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Safety of Immunosuppression in A Prospective Cohort of Inflammatory Bowel Disease Patients with a HIstoRy of CancEr: SAPPHIRE Registry
Itzkowitz, Steven H; Jiang, Yue; Villagra, Cristina; Colombel, Jean-Frederic; Sultan, Keith; Lukin, Dana J; Faleck, David M; Scherl, Ellen; Chang, Shannon; Chen, LeaAnn; Katz, Seymour; Kwah, Joann; Swaminath, Arun; Petralia, Francesca; Sharpless, Virginia; Sachar, David; Jandorf, Lina; Axelrad, Jordan E; ,
BACKGROUND AND AIMS/OBJECTIVE:In patients with inflammatory bowel disease (IBD) and a history of cancer, retrospective studies suggest that exposure to immunosuppressive agents does not increase the risk of incident (recurrent or new) cancer compared to unexposed patients. SAPPHIRE is a prospective registry aimed at addressing this issue. METHODS:Since 2016, patients with IBD and confirmed index cancer prior to enrollment were followed annually. Patients receiving chemotherapy or radiation at enrollment, or recurrent cancer within five years were excluded. Primary outcome was development of incident cancer related to exposure to immunosuppressive medications. RESULTS:Among 305 patients (47% male, 88% white), median age at IBD diagnosis and cancer were 32 and 52 years, respectively. Index cancers were solid organ (46%), dermatologic (32%), gastrointestinal (13%), and hematologic (9%). During median follow-up of 4.8 years, 210 (69%) were exposed to immunosuppressive therapy and 46 (15%) developed incident cancers (25 new, 21 recurrent). In unadjusted analysis, the crude rate of incident cancer in unexposed patients was 2.58/100 person-years versus 4.78/100 PY (relative risk 1.85, 95% CI 0.92-3.73) for immunosuppression exposed patients. In a proportional hazards model adjusting for sex, smoking history, age and stage at index malignancy, and non-melanoma skin cancer, no significant association was found between receipt of immunosuppression and incident cancer (adjusted hazard ratio, aHR, 1.41, 95% CI: 0.69-2.90), or with any major drug class. CONCLUSION/CONCLUSIONS:In this interim analysis of patients with IBD and a history of cancer, despite numerically elevated aHRs, we did not find a statistically significant association between subsequent exposure to immunosuppressive therapies and development of incident cancers.
PMID: 38768673
ISSN: 1542-7714
CID: 5654242
Changes in Therapy Are Not Associated with Increased Remission in Patients with Crohn's Disease of the Pouch
Kayal, Maia; Deepak, Parakkal; Beniwal-Patel, Poonam; Raffals, Laura; Dubinsky, Marla; Chang, Shannon; Higgins, Peter D R; Jiang, Yue; Cross, Raymond K; Long, Millie D; Herfarth, Hans H; Barnes, Edward L
BACKGROUND:There is a paucity of data on the real-world effectiveness of therapies in patients with Crohn's Disease of the Pouch (CDP). METHODS:This was a prospective, multicenter study evaluating the primary outcome of remission at 12 months of therapy for CDP. RESULTS:134 patients were enrolled. Among the 77 patients with symptoms at baseline, 35 (46.7%) achieved remission at 12-months. Of these, 12 (34.3%) changed therapy. There was no significant association between therapy patterns and remission status. CONCLUSION/CONCLUSIONS:Approximately 50% with symptoms at enrollment achieved clinical remission at 12 months, the majority of whom did so without a change in therapy.
PMID: 37975591
ISSN: 1572-0241
CID: 5610502
A Review of Available Medical Therapies to Treat Moderate-to-Severe Inflammatory Bowel Disease
Chang, Shannon; Murphy, Megan; Malter, Lisa
The treatment armamentarium for inflammatory bowel disease has expanded rapidly in the past several years with new biologic and small molecule-agents approved for moderate-to-severe ulcerative colitis and Crohn's disease. This has made treatment selection more challenging with limited but evolving guidance as to where to position each medication. In this review, we discuss the efficacy data for each agent approved in the United States by reviewing their phase 3 trial data and other comparative effectiveness studies. In addition, safety considerations and use in special populations are summarized with proposed algorithms for positioning therapies. The aim is to provide a synopsis of high-impact data and aid in outpatient treatment decision-making for patients with inflammatory bowel disease.
PMID: 37615291
ISSN: 1572-0241
CID: 5599302
Pulmonary Crohn's Disease Masquerading as Lymphoma [Case Report]
Beaty, William; Katragadda, Anila; Condos, Rany; Dane, Bari; Sarkar, Suparna; Shaffer, Emily; Chang, Shannon
Although extraintestinal manifestations of inflammatory bowel disease (IBD) are common, pulmonary IBD is extremely rare. Owing to its nonspecific clinical, radiologic, and pathologic features, pulmonary IBD is difficult to diagnose and may mimic more concerning disease processes. We present a rare case of a patient with known Crohn's disease whose initial presentation was highly suspicious for malignancy before further investigation revealed pulmonary IBD.
