scholarly journals DOP45 Utilization and sustainability of biologics in CD - A nationwide study from the epi-IIRN

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S082-S083
Author(s):  
O Atia ◽  
D Yogev ◽  
F Chagit ◽  
F Gili ◽  
E Orlanski-Meyer ◽  
...  

Abstract Background Real-world studies demonstrate that ~33% of CD patients fail to respond to induction therapy with biologics. In this nationwide study we aimed to evaluate trends in biologics utilization and sustainability in CD during the last 15 years. Methods This study was performed on data from the four Israeli Health Maintenance Organizations, covering 98% of the population. Sustainability was defined as continuous treatment without IBD-related surgeries and at most one short steroid course. Sustainability was compared across different biologics utilizing a propensity score (PS) weighted analysis, estimated by generalized boosted modeling (GBM). Results 16,936 patients were diagnosed with CD in Israel since 2005 (2,932 [17%] pediatric-onset, 14,004 [83%] adult-onset), of whom 5,804 (34%) were ever treated with biologics (1,659 [57%] pediatric-onset, 4,145 adults [30%], OR 3.1 [95%CI 2.9–3.4]) with a median of 6.4 years follow up (IQR 3.4–9.9). Infliximab was the most common first-line treatment in children (58%, p<0.001), while adalimumab was the most common in adults (63%, p<0.001). However, in recent years there was an increase in adalimumab and vedolizumab utilization in parallel with a decrease in infliximab (Figure). The rate of initiating biologics in the first year of diagnosis increased from 20% among all biologics users during 2005–2010 through 36% during 2011–2014 and 74% since 2015 (p<0.001). The use of combination therapy with immunomodulators is becoming less common in last years and decreased in infliximab from 38% until 2010 to 21% in 2018 (P<0.001) and in adalimumab from 22% to 7%, respectively (p<0.001). The sustainability rate in those treated with infliximab was 65% at one year from initiation of biologics, and 46% and 42% at three and five years, thereafter; compared to 72%, 61% and 57% with adalimumab and 84% and 80% after one and two years in vedolizumab. The rate of primary non-response was 21% with infliximab, 17% with adalimumab and 12% with vedolizumab. Sustainability was associated with male sex (HR 0.9 [95%CI 0.8–0.95]) and earlier initiation of biologics (HR 0.92 [95%CI 0.9–0.95]). In the PS-adjusted model the sustainability of both infliximab (HR 0.7 [95%CI 0.6–0.8]) and vedolizumab (HR 0.8 [95%CI 0.7–0.95]) were lower than adalimumab. Compared with monotherapy, combination therapy did not change significantly the sustainability rate of all three biologics (adalimumab: HR 1.3 [95%CI 0.8–2.1], infliximab: HR 1.2 [95%CI 0.7–1.9], and vedolizumab: HR 0.8 [95%CI 0.5–1.3]). Conclusion Biologics are being increasingly used in CD and earlier during the disease course, but most patients do not sustain treatment at five years. Sustainability rate was higher with adalimumab compared with either infliximab or vedolizumab

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S077-S078
Author(s):  
O Atia ◽  
D Yogev ◽  
C Friss ◽  
G Focht ◽  
E Orlanski-Meyer ◽  
...  

Abstract Background 25% of UC patients fail to respond to induction therapy with biologics. In this nationwide study we aimed to evaluate trends in biologics utilization and sustainability in UC during the last 15 years. Methods This study was performed on data from four the four Israeli Health Maintenance Organizations, covering 98% of the population. Sustainability was defined as continuous treatment without IBD-related surgeries and at most one short steroid course. Sustainability was compared across different biologics utilizing a propensity score (PS) weighted analysis, estimated by generalized boosted modeling (GBM). Results 13,231 patients were diagnosed with UC in Israel since 2005 (1,426 [11%] pediatric-onset,11,805 [89%] adult-onset), of whom 1,692 (13%) were ever treated with biologics (400 [24%] pediatric-onset, 1,292 adults [76%], OR 3.2 [95%CI 2.8–3.6]; p<0.001) with a median of 6.4 years follow up (IQR 3.4–9.9). Infliximab was the most common first-line treatment in both children and adults (75% and 54%, respectively, p<0.001). However, in recent years there was an increase in adalimumab and vedolizumab utilization in parallel with a decrease in infliximab (Figure). The rate of initiating biologics in the first year of diagnosis increased from from 11% during 2005–2010 to 25% during 2011–2014 and 61% since 2015 (p<0.001). The use of combination therapy with immunomodulators is becoming less common and decreased with infliximab: from 36% in 2010 to 17% in 2018 (p<0.001) and with adalimumab from 32% to 12%, respectively (p<0.001). The sustainability rate in those treated with infliximab was 52% at one year from initiation of biologics, and 37% and 34% at three and five years, thereafter; compared to 55%, 43% and 40% with adalimumab and 72% and 67% after one and two years with vedolizumab. The primary non-response rate was 30% with infliximab, 31% with adalimumab and 16% with vedolizumab. Sustainability was associated with earlier initiation of biologics during the disease course (HR 0.9 [95%CI 0.85–0.95]). In the PS-adjusted model where vedolizumab served as the reference, the sustainability of both infliximab (HR 0.7 [95%CI 0.6–0.95]) and adalimumab (HR 0.8 [95%CI 0.6–0.99]) were lower. Compared with monotherapy, combination therapy increased the sustainability rate with both adalimumab (HR 0.3 [95%CI 0.2–0.6]) and infliximab (HR 0.4 [95%CI 0.-0.6]), but not with vedolizumab (HR 1.4 [95%CI 0.98–2.1]). Conclusion Biologics are being increasingly used in UC but only half of patients sustain treatment at one year. Treatment is commenced earlier during the disease course, and this is associated with improved sustainability. Sustainability rate is higher with vedolizumab, and in combination therapy of IMM and infliximab or adalimumab.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S559-S559
Author(s):  
O Atia ◽  
C Friss ◽  
A Mendelovici ◽  
E Shteyer ◽  
E Orlanski-Meyer ◽  
...  

Abstract Background Thiopurines have been long used to maintain remission in ulcerative colitis (UC) but are also associated with toxicity and therapeutic failure. We aimed to assess the sustainability rate of thiopurines commenced as monotherapy in UC, and to explore predictors of sustainability. Methods This study was performed on data from four Health Maintenance Organizations (HMOs), covering 98% of the Israeli population. We included all biologic-naïve UC patients diagnosed after 2005 and treated with thiopurines monotherapy for at least three months. Treatment with 5- aminosalicylic acid (ASA) was allowed if initiated prior to or during the first three months from initiation of thiopurines. Sustainability was defined as continued thiopurines treatment without switching therapy, adding biologics or requiring surgery. At most one short steroid course was allowed. Cox regression model was used to explore estimated predictors to sustainability. Results A total of 1,897 (370 [20%] pediatric-onset and 1,527 [80%] adults) thiopurines-treated patients were included with a 15,033 person-years of follow-up. The median time from UC diagnosis to initiation of thiopurines was 12.7 months (IQR 4.6–30.9), and the median treatment duration was 13.0 months (6.3–28.4). Sustainability rate was evident in 92% of patients after 6 months from initiation of thiopurines and 83%, 65% and 42% at one, three and five years, thereafter. Sustainability was associated with early initiation of thiopurines during disease course (HR 0.99 [95%CI 0.985–0.995]) and lack of 5-ASA at initiation of thiopurines (HR 0.7 [95%CI 0.6–0.8]). Conclusion As many as two thirds of biologic-naïve UC patients treated with thiopurines monotherapy sustain this treatment after five years, especially when initiated early and without 5-ASA.


1992 ◽  
Vol 5 (3) ◽  
pp. 198-206 ◽  
Author(s):  
Myde Boles ◽  
Thomas T. H. Wan

Based on a randomly selected nationwide sample of Medicare beneficiaries, this study analyzes changes in patient satisfaction over a one year period for beneficiaries receiving care in a variety of delivery settings: fee for service, group model HMO, staff model HMO, and Independent Practice Association model HMO. The findings reveal the patient satisfaction changes significantly over a one year period, from lower levels of satisfaction to higher levels of satisfaction. The primary explanation for this change in satisfaction is a decline in health status over the same one year period. Additional differences in satisfaction with care were observed for Medicare beneficiaries served by different types of delivery settings with varying degrees of utilization controls.


1993 ◽  
Vol 99 (1) ◽  
pp. 164-200 ◽  
Author(s):  
Douglas R. Wholey ◽  
Jon B. Christianson ◽  
Susan M. Sanchez

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
M. A. Salinero-Fort ◽  
F. J. San Andrés-Rebollo ◽  
J. Cárdenas-Valladolid ◽  
M. Méndez-Bailón ◽  
R. M. Chico-Moraleja ◽  
...  

AbstractWe aimed to develop two models to estimate first AMI and stroke/TIA, respectively, in type 2 diabetes mellitus patients, by applying backward elimination to the following variables: age, sex, duration of diabetes, smoking, BMI, and use of antihyperglycemic drugs, statins, and aspirin. As time-varying covariates, we analyzed blood pressure, albuminuria, lipid profile, HbA1c, retinopathy, neuropathy, and atrial fibrillation (only in stroke/TIA model). Both models were stratified by antihypertensive drugs. We evaluated 2980 patients (52.8% women; 67.3 ± 11.2 years) with 24,159 person-years of follow-up. We recorded 114 cases of AMI and 185 cases of stroke/TIA. The factors that were independently associated with first AMI were age (≥ 75 years vs. < 75 years) (p = 0.019), higher HbA1c (> 64 mmol/mol vs. < 53 mmol/mol) (p = 0.003), HDL-cholesterol (0.90–1.81 mmol/L vs. < 0.90 mmol/L) (p = 0.002), and diastolic blood pressure (65–85 mmHg vs. < 65 mmHg) (p < 0.001). The factors that were independently associated with first stroke/TIA were age (≥ 75 years vs. < 60 years) (p < 0.001), atrial fibrillation (first year after the diagnosis vs. more than one year) (p = 0.001), glomerular filtration rate (per each 15 mL/min/1.73 m2 decrease) (p < 0.001), total cholesterol (3.88–6.46 mmol/L vs. < 3.88 mmol/L) (p < 0.001), triglycerides (per each increment of 1.13 mmol/L) (p = 0.031), albuminuria (p < 0.001), neuropathy (p = 0.01), and retinopathy (p = 0.023).


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jacques P. Brown ◽  
Jonathan D. Adachi ◽  
Emil Schemitsch ◽  
Jean-Eric Tarride ◽  
Vivien Brown ◽  
...  

Abstract Background Recent studies are lacking reports on mortality after non-hip fractures in adults aged > 65. Methods This retrospective, matched-cohort study used de-identified health services data from the publicly funded healthcare system in Ontario, Canada, contained in the ICES Data Repository. Patients aged 66 years and older with an index fragility fracture occurring at any osteoporotic site between 2011 and 2015 were identified from acute hospital admissions, emergency and ambulatory care using International Classification of Diseases (ICD)-10 codes and data were analyzