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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

Ustekinumab and Vedolizumab Are Not Associated With Subsequent Cancer in IBD Patients with Prior Malignancy

Hong, Simon J; Zenger, Cameron; Pecoriello, Jillian; Pang, Alice; Vallely, Margaret; Hudesman, David P; Chang, Shannon; Axelrad, Jordan E
BACKGROUND:There is little data regarding the risk of new or recurrent cancer in patients with inflammatory bowel disease (IBD) and a prior history of cancer who are exposed to ustekinumab or vedolizumab. We assessed the risk of subsequent cancer in patients exposed to these agents. METHODS:We performed a retrospective cohort study of patients with IBD and a history of cancer at an academic medical center between January 2013 and December 2020. We collected data on demographics, IBD and cancer disease characteristics, and drug exposures. The primary exposure was immunosuppressive therapy after diagnosis of cancer. The primary outcome was interval development of new or recurrent cancer. RESULTS:Of 390 patients with IBD and a previous history of cancer, 37 were exposed to vedolizumab, 14 ustekinumab, 41 antitumor necrosis factor (anti-TNF), and 31 immunomodulator; and 267 were not exposed to immunosuppression following cancer diagnosis. During a total median follow-up time of 52 months, 81 (20%) patients developed subsequent cancer: 6 (16%) were exposed to vedolizumab, 2 (14%) to ustekinumab, 3 (10%) to immunomodulators, 12 (29%) to anti-TNF, and 56 (21%) with no immunosuppression (P = .41). In a multivariable Cox model adjusting for age, IBD subtype, smoking, cancer recurrence risk, and cancer stage, there was no increase in subsequent cancer with vedolizumab (adjusted hazard ratio, 1.36; 95% CI, 0.27-7.01) or ustekinumab (adjusted hazard ratio, 0.96; 95% CI, 0.17-5.41). Patients with more than 1 biologic exposure also did not have an increased risk of subsequent cancer. CONCLUSIONS:Exposure to ustekinumab or vedolizumab in patients with IBD and a prior history of cancer does not appear to be associated with an increased risk of subsequent new or recurrent cancer.
PMID: 35262671
ISSN: 1536-4844
CID: 5182262

Frailty, Thy Diagnosis Is Uncertain: Impact on IBD Readmission and Mortality [Editorial]

Hong, Simon J; Katz, Seymour
PMID: 33748912
ISSN: 1573-2568
CID: 4875382

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

Validation of diffusion tensor imaging of the physis and metaphysis as predictor of child growth [Meeting Abstract]

Jaramillo, D; Dong, P; Nguyen, J C; Mostoufi-Moab, S; Nguyen, M; Moreau, A; Barrera, C; Hong, S; Raya, J
Background: Diffusion tensor imaging of the physis/metaphysis (DTI-P/M) depicts physeal columns and provides measures of tract volume that may predict growth.
Objective(s): To validate DTI-P/M as predictive biomarker of height velocity (1-year height change from MRI) and total height gain (height change from MRI until after growth cessation).
Method(s):We analyzed distal femoral DTI-P/M in 160 children using a standard diffusion sequence (20 directions, b=600 s/mm2) and calculated tract volume, tract length, and fractional anisotropy. Children studied had measurements of height velocity (n=90), or total height gain (n=70, mean=34 months from DTI-P/M). We excluded children with height change < 0.5 cm, abnormal physes or inadequate imaging. In both groups, we used multilinear regression to assess the potential of DTI parameters to predict height velocity and total height gain. We compared DTI-P/M predictions to standard predictions based on bone age determinations.
Result(s): Larger tract volumes correlated with height gains one year after DTI-P/M (r=0.70) and with total height gain at skeletal maturity measured after cessation of growth (r=0.68) (P<0.01). Tract volume alone after controlling for age and sex accounted for over 50% of the total variance in velocity height (r2=0.51). A multilinear stepwise model algorithm identified tract volume as the strongest predictor for velocity height and total height gain. Optimal multilinear model significantly improved prediction of height velocity (r2=0.65, root mean square error (RMSE)=1.76 cm) and of total height gain (r2=0.59, RMSE=1.83 cm) compared to the standard method based on bone age (height velocity: r2=0.32, RMSE=2.87 cm; total height gain: r2=0.42, RMSE=4.97 cm
Conclusion(s): Models using tract volume may overperform clinical standards in predicting height velocity and total height gain and may become a predictive biomarker of skeletal growth. Bland-Altman Plots: Predicted and measured height velocity (left) and total height gain (right). Tract volume model (top) reduced error and bias compared to bone age model (bottom). boys: purple, girls: pink
EMBASE:636152768
ISSN: 1432-1998
CID: 5024962

Defining the disease characteristics of concurrent inflammatory bowel disease and psoriasis or psoriatic arthritis [Meeting Abstract]

