scholarly journals Risk Factors for Medication Nonadherence to Self-Injectable Biologic Therapy in Adult Patients With Inflammatory Bowel Disease

2019 ◽  
Vol 26 (2) ◽  
pp. 314-320 ◽  
Author(s):  
Nisha B Shah ◽  
Jennifer Haydek ◽  
James Slaughter ◽  
Jonathan R Ashton ◽  
Autumn D Zuckerman ◽  
...  

Abstract Background In inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), nonadherence to biologic therapy increases risk of disease flare. The aim of this study was to identify risk factors for nonadherence. Methods This was a single-center retrospective study evaluating patients with IBD treated at a tertiary care center and prescribed self-injectable biologic therapy using the center’s specialty pharmacy. Adherence was defined using medication possession ratio (MPR). Nonadherence was defined as MPR <0.86. Results Four hundred sixty patients (n = 393 with CD and n = 67 with UC) were evaluated with mean MPR (interquartile range) equaling 0.89 (0.48–1). Overall, 69% of patients were adherent (defined as MPR ≥0.86), 66% of patients with CD and 87% of patients with UC. In univariate analysis, several factors increased risk of nonadherence: CD diagnosis, insurance type, psychiatric history, smoking, prior biologic use, and narcotic use (P < 0.05). In multivariable analysis, Medicaid insurance (odds ratio [OR], 5.5; 95% confidence interval [CI], 1.85–15.6) and CD diagnosis (OR, 2.8; 95% CI, 1.3–6.0) increased risk of nonadherence. In CD, as the number of risk factors increased (narcotic use, psychiatric history, prior biologic use, and smoking), the probability of nonadherence increased. Adherence was 72% in patients with 0–1 risk factors, decreasing to 62%, 61%, and 42% in patients with 2, 3, and 4 risk factors, respectively (P < 0.05). Conclusions This study identified risk factors for nonadherence to biologic therapy. In patients with CD, the probability of nonadherence increased as the number of risk factors increased.

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S52-S53
Author(s):  
David Drevno ◽  
Sherry Hickok ◽  
Sabina Ali

Abstract Background Biological agents have revolutionized the management of inflammatory bowel disease (IBD). There is a known increased risk of tuberculosis (TB) reactivation with biologic therapy (1). ACG guidelines recommend screening for active and latent TB infection (LTBI) prior to starting certain biologic agents (2). However, there are no consensus guideline on the utility of yearly screening testing in IBD patients without TB risk factors. With a number of patients now receiving the biologic therapy outside their primary care centers it has become increasingly difficult to effectively provide ongoing TB screening. With this quality improvement exercise, we aim to improve TB re-screening in patients receiving biologics by completing a yearly phone screening for exposure history. Method An interdisciplinary team from GI and ID developed a TB risk factor screening questionairre, adapting the California Department of Public Health’s Pediatric TB Risk Assessment tool (3). A list of patients receiving biologics was sorted by month of birth in the EMR. When the current calendar month aligned with the patient’s birth month, a GI RN reviewed the TB questionnaire with the patient (≥18 yo) and/or legal guardian by phone. If one or more TB risk factors were identified, the GI RN would notify the provider and a QuantiFERON-TB Gold (QFT) was ordered to be completed. Results 60 patients were found on biologic therapy (median age 17 yo) (38 males, 22 females) (68% CD, 28% UC, 3.3% IBD-U)(75% IFX, 12% ADA, and 3% other) to be to eligible TB screening between January - July 2019, 48 patients completed the phone screening. All 61 patients had completed TB screening prior to starting biologic therapy, which was reported to be negative. 13 patients were unable to be reached. 6/48 were identified as having at least 1 risk factor for TB. 5/6 patients with a positive screen had a negative QFT. 1 patient was away at college and a request to his adult GI managing his biologic was sent. Conclusion Screening for LTBI is required prior to starting a biologic therapy, though there are no guidelines for routine TB screening following initiation of the biologic. We propose performing an annual phone screening for TB exposure history for IBD patients on biologic therapy. QTF testing remains appropriate in patients with potential risk factors, such as being a health care worker or travel to/living in high endemic TB regions. References


Author(s):  
R L Goetgebuer ◽  
J E Kreijne ◽  
C A Aitken ◽  
G Dijkstra ◽  
F Hoentjen ◽  
...  

Abstract Background and Aims Women with inflammatory bowel disease [IBD] may be at higher risk for cervical intraepithelial neoplasia [CIN]. However, data are conflicting. The aim of this study was to assess the risk of high-grade dysplasia and cancer [CIN2+] in IBD women and identify risk factors. Methods Clinical data from adult IBD women in a multicentre Dutch IBD prospective cohort [PSI] from 2007 onwards were linked to cervical cytology and histology records from the Dutch nationwide cytology and pathology database [PALGA], from 2000 to 2016. Patients were frequency-matched 1:4 to a general population cohort. Standardised detection rates [SDR] were calculated for CIN2+. Longitudinal data were assessed to calculate CIN2+ risk during follow-up using incidence rate ratios [IRR] and risk factors were identified in multivariable analysis. Results Cervical records were available from 2098 IBD women [77%] and 8379 in the matched cohort; median follow-up was 13 years. CIN2+ detection rate was higher in the IBD cohort than in the matched cohort (SDR 1.27, 95% confidence interval [CI] 1.05–1.52). Women with IBD had an increased risk of CIN2+ [IRR 1.66, 95% CI 1.21–2.25] and persistent or recurrent CIN during follow-up (odds ratio [OR] 1.89, 95% CI 1.06–3.38). Risk factors for CIN2+ in IBD women were smoking and disease location (ileocolonic [L3] or upper gastrointestinal [GI] [L4]). CIN2+ risk was not associated with exposure to immunosuppressants. Conclusions Women with IBD are at increased risk for CIN2+ lesions. These results underline the importance of human papillomavirus [HPV] vaccination and adherence to cervical cancer screening guidelines in IBD women, regardless of exposure to immunosuppressants.


2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S43-S43
Author(s):  
Joana Lemos Garcia ◽  
Isadora Rosa ◽  
Joana Moleiro ◽  
João Pereira da Silva ◽  
António Dias Pereira

Abstract Introduction and goals Inflammatory Bowel Disease (IBD) patients may have an increased risk of neoplasia due to IBD itself or its therapy. The aim of this study was to evaluate the incidence of malignant neoplasia in IBD patients in a portuguese hospital, the associated risk factors and the therapy adjustments made. Methods Unicentric retrospective cohort study. All patients followed for IBD in a tertiary portuguese hospital and oncological center during 2015–2020 were included. Demographic and clinical data were registered. Results A total of 318 patients were included: female n=175(55.0%), age at diagnosis=37.24(±15,28)years-old, Crohn’s disease (CD) n=168(52.8%), Primary Sclerosing Cholangitis n=7, family history of cancer n=12, previous diagnosis of neoplasia n=23(7.2%), smokers n=49 (15.4%). A total of 42 cancers were diagnosed in 36 patients (11.3%) - median of 12.0(IQR=8.0–21.0) years after IBD diagnosis. Most affected organs: skin (n=15 in 11 patients; melanoma=1), colon and rectum (n=8 in 6 patients), prostate (n=4), breast (n=3) and anal canal (n=2). In those with non-melanoma skin cancer, 6 patients were under active treatment with azathioprine and 2 had stopped it for more than two years. In both univariate/multivariate analysis, the occurrence of neoplasia was associated with tobacco exposure (p=0.0.29/p=0.004), age (p<0.001/p=0,003) and IBD duration (p=0.001/p=0.017). There was no association with IBD therapy. In 9 cases, the cancer treatment was different because of the IBD (type of surgery n=6, drugs used n=2, radiotherapy not used n=1); IBD treatment was changed in 9 patients; clinical remission was lost in 1 patient in whom azathioprine treatment was halted after cancer. In the last follow-up, 3 patients remained with active oncological disease and 5 had died, 3 of which with active cancer. In those affected by cancer, in the univariate analysis, its cure/remission was negatively associated with tobacco exposure (p=0.003) and positively with salicylates use (p=0.016) and IBD remission before cancer diagnosis (p=0.008). In the multivariate analysis, the statistical significance was lost. Overall survival was lower in smokers with or without neoplasia (p<0.001) and in those who developped cancer (p=0.003). Conclusion In IBD patients, cancer mostly affected the skin and the lower digestive system. As in the general population, age and tobacco exposure were risk factors for the development of neoplasia. Tobacco is globally associated with lower survival rates and may be associated with a lower cure/remission rate, while salicylates and IBD remission may have a beneficial effect.


2019 ◽  
Vol 26 (7) ◽  
pp. 1060-1067
Author(s):  
Steffi E M van de Ven ◽  
Lauranne A A P Derikx ◽  
Iris D Nagtegaal ◽  
Carla M van Herpen ◽  
Robert P Takes ◽  
...  

Abstract Background Inflammatory bowel disease (IBD) patients are at increased risk for developing extra-intestinal malignancies, mainly due to immunosuppressive medication. The risk of developing head and neck cancer in immunosuppressed transplant patients is increased. The relation between IBD patients and laryngeal cancer (LC) remains unclear. We aimed (1) to identify risk factors in IBD patients for LC development and (2) to compare clinical characteristics, outcome, and survival of LC in IBD patients with the general population. Methods All IBD patients with LC (1993–2011) were retrospectively identified using the Dutch Pathology Database. We performed 2 case–control studies: (1) to identify risk factors, we compared patients with IBD and LC (cases) with the general IBD population; (2) to analyze LC survival, we compared cases with controls from the general LC population. Results We included 55 cases, 1800 IBD controls, and 2018 LC controls. Cases were more frequently male compared with IBD controls (P < 0.001). For ulcerative colitis (UC), cases were older at IBD diagnosis (P < 0.001). Crohn’s disease (CD) cases were more frequently tobacco users (P < 0.001) and more often had stricturing (P = 0.006) and penetrating (P = 0.008) disease. We found no survival difference. Immunosuppressive medication had no impact on survival. Conclusions Male sex was a risk factor for LC in IBD patients. Older age at IBD diagnosis was a risk factor for UC to develop LC. Tobacco use and stricturing and penetrating disease were risk factors for LC development in CD patients. Inflammatory bowel disease was not associated with impaired survival of LC. Immunosuppressive medication had no influence on survival.


2018 ◽  
Vol 52 (6) ◽  
pp. 571-579 ◽  
Author(s):  
Sean M. McConachie ◽  
Sheila M. Wilhelm ◽  
Ashish Bhargava ◽  
Pramodini B. Kale-Pradhan

Objective: To review the mechanism and association of infectious risk among the tumor-necrosis factor α (TNF-α) antagonists used in inflammatory bowel disease. Data Sources: A PubMed literature search was performed using the following search terms: infliximab, adalimumab, certolizumab, golimumab, inflammatory bowel disease, crohn’s, ulcerative colitis, adverse effects, adverse events, safety, and infection. Study Selection and Data Extraction: Meta-analyses and cohort studies with outcomes pertaining to quantitative infectious risk were reviewed. Case reports and case series describing association between TNF-α inhibitors and infection were also reviewed. Data Synthesis: A total of 7 recent meta-analyses of randomized trials demonstrate inconclusive association of infection with TNF-α antagonists. Registry data suggest that medications carry an independent risk of opportunistic infections. Risk factors for infection include older age, malnutrition, diabetes, and possibly combination therapy. Reported infections vary widely but include intracellular and granulomatous bacteria, viruses, and fungi. Conclusion: TNF-α antagonists are associated with an increased risk of opportunistic infection, although this risk has not been demonstrated conclusively in randomized controlled trials. Knowledge of concomitant risk factors, mechanism of infectious risk, and available treatment options can improve patient care in the clinical setting.


2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
William Gillespie ◽  
Neil Marya ◽  
Julien Fahed ◽  
Gregory Leslie ◽  
Krunal Patel ◽  
...  

Aim. To investigate the epidemiology and risk factors of Clostridium difficile infections (CDI) in patients with inflammatory bowel disease (IBD). Methods. This is a retrospective study of patients diagnosed with IBD. 1006 charts were screened and 654 patients met the inclusion criteria. Patients were divided into 2 cohorts based on the presence of prior diagnosis of CDI. Statistical analysis with Pearson’s chi-squared and two-sample t-test was performed. Results. The incidence of CDI among IBD patients was 6.7%. There was equal prevalence of CDI among Crohn’s disease (CD) (n=21, 49%) and ulcerative colitis (UC) (n=22, 51%). IBD patients acquired CDI at a mean age of 42.7 years, with 56% of infections acquired in the community and only 28% associated with healthcare. Only 30% of IBD patients with CDI had prior antibiotic use, and 16% had prior steroid use. IBD patients were significantly more likely to require biologic therapy (57% versus 37%, p<0.01) and have extraintestinal manifestations of IBD (43% versus 28%, p<0.02). Conclusions. IBD patients are more susceptible to CDI at a younger age and often lack traditional risk factors. IBD patients with at least one CDI were more likely to require biologic therapy and had greater rates of extraintestinal manifestations.


