Biologics In Inflammatory Bowel Disease Research Articles

P467 Therapeutic drug monitoring of biologics in Inflammatory Bowel Disease: Nordic survey on implementation and barriers in clinical practice

Abstract Background Therapeutic drug monitoring (TDM) is a useful tool to optimise biologic treatments of patients with inflammatory bowel disease (IBD). Albeit broadly recommended by gastrointestinal societies, it is, however, currently unknown how TDM has been adopted and is being used in everyday clinical practice. The aim of the study was to investigate how TDM has been taken up by physicians including barriers for implementation. Methods A web-based survey on TDM was distributed to all gastroenterology consultants in the Nordic countries via national gastroenterology- and IBD societies. Results Out of 377 physicians responding, 297 handled IBD patients on biologic therapies and were thus eligible for inclusion (NO 118 (40%), DK 86 (29%), SE 50 (17%), FI 33 (11%), IS 10 (3%)). The vast majority were consultant gastroenterologists (n=252, 85%), 152 (51%) were employed at university hospitals, 136 (46%) at community hospitals, and 9 (3%) in private practice. Overall, 257 (87%) used TDM during biologic therapies; 231 (90%) used reactive TDM and 163 (63%) proactive TDM. Common indications were to improve efficacy (70%), aid treatment decisions (62%), improve safety (36%), and improve cost-effectiveness (32%). Notably, Danish physicians used TDM to a significantly lesser extent than all others (58% vs 98%; odds ratio (OR) 0.03 [95%CI 0.01- 0.09], p<0.001); in particular outside the capital region (OR 0.15 [0.05–0.46], p=0.001). Reactive TDM was applied both at primary (74%) and secondary treatment failure (99%) and predominantly for TNF-inhibitors (90–98%) (vedolizumab 63%, ustekinumab 46%). Proactive TDM was used by 80% during maintenance therapy and 56% during induction, and mostly for TNF-inhibitors (79–97%) (vedolizumab 70%, ustekinumab 54%). Proactive TDM was more commonly used in NO, SE, and FI (p<0.001), and by physicians managing >10 IBD patients per week (OR 2.71 [1.34–5.48], p=0.005), but was not associated with employment at university hospital, size of hospital catchment area, or seniority. Main barriers to the use of TDM were lack of guidelines (51%), long response time from the laboratory (49%), lack of knowledge regarding how to use and interpret test results (42%), costs (38%), and currently available evidence (31%). Among physicians using TDM, only 66% reported awareness of TDM guidelines or recommendations. Conclusion TDM, and in particular reactive TDM of TNF-inhibitors, has been broadly adopted into clinical practice in the Nordic countries to improve efficacy and assist treatment decisions. Across the Nordic countries, IBD physicians call for improved test response times and, notably, TDM guidelines detailing indications for TDM and interpretation of test results.

Risk of Infections With Ustekinumab and Tofacitinib Compared to Tumor Necrosis Factor α Antagonists in Inflammatory Bowel Diseases

The comparative safety of therapies is important to inform relative positioning within the therapeutic algorithm. Tumor necrosis factor α antagonists (anti-TNF) are associated with an increased risk of infections. Whether there is a similar increase with ustekinumab (UST) or tofacitinib has not been established. We identified patients with Crohn's disease or ulcerative colitis from a national commercial health insurance plan in the United States between 2008 and 2019. Infectious outcomes were ascertained for patients newly initiating anti-TNF, UST, or tofacitinib therapy. Cox proportional hazards models were fit in propensity score-weighted cohorts to compare rates between patients treated with UST or tofacitinib and anti-TNF therapy. Our study included 19,096, 2420, and 305 patients with inflammatory bowel disease initiating anti-TNF, UST, and tofacitinib therapy, respectively. Over follow-up on-treatment, 7% and 44% of anti-TNF patients had infection-related hospitalizations and developed infections, respectively, compared with 4% and 32% of UST patients and 6% and 41% of tofacitinib patients. In the weighted Cox analysis, UST was associated with a significantly lower risk of infection (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.86-0.99) compared with anti-TNF therapy. There was a trend towards a reduction in infection-related hospitalizations (HR, 0.84; 95% CI, 0.66-1.03). The risk of infections (HR, 0.97; 95% CI, 0.75-1.24) or infection-related hospitalizations (HR, 0.59; 95% CI, 0.27-1.05) were similar between patients on tofacitinib and anti-TNF. UST is associated with reduced risk of infections compared to anti-TNF biologics in inflammatory bowel disease, whereas no difference was observed between tofacitinib and anti-TNF therapy.

