scholarly journals A151 COMPARABLE NEONATAL AND PREGNANCY-RELATED OUTCOMES BETWEEN EARLY AND LATE DISCONTINUATION OF BIOLOGICS IN PREGNANT WOMEN WITH INFLAMMATORY BOWEL DISEASE

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 154-155
Author(s):  
J J Tao ◽  
P Tandon ◽  
V W Huang

Abstract Background Inflammatory bowel disease (IBD) disease activity during pregnancy is related to adverse neonatal and pregnancy-related outcomes. Biologics are used to suppress disease activity, however, since there is known transplacental passage, the American Gastroenterology Association (AGA) recommends timing the final dose with drug-specific half-lives although there is little evidence demonstrating adverse outcomes. Aims We aim to assess the safety of early versus late discontinuation of biologics according to drug-specific half-lives by comparing various neonatal and pregnancy-related outcomes. Methods This is a REB approved single-center retrospective cohort study on all patients with IBD ≥18 years of age on a biologic agent prior to conception, have a documented final dose during pregnancy, and were seen at Mount Sinai Hospital from 2016–2019. Neonate and pregnancy-related outcomes were compared amongst the two groups (Table 1) using the student’s t-test (birthweight, gestational age, Apgar scores) and Fischer’s exact test (NICU admission, congenital anomalies, GBS, chorioamnionitis) analyzed in SPSS Version 27. The level of significance was set at p<0.05. Results We identified 53 patients on biologics pre-conception. 26 patients had a documented final dose (19 early cohort, 7 late cohort) and were included in the analysis. Aside from mean birthweight (3014 vs 3561 g, p=0.036), there were no statistically significant differences between the early and late cohorts for gestational age (37.4 vs 39.0 weeks, p=0.20), 1- and 5-min Apgar scores (7.8 vs 8.8, p=0.37 and 8.5 vs 9.0, p=0.49), NICU admissions (p=0.54), congenital anomalies (p=1.00), GBS (p=0.55), and chorioamnionitis (p=1.00). Conclusions Overall, our study suggests that early and late discontinuation of biologics have comparable safety profiles based on various neonatal and pregnancy-related outcomes. In fact, we see significantly higher birthweights in the late cohort along with a consistent (non-statistically significant) trend of later gestational ages, and higher Apgar scores. Further, no cases involving NICU admissions, congenital abnormalities, GBS, or chorioamnionitis were seen in the late cohort. Next, we hope to verify our findings by conducting a prospective cohort study with a larger study population and more comprehensive data collection. This will provide higher statistical power and allow for additional subgroup analyses based on objective disease activity (FCP levels) and therapeutic drug monitoring (serum drug levels). Funding Agencies None

2020 ◽  
pp. 1-10
Author(s):  
Ilana Reinhold ◽  
Sena Blümel ◽  
Jens Schreiner ◽  
Onur Boyman ◽  
Jan Bögeholz ◽  
...  

<b><i>Background and Aims:</i></b> The majority of patients treated with anti-tumor necrosis factor (TNF) therapy develop anti-drug antibodies (ADAs), which might result in loss of treatment efficacy. Strict guidelines on measuring trough levels (TLs) and ADA in clinical routine do not exist. To provide real-world data, we took advantage of our tertiary inflammatory bowel disease (IBD) center patient cohort and determined indicators for therapeutic drug monitoring (TDM) and actual consequences in patient care. <b><i>Methods:</i></b> We retrospectively collected clinical data of 104 IBD patients treated with infliximab or adalimumab in our IBD clinic. Patients with TL and ADA measurements between June 2015 and February 2018 were included. <b><i>Results:</i></b> The main reason for determining TL was increased clinical disease. Subtherapeutic TLs were found in 33 patients, therapeutic TLs in 33 patients, and supratherapeutic TLs in 38 patients. Adjustments in anti-TNF therapy occurred more frequently (<i>p</i> = 0.01) in patients with subtherapeutic TL (24 of 33 patients; 73%) as compared to patients with therapeutic and supratherapeutic TLs (26 of 71 patients; 37%). No correlation could be found between TL and disease activity (<i>p</i> = 0.16). Presence of ADA was found in 16 patients, correlated with the development of infusion reactions (OR: 10.6, RR: 5.4, CI: 2.9–38.6), and was associated with subtherapeutic TL in 15 patients (93.8%). Treatment adaptations were based on TL and/or ADA presence in 36 of 63 patients. <b><i>Conclusions:</i></b> TDM showed significant treatment adaptations in patients with subtherapeutic TL. Conversely, in patients with therapeutic and supratherapeutic TLs, reasons for adaptations were based on considerations other than TL, such as clinical disease activity. Further studies should focus on decision-making in patients presenting with supratherapeutic TL in remission.


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