Rabbenou, W; Jaros, B; Chang, S; Axelrad, J; Scher, J; Hudesman, D; Haberman, R; Hong, S J
Introduction: Inflammatory bowel disease (IBD), psoriasis (PsO), and psoriatic arthritis (PsA) are immune-mediated inflammatory diseases characterized by dysregulation of the immune system. Evidence suggests that they share a common genetic and pathophysiologic pathway and that the presence of one increases the risk of developing others. While rates of PsO and PsA are increased in patients with IBD, data is lacking regarding whether phenotypic differences exist in patients with concurrent disease. In this study, we describe the disease characteristics of patients with IBD and PsO/PsA overlap.
Method(s): We performed a single-center case-control observational study. Eighty-five patients with IBD and PsO and/or PsA were identified and matched with a control group of patients with IBD alone in a 1:2 fashion based on age, sex and IBD type (n=190). Patient demographics, IBD phenotype and history, treatment patterns, and family history were collected.
Result(s): We identified 85 patients with IBD and PsO +/-PsA, matched with 190 controls. IBD 1 PsO/PsA patients were less frequently White (85% vs. 94%) and more frequently Asian (7% vs. 3%), compared with IBD only patients (P, 0.01, Table 1). There were no differences in extent of ulcerative colitis (UC) or distribution of Crohn's disease (CD), but patients with IBD alone were more likely to have penetrating Crohn's disease (48% vs. 7%; P, 0.01), prior hospitalizations (48% vs. 28%; P, 0.01), and prior surgeries (35% vs. 17%; P=0.02), compared to patients with overlap PsO +/-PsA. Rates of exposure to various biologic therapies were similar between the two groups, with the exception of decreased vedolizumab use in the IBD 1 PsO/PsA group (12% vs. 31% respectively; P, 0.01, Table 2). IBD only patients were more likely to have first-degree relatives (FDR) with IBD (35% vs. 23%; P=0.02) and numerically less likely to have a FDR with PsO or PsA (14% vs. 20%; P=0.21) than patients with PsO/PsA overlap (Table 1).
Conclusion(s): In this study, we report for the first time disease characteristics of patients with IBD and overlap PsO or PsA. Our results suggests that patients with IBD and PsO/PsA may have a less severe disease phenotype than patients with IBD alone, and that genetic risks may differ between these two groups. Further prospective studies are needed to confirm these findings
EMBASE:636476207
ISSN: 1572-0241
CID: 5083712

Comparative safety of biologic agents in patients with inflammatory bowel disease with active or recent malignancy: A multi-center cohort study [Meeting Abstract]

Holmer, A K; Luo, J; Park, S; Yang, J Y; Nguyen, V Q; Sofia, M A; Ertem, F; Dueker, J M; Petrov, J C; Al, Bawardy B F; Llano, E M; Fudman, D; Joseph, D; Jangi, S; Russ, K; Khakoo, N S; Damas, O; Barnes, E L; Hong, S J; Zenger, C; Axelrad, J; Scott, F I; Ungaro, R; Singh, S
Introduction: With an aging population, management of biologic therapy in IBD patients with active or recent cancer is challenging. We evaluated the comparative safety of non-tumor necrosis factor (TNF)-a directed therapy vs. TNFa antagonists vs. immunomodulator monotherapy (IMM) in IBD patients with active or recent cancer (<=5 years).
Method(s): Through the collaborative REACH-IBD (Rising Educators Academics and Clinicians Helping IBD) research initiative, we conducted a retrospective, multi-center cohort study. We included IBD patients from 12 centers with active cancer (Cohort A) or recent cancer within = years (Cohort B) who were treated with non-TNFa biologics vs. TNFa antagonists (reference) after cancer diagnosis.We excluded patients with nonmelanoma skin cancer. Primary outcomes were cancer progression (Cohort A) or new/recurrent cancer (Cohort B). We performed Cox proportional hazard analysis to compare the safety of different biologics.
Result(s): (Cohort A)We included 107 patients with active cancer (5416y, 62% male, 72% solid cancer, 400 person-year follow-up), of whom 35 were treated with non-TNFa biologics (29 vedolizumab, 6 ustekinumab), 45 with TNFa antagonists and 27 with IMM (Table 1). Overall, 19 patients had progression of cancer, 13 died and 20 were hospitalized for serious infection (Figure 1A). After adjusting for age and type of active cancer, there was no difference in the risk of cancer progression (non-TNFa biologics vs. TNFa antagonists: HR, 1.55; 95% CI, 0.48-5.03), mortality (HR, 2.74; 95% CI, 0.25-30.5) and serious infections (HR, 1.90; 95% CI, 0.15-24.0) between patients treated with non-TNFa biologics vs. TNFa antagonists. (Cohort B) We included 141 patients with recent prior cancer (5214y, 51% male, 86% solid cancer; duration of remission prior to starting biologics, 1719m) of whom 54 were treated with non-TNFa biologics (40 vedolizumab, 14 ustekinumab), 63 with TNFa antagonists and 24 with IMM (Table 1). Overall, 14 patients had recurrence of cancer (or developed new incident cancer) and 6 died (Figure 1B). After adjusting for age, type of prior cancer and duration of remission, there was no difference in the risk of cancer recurrence between non-TNFa biologics vs. TNFa antagonists (HR, 0.97; 95% CI, 0.16-5.75).
Conclusion(s): In IBD patients with active or recent cancer (within = years), non-TNFa-directed biologics and TNFa antagonists have comparable safety. Choice of biologic should be dictated by IBD disease severity, in collaboration with an oncologist
EMBASE:636475073
ISSN: 1572-0241
CID: 5083932