A single dedicated vaccination visit improves vaccination coverage of patients with inflammatory bowel disease

Introduction:Patients treated with biologics for inflammatory bowel disease (IBD) have an increased risk of severe infections. Real-life vaccination coverage in this population remains low despite international vaccination guidelines. The aim of this study was to evaluate the impact of a dedicated vaccination visit on vaccination coverage.Methods:A dedicated vaccination visit was offered to all patients admitted for an infusion of a biologic in a tertiary IBD center during a 4-week period. At baseline, vaccination status was collected. Patients received specific information on recommended vaccinations. Perceived utility of both vaccination and the dedicated visit were assessed by visual analogue scale (VAS). Vaccination coverage was reassessed 6 months later by phone call.Results:Among the 207 patients analyzed (1 patient declined), rates of vaccination at baseline and 6 months later against diphtheria were 52.7% and 68.6% (p < 0.001), tetanus 55.1% and 70% (p < 0.001), poliomyelitis 51.7% and 68.6% (p < 0.001), pertussis 33.3% and 51.2% (p < 0.001), hepatitis B virus (HBV) 61.4% and 66.7% (p < 0.01), pneumococcus 15.5% and 42.0% (p < 0.001), influenza 29.5% and 36.2% (p < 0.01), and meningococcus C 11.6% and 13.0% (p = 0.083), respectively. A quarter of the patients declined at least one recommended vaccination after the visit. The main reason for this refusal was distrust toward one or more vaccines.Conclusion:A single visit dedicated to vaccination significantly increases rates of vaccination in patients with IBD treated with biologics.

Continuing Medical Education Questions: October 2021.

Article Title: A comprehensive literature review and expert consensus statement on therapeutic drug 2 monitoring of biologics in inflammatory bowel disease.

S702 Evaluation of a Novel Pharmacy Program for Reducing Variation in Prescribing Biologics for Inflammatory Bowel Disease

S702 Evaluation of a Novel Pharmacy Program for Reducing Variation in Prescribing Biologics for Inflammatory Bowel Disease

S838 Infusible Biologics in Gastroenterology Physician Clinics Were Not Impacted by the COVID-19 Pandemic

Introduction: The COVID-19 pandemic drastically changed the provision of outpatient healthcare services. Patients on infusible biologics for inflammatory bowel disease (IBD) were advised to continue therapy to prevent disease relapse and consequential healthcare exposure. There was little guidance for patients scheduled to begin infusions, and facility closures further complicated therapy options. The purpose of this study is to describe the impact of COVID-19 on IBD patients initiating infusible biologic therapy in an outpatient gastroenterology physician clinic setting. Methods: We conducted a retrospective analysis of all IBD patients started on infliximab (IFX) and vedolizumab (VDZ) therapy from January 1st to June 30th, 2020 at large multicenter gastroenterology private practices in Texas. The same clinics and time period in 2019 were used as a comparator. Data collection consisted of demographics, referral dates, infusion dates, and clinical outcomes between referral and first infusion. Evaluation of outcome measures including IBD flare symptoms, corticosteroid use, and healthcare utilization is ongoing. Primary outcomes were the number of new-starts and adherence to infusible biologics during the pandemic. Infusions administered beyond 3 days for induction dosing and 7 days for maintenance dosing were considered delayed. Results: There were 258 patients (122 IFX, 136 VDZ) and 222 patients (99 IFX, 123 VDZ) initiated on infusible biologics in 2020 and 2019, respectively [Table 1]. Median time from referral to first infusion was 33 days (IQR 23-50) in 2020, compared to 29 days (IQR 22-45) in 2019 (p=0.08). A total of 859 infusions were administered from January 1st to June 30th, 2020 and 713 infusions were administered in the same time period in 2019. Infusion delays were experienced by 70 (27%) patients in 2020 and 61 (27%) patients in 2019 (p=0.93). There were 104 (12%) delayed infusions in 2020 and 71 (10%) delayed infusions in 2019 (p=0.18) [Figure 1]. No significant differences in induction infusion delays (11% in 2020 vs. 9% in 2019, p=0.42) or maintenance infusion delays (18% in 2020 vs. 13% in 2019, p=0.24) year-over-year were seen. Conclusion: We observed a comparable number of patients initiated on IFX and VDZ in 2020 versus the previous year. Additionally, there were no significant delays in therapy. Even with global challenges in the provision of healthcare services, the outpatient gastroenterology physician clinics were able to successfully treat patients during the COVID-19 pandemic.Figure 1.: Delayed Infusions of Infusible Biologics in 2020 vs. 2019.Table 1.: Infusible Biologics in Gastroenterology Physician Clinics in 2020 vs. 2019.

A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease.

Therapeutic drug monitoring (TDM) of biologics is a rapidly evolving field. We aimed to provide a consensus statement regarding the clinical utility of TDM for biologics in inflammatory bowel disease (IBD). A modified Delphi method was applied to develop consensus statements. A comprehensive literature review was performed regarding TDM of biologic therapies in IBD, and 45 statements were subsequently formulated on the potential application of TDM in IBD. The statements, along with literature, were then presented to a panel of 10 gastroenterologists with expertise in IBD and TDM who anonymously rated them on a scale of 1-10 (1 = strongly disagree and 10 = strongly agree). An expert consensus development meeting was held virtually to review, discuss, refine, and reformulate statements that did not meet criteria for agreement or that were ambiguous. During the meeting, additional statements were proposed. Panelists then confidentially revoted, and statements rated ≥7 by 80% or more of the participants were accepted. During the virtual meeting, 8 statements were reworded, 7 new statements were proposed, and 19 statements were rerated. Consensus was finally reached in 48/49 statements. The panel agreed that reactive TDM should be used for all biologics for both primary nonresponse and secondary loss of response. It was recommended that treatment discontinuation should not be considered for infliximab or adalimumab until a drug concentration of at least 10-15 μg/mL was achieved. Consensus was also achieved regarding the utility of proactive TDM for anti-tumor necrosis factor therapy. It was recommended to perform proactive TDM after induction and at least once during maintenance. Consensus was achieved in most cases regarding the utility of TDM of biologics in IBD, specifically for reactive and proactive TDM of anti-tumor necrosis factors.

Safety of biologics in inflammatory bowel disease patients with COVID-19.

BackgroundPatients with Inflammatory bowel disease (IBD) remain highly concerned that either their disease or medications—namely, biologics—may increase the risk of severe coronavirus-2019 (COVID-19). We aimed to assess the safety of biologics in Inflammatory bowel disease (IBD) patients with COVID-19.MethodsWe systematically reviewed multiple databases to find relevant articles reporting the effect of biologics on “severe” COVID-19 in IBD patients. Those in the form of case series (> 10 patients), case–control, and cohort studies were included. Severe COVID-19 was defined as intensive care unit (ICU) admission, mechanical ventilation, and/or mortality. Pooled analysis with multivariate regression was performed.ResultsA total of 12 studies with 2681 patients were included. The proportion of females was (48.3%, 95% confidence interval (CI) 47.0–49.5%). The proportion of UC patients was (44.8%, 95% CI 41.0–48.5%). Overall, in IBD patients, the need for mechanical ventilation, intensive care unit (ICU) admission, and mortality was 5.1%, 6.1%, and 4.5%, respectively. Use of biologics did not show a moderating effect on mechanical ventilation (p = 0.68), ICU admission (p = 0.27), or mortality (p = 0.20).ConclusionsOur findings advocate for the continued biologic therapy in IBD patients during the COVID-19 pandemic. Nevertheless, the incidence, severity, and outcomes related to COVID-19 in IBD patients’ needs to be reassessed as data continues to emerge.

