Background Women with inflammatory bowel disease (IBD) with poor IBD-specific reproductive knowle... more Background Women with inflammatory bowel disease (IBD) with poor IBD-specific reproductive knowledge experience more childlessness and fear of IBD medications in pregnancy. The Pregnancy in IBD Decision Aid (PIDA), developed by an international multidisciplinary team, offers personalized online decision support regarding pregnancy in IBD. Aims Assess the impact of PIDA on quality of reproductive decision-making and pregnancy-related knowledge among preconception (PC) and pregnant patients with IBD, and evaluate acceptability to patients and clinicians. Methods PC and pregnant patients with IBD aged 18–45 completed questionnaires pre- and post-PIDA to assess quality of decision-making (Decisional Conflict Scale (DCS); Decision Self-Efficacy Scale (DSES) and IBD-in-pregnancy knowledge (Crohn's and Colitis Pregnancy Knowledge Score (CCPKnow)). Paired t test assessed for differences pre- and post-PIDA. Patients and clinicians completed acceptability surveys. Results DCS and DSES wer...
Poster presentations (4), urgency (3.8), stool consistency (3.7), nocturnal stools (3.5) and weak... more Poster presentations (4), urgency (3.8), stool consistency (3.7), nocturnal stools (3.5) and weakness (3.2). Reassuringly, the same rank-order was noticed for the children younger than 11 years. Grading of the TUMMY-UC items. Conclusions: In this phase 2B study, the exact wording, response options and weighting of the eight TUMMY-UC items were finalised. An obsRO version of the TUMMY-UC has been developed for the younger children. The TUMMY-UC will be now validated and evaluated for cutoff scores in a phase 3 study.
Journal of the Canadian Association of Gastroenterology, 2021
Background Inflammatory bowel disease (IBD) disease activity during pregnancy is related to adver... more 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, gestationa...
Background Patients with inflammatory bowel disease (IBD) may be at increased risk of adverse neo... more Background Patients with inflammatory bowel disease (IBD) may be at increased risk of adverse neonatal outcomes. The aim of this study was to determine pooled incidences and risk factors for these outcomes. Methods Medline, Embase, and Cochrane Library were searched through May 2019 for studies reporting adverse neonatal outcomes in IBD. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated. Results The pooled incidence of preterm birth, low birth weight, congenital anomalies, and infants transferred to the neonatal intensive care unit was 8.6% (95% CI, 7.0%–10.1%), 8.9% (95% CI, 7.3%–10.5%), 2.1% (95% CI, 1.6%–2.6%), and 4.9% (95% CI, 2.9%–6.9), respectively. Compared with healthy controls, patients with IBD were more likely to deliver infants with low birth weight (<2500 grams; OR, 2.78; 95% CI, 1.16–6.66) and infants admitted to the intensive care unit (OR, 3.33; 95% CI, 1.83–6.05). Patients with Crohn’s disease had an increased incidence of congenital anomalie...
Pregnancy and inflammatory bowel disease (IBD) are independent risk factors for venous thromboemb... more Pregnancy and inflammatory bowel disease (IBD) are independent risk factors for venous thromboembolism (VTE). Nevertheless, the optimal VTE prevention strategy for women with IBD in pregnancy and postpartum period has not been established yet. We assessed VTE risks during pregnancy and the postpartum period in women with IBD through systematic review and meta-analysis. Systematic searches were conducted in MEDLINE (Ovid), Embase (Ovid), CENTRAL (Ovid), and Web of Science (Tomson Reuters) from the database inception till May 2017 to identify relevant studies reporting the risk of VTE during pregnancy and/or the postpartum period in women with IBD. Random effect meta-analyses were performed to compare VTE-related outcomes between women with IBD and without IBD. Our protocol was registered: CRD 42017060199 in the PROSPERO International prospective register of systematic reviews. In the analysis of 5 studies reviewed, IBD population (n = 17,636) had a significantly increased risk of VTE during pregnancy (pooled risk ratio (RR) 2.13, 95% confidence interval (CI) 1.66-2.73) and postpartum (RR 2.61, 95% CI 1.84-3.69), comparing to the non-IBD population (n = 11,251,778). According to the location of VTE, the risk of deep vein thrombosis increased significantly by RR of 2.74 (95% CI 1.73-4.36) during pregnancy, whilst risk increase of pulmonary embolism was not statistically significant. In the subgroup analysis, the degree of VTE risk was higher in both periods in the UC group than in the CD group, as compared to that in the non-IBD population (UC group, during pregnancy: RR 2.24, 95% CI 1.6-3.11; postpartum period: RR 2.85, 95% CI 1.79-4.52). Significantly increased risks of VTE during pregnancy were found in the women with IBD, according to the periods and type of IBD, which might support a detailed strategy regarding administration of prophylactic anticoagulants to women with IBD.
