scholarly journals Management of the Pregnant Inflammatory Bowel Disease Patient on Antitumour Necrosis Factor Therapy: State of the Art and Future Directions

2014 ◽  
Vol 28 (9) ◽  
pp. 505-509 ◽  
Author(s):  
Yvette PY Leung ◽  
Remo Panaccione ◽  
Subrata Ghosh ◽  
Cynthia H Seow
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Disease Patient ◽  
Mucosal Healing ◽  
Infectious Complications ◽  
Major Advance ◽  
Third Trimester ◽  
The Third ◽  
Inflammatory Bowel ◽  
Necrosis Factor

Antitumour necrosis factor (anti-TNF) therapy has been a major advance in the treatment of inflammatory bowel disease (IBD) by improving rates of mucosal healing, steroid-free remission, and decreasing rates of hospitalization and surgery. Because IBD affects women in their reproductive years, clinicians have and will continue to be asked in the future about the safety profile of these agents and their potential impact on pregnancy, the developing fetus and newborn. Immunoglobulin G transfer from the mother to fetus begins in the second trimester, with an elevation starting at 22 weeks of gestation and the largest amount transferred in the third trimester. Although research investigating the long-term outcomes of children exposed to anti-TNF therapy in utero is limited, there is no known adverse effect on either pregnancy or newborn outcomes including infectious complications with this class of drugs. The World Congress of Gastroenterology consensus statement on biological therapy for IBD considered infliximab and adalimumab to be low risk and compatible with use during conception and during pregnancy in at least the first two trimesters. Based on a clinical algorithm used at the University of Calgary Pregnancy and IBD clinic (Calgary, Alberta), recommendations have been provided on the management of pregnant patients on anti-TNF therapy, particularly with regard to third-trimester dosing, taking into account disease characteristics of individual patients. When educated about the safety of anti-TNF therapy during pregnancy, patients often choose to continue on therapy during the third trimester.

scholarly journals Infliximab clearance decreases in the second and third trimesters of pregnancy in inflammatory bowel disease

2020 ◽  
pp. 205064062096461
Author(s):  
Ana-Marija Grišić ◽  
Maria Dorn-Rasmussen ◽  
Bella Ungar ◽  
Jørn Brynskov ◽  
Johan F K F Ilvemark ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
First Trimester ◽  
Interquartile Range ◽  
Therapeutic Drug ◽  
Population Pharmacokinetic ◽  
Second Trimester ◽  
Third Trimester ◽  
The Third ◽  
Inflammatory Bowel

Background Infliximab therapy during pregnancy in inflammatory bowel disease is challenged by a dilemma between maintaining adequate maternal disease control while minimizing fetal infliximab exposure. We investigated the effects of pregnancy on infliximab pharmacokinetics. Methods The study population comprised 23 retrospectively identified pregnancies. Patients with inflammatory bowel disease were generally in clinical remission at pregnancy conception (74%) and received steady infliximab maintenance therapy (5 mg/kg q8w n = 17; q6w n = 4; q10w n = 1; 10 mg/kg q8w n = 1). Trough blood samples had been obtained in the same patients prior to pregnancy ( n = 119), the first trimester ( n = 16), second trimester ( n = 18), third trimester ( n = 7), and post-pregnancy ( n = 12). Data were analyzed using nonlinear mixed-effects population pharmacokinetic modelling. Results Dose-normalized infliximab concentrations were significantly higher during the second trimester (median 15 µg/mL/kg, interquartile range 10–21) compared to pre-pregnancy (7, 2–12; p = 0.003), the first trimester (9, 1–12; p = 0.04), or post-pregnancy (6, interquartile range 3–11; p > 0.05) in patients with inflammatory bowel disease. Similar trends were observed in the third trimester (13, 7–36; p > 0.05). A one-compartment model with linear elimination described the pharmacokinetics of infliximab (volume of distribution = 18.2 L; clearance 0.61 L/day). Maternal infliximab exposure was influenced by the second and third trimester of pregnancy and anti-infliximab antibodies, and not by pregnancy-imposed physiological changes in, for example, body weight or albumin. Infliximab clearance decreased significantly during the second and third trimesters by up to 15% as compared to pre- and post-pregnancy and the first trimester. The increased maternal infliximab exposure was weakly associated with lowered clinical disease activity. Pharmacokinetic model simulations of virtual patients indicated the increased maternal infliximab trough concentrations imposed by pregnancy will not completely counteract the decrease in infliximab concentration if therapy is paused in the third trimester. Conclusion Infliximab clearance decreases significantly in the second and third trimesters, leading to increasing maternal infliximab concentrations in any given regimen. Maternal infliximab levels may thus be maintained as constant in a de-intensified regimen by therapeutic drug monitoring guidance in inflammatory bowel disease.

Safety and Optimal Timing of BCG Vaccination in Infants Born to Mothers Receiving Anti-TNF Therapy for Inflammatory Bowel Disease

2020 ◽  
Vol 14 (12) ◽  
pp. 1780-1784 ◽  
Author(s):  
Sang Hyoung Park ◽  
Hyo Jong Kim ◽  
Chang Kyun Lee ◽  
Eun Mi Song ◽  
Sang-Bum Kang ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Optimal Timing ◽  
Third Trimester ◽  
Serious Adverse Events ◽  
Bcg Vaccination ◽  
The Third ◽  
Gestational Week ◽  
Inflammatory Bowel

Abstract Backgrounds and Aims We aimed to evaluate the safety of Bacille Calmette–Guérin [BCG] vaccination in infants born to mothers receiving anti-tumour necrosis factor [anti-TNF] therapy for inflammatory bowel disease. Methods Adverse events of BCG vaccination were evaluated in 90 infants who were last exposed to anti-TNF agents at a median of gestational week 30. Results After receiving BCG vaccination at a median age of 6 months [range, 0.25–11 months], three infants [3.3%] showed injection site swelling, two of whom also showed axillar lymphadenopathy. The rates of adverse events were similar between infants who were last exposed to anti-TNF agents before the third trimester [n = 35] and those who were last exposed in the third trimester [n = 55] [2.9% vs 3.6%; p = 1.00]. All adverse events were spontaneously resolved and there were no serious adverse events such as active tuberculosis infection or death. Conclusions BCG vaccination after 6 months of age is of low risk in infants exposed to anti-TNF agents in utero.

scholarly journals TNF Blocking Therapies and Immunomonitoring in Patients with Inflammatory Bowel Disease

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Romain Altwegg ◽  
Thierry Vincent
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Mucosal Healing ◽  
Primary Resistance ◽  
Current State ◽  
Serum Trough ◽  
Inflammatory Bowel ◽  
Trough Levels ◽  
Necrosis Factor

Since their appearance in the armamentarium for inflammatory bowel disease (IBD) more than a decade ago, antitumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in induction and maintenance of clinical remission, mucosal healing, improvement in quality of life, and reduction in surgeries and hospitalizations. However, more than one-third of patients present primary resistance, and another one-third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antidrug antibodies (ADAbs) accelerating their clearance. In this review we present the current state of the literature on the place of TNF and its blockage in the treatment of patients with IBD and discuss the usefulness of serum trough levels and ADAb monitoring in the optimization of anti-TNF therapies.

scholarly journals P246 Development of a new Inflammatory Bowel Disease Patient Identifier shortens time to clinic review and initiation of treatment

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S288-S289
Author(s):  
D Chee ◽  
B Hamilton ◽  
V Cairnes ◽  
S Lin ◽  
N Chanchlani ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Disease Patient ◽  
Mucosal Healing ◽  
Outcome Data ◽  
Endoscopic Diagnosis ◽  
Continuous Variables ◽  
Electronic Screening ◽  
Before And After ◽  
Inflammatory Bowel

Abstract Background Timely diagnosis of inflammatory bowel disease (IBD) is important because earlier use of biologic therapies leads to mucosal healing, a reduction in hospitalisations and surgeries and improvements in quality of life. In the United Kingdom, general practitioners refer patients with symptoms suggestive of IBD to colorectal surgeons, emergency department physicians, gastroenterologists or directly for a lower gastrointestinal endoscopy. Consequently, there is variation in the time from endoscopic diagnosis of IBD to specialist review. We created an electronic tool that screens all endoscopy reports for a new diagnosis of IBD. These cases are then reviewed in our weekly complex multidisciplinary team (MDT) meeting and new patients are allocated an IBD specialist. We sought to determine whether our new patient identifier reduced the time to clinical review by an IBD specialist and initiation of IBD treatment. Methods We designed a retrospective observational cohort study comparing time from endoscopic diagnosis of IBD to initiation of treatment and IBD specialist review. Outcomes were compared in the 18 months before and after the introduction, in January 2018, of our new IBD patient identifier. Demographic, endoscopic and treatment outcome data were recorded from our electronic patient record. Categorical and continuous variables were summarised as frequencies (%) and median [IQR] and compared with Fisher’s exact and Mann Whitney U tests respectively. Results Between the 1st January 2018 and 30th June 2019, 116 new patients diagnosed with IBD were identified and reviewed in our MDT meeting. In the preceding 18 months, 111 patients were diagnosed with IBD. There were no significant differences between groups according to sex, age, age at diagnosis, disease type, or phenotype according to the Montreal classification (Table 1). Both the median time from endoscopic diagnosis to treatment initiation (0 days [IQR 0 – 14.2] vs 14 days [IQR 0 – 31.6], p=0.007) and specialist clinic review (21 days [IQR 7 - 25] vs 48 days [IQR 34 – 63], p<0.0001) were shorter following the introduction of the new IBD patient identifier screening tool (Figure 1). Conclusion Systematic electronic screening of endoscopic reports linked to MDT review reduces the time to first treatment and specialist review in newly diagnosed patients with IBD.

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