MIN score predicts primary response to infliximab/adalimumab and vedolizumab therapy in patients with inflammatory bowel diseases

Infliximab/adalimumab (IFX/ADA) and vedolizumab (VDZ) are the most widely used biologics in inflammatory bowel diseases. Current models used to predict their efficacies are restricted to either Crohn's disease or ulcerative colitis or to only one type of biologic, which makes them limited in external validation. We therefore designed a comprehensive comparison among these models to identify the most meaningful predictors for patient responses. Several biomarkers and models were compared for their abilities to predict both IFX/ADA and VDZ responses by receiver operating characteristic curves. Least absolute shrinkage and selection operator regression was adopted to determine a simplified gene signature. Verification was performed in biopsy samples by immunohistochemical staining. The GIMATS module (based on counts of IgG plasma cells, inflammatory monocytes, activated T cells, and stromal cells) had the best overall performance for response prediction in both biologics (IFX/ADA, AUC = 0.720–0.853; VDZ, AUC = 0.661–0.728). Based on this module, patients were equally divided into 3 groups: M type (GIMATS-low, metabolism), with a preference for IFX/ADA; I type (GIMATS-high, immune), with a preference for VDZ; and N type (GIMATS-medium, normal), with no preference for either treatment. Furthermore, to improve clinical utility, a simplified 6-gene model, MIN score, was established to determine the baseline expression of G0S2, S100A9, SELE, CHI3L1, MMP1 and CXCL13 and function as a substitute for GIMATS module. Our study suggested that the classification of metabolic or immune type by MIN score was valuable for IBD diagnosis to assist with selection of IFX/ADA and VDZ.

Intracolic Ultrasound Molecular Imaging Targeting to Tumor Necrosis Factor-α: A Potential Tool for Predicting Response to Biologics in Inflammatory Bowel Disease

Intracolic Ultrasound Molecular Imaging Targeting to Tumor Necrosis Factor-α: A Potential Tool for Predicting Response to Biologics in Inflammatory Bowel Disease

Novel trends with biologics in inflammatory bowel disease: sequential and combined approaches.

Inflammatory bowel disease (IBD) management has changed dramatically over the past 20 years, after the introduction of targeted biological therapies. However, the impact of these new drugs in changing the natural history of disease is still under debate. Recent evidence seems to suggest that the extent of their efficacy might be, at least partially, dependent on the timing of their introduction and on the subsequent management strategy. In this complex landscape, the potential role for a more dynamic approach with treatments based on sequencing and combining targeted therapies has been explored only minimally so far. In this review, we aim to explore the potential biological rationale behind the use of sequential and combination therapies in IBD, to summarise the current knowledge on this topic and to propose a management algorithm that combines these notions.

Drug survival of anti-TNF agents compared with vedolizumab as a second-line biological treatment in inflammatory bowel disease: results from nationwide Swedish registers.

SummaryBackgroundComparisons of second‐line anti‐tumour necrosis factor (TNF) agents and vedolizumab are sparse.AimTo evaluate the effectiveness of anti‐TNF agents compared to vedolizumab as second‐line biologics in inflammatory bowel disease (IBD).MethodsA propensity score‐matched cohort was created using Swedish nationwide registers. Patients with Crohn's disease or ulcerative colitis, exposed to first‐line anti‐TNF treatment, who initiated a second anti‐TNF agent or vedolizumab in 2014‐2016 (N = 1363) were included. The primary outcome was drug survival at 12 months. Secondarily, we assessed survival without IBD‐related hospitalisation, IBD‐related surgery, antibiotics, or hospitalisation because of infection, and also corticosteroid exposure.ResultsAfter 1:1 propensity score matching, 400 patients (Crohn's disease, N = 198; ulcerative colitis, N = 202) remained. For Crohn's disease, drug survival was 73% in the vedolizumab group vs 74% in the anti‐TNF group (difference: 1 percentage point; 95% confidence interval [CI]:‐11‐13; P = 0.87). Survival without IBD‐related hospitalisation (82% vs 88%), surgery (82% vs 89%), antibiotics (65% vs 71%), hospitalisation due to infection (95% vs 88%) and corticosteroids (58% vs 48%) were not statistically significantly different between groups. For ulcerative colitis, drug survival was 69% in the vedolizumab group vs 62% in the anti‐TNF group (difference: −7 percentage points; 95% CI: −20 to 6; P = 0.30). Vedolizumab‐treated patients had lower survival without IBD‐related hospitalisation (82% vs 93%, P = 0.02). Survival without colectomy (93% vs 97%), antibiotics (81% vs 70%), hospitalisation due to infection (92% vs 92%) and corticosteroids (58% vs 48%) were not statistically significantly different.ConclusionsBased on Swedish clinical practice, the effectiveness and safety of second‐line anti‐TNF and vedolizumab at 12 months appeared largely similar.