PMCID:10766257
PMID: 38179265
ISSN: 2326-3253
CID: 5624152
Oral vs Intravenous Discharge Antibiotic Regimens in the Management of Intra-abdominal Abscesses in Penetrating Crohn's Disease
Fansiwala, Kush; Rusher, Alison; Shore, Brandon; Herfarth, Hans H; Barnes, Edward; Kochar, Bharati; Chang, Shannon
BACKGROUND:Antibiotics are a cornerstone in management of intra-abdominal abscesses in Crohn's disease (CD). Yet, the optimal route of antibiotic administration is poorly studied. We aimed to compare surgical and nonsurgical readmission outcomes for patients hospitalized for intra-abdominal abscesses from CD discharged on oral (PO) or intravenous (IV) antibiotics. METHODS:Data for patients with CD hospitalized for an intra-abdominal abscess were obtained from 3 institutions from January 2010 to December 2020. Baseline patient characteristics were obtained. Primary outcomes of interest included need for surgery and hospital readmission within 1 year from hospital discharge. We used multivariable logistic regression models and Cox regression analysis to adjust for abscess size, history of prior surgery, history of penetrating disease, and age. RESULTS:We identified 99 patients discharged on antibiotics (PO = 74, IV = 25). Readmissions related to CD at 12 months were less likely in the IV group (40% vs 77% PO, P = .01), with the IV group demonstrating a decreased risk for nonsurgical readmissions over time (hazard ratio, 0.376; 95% confidence interval, 0.176-0.802). Requirement for surgery was similar between the groups. There were no differences in time to surgery between groups. CONCLUSIONS:In this retrospective, multicenter cohort of CD patients with intra-abdominal abscess, surgical outcomes were similar between patients receiving PO vs IV antibiotics at discharge. Patients treated with IV antibiotics demonstrated a decreased risk for nonsurgical readmission. Further prospective trials are needed to better delineate optimal route of antibiotic administration in patients with penetrating CD.
PMID: 38150318
ISSN: 1536-4844
CID: 5623192
Shedding New Light on High-Risk Phenotypes for Pouchitis
Barnes, Edward L; Chang, Shannon
PMID: 36869847
ISSN: 1536-4844
CID: 5432462
Histologic Predictors of Clinical Outcomes and Healthcare Utilization in Patients With Ileal Pouch-Anal Anastomosis
Chang, Shannon; Hong, Simon; Hudesman, David; Remzi, Feza; Sun, Katherine; Cao, Wenqing; Tarik Kani, H; Axelrad, Jordan; Sarkar, Suparna A
BACKGROUND:The prognostic significance of histology in ileal pouch-anal anastomosis (IPAA) remains unclear. The aim of this study was to evaluate if histologic variables are predictive of IPAA clinical outcomes and healthcare utilization. METHODS:This was a retrospective cohort study of patients with IPAA undergoing surveillance pouchoscopy at a tertiary care institution. Pouch body biopsies were reviewed by gastrointestinal pathologists, who were blinded to clinical outcomes, for histologic features of acute or chronic inflammation. Charts were reviewed for clinical outcomes including development of acute pouchitis, chronic pouchitis, biologic or small molecule initiation, hospitalizations, and surgery. Predictors of outcomes were analyzed using univariable and multivariable logistic and Cox regression. RESULTS:A total of 167 patients undergoing surveillance pouchoscopy were included. Polymorphonuclear leukocytes (odds ratio [OR], 1.67), ulceration and erosion (OR, 2.44), chronic inflammation (OR, 1.97), and crypt distortion (OR, 1.89) were associated with future biologic or small molecule initiation for chronic pouchitis. Loss of goblet cells was associated with development of chronic pouchitis (OR, 4.65). Pyloric gland metaplasia was associated with hospitalizations (OR, 5.24). No histologic variables were predictive of development of acute pouchitis or surgery. In an exploratory subgroup analysis of new IPAA (<1 year), loss of goblet cells was associated with acute pouchitis (OR, 14.86) and chronic pouchitis (OR, 12.56). Pyloric gland metaplasia was again associated with hospitalizations (OR, 13.99). CONCLUSIONS:Histologic findings may be predictive of IPAA outcomes. Pathologists should incorporate key histologic variables into pouchoscopy pathology reports. Clinicians may need to more closely monitor IPAA patients with significant histologic findings.
