UEG Journal Abstracts 2022 - 683
Aims & Methods: This study aimed to elucidate the role of toxin gene PCR
assay for C.difficile in predicting the course of inflammatory bowel disease
(IBD). This study also investigate the potential factors associated with the
PCR positivity in patients with IBD.
This is a retrospective single-center cohort study at Seoul national university
hospital from 2020 to 2021. Patients with IBD who underwent stool
analysis with Toxin gene PCR of C.difficile were retrospectively enrolled.
Medical records were reviewed and data including IBD subtype, extent,
severity and medications were collected. Patients were followed for 180
days after the date of PCR test to assess the clinical course of IBD.
Results: A total of 156 patients with IBD who underwent a C.difficile toxin
PCR test were enrolled in this study, including 123 with ulcerative colitis
(UC) and 33 with Crohn's disease (CD). Among them, the PCR-positive rate
was 16.03%.
Further analyzing the PCR-positive patients, 76% of patients were treated
for CDI and 24% of those did not receive treatment. 89% of the treated
patients received oral vancomycin, and 11% of patients received metronidazole.
Although
there was no significant difference in baseline IBD severity between
the PCR positive group and the PCR negative group, the patients
with PCR positivity had a statistically significant increase in drug escalation
for IBD treatment within 180 days after PCR test (48% in PCR positive
group vs 4.58% in PCR negative; P= 0.006).
This result was maintained even after adjusting through inverse probability
of treatment weighting (IPTW) based on the propensity score. In
the multivariable analysis, treatment with azathioprine was the only risk
factor associated with PCR positivity in patients with IBD (OR 5.19, CI 1.3223.3,
P= 0.023).
Conclusion: C.difficile toxin PCR positive IBD patients showed a significantly
higher rate of treatment escalation, regardless of IBD severity.
Therefore, it is important to carefully monitor PCR-positive IBD patients
and to intervene in treatment quickly without delay, keeping in mind that
PCR-positive IBD patients are more likely to worsen symptoms. Further
research is needed on the underlying mechanism between PCR positivity
and the course of IBD.
Disclosure: Nothing to disclose.
P0344
HIGHER ADALIMUMAB TROUGH LEVELS ARE ASSOCIATED WITH
HISTOLOGIC REMISSION AND MUCOSAL HEALING
R. Wong1, L. Qin2, Y. Pan1, P. Mahtani1
E. Scherl1
, R. Battat1
1Weill Cornell Medicine, Dept of Medicine, Division of
Gastroenterology and Hepatology, New York, United States,
2
Weill Cornell Medicine, Dept of Pathology, New York, United
States
Contact E-Mail Address: rew9046@nyp.org
Introduction: Therapeutic drug monitoring is a mainstay in Crohn's disease
(CD) and ulcerative colitis (UC). Data demonstrate that elimination of
histologic inflammation is associated with improved outcomes.1,2
Recent
data found reduced efficacy of adalimumab (ADA) to achieve histologic remission
defined using the Robarts Histopathologic Index (RHI).3
A plausible explanation for suboptimal histologic outcomes may be inadequate
drug exposure. However, data on the relationship between serum
adalimumab concentrations and histologic outcomes with validated indices
are lacking.
Aims & Methods: Aim: To perform the first real-world study assessing the
relationship between adalimumab concentrations and a validated histologic
disease activity index.
Vol. 10 | October 2022
, R. Longman1, D. Lukin1
,
Patients from a tertiary IBD center with adalimumab (ADA) trough drug
concentrations measured during maintenance therapy (≥14 weeks), and
colonoscopy with biopsy performed within 90 days from 2013-2020 were
included. Chart review was performed for demographic data and disease
characteristics. RHI scores were assigned to biopsies by a blinded pathologist.
Rates of endoscopic (CD: absence of ulcers, UC: Mayo endoscopic score
<2) and histologic (RHI = 0) remission were assessed. Mucosal healing (MH)
was defined as achieving both endoscopic and histologic remission.
The primary analysis evaluated the relationship between drug concentration
and histologic remission using receiver operating characteristic curve
analysis. Outcome proportions were compared above and below identified
optimal (youden) thresholds using Fisher's exact test. Serum ADA
concentrations were measured using homogeneous mobility shift assay
(Prometheus Laboratories, San Diego).
Results: Thirty-six patients were included (26 CD, 9 UC, Table 1). Median
cohort age was 34 years old, and 56% were female. The median ADA drug
concentration was 11.1ug/mL (IQR: 7.0-15.5ug/mL). Median time from
treatment initiation to drug concentration measurement was 103 weeks
(Table 1).
The area under the curve for ADA concentrations to identify histologic remission
was 0.80 (95% CI 0.61-0.99). The optimal ADA concentration was
≥16.3ug/mL (sensitivity 70%, specificity 90%). Patients with ADA ≥16.3ug/
mL had higher histologic remission rates (78%) compared to lower ADA
concentrations (14%, p= 0.002). ADA ≥16.3ug/mL had higher endoscopic
remission (100%) compared to lower ADA levels (57%, p=0.04). ADA
≥16.3ug/mL also had higher MH rates (86%) compared to lower levels
(12%, p=0.001).
Median Age at Drug Level (years)
Gender (female)
Type of IBD
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Adalimumab
Median Drug Level Concentration (ug/mL) [IQR 25-75]
Median Dose (mg)
Median Frequency (every X weeks)
Median Weeks of Therapy (wk)
Endoscopy
CD: Presence of ulcers (lack of remission)
UC: Mayo Score <2 (presence of remission)
Histology
RHI score = 0 (histologic remission)
Median RHI Score
Mucosal Healing
Endohistologic Remission
Table 1. Cohort Demographics (n=36)
Conclusion: These first real-world data on the relationship between
adalimumab concentrations and RHI demonstrate higher adalimumab
drug concentrations are strongly associated with histologic remission
and MH. A serum ADA concentration that is higher than traditional targets
(≥16.3ug/mL) is needed for histologic remission.
References:
1. Baars JE, Nuij VJ, Oldenburg B, Kuipers EJ, van der Woude CJ. Majority
of patients with inflammatory bowel disease in clinical remission have
mucosal inflammation. Inflamm Bowel Dis. 2012 Sep;18(9):1634-40. doi:
10.1002/ibd.21925. Epub 2011 Nov 8. PMID: 22069022.
2. Lichtenstein GR, Rutgeerts P. Importance of mucosal healing in ulcerative
colitis. Inflamm Bowel Dis. 2010 Feb;16(2):338-46. doi: 10.1002/
ibd.20997. PMID: 19637362.
683
8/24 (0.33)
10/30 (0.33)
8.5
7/24 (0.29)
1/4 (0.25)
11.1 [7.0-15.5]
40
2
103
N (%)
34
20 (0.56)
26 (0.72)
9 (0.25)
1 (0.02)
IBD
UEG Journal Abstracts 2022
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