World Congress at ACG2017

Simultaneous Plenary Session 1B: IBD

16 - Therapy Escalation in Patients With Inflammatory Bowel Disease Following Clostridium difficile Infection Is not Associated With Adverse Clinical Outcomes: An IBD ReMEdY Study

Monday, October 16
4:50 PM - 5:00 PM
Location: Valencia Ballroom BC (Level 4)



Category: IBD       

Dana J. Lukin, MD, PhD1, Garrett Lawlor, MD2, David P. Hudesman, MD3, Laura Durbin, MPH4, Alexandra Feathers, MPA, MPH4, Monica Passi, MD5, Kimberly Cavaliere, MD1, Jordan E. Axelrad, MD, MPH6, Elliot Coburn, MD3, Michelle Loftus, DO4, Henry Jen, MD7, Melissa H. Rosen, MD3, Lisa B. Malter, MD8, Arun Swaminath, MD4
1Montefiore Medical Center, Bronx, NY; 2New York-Presbyterian/Columbia University Medical Center, New York, NY; 3New York University Langone Medical Center, New York, NY; 4Northwell Lenox Hill Hospital, New York, NY; 5Northwell Health, Manhasset, NY; 6Columbia University Medical Center, New York, NY; 7Northwell Health Lenox Hill Hospital, New York, NY; 8NYU School of Medicine, New York, NY
Introduction:Clostridium difficile infection (CDI) occurs frequently in patients with inflammatory bowel disease (IBD) and is associated with increased disease activity. Due to concern for complications, immunosuppressive medication (ISM) is often withheld after CDI, although few data exist to inform this decision. This study aims to assess the influence of ISM on outcomes following CDI in IBD patients.

Methods: This multicenter, retrospective cohort study was performed at 4 academic medical centers in New York City. Patient demographic and clinical data was abstracted from databases at each site for adult patients with an established diagnosis of IBD also diagnosed with CDI. Escalation of therapy was defined as initiation or dose escalation of corticosteroids or new biologic use following antibiotic therapy for CDI. Outcomes were assessed at 30 and 90 days after last positive C. difficile test. Continuous variables were compared using two-sided T-tests and proportions were compared using Chi-squared tests. Exact methods were used for expected cell size.

Results: 207 patients met inclusion criteria (49 outpatient, 158 inpatient). Demographic information is listed in Table 1. Escalation of IBD regimen (Table 2) was more frequent in outpatients at 90 days (43% vs. 22%, p < 0.01), with 49% (39/61) of ISM escalation occurring within 14 days of CDI.) Patients not escalated had higher rates of sepsis than escalated patients (11% vs. 2%, p=0.04). Severe outcomes (death, sepsis, or colectomy) at 90 days were markedly increased in the non-escalation group (15% vs 2%, p < 0.01). There was no difference in CDI recurrence or rehospitalization between groups.

In this multicenter study assessing outcomes of ISM use in patients with IBD and CDI, initiation of steroid or biologic therapy following CDI treatment was not associated with adverse clinical outcomes. While no difference was observed between CDI recurrence or rehospitalization among groups, sepsis and severe outcomes were significantly more common in patients not undergoing escalation. These data suggest that escalation of IBD therapy following CDI is not associated with worse clinical outcomes and a subset of patients may benefit from timely treatment of underlying inflammatory disease. Prospective studies are needed to validate these data and to inform clinical guidelines regarding the timing of ISM use following CDI.

Supported by Industry Grant: No


Table 1: Patient Demographics and Clinical Characteristics









































































































































































































































































































































































































               
               
               
               
               
Demographic Outpatients            n=49 Inpatients         n=158 Total        n=207 p-Value      
  #                   % #                   % #               %        
Age, years, mean (SD) 40(16) 44(21) 43(20) 0.23      
Sex, Male 28                  57 66                 42 94             45 0.06      
Ethnicity       0.39      
Caucasian 22                   48 70                  47 92            47        
African American 12                   26 35                  23 47            24        
Hispanic or Latino 9                     20  23                  15 32            16        
Asian or Pacific Islander 3                      7 10                   7 13              7        
CDI Initial Treatment       0.09      
PO Metronidazole 20                   45 69                 45 89             45        
PO + IV Metronidazole 1                       2 15                  10 16              8        
PO Vancomycin 22                    50 62                  41  84             43        
FMT 1                      2 0                       0 1                1        
Combination or Other 0                      0 7                       5 7               4        
Mean Duration IBD, years (SD) 7.6 (9.6) 7.5(9.6) 7.5(9.6) 0.95      
IBD Subtype       0.14      
Crohn's disease 17                 35 74                47 91         44        
Ulcerative Colitis 32                 65 79                50 111       54        
Indeterminate Colitis 0                    0 4                  3 4           2        
Prior CDI 9                    18 21               13 30         15 0.39      
PPI Use past month 4                     8 34                22 38         18 0.03      
Antibiotic use past 3 months 18                  39  49                32 67         34 0.36      
Prior IBD Therapy              
Aminosalicylates 44                   90 112              72 156       76 0.01      
Corticosteroids 24                  49 43                28 67        33 <0.01      
Immune Modulators 12                  24 21                14 33        16 0.07      
Biologics 13                  27 25                16 38        19 0.10      
Escalation of Therapy within 90 Days       <0.01      
None 28                  57 115              78 143       73        
Steroids 3                    6 19                13 22         11        
Biologics 17                  35 12                 8 29         15        
Combination Therapy 1                    2 2                   1 3           2        
               

Table 2: Outcomes According To Therapy Escalation (At 90 Days)



























































































































                                  No Escalation    n=143          Escalation          n=61        Total       n=204     P-Value
  # % # % # %  
Inpatient 115 80 40 66 155 76 0.02
Outcome Within 90 Days              
Death 9 7 0 0 9 5 0.06
Sepsis 15 11 1 2 16 8 0.04
Colectomy 9 7 1 2 10 5 0.29
CDI Recurrence 38 28 17 30 55 29 0.78
Worsening of IBD 18 18 18 33 36 23 0.03
Rehospitalization 29 22 11 20 40 22 0.79
Severe Outcomes* 21 15 1 2 22 11 <0.01
               

*Severe ouctcomes defined as: death, sepsis, and/or colectomy

Citation: . THERAPY ESCALATION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE FOLLOWING CLOSTRIDIUM DIFFICILE INFECTION IS NOT ASSOCIATED WITH ADVERSE CLINICAL OUTCOMES: AN IBD REMEDY STUDY. Program No. 16. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.

Dana J. Lukin

Assistant Professor
Montefiore Medical Center
Bronx, New York

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16 - Therapy Escalation in Patients With Inflammatory Bowel Disease Following Clostridium difficile Infection Is not Associated With Adverse Clinical Outcomes: An IBD ReMEdY Study



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