scholarly journals Effect of Age on the Initiation of Biologic Agent Therapy in Patients With Inflammatory Bowel Disease: Korean Common Data Model Cohort Study

10.2196/15124 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e15124
Author(s):  
Youn I Choi ◽  
Yoon Jae Kim ◽  
Jun-Won Chung ◽  
Kyoung Oh Kim ◽  
Hakki Kim ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Data Model ◽  
Biologic Agents ◽  
Age At Diagnosis ◽  
Common Data Model ◽  
Event Free Survival ◽  
Free Survival ◽  
Network Database ◽  
Inflammatory Bowel

Background The Observational Health Data Sciences and Informatics (OHDSI) network is an international collaboration established to apply open-source data analytics to a large network of health databases, including the Korean common data model (K-CDM) network. Objective The aim of this study is to analyze the effect that age at diagnosis has on the prognosis of inflammatory bowel disease (IBD) in Korea using a CDM network database. Methods We retrospectively analyzed the K-CDM network database from 2005 to 2015. We transformed the electronic medical record into the CDM version 5.0 used in OHDSI. A worsened IBD prognosis was defined as the initiation of therapy with biologic agents, including infliximab and adalimumab. To evaluate the effect that age at diagnosis had on the prognosis of IBD, we divided the patients into an early-onset (EO) IBD group (age at diagnosis <40 years) and a late-onset (LO) IBD group (age at diagnosis ≥40 years) with the cutoff value of age at diagnosis as 40 years, which was calculated using the Youden index method. We then used the logrank test and Cox proportional hazards model to analyze the effect that age at diagnosis (EO group vs LO group) had on the prognosis in patients with IBD. Results A total of 3480 patients were enrolled. There was 2017 patients with ulcerative colitis (UC) and 1463 with Crohn’s disease (CD). The median follow up period was 109.5 weeks. The EO UC group was statistically significant and showed less event-free survival (ie, experiences of biologic agents) than the LO UC group (P<.001). In CD, the EO CD group showed less event-free survival (ie, experiences of biologic agents) than the LO CD group. In the Cox proportional hazard analysis, the odds ratio (OR) of the EO UC group on experiences of biologic agents compared with the LO UC group was 2.3 (95% CI 1.3-3.8, P=.002). The OR of the EO CD group on experiences of biologic agents compared with the LO CD group was 5.4 (95% CI 1.9-14.9, P=.001). Conclusions The EO IBD group showed a worse prognosis than the LO IBD group in Korean patients with IBD. In addition, this study successfully verified the CDM model in gastrointestinal research.

scholarly journals Effect of Age on the Initiation of Biologic Agent Therapy in Patients With Inflammatory Bowel Disease: Korean Common Data Model Cohort Study (Preprint)

2019 ◽  
Author(s):  
Youn I Choi ◽  
Yoon Jae Kim ◽  
Jun-Won Chung ◽  
Kyoung Oh Kim ◽  
Hakki Kim ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Data Model ◽  
Biologic Agents ◽  
Age At Diagnosis ◽  
Common Data Model ◽  
Event Free Survival ◽  
Free Survival ◽  
Network Database ◽  
Inflammatory Bowel

BACKGROUND The Observational Health Data Sciences and Informatics (OHDSI) network is an international collaboration established to apply open-source data analytics to a large network of health databases, including the Korean common data model (K-CDM) network. OBJECTIVE The aim of this study is to analyze the effect that age at diagnosis has on the prognosis of inflammatory bowel disease (IBD) in Korea using a CDM network database. METHODS We retrospectively analyzed the K-CDM network database from 2005 to 2015. We transformed the electronic medical record into the CDM version 5.0 used in OHDSI. A worsened IBD prognosis was defined as the initiation of therapy with biologic agents, including infliximab and adalimumab. To evaluate the effect that age at diagnosis had on the prognosis of IBD, we divided the patients into an early-onset (EO) IBD group (age at diagnosis &lt;40 years) and a late-onset (LO) IBD group (age at diagnosis ≥40 years) with the cutoff value of age at diagnosis as 40 years, which was calculated using the Youden index method. We then used the logrank test and Cox proportional hazards model to analyze the effect that age at diagnosis (EO group vs LO group) had on the prognosis in patients with IBD. RESULTS A total of 3480 patients were enrolled. There was 2017 patients with ulcerative colitis (UC) and 1463 with Crohn’s disease (CD). The median follow up period was 109.5 weeks. The EO UC group was statistically significant and showed less event-free survival (ie, experiences of biologic agents) than the LO UC group (<i>P</i>&lt;.001). In CD, the EO CD group showed less event-free survival (ie, experiences of biologic agents) than the LO CD group. In the Cox proportional hazard analysis, the odds ratio (OR) of the EO UC group on experiences of biologic agents compared with the LO UC group was 2.3 (95% CI 1.3-3.8, <i>P</i>=.002). The OR of the EO CD group on experiences of biologic agents compared with the LO CD group was 5.4 (95% CI 1.9-14.9, <i>P</i>=.001). CONCLUSIONS The EO IBD group showed a worse prognosis than the LO IBD group in Korean patients with IBD. In addition, this study successfully verified the CDM model in gastrointestinal research.

scholarly journals Development of Machine Learning Model to Predict the 5-Year Risk of Starting Biologic Agents in Patients with Inflammatory Bowel Disease (IBD): K-CDM Network Study

2020 ◽  
Vol 9 (11) ◽  
pp. 3427 ◽  
Author(s):  
Youn I Choi ◽  
Sung Jin Park ◽  
Jun-Won Chung ◽  
Kyoung Oh Kim ◽  
Jae Hee Cho ◽  
...  
Keyword(s):  
Machine Learning ◽  
Inflammatory Bowel Disease ◽  
Validation Study ◽  
Bowel Disease ◽  
Medical Center ◽  
External Validation ◽  
Biologic Agents ◽  
Risk Level ◽  
Common Data Model ◽  
Inflammatory Bowel

Background: The incidence and global burden of inflammatory bowel disease (IBD) have steadily increased in the past few decades. Improved methods to stratify risk and predict disease-related outcomes are required for IBD. Aim: The aim of this study was to develop and validate a machine learning (ML) model to predict the 5-year risk of starting biologic agents in IBD patients. Method: We applied an ML method to the database of the Korean common data model (K-CDM) network, a data sharing consortium of tertiary centers in Korea, to develop a model to predict the 5-year risk of starting biologic agents in IBD patients. The records analyzed were those of patients diagnosed with IBD between January 2006 and June 2017 at Gil Medical Center (GMC; n = 1299) or present in the K-CDM network (n = 3286). The ML algorithm was developed to predict 5- year risk of starting biologic agents in IBD patients using data from GMC and externally validated with the K-CDM network database. Result: The ML model for prediction of IBD-related outcomes at 5 years after diagnosis yielded an area under the curve (AUC) of 0.86 (95% CI: 0.82–0.92), in an internal validation study carried out at GMC. The model performed consistently across a range of other datasets, including that of the K-CDM network (AUC = 0.81; 95% CI: 0.80–0.85), in an external validation study. Conclusion: The ML-based prediction model can be used to identify IBD-related outcomes in patients at risk, enabling physicians to perform close follow-up based on the patient’s risk level, estimated through the ML algorithm.

Development of machine learning model to predict the risk of 5- year disease related outcomes in patients with inflammatory bowel disease (Preprint)

2019 ◽  
Author(s):  
Youn I Choi ◽  
Sung Jin Park ◽  
Yoon Jae Kim ◽  
Kwang Gi Kim ◽  
Dong Kyun Park ◽  
...  
Keyword(s):  
Machine Learning ◽  
Inflammatory Bowel Disease ◽  
Validation Study ◽  
Bowel Disease ◽  
Medical Center ◽  
External Validation ◽  
Biologic Agents ◽  
Risk Level ◽  
Common Data Model ◽  
Inflammatory Bowel

BACKGROUND The incidence and global burden of inflammatory bowel disease (IBD) have steadily increased in the past few decades. Improved methods to stratify risk and predict disease-related outcomes are required for IBD. OBJECTIVE The aim of this study was to develop and validate a machine learning (ML) model to predict the 5-year risk of starting biologic agents in IBD patients. METHODS We applied an ML method to the database of the Korean common data model (K-CDM) network, a data sharing consortium of tertiary centers in Korea, to develop a model to predict the 5-year risk of starting biologic agents in IBD patients. The records analyzed were those of patients diagnosed with IBD between January 2006 and June 2017 at Gil Medical Center (GMC; n = 1,299) or present in the K-CDM network (n = 3,286). The ML algorithm was developed using data from GMC and externally validated with the K-CDM network database. RESULTS The ML model for prediction of IBD-related outcomes at 5 years after diagnosis yielded an area under the curve (AUC) of 0.86 (95% CI: 0.82–0.92), in an internal validation study carried out at GMC. The model performed consistently across a range of other datasets, including that of the K-CDM network (AUC = 0.81; 95% CI: 0.80–0.85), in an external validation study. CONCLUSIONS The ML-based prediction model can be used to identify IBD-related outcomes in patients at risk, enabling physicians to perform close follow-up based on the patient’s risk level, estimated through the ML algorithm.

Prognosis of Lymphoma in Patients With Known Inflammatory Bowel Disease: A French Multicentre Cohort Study

2020 ◽  
Vol 14 (9) ◽  
pp. 1222-1230 ◽  
Author(s):  
T Severyns ◽  
J Kirchgesner ◽  
J Lambert ◽  
C Thieblemont ◽  
A Amiot ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
B Cell ◽  
Bowel Disease ◽  
Cohort Analysis ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
B Cell Lymphomas ◽  
Free Survival ◽  
Significant Difference ◽  
Inflammatory Bowel

Abstract Background and Aims The prognosis of lymphoma that occurs in patients with inflammatory bowel disease [IBD] is poorly known. Methods A multicentre retrospective cohort analysis was done in seven French tertiary centres from 1999 to 2019. Only lymphoma occurring in patients with previous established diagnosis of IBD were analysed. The primary outcome was progression-free survival at 3 years. Results A total of 52 patients [male 65%, Crohn’s disease 79%, median age 48.3 years, median duration of IBD 10.1 years] were included, of whom 37 had been previously exposed to immunosuppressants and/or biologics for at least 3 months and 20 had primary intestinal lymphomas. The lymphoma histological types were: diffuse large B cell lymphomas [N = 17], Hodgkin lymphomas [N = 17], indolent B cell lymphomas [N = 12], and others including T cell lymphomas, mantle cell lymphomas, and unclassifiable B cell lymphoma [N = 6]. The median follow-up after lymphoma was 5.1 years (interquartile range [IQR] 4–7.8). Progression-free survival at 3 years was 85% in the overall population (95% confidence interval [CI] 75%–96%) with no significant difference between the exposed and unexposed group, 79% for patients exposed to immunosuppressants and/or biologics [95% CI 67%–94%], and 83% for patients diagnosed with primary intestinal lymphoma [95% CI 67%–100%]. No relapse of IBD has been observed during chemotherapy. The IBD relapse rate at the end of the last chemotherapy cycle was 23% at 3 years [95% CI 11%-39%] in the overall population. Conclusions In this large cohort, the prognosis for lymphomas occurring in IBD appears to be good and similar to what is expected, irrespective of the exposure to biologics and/or immunosuppressants.

scholarly journals P323 Efficacy and safety of tofacitinib treatment for one year in Japanese patients with Ulcerative Colitis in a specialized Inflammatory Bowel Disease center

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S348-S348
Author(s):  
K Kojima ◽  
K Yokoyama ◽  
K Kaku ◽  
Y Takashima ◽  
T Sato ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Herpes Zoster ◽  
Adverse Events ◽  
Rectal Bleeding ◽  
Bowel Disease ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Inflammatory Bowel ◽  
One Year

Abstract Background Few reports of the real-world efficacy and safety of tofacitinib (TFB) in Asians are available, and potential predictors of the response to therapy are unclear. We investigated the efficacy and safety profiles of TFB treatment for one year in patients with active Ulcerative Colitis (UC) in our specialized Inflammatory Bowel Disease center. Methods This study included 111 patients who received TFB between May 2018 and February 2020. We assessed disease activity using the partial Mayo Score (pMS). Clinical remission was defined as pMS ≤2, with no subscore &gt;1 and a rectal bleeding subscore of 0. Clinical response was defined as a decrease in pMS of ≥2 points from baseline with an accompanying decrease in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point. Results Mean patient age was 35 years (interquartile range [IQR]: 28-47), 60 (59.4%) were men, and mean disease duration was 4.8 years (IQR:1.5-10). The pMS was 6 (IQR:4-7) and C-reactive protein was 0.30 mg/dl (IQR: 0.1-1.0). At baseline, 63 (62.4%) patients received an anti-TNFα agent, 11 (10.9%) received vedolizumab, and 7 (6.9%) received both. Clinical response and clinical remission were, respectively, 66.3% (67/101) and 50.5% (51/101) at week 8, and 47.1% (40/85) and 43.5% (37/85) at week 48. The cumulative remission rate was 61.7% at 1 year and 51.7% at 2 years, and tended to be better in the ≥2 anti-TNFα agents failure group than in the 1 anti-TNFα agent failure and bio-naïve groups (P=0.10). Cumulative colectomy-free survival was 91.9% at 1 year and 89.1% at 2 years. Cumulative drug-free survival in the non-remission group at week 8 was 30.9% at 1 year and 30.9% at 2 years, significantly lower than in the remission-achieving group at week 8 (P&lt;0.01). Baseline pMS was significantly lower in responders vs non-responders at week 8 (odds ratio, 0.61; 95% confidence interval, 0.45-0.82). Relapse occurred in 45.7% of patients after tapering TFB, and 85.7% of patients with re-increased TFB responded by week 4. Herpes zoster occurred in 6 unvaccinated patients (46±16 years old). There were no specific features regarding age, TFB dosage, duration of administration, or lymphocyte count in these patients. No thrombotic adverse events occurred, even though 54.1% patients continued treatment with 10 mg twice daily at week 48. Conclusion TFB was more effective in low-activity UC patients and its efficacy was not affected by previous treatment with anti-TNF agents. Most patients in the remission groups at week 8 could continue TFB for one year without severe adverse events, although careful monitoring for herpes zoster is necessary. The risk of thrombotic adverse events might be lower in Japanese UC patients.

scholarly journals P626 SARS-CoV-2 seroprevalence in patients with Inflammatory Bowel Disease

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 ◽  
...  
Keyword(s):  
Risk Factors ◽  
Inflammatory Bowel Disease ◽  
Potential Risk ◽  
Bowel Disease ◽  
Biologic Agents ◽  
World Health ◽  
Indeterminate Colitis ◽  
Increased Risk ◽  
Potential Risk Factors ◽  
Inflammatory Bowel

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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