Risk of new or recurrent cancer after vedolizumab or ustekinumab exposure in patients with inflammatory bowel disease and previous cancer [Meeting Abstract]

Zenger, C; Hong, S J; Pecoriello, J; Pang, A S; Vallely, M; Hudesman, D; Chang, S; Axelrad, J
Introduction: Previous studies have demonstrated that exposure to anti-TNFa medications or immunomodulators (IMM) does not increase the risk of new or recurrent cancer in patients with inflammatory bowel disease (IBD) and a previous history of cancer. There is little data regarding this risk after the use of newer biologics such as ustekinumab and vedolizumab. In this study, we assessed whether patients with IBD and a history of previous cancer who are exposed to these newer agents have an increased risk of developing subsequent cancer.
Method(s): We performed a retrospective cohort study of patients with IBD and cancer from a single academic medical center between January 2013 and December 2020. We recorded information on demographics, cancer type and treatment, and IBD characteristics and drug exposures. The primary exposure was type of IBD monotherapy after a cancer diagnosis. The primary outcome was development of new or recurrent cancer.
Result(s): Of 401 patients with IBD and a history of cancer, 37 subsequently received vedolizumab, 14 ustekinumab, 31 IMM, 41 anti-TNF, 11 combination anti-TNF with an IMM, and 267 were not exposed to any immunosuppression following a cancer diagnosis (Table 1). There were no differences in duration of IBD, median age at cancer diagnosis, or smoking history. During a total median follow-up of 52 months, 81 (20%) patients developed incident cancer including 6 (16%) exposed to vedolizumab, 2 (14%) to ustekinumab, 3 (10%) to IMM, 12 (29%) to anti-TNF, 2 (18%) to combination anti-TNF with an IMM, and 56 (21%) with no immunosuppression (P = 0.41). Sensitivity analyses assessing any history of exposure to vedolizumab or ustekinumab, inclusive of both single and multiple biologic exposures, also did not reveal an increased rate of incident cancer.
Conclusion(s): In this single-center study, vedolizumab or ustekinumab monotherapy in patients with IBD and a history of cancer was not associated with an increase in new or recurrent cancer compared with anti-TNF, IMM, or no immunosuppression. Prospective studies are needed to confirm this conclusion
EMBASE:636474994
ISSN: 1572-0241
CID: 5083972

Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials

Rolston, Vineet S; Kimmel, Jessica; Popov, Violeta; Bosworth, Brian P; Hudesman, David; Malter, Lisa B; Hong, Simon; Chang, Shannon
GOALS AND BACKGROUND/OBJECTIVE:Ustekinumab (UST) is a monoclonal antibody inhibitor of IL-12/IL-23 approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). We conducted a meta-analysis to compare rates of adverse events (AEs) in randomized controlled trials (RCTs) of UST for all indications. STUDY/METHODS:A systematic search was performed of MEDLINE, Embase, and PubMed databases through November 2019. Study inclusion included RCTs comparing UST to placebo or other biologics in patients aged 18 years or older with a diagnosis of an autoimmune condition. RESULTS:Thirty RCTs with 16,068 patients were included in our analysis. Nine thousand six hundred and twenty-six subjects were included in the UST vs placebo analysis. There was no significant difference in serious or mild/moderate AEs between UST and placebo with an OR of 0.83 (95% CI 0.66, 1.05) and 1.08 (95% CI 0.99, 1.18), respectively, over a median follow-up time of 16 weeks. In a sub-analysis of CD and UC trials, no difference in serious or mild/moderate AEs in UST versus placebo was seen. CONCLUSIONS:UST was not associated with an increase in short-term risk of AEs.
PMID: 32445049
ISSN: 1573-2568
CID: 4447192

From the American Epicenter: Coronavirus Disease 2019 in Patients with Inflammatory Bowel Disease in the New York City Metropolitan Area

Axelrad, Jordan E; Malter, Lisa; Hong, Simon; Chang, Shannon; Bosworth, Brian; Hudesman, David
BACKGROUND:We aimed to characterize patients with inflammatory bowel disease (IBD) and novel coronavirus disease 2019 (COVID-19). METHODS:We performed a case series of patients with IBD and confirmed or highly suspected COVID-19 to assess rates of severe outcomes. RESULTS:We identified 83 patients with IBD with confirmed (54%) or highly suspected (46%) COVID-19. The overall hospitalization rate was 6%, generally comprising patients with active Crohn's disease or older men with comorbidities, and 1 patient expired. DISCUSSION/CONCLUSIONS:In this series of patients with IBD, severe outcomes of COVID-19 were rare and comparable to similarly aged individuals in the general population.
PMID: 32578843
ISSN: 1536-4844
CID: 4493232