD presenting to NYU Langone Health with flare from September 2015 to April 2019, we compared patients who underwent stool testing with GI PCR to age-, sex-, and IBD-subtype-matched patients who underwent culture and ova and parasite exam (conventional testing). The primary outcome was IBD therapy escalation after testing. Secondary outcomes included rates of posttesting endoscopy, abdominal radiography, antibiotics, and IBD-related emergency department visits, hospitalizations, and abdominal surgeries. RESULTS:We identified 134 patients who underwent GI PCR matched to 134 patients who underwent conventional testing. Pathogens were more frequently identified on GI PCR (26 vs 5%; P < 0.01). We found that GI PCR was associated with less escalation in IBD therapy (16 vs 29%; P < 0.01) and fewer posttest endoscopies (10% vs 18%; P = 0.04), with no differences in IBD outcomes. On multivariate analysis, testing with GI PCR was associated with an odds ratio of 0.26 (95% confidence interval, 0.08-0.84; P = 0.02) for escalation of IBD therapies. CONCLUSIONS:Testing with GI PCR was associated with higher rates of pathogen detection and lower rates of IBD therapy escalation and endoscopy in the outpatient setting. These changes in management were not associated with a difference in IBD outcomes.
PMID: 33386740
ISSN: 1536-4844
CID: 4738342