This article presents data collected from a cohort of patients with inflammatory bowel disease, w... more This article presents data collected from a cohort of patients with inflammatory bowel disease, who expressed interest in family planning and reproductive health in their clinical context. They were randomized (1:1, text-only vs. multimedia content) to access an online e-health portal containing educational information on the topic. The data collected includes baseline demographics, medication history, reproductive history, as well as standardized, validated questionnaires on knowledge ('CCPKnow'), reproductive concerns, beliefs about medications ('BMQ'), and medication adherence ('MARS-5'). These questionnaires were administered prior to the intervention, immediately after accessing the materials, and a minimum of 6 months later (without re-accessing the online material). Two publications have been generated from analysis and aggregation of the CCPKnow data ("Pregnancy-related Beliefs and Concerns of Inflammatory Bowel Disease Patients are Modified After Accessing e-Health Portal" (Sutton et al., in press), "Innovative Online Educational Portal Improves Disease-Specific Reproductive Knowledge Among Patients With Inflammatory Bowel Disease" (Sutton et al., 2018) however this is an extensive dataset that could be analyzed or combined with others' datasets for further insights.
CD71 + erythroid cells are enriched during pregnancy with immunosuppressive properties. We invest... more CD71 + erythroid cells are enriched during pregnancy with immunosuppressive properties. We investigated the frequency and functionality of CD71 + erythroid cells in peripheral blood, cord blood and placenta of IBD patients vs. healthy controls. We aimed to determine their role in IBD pathogenesis during pregnancy. Peripheral blood was collected at preconception, 1st, 2nd, 3rd trimesters and postpartum. Cord blood and placental tissues were collected at the time of birth. Cells from different specimens were subjected to immune-phenotyping and functional assays. CD71+ erythroid cells were purified for qPCR analysis. Using an allogeneic mouse model of pregnancy, the effects of CD71+ erythroid cells depletion on intestinal homeostasis and dysbiosis was studied. IBD patients had lower CD71+ erythroid cells during pregnancy compared to HCs. Placenta and cord blood CD71+ erythroid cells from IBD patients exhibited impaired functionality and expressed lower inhibitory molecules including VI...
AIM To understand the effects of delivery mode on the immune cells frequency and function in cord... more AIM To understand the effects of delivery mode on the immune cells frequency and function in cord blood and placenta.
Inflammatory bowel disease (IBD) usually affects women during their reproductive years and many c... more Inflammatory bowel disease (IBD) usually affects women during their reproductive years and many concerns arise among these young patients. Pre-pregnancy consultation with a multi-disciplinary team is very important. The team should make patients aware of the critical importance of ensuring that conception occurs during a period of disease remission. Conception during an IBD flare-up results in disease activity or even exacerbates disease in two-thirds of women. Exacerbation of the disease is associated with increased frequency of maternal and fetal complications. Drug therapy constitutes a considerable source of patient anxiety but most drugs used for treating IBD are considered safe. Therefore, continuing pharmacological therapy during pregnancy is necessary to maintain disease control. Optimization of pre-conception nutritional status and smoking cessation are also emphasized. The general guideline for most patients, except for active perianal disease patients, is to aim for vaginal delivery in the absence of obstetric contraindications. Consistent, ongoing follow-up, as detailed in this review, should allay the anxieties and fears surrounding continuing immunosuppressive drugs during pregnancy, allowing each patient to attain the optimal conditions for achieving her goal of holding a healthy baby.