Infliximab Trough Levels Are Not Predictive of Relapse in Patients with IBD in Endoscopic Remission: A Multicenter Cohort Study.

Therapeutic drug monitoring (TDM) is important in optimizing use of biologics in inflammatory bowel diseases (IBD). However, the role of proactive TDM during remission remains uncertain. This retrospective study included patients receiving infliximab (IFX) therapy at Massachusetts General Hospital or Erasmus University Medical Center. All eligible patients had completed induction phase of IFX and were in clinical and endoscopic remission. Our primary outcome was clinical relapse within 2years after baseline. Multivariable regression models examined the association between infliximab trough levels during remission and relapse, need for IBD-related surgery or hospitalization. Our study cohort included 110 patients with IBD (72 CD, 38 UC) on IFX maintenance therapy. In total, 12 patients (10.9%) experienced relapse of disease over 2years. The mean IFX trough level at baseline was 8.0µg/mL (± 8.6) and did not differ between the institutions. 49.1% of patients had levels < 5µg/mL and 2.7% had antibodies to infliximab at baseline. There was no difference in the mean IFX trough levels between patients who relapsed (7.5µg/mL ± 3.7µg/mL) over 24months compared to those who did not (8.1µg/mL ± 7.9µg/mL, p = 0.815). On multivariable logistic regression analysis, IFX trough levels at baseline were not associated with relapse of disease over 24months (OR 1.01, 95% CI 0.93-1.09, p = 0.856). This retrospective multicenter study provides evidence that IFX trough levels during quiescent disease do not predict relapse over 2years, suggestive that proactive TDM in this setting is not warranted.

Risks and Safety of Advanced Therapies and Biologics in Inflammatory Bowel Disease: A Review for Nurses.

Advanced therapies, including biologics, are a core component of managing inflammatory bowel disease, which is increasing in prevalence. These therapies may offer an improved safety and tolerability profile compared with conventional treatments. However, they can interact with a patient's immune system via different mechanisms. Healthcare providers need to be aware of the possible adverse effects, such as infection and immune-mediated reactions, as well as risk management methods, such as patient screening and vaccination. As central members of the multidisciplinary team, nurses have an important role in educating patients with inflammatory bowel disease on disease course, treatment options, monitoring patient adherence, and response to treatment. This narrative review summarizes key safety considerations for the treatment of inflammatory bowel disease with advanced therapies, including risk of infection and malignancy; immunologic, metabolic, and hematologic complications; and what nurses can do to manage these risks. Special considerations for pediatric, elderly, and pregnant populations are also discussed.

Clinical outcomes, predictors of prognosis and health economics consequences in IBD patients after discontinuation of the first biological therapy.

Background:In real-world clinical practice, biologics in inflammatory bowel diseases (IBD) may be discontinued for a variety of reasons, including discontinuation initiated by gastroenterologists. The aims of the study are to report outcomes after discontinuation and predictors of prognosis after a minimum follow-up of 24 months; outcomes of gastroenterologist-initiated discontinuation with resulting direct cost implications on the health system were also studied.Methods:IBD patients who discontinued their first-use biologics between January 2013 and December 2016 were identified at our tertiary centre. Reasons for discontinuation and pre-defined adverse outcomes (AO) were recorded. Data were analysed using univariable and multivariable logistic regressions within a machine learning technique to predict AO. Gastroenterologist-initiated discontinuations were analysed separately, and Kaplan–Meier survival analysis performed; direct costs of AO due to discontinuation were assessed.Results:A total of 147 patients discontinued biologics (M = 74; median age 39 years; Crohn’s Disease = 110) with median follow-up of 40 months (range 24–60 months). In the total cohort, there were fewer AO among gastroenterologist-initiated discontinuations compared with patient-initiated; 54% (of the total group) had AO within 6 months. Among 59 gastroenterologist-initiated discontinuations, 23 (40%) had IBD-related AO within 6 months and 53 (90%) patients had AO by end of follow-up. Some 44 (75%) patients needed to restart biologics during follow-up, and direct costs due to AO and restart of biologics were high.Conclusions:The proportion of patients who have AO following discontinuation of biologics is high; clinicians need to carefully consider predictors of poor prognosis and high relapse rates when discussing discontinuation. The direct costs of managing AO probably offset theoretical economic gains, especially in the era where cost of biologics is reducing. Biologics should probably be continued without interruptions in most patients who have achieved remission for the duration these remain effective and safe.