PMID: 36702534
ISSN: 1536-4844
CID: 5419702
Anorectal Manometry in Patients With Fecal Incontinence After Ileal Pouch-Anal Anastomosis for Ulcerative Colitis: A Cohort Study
Young, Sigrid; Lee, Briton; Smukalla, Scott; Axelrad, Jordan; Chang, Shannon
BACKGROUND/UNASSIGNED:Fecal incontinence commonly occurs in patients with ulcerative colitis and ileal pouch-anal anastomosis. There is a paucity of manometric data in pouch patients. We aimed to better define manometric parameters in pouch patients with fecal incontinence. METHODS/UNASSIGNED: < .05). RESULTS/UNASSIGNED: = .033) each independently predicted fecal incontinence in pouch patients. CONCLUSIONS/UNASSIGNED:Pouch patients with fecal incontinence have lower anorectal pressures compared to pouch patients without incontinence, though have similar pressures to non-ulcerative colitis patients with fecal incontinence. Pouch patients with fecal incontinence have similar resting pressures as healthy controls. Distinct manometric normative values for pouch patients are needed.
PMCID:10708921
PMID: 38077748
ISSN: 2631-827x
CID: 5589582
Dietary Patterns Are Not Associated With Disease Activity Among Patients With Inflammatory Conditions of the Pouch in a Prospective Cohort
Barnes, Edward L.; Beniwal-Patel, Poonam; Deepak, Parakkal; Raffals, Laura; Kayal, Maia; Dubinsky, Marla; Chang, Shannon; Higgins, Peter D.R.; Barr, Jennifer I.; Anderson, Chelsea; Cross, Raymond K.; Long, Millie D.; Herfarth, Hans H.
Background: Evidence-based recommendations regarding the influence of diet on inflammatory conditions of the pouch after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) are limited. Methods: We analyzed dietary patterns at enrollment in a prospective registry of patients with 1 of 4 inflammatory conditions of the pouch (acute pouchitis, chronic antibiotic-dependent pouchitis, chronic antibiotic refractory pouchitis, and Crohn's disease of the pouch). We analyzed dietary intake by disease activity at enrollment and then compared dietary patterns among patients who remained in remission throughout the 12-month follow-up to those patients who experienced a disease relapse. We also compared dietary patterns among patients with inflammatory conditions of the pouch to the United States Department of Agriculture (USDA) recommended daily goals. Results: Among 308 patients, there were no differences in dietary patterns among patients with 1 of the 4 disease states at enrollment. Additionally, among the 102 patients in remission at baseline, there were no significant differences noted among patients who went on to experience a disease flare in the 12 months after enrollment compared to those patients who remained in remission. However, patients with inflammatory conditions of the pouch demonstrated decreased intake of several food groups and macronutrients including dairy, fruits, vegetables, whole grains, and fiber when compared to USDA recommendations. Conclusions: In a prospective cohort, we demonstrated no impact of dietary patterns on disease activity. The relative deficiencies in several food groups and macronutrients among patients after IPAA indicate the potential role of targeted nutritional counseling in this population.
SCOPUS:85168102358
ISSN: 2631-827x
CID: 5567942
Early Initiation of Antitumor Necrosis Factor Therapy Reduces Postoperative Recurrence of Crohn's Disease Following Ileocecal Resection
Axelrad, Jordan E; Li, Terry; Bachour, Salam P; Nakamura, Takahiro I; Shah, Ravi; Sachs, Michael C; Chang, Shannon; Hudesman, David P; Holubar, Stefan D; Lightner, Amy L; Barnes, Edward L; Cohen, Benjamin L; Rieder, Florian; Esen, Eren; Remzi, Feza; Regueiro, Miguel; Click, Benjamin
BACKGROUND:Postoperative recurrence (POR) of Crohn's disease (CD) is common after surgical resection. We aimed to compare biologic type and timing for preventing POR in adult CD patients after ileocecal resection (ICR). METHODS:We performed a retrospective cohort study of CD patients who underwent an ICR at 2 medical centers. Recurrence was defined by endoscopy (≥ i2b Rutgeerts score) or radiography (active inflammation in neoterminal ileum) and stratified by type and timing of postoperative prophylactic biologic within 12 weeks following an ICR (none, tumor necrosis factor antagonists [anti-TNF], vedolizumab, and ustekinumab). RESULTS:We identified 1037 patients with CD who underwent an ICR. Of 278 (26%) who received postoperative prophylaxis, 80% were placed on an anti-TNF agent (n = 223) followed by ustekinumab (n = 28, 10%) and vedolizumab (n = 27, 10%). Prophylaxis was initiated in 35% within 4 weeks following an ICR and in 65% within 4 to 12 weeks. After adjusting for factors associated with POR, compared with no biologic prophylaxis, the initiation of an anti-TNF agent within 4 weeks following an ICR was associated with a reduction in POR (adjusted hazard ratio, 0.61; 95% CI, 0.40-0.93). Prophylaxis after 4 weeks following an ICR or with vedolizumab or ustekinumab was not associated with a reduction in POR compared with those who did not receive prophylaxis. CONCLUSION/CONCLUSIONS:Early initiation of an anti-TNF agent within 4 weeks following an ICR was associated with a reduction in POR. Vedolizumab or ustekinumab, at any time following surgery, was not associated with a reduction in POR, although sample size was limited.
PMID: 35905032
ISSN: 1536-4844
CID: 5276992