Canadian Journal of Gastroenterology and Hepatology, 2015
BACKGROUND: Although infliximab is an effective therapy for inflammatory bowel disease (IBD), it ... more BACKGROUND: Although infliximab is an effective therapy for inflammatory bowel disease (IBD), it is associated with dermatological events and infusion reactions. It is not known whether a relationship between these adverse events (AEs) and infliximab trough levels (ITLs) exists.OBJECTIVES: To report the prevalence of infliximab-associated AEs in IBD patients receiving stable maintenance infliximab therapy, and to correlate ITLs with dermatological and infusion reactions to infliximab.METHODS: Adult IBD patients receiving stable maintenance infliximab therapy were recruited from the University of Alberta Infusion Clinic (Edmonton, Alberta). ITLs were measured in blood samples collected before infusion, and the patients’ records were reviewed for dermatological and infusion reactions to infliximab.RESULTS: One-quarter (18 of 71 [25.4%]) of patients experienced dermatological or infusion reactions to infliximab: nine (12.7%) dermatological events and nine (12.7%) infusion reactions. Th...
Canadian Journal of Gastroenterology and Hepatology, 2015
BACKGROUND: Adherence to maintenance medication regimens in inflammatory bowel disease patients h... more BACKGROUND: Adherence to maintenance medication regimens in inflammatory bowel disease patients has traditionally been poor. Although infliximab has demonstrated efficacy in inducing and maintaining disease remission, adherence to regularly scheduled infliximab infusions is required to maintain therapeutic trough drug levels and prevent the development of anti-infliximab antibodies.OBJECTIVES: To characterize patient adherence to regularly scheduled induction and maintenance infliximab infusions.METHODS: A retrospective cohort study was conducted evaluating adult outpatients with Crohn disease or ulcerative colitis on an induction or maintenance regimen of regularly scheduled infliximab from 2008 to 2010 at the University of Alberta (Edmonton, Alberta). Nonadherence was defined by a discrepancy of >72 h between the scheduled date of infusion and the actual date of administration. Patients were defined as nonadherent if they received <80% of their infliximab infusions per sched...
Canadian Journal of Gastroenterology and Hepatology, 2015
BACKGROUND: Women with inflammatory bowel disease (IBD) may choose to remain childless due to a l... more BACKGROUND: Women with inflammatory bowel disease (IBD) may choose to remain childless due to a lack of IBD-specific reproductive knowledge.OBJECTIVES: To examine the effects of IBD-specific reproductive knowledge and discussion of family planning with a physician on childlessness among women with IBD.METHODS: Female IBD patients 18 to 45 years of age completed the Crohn’s and Colitis Pregnancy Knowledge questionnaire (CCPKnow), and answered questions regarding reproductive history, plans to have children and discussion of family planning with a physician. CCPKnow scores were grouped according to poor (0 to 7), adequate (8 to 10), good (11 to 13) and very good (14 to 17).RESULTS: Of 434 eligible women, 248 (57.1%) completed the questionnaires. Of these 248 women, 51.6% were childless and, among these, 12.9% were voluntarily childless and 12.1% were trying to become pregnant. Childless women had a lower median CCPKnow score than women with children (6.0 versus 8.0; P=0.001). After ad...