117: Is there neonatal risk associated with biologic exposure in pregnancies affected by inflammatory bowel disease?

Biologic use to treat inflammatory bowel disease (IBD) during pregnancy has become more prevalent; however, few studies have examined the neonatal risk of biologic exposure in utero. We sought to evaluate the impact of biologic use on neonatal outcomes in pregnancies affected by inflammatory bowel disease. This was a retrospective study of patients with IBD who were pregnant and delivered at a single tertiary care institution from 2012 to 2017. Neonatal adverse outcome was defined as a composite outcome of preterm birth, small for gestational age (SGA), neonatal infection, or NICU admission. Incidence of the neonatal adverse outcome was compared between patients that used a biologic versus those that did not using a Chi-square test. Of the 273 patients included in this analysis, 72 (26.4%) used biologics. Overall, mean maternal age was 32.9 ±5.1 years, mean BMI was 24.4 ±4.6, 82.8% of the patients were Caucasian, and 35.4% of patents were advanced maternal age (>= 35 years). Demographics were similar between biologic users and non-users (Table 1). There was one neonatal death in the group not exposed to biologics which was due to hypoxic ischemic encephalopathy secondary to perinatal asphyxia as a result of feto-maternal hemorrhage. The use of biologics in utero was not associated with an increased risk of neonatal adverse outcome (14/70 (20.0%) versus 49/196 (25.0%), p = 0.40). The use of biologics for inflammatory bowel disease during pregnancy was not associated with an increased risk of adverse neonatal outcome. Future studies should evaluate the long term outcomes of neonates exposed to biologics in utero.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

3334 Insurance Generosity and Inflammatory Bowel Disease: Does Higher Patient Cost-Sharing Result in Suboptimal Medication Habits and Inferior Clinical Outcomes?

OBJECTIVES/SPECIFIC AIMS: Our primary objectives were to examine the impact of biologic cost sharing on 1) adherence to biologics and 2) persistence on biologics in inflammatory bowel disease (IBD) patients. Our secondary objective was to assess the effect of biologic cost sharing on clinical IBD outcomes, including rates of hospitalization, abdominal surgery, and corticosteroid treatment. METHODS/STUDY POPULATION: This retrospective cohort analysis used a national insurance claims database (Optum Clinformatics DataMart) to assess adult IBD patients enrolled in medium or large private insurance plans from 2007-2016. Patients were followed for one year of continuous enrollment after their index biologic claim. We assessed adherence to biologic medications (medication possession ratio &gt;0.8) dependent on patient cost sharing, as measured by an employer-plan’s average out-of-pocket biologic medication cost. We also examined the effects of patient cost sharing for biologics on need for hospitalization, abdominal surgery, or corticosteroid treatment. We used multivariate logistic regression models adjusting for clinical and demographic characteristics. We estimated the effect of cost sharing on biologic therapy persistence using repeated measures proportional hazard survival models. RESULTS/ANTICIPATED RESULTS: We identified 2,193 adult IBD patients who initiated biologic therapy and met study criteria (Crohn’s disease 66.1% vs. ulcerative colitis 24.9%, mean age 40.8 years, mean Charlson index 0.50). Median [IQR] out-of-pocket cost per 30-day biologic prescription was $62 [$34 - $157]. 66.9% of patients were adherent to biologic therapy. Higher out-of-pocket costs for biologics were associated with increased odds of nonadherence; patients with ulcerative colitis were more price-responsive than patients with Crohn’s disease or indeterminate colitis (Figure 1). However, higher out-of-pocket biologic costs were not associated with increased odds of all-cause or IBD-related hospitalization, IBD-related surgery, or corticosteroid prescriptions for IBD flares. Patients whose out-of-pocket costs were less than $10 per 30-day biologic prescription persisted on biologic therapy for significantly longer than patients who paid &gt;$10 (Figure 2). DISCUSSION/SIGNIFICANCE OF IMPACT: Nonadherence to biologics increases when IBD patients face higher out-of-pocket costs, particularly for ulcerative colitis patients. However, this is not associated with worse clinical outcomes. Patients with cost-sharing&lt;$10 persisted on biologics longer than patients whose cost sharing exceeded $10.

