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)
Dana Lukin, MD, PhD
Assistant Professor
Montefiore Medical Center
Bronx, New York
Presenting Author(s)
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.
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.
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.