Although biological agents targeting tumor necrosis factor (TNF) alpha are effective in the manag... more Although biological agents targeting tumor necrosis factor (TNF) alpha are effective in the management of Crohn's disease (CD), use of anti-TNF agents is often delayed until after failure of other treatment modalities, resulting in potentially long delays between diagnosis and initiation of infliximab or adalimumab. We aim to determine if early treatment with anti-TNF agents reduces the rate of surgical resection and clinical secondary loss of response in CD patients. A retrospective cohort study was conducted evaluating CD outpatients who were primary responders to anti-TNF therapy, on a maintenance regimen with infliximab or adalimumab from 2003 to 2014. Patients were stratified by time to first dose of anti-TNF therapy; early initiation was defined as starting anti-TNF therapy within 2 years of diagnosis. The primary outcome was occurrence of surgical resection or clinical secondary loss of response requiring dose escalation. Kaplan-Meier analysis was used to assess time to t...
The management of inflammatory bowel disease (IBD) poses a particular challenge during pregnancy ... more The management of inflammatory bowel disease (IBD) poses a particular challenge during pregnancy since the health of both the mother and the fetus must be considered. A systematic literature search identified studies on the management of IBD during pregnancy. The quality of evidence and strength of recommendations were rated using the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Consensus was reached on 29 of the 30 recommendations considered. Preconception counseling and access to specialist care are paramount in optimizing disease management. In general, women on 5-ASA, thiopurine, or anti-TNF monotherapy for maintenance should continue therapy throughout pregnancy. Discontinuation of anti-TNF therapy or switching from combination therapy to monotherapy may be considered in very select low-risk individuals. Women who have a mild-to-moderate disease flare while on optimized 5-ASA or thiopurine should be managed with systemic corticosteroids or...
Background: Infliximab is an effective therapy for inflammatory bowel disease (IBD). However, mor... more Background: Infliximab is an effective therapy for inflammatory bowel disease (IBD). However, more than 50% of patients lose response. Empiric dose intensification is not effective for all patients because not all patients have objective disease activity or subtherapeutic drug level. The aim was to determine how an objective marker of disease activity or therapeutic drug monitoring affects clinical decisions regarding maintenance infliximab therapy in outpatients with IBD. Methods: Consecutive patients with IBD on maintenance infliximab therapy were invited to participate by providing preinfusion stool and blood samples. Fecal calprotectin (FCP) and infliximab trough levels (ITLs) were measured by enzyme linked immunosorbent assay. Three decisions were compared: (1) actual clinical decision, (2) algorithmic FCP or ITL decisions, and (3) expert panel decision based on (a) clinical data, (b) clinical data plus FCP, and (c) clinical data plus FCP plus ITL. In secondary analysis, Receiver-operating curves were used to assess the ability of FCP and ITL in predicting clinical disease activity or remission. Results: A total of 36 sets of blood and stool were available for analysis; median FCP 191.5 mg/g, median ITLs 7.3 mg/mL. The actual clinical decision differed from the hypothetical decision in 47.2% (FCP algorithm); 69.4% (ITL algorithm); 25.0% (expert panel clinical decision); 44.4% (expert panel clinical plus FCP); 58.3% (expert panel clinical plus FCP plus ITL) cases. FCP predicted clinical relapse (area under the curve [AUC] ¼ 0.417; 95% confidence interval [CI], 0.197-0.641) and subtherapeutic ITL (AUC ¼ 0.774; 95% CI, 0.536-1.000). ITL predicted clinical remission (AUC ¼ 0.498; 95% CI, 0.254-0.742) and objective remission (AUC ¼ 0.773; 95% CI, 0.622-0.924). Conclusions: Using FCP and ITLs in addition to clinical data results in an increased number of decisions to optimize management in outpatients with IBD on stable maintenance infliximab therapy.
Author contributions: Huang VW designed the study and wrote the manuscript; Huang VW and Reich KM... more Author contributions: Huang VW designed the study and wrote the manuscript; Huang VW and Reich KM performed the systematic review and meta-analysis; Fedorak RN contributed to the systematic review and meta-analysis, and reviewed the manuscript.
Background Women with inflammatory bowel disease (IBD) with poor IBD-specific reproductive knowle... more Background Women with inflammatory bowel disease (IBD) with poor IBD-specific reproductive knowledge experience more childlessness and fear of IBD medications in pregnancy. The Pregnancy in IBD Decision Aid (PIDA), developed by an international multidisciplinary team, offers personalized online decision support regarding pregnancy in IBD. Aims Assess the impact of PIDA on quality of reproductive decision-making and pregnancy-related knowledge among preconception (PC) and pregnant patients with IBD, and evaluate acceptability to patients and clinicians. Methods PC and pregnant patients with IBD aged 18–45 completed questionnaires pre- and post-PIDA to assess quality of decision-making (Decisional Conflict Scale (DCS); Decision Self-Efficacy Scale (DSES) and IBD-in-pregnancy knowledge (Crohn's and Colitis Pregnancy Knowledge Score (CCPKnow)). Paired t test assessed for differences pre- and post-PIDA. Patients and clinicians completed acceptability surveys. Results DCS and DSES wer...
Poster presentations (4), urgency (3.8), stool consistency (3.7), nocturnal stools (3.5) and weak... more Poster presentations (4), urgency (3.8), stool consistency (3.7), nocturnal stools (3.5) and weakness (3.2). Reassuringly, the same rank-order was noticed for the children younger than 11 years. Grading of the TUMMY-UC items. Conclusions: In this phase 2B study, the exact wording, response options and weighting of the eight TUMMY-UC items were finalised. An obsRO version of the TUMMY-UC has been developed for the younger children. The TUMMY-UC will be now validated and evaluated for cutoff scores in a phase 3 study.
Journal of the Canadian Association of Gastroenterology, 2021
Background Inflammatory bowel disease (IBD) disease activity during pregnancy is related to adver... more 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, gestationa...
Background Patients with inflammatory bowel disease (IBD) may be at increased risk of adverse neo... more Background Patients with inflammatory bowel disease (IBD) may be at increased risk of adverse neonatal outcomes. The aim of this study was to determine pooled incidences and risk factors for these outcomes. Methods Medline, Embase, and Cochrane Library were searched through May 2019 for studies reporting adverse neonatal outcomes in IBD. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated. Results The pooled incidence of preterm birth, low birth weight, congenital anomalies, and infants transferred to the neonatal intensive care unit was 8.6% (95% CI, 7.0%–10.1%), 8.9% (95% CI, 7.3%–10.5%), 2.1% (95% CI, 1.6%–2.6%), and 4.9% (95% CI, 2.9%–6.9), respectively. Compared with healthy controls, patients with IBD were more likely to deliver infants with low birth weight (<2500 grams; OR, 2.78; 95% CI, 1.16–6.66) and infants admitted to the intensive care unit (OR, 3.33; 95% CI, 1.83–6.05). Patients with Crohn’s disease had an increased incidence of congenital anomalie...
Pregnancy and inflammatory bowel disease (IBD) are independent risk factors for venous thromboemb... more Pregnancy and inflammatory bowel disease (IBD) are independent risk factors for venous thromboembolism (VTE). Nevertheless, the optimal VTE prevention strategy for women with IBD in pregnancy and postpartum period has not been established yet. We assessed VTE risks during pregnancy and the postpartum period in women with IBD through systematic review and meta-analysis. Systematic searches were conducted in MEDLINE (Ovid), Embase (Ovid), CENTRAL (Ovid), and Web of Science (Tomson Reuters) from the database inception till May 2017 to identify relevant studies reporting the risk of VTE during pregnancy and/or the postpartum period in women with IBD. Random effect meta-analyses were performed to compare VTE-related outcomes between women with IBD and without IBD. Our protocol was registered: CRD 42017060199 in the PROSPERO International prospective register of systematic reviews. In the analysis of 5 studies reviewed, IBD population (n = 17,636) had a significantly increased risk of VTE during pregnancy (pooled risk ratio (RR) 2.13, 95% confidence interval (CI) 1.66-2.73) and postpartum (RR 2.61, 95% CI 1.84-3.69), comparing to the non-IBD population (n = 11,251,778). According to the location of VTE, the risk of deep vein thrombosis increased significantly by RR of 2.74 (95% CI 1.73-4.36) during pregnancy, whilst risk increase of pulmonary embolism was not statistically significant. In the subgroup analysis, the degree of VTE risk was higher in both periods in the UC group than in the CD group, as compared to that in the non-IBD population (UC group, during pregnancy: RR 2.24, 95% CI 1.6-3.11; postpartum period: RR 2.85, 95% CI 1.79-4.52). Significantly increased risks of VTE during pregnancy were found in the women with IBD, according to the periods and type of IBD, which might support a detailed strategy regarding administration of prophylactic anticoagulants to women with IBD.