Trends in emergency department visits and hospitalization rates for inflammatory bowel disease in the era of biologics.

BackgroundThe use of biologics in inflammatory bowel disease (IBD) has increased recently. However, studies on whether the proportion of IBD patient visits to the emergency department (ED) has decreased are scarce. We investigated the trends in IBD-related ED visits and hospitalization rates.MethodsMedical records of IBD-related visits to the ambulatory department (AD) and the ED of the Seoul National University Bundang Hospital in 2007, 2009, 2012, and 2014 were reviewed. Multiple-variable logistic regression analysis was used to identify significant risk factors for hospitalization.ResultsThe proportion of IBD patients who visited ED was 12.3% in 2007, 9.7% in 2009, 8.3% in 2012, and 6.4% in 2014 (P = 0.002). The most common chief complaints were abdominal pain (66.9%) in Crohn’s disease (CD) patients and hematochezia (36.5%) in ulcerative colitis (UC) patients. The hospitalization rate following ED visits was 47.2% in CD patients and 55.6% in UC patients (P = 0.100). Multiple-variable analysis showed that significant risk factors associated with hospitalization in CD were aggressive disease behavior (odds ratio[OR] 3.54, P = 0.017) and presence of steroid exposure (OR 2.35, P = 0.047). Elevated C-reactive protein (CRP) (>0.5 mg/dL) (OR 5.40, P = 0.016) was the only risk factor associated with hospitalization in UC.ConclusionsThe proportion of ED visits decreased from 2007 to 2014; there was no significant change in hospitalization rates. Disease behavior/presence of steroid exposure and elevated CRP were associated with hospitalization among CD and UC patients who visited the ED, respectively.

Monitoring biologics in inflammatory bowel disease (IBD) using the Patients Know Best electronic portal: pilot study of uptake, acceptability and outcomes

Background: The number of inflammatory bowel disease (IBD) patients on biologics in the UK is increasing; this and the expansion of available drugs have contributed to delays in delivering treatment. E-health applications, such as the Patients Know Best (PKB) personal online healthcare record system, can improve efficiency of patient management in stable IBD. This pilot study aimed to explore the uptake, acceptability and outcomes of PKB in the management of patients starting biologics. Methods: IBD patients prescribed biologics were invited to register and trained online. The authors measured the number of new starters, PKB registrants, time intervals to treatment and the nature of online activity. Patients using the application received an evaluation questionnaire 6 months after enrolment. Results: Out of 40 patients newly started on biologics, 33 years were included, with a mean (SD) age of 44.3 (13.3) years. The mean time interval from decision to treatment administration was 82.7 days (44.0). Ten patients raised at least one issue on PKB; 45 new issues were raised, mostly relevant to active disease (18/45), adverse events of treatments (6/45) and the funding application process (5/45)—39 were resolved online. Of patients, 16 answered the questionnaire, and 11 found it at least somewhat helpful. More training was requested. Conclusions: The use of PKB did not accelerate the process of drug administration. However, patients engaged with the use of the platform, several issues were raised and most of these were resolved electronically. Regular training and individual treatment plans for patients starting biologics may optimise PKB's use for long-term monitoring.

Biologic treatment of Japanese patients with inflammatory bowel disease

BackgroundThere is little information regarding the use of biologics in Inflammatory Bowel Disease (IBD) patients in Japan. The aim of this study was to determine the factors associated with the use of biologics in the treatment of Japanese patients with IBD.MethodsAn online survey was conducted among Japanese patients with IBD (n = 1035). Socioeconomic as well as treatment related information was collected. Logistic regression was applied to analyze the determinants of biologic treatment.ResultsYounger age (≤ 40 years vs. > 65 years; OR:0.24), time since diagnosis (< 2 years vs. < 15 years; OR: 4.16), surgical history (OR:1.98) and visiting university hospitals (university hospitals vs. clinics; OR: 0.47) were associated with biologic treatment for Japanese IBD patients.ConclusionsCurrently, biologics have been used in younger IBD patients which may give rise to the presence of an age bias in biologic treatment. Further studies are required to confirm these results and to define appropriate IBD patients who should be treated with biologic agent.