Author(s):  
Hao Wu ◽  
Tingzi Hu ◽  
Hong Hao ◽  
Michael A Hill ◽  
Canxia Xu ◽  
...  

Abstract Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality despite aggressive treatment of traditional risk factors. Chronic inflammation plays an important role in the initiation and progression of CVDs. Inflammatory bowel disease (IBD) is a systemic state of inflammation exhibiting increased levels of pro-inflammatory cytokines including tumor necrosis factor-α, interleukin (IL)-1β, and IL-6. Importantly, IBD is associated with increased risk for CVDs especially in women and young adults, including coronary artery disease, stroke, thromboembolic diseases, and arrhythmias. Potential mechanisms underlying the increased risk for CVDs in IBD patients include increased levels of inflammatory cytokines and oxidative stress, altered platelet function, hypercoagulability, decreased numbers of circulating endothelial progenitor cells, endothelial dysfunction, and possible interruption of gut microbiota. Although IBD does not appear to exacerbate the traditional risk factors for CVDs, including hypertension, hyperlipidemia, diabetes mellitus, and obesity, aggressive risk stratifications are important for primary and secondary prevention of CVDs for IBD patients. Compared to 5-ASA and corticosteroids, anti-TNF-α therapy in IBD patients was consistently associated with decreasing cardiovascular events. In the absence of contraindications, low-dose aspirin and statins appear to be beneficial for IBD patients. Low-molecular-weight heparin is also recommended for patients who are hospitalized with acute IBD flares without major bleeding risk. A multidisciplinary team approach should be considered for the management of IBD patients.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S564-S564
Author(s):  
S García Mateo ◽  
S J Martínez-Domínguez ◽  
M C Aso Gonzalvo ◽  
C J Gargallo-Puyuelo ◽  
B Gallego Llera ◽  
...  

Abstract Background Patients with Inflammatory Bowel Disease (IBD) suffer from a chronic illness and many of them need immunosuppressive therapy throughout the course of the disease. Consequently, COVID-19 pandemic has caused uncertainty about the possible increased risk of suffering SARS-CoV-2 infection that could confer IBD or its treatments. The aim of this study is to assess SARS-CoV-2 seroprevalence in patients with IBD as well as the existence of potential risk factors for its development. Methods This is a unicentric cross-sectional study developed in IBD unit of University Hospital “Lozano Blesa” of Zaragoza. Patients older than 18 years with established diagnosis of Crohn′s Disease (CD), Ulcerative Colitis (UC) or Indeterminate Colitis (IC) have been included. A blood sample has been drawn from each patient to detect IgG against SARS-CoV-2 (ELISA method) and each patient has completed a questionnaire to know symptoms related to infection and previous comorbidity. We have performed a descriptive analysis and a univariate analysis to study relationship between potential risk factors and seroconversion against SARS-CoV-2. Results 431 patients have been included, with a mean age of 50.2 ± 14.1 years and a 51.3% of women. Of them, 49.7% suffer from UC, 49.2% CD and 1.2% IC. Related to the treatment, 23.5% receive anti-TNF biologic agents, 13.1% other kind of biologic agents, 9.3% immunomodulators, 7.7% combined treatment (biologic agent and immunomodulator), 33.1% other treatment and 13.3% no treatment. According to World Health Organization (WHO) definitions, 85.6% had not suffered the infection, 7.7% were confirmed cases (only 3 admitted patients) and 6.7% were probable cases. The seroprevalence of SARS-CoV-2 obtained is 8.8%, being significantly higher among confirmed cases than among probable cases (71.0% in confirmed vs 6.9% in probable; RR 10.3; p&lt;0.001). A higher risk of seroconversion has been detected among patients without biologic agents (11.8% in patients without biologic agents vs 5.3% in patients with biologic agents; RR 2.2; p=0.021). No differences have been observed in the seroprevalence of patients with other treatments for IBD or in terms of age, active smoking, level of inflammation markers, the presence of symptoms of infection or hospital admission. Conclusion The seroprevalence of SARS-CoV-2 of Aragon′s patients with IBD is similar to that described in national seroprevalence study of Ministry of Health for the region (8.8%). The treatment with biologic agents is associated with a lower risk of seroconversion


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