This article presents data collected from a cohort of patients with inflammatory bowel disease, w... more This article presents data collected from a cohort of patients with inflammatory bowel disease, who expressed interest in family planning and reproductive health in their clinical context. They were randomized (1:1, text-only vs. multimedia content) to access an online e-health portal containing educational information on the topic. The data collected includes baseline demographics, medication history, reproductive history, as well as standardized, validated questionnaires on knowledge ('CCPKnow'), reproductive concerns, beliefs about medications ('BMQ'), and medication adherence ('MARS-5'). These questionnaires were administered prior to the intervention, immediately after accessing the materials, and a minimum of 6 months later (without re-accessing the online material). Two publications have been generated from analysis and aggregation of the CCPKnow data ("Pregnancy-related Beliefs and Concerns of Inflammatory Bowel Disease Patients are Modified After Accessing e-Health Portal" (Sutton et al., in press), "Innovative Online Educational Portal Improves Disease-Specific Reproductive Knowledge Among Patients With Inflammatory Bowel Disease" (Sutton et al., 2018) however this is an extensive dataset that could be analyzed or combined with others' datasets for further insights.
CD71 + erythroid cells are enriched during pregnancy with immunosuppressive properties. We invest... more CD71 + erythroid cells are enriched during pregnancy with immunosuppressive properties. We investigated the frequency and functionality of CD71 + erythroid cells in peripheral blood, cord blood and placenta of IBD patients vs. healthy controls. We aimed to determine their role in IBD pathogenesis during pregnancy. Peripheral blood was collected at preconception, 1st, 2nd, 3rd trimesters and postpartum. Cord blood and placental tissues were collected at the time of birth. Cells from different specimens were subjected to immune-phenotyping and functional assays. CD71+ erythroid cells were purified for qPCR analysis. Using an allogeneic mouse model of pregnancy, the effects of CD71+ erythroid cells depletion on intestinal homeostasis and dysbiosis was studied. IBD patients had lower CD71+ erythroid cells during pregnancy compared to HCs. Placenta and cord blood CD71+ erythroid cells from IBD patients exhibited impaired functionality and expressed lower inhibitory molecules including VI...
AIM To understand the effects of delivery mode on the immune cells frequency and function in cord... more AIM To understand the effects of delivery mode on the immune cells frequency and function in cord blood and placenta.
Inflammatory bowel disease (IBD) usually affects women during their reproductive years and many c... more Inflammatory bowel disease (IBD) usually affects women during their reproductive years and many concerns arise among these young patients. Pre-pregnancy consultation with a multi-disciplinary team is very important. The team should make patients aware of the critical importance of ensuring that conception occurs during a period of disease remission. Conception during an IBD flare-up results in disease activity or even exacerbates disease in two-thirds of women. Exacerbation of the disease is associated with increased frequency of maternal and fetal complications. Drug therapy constitutes a considerable source of patient anxiety but most drugs used for treating IBD are considered safe. Therefore, continuing pharmacological therapy during pregnancy is necessary to maintain disease control. Optimization of pre-conception nutritional status and smoking cessation are also emphasized. The general guideline for most patients, except for active perianal disease patients, is to aim for vaginal delivery in the absence of obstetric contraindications. Consistent, ongoing follow-up, as detailed in this review, should allay the anxieties and fears surrounding continuing immunosuppressive drugs during pregnancy, allowing each patient to attain the optimal conditions for achieving her goal of holding a healthy baby.
Canadian Journal of Gastroenterology and Hepatology, 2015
BACKGROUND: Although infliximab is an effective therapy for inflammatory bowel disease (IBD), it ... more BACKGROUND: Although infliximab is an effective therapy for inflammatory bowel disease (IBD), it is associated with dermatological events and infusion reactions. It is not known whether a relationship between these adverse events (AEs) and infliximab trough levels (ITLs) exists.OBJECTIVES: To report the prevalence of infliximab-associated AEs in IBD patients receiving stable maintenance infliximab therapy, and to correlate ITLs with dermatological and infusion reactions to infliximab.METHODS: Adult IBD patients receiving stable maintenance infliximab therapy were recruited from the University of Alberta Infusion Clinic (Edmonton, Alberta). ITLs were measured in blood samples collected before infusion, and the patients’ records were reviewed for dermatological and infusion reactions to infliximab.RESULTS: One-quarter (18 of 71 [25.4%]) of patients experienced dermatological or infusion reactions to infliximab: nine (12.7%) dermatological events and nine (12.7%) infusion reactions. Th...
Canadian Journal of Gastroenterology and Hepatology, 2015
BACKGROUND: Adherence to maintenance medication regimens in inflammatory bowel disease patients h... more BACKGROUND: Adherence to maintenance medication regimens in inflammatory bowel disease patients has traditionally been poor. Although infliximab has demonstrated efficacy in inducing and maintaining disease remission, adherence to regularly scheduled infliximab infusions is required to maintain therapeutic trough drug levels and prevent the development of anti-infliximab antibodies.OBJECTIVES: To characterize patient adherence to regularly scheduled induction and maintenance infliximab infusions.METHODS: A retrospective cohort study was conducted evaluating adult outpatients with Crohn disease or ulcerative colitis on an induction or maintenance regimen of regularly scheduled infliximab from 2008 to 2010 at the University of Alberta (Edmonton, Alberta). Nonadherence was defined by a discrepancy of >72 h between the scheduled date of infusion and the actual date of administration. Patients were defined as nonadherent if they received <80% of their infliximab infusions per sched...
Canadian Journal of Gastroenterology and Hepatology, 2015
BACKGROUND: Women with inflammatory bowel disease (IBD) may choose to remain childless due to a l... more BACKGROUND: Women with inflammatory bowel disease (IBD) may choose to remain childless due to a lack of IBD-specific reproductive knowledge.OBJECTIVES: To examine the effects of IBD-specific reproductive knowledge and discussion of family planning with a physician on childlessness among women with IBD.METHODS: Female IBD patients 18 to 45 years of age completed the Crohn’s and Colitis Pregnancy Knowledge questionnaire (CCPKnow), and answered questions regarding reproductive history, plans to have children and discussion of family planning with a physician. CCPKnow scores were grouped according to poor (0 to 7), adequate (8 to 10), good (11 to 13) and very good (14 to 17).RESULTS: Of 434 eligible women, 248 (57.1%) completed the questionnaires. Of these 248 women, 51.6% were childless and, among these, 12.9% were voluntarily childless and 12.1% were trying to become pregnant. Childless women had a lower median CCPKnow score than women with children (6.0 versus 8.0; P=0.001). After ad...
Although biological agents targeting tumor necrosis factor (TNF) alpha are effective in the manag... more Although biological agents targeting tumor necrosis factor (TNF) alpha are effective in the management of Crohn's disease (CD), use of anti-TNF agents is often delayed until after failure of other treatment modalities, resulting in potentially long delays between diagnosis and initiation of infliximab or adalimumab. We aim to determine if early treatment with anti-TNF agents reduces the rate of surgical resection and clinical secondary loss of response in CD patients. A retrospective cohort study was conducted evaluating CD outpatients who were primary responders to anti-TNF therapy, on a maintenance regimen with infliximab or adalimumab from 2003 to 2014. Patients were stratified by time to first dose of anti-TNF therapy; early initiation was defined as starting anti-TNF therapy within 2 years of diagnosis. The primary outcome was occurrence of surgical resection or clinical secondary loss of response requiring dose escalation. Kaplan-Meier analysis was used to assess time to t...
The management of inflammatory bowel disease (IBD) poses a particular challenge during pregnancy ... more The management of inflammatory bowel disease (IBD) poses a particular challenge during pregnancy since the health of both the mother and the fetus must be considered. A systematic literature search identified studies on the management of IBD during pregnancy. The quality of evidence and strength of recommendations were rated using the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Consensus was reached on 29 of the 30 recommendations considered. Preconception counseling and access to specialist care are paramount in optimizing disease management. In general, women on 5-ASA, thiopurine, or anti-TNF monotherapy for maintenance should continue therapy throughout pregnancy. Discontinuation of anti-TNF therapy or switching from combination therapy to monotherapy may be considered in very select low-risk individuals. Women who have a mild-to-moderate disease flare while on optimized 5-ASA or thiopurine should be managed with systemic corticosteroids or...
Background: Infliximab is an effective therapy for inflammatory bowel disease (IBD). However, mor... more Background: Infliximab is an effective therapy for inflammatory bowel disease (IBD). However, more than 50% of patients lose response. Empiric dose intensification is not effective for all patients because not all patients have objective disease activity or subtherapeutic drug level. The aim was to determine how an objective marker of disease activity or therapeutic drug monitoring affects clinical decisions regarding maintenance infliximab therapy in outpatients with IBD. Methods: Consecutive patients with IBD on maintenance infliximab therapy were invited to participate by providing preinfusion stool and blood samples. Fecal calprotectin (FCP) and infliximab trough levels (ITLs) were measured by enzyme linked immunosorbent assay. Three decisions were compared: (1) actual clinical decision, (2) algorithmic FCP or ITL decisions, and (3) expert panel decision based on (a) clinical data, (b) clinical data plus FCP, and (c) clinical data plus FCP plus ITL. In secondary analysis, Receiver-operating curves were used to assess the ability of FCP and ITL in predicting clinical disease activity or remission. Results: A total of 36 sets of blood and stool were available for analysis; median FCP 191.5 mg/g, median ITLs 7.3 mg/mL. The actual clinical decision differed from the hypothetical decision in 47.2% (FCP algorithm); 69.4% (ITL algorithm); 25.0% (expert panel clinical decision); 44.4% (expert panel clinical plus FCP); 58.3% (expert panel clinical plus FCP plus ITL) cases. FCP predicted clinical relapse (area under the curve [AUC] ¼ 0.417; 95% confidence interval [CI], 0.197-0.641) and subtherapeutic ITL (AUC ¼ 0.774; 95% CI, 0.536-1.000). ITL predicted clinical remission (AUC ¼ 0.498; 95% CI, 0.254-0.742) and objective remission (AUC ¼ 0.773; 95% CI, 0.622-0.924). Conclusions: Using FCP and ITLs in addition to clinical data results in an increased number of decisions to optimize management in outpatients with IBD on stable maintenance infliximab therapy.
Author contributions: Huang VW designed the study and wrote the manuscript; Huang VW and Reich KM... more Author contributions: Huang VW designed the study and wrote the manuscript; Huang VW and Reich KM performed the systematic review and meta-analysis; Fedorak RN contributed to the systematic review and meta-analysis, and reviewed the manuscript.
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Papers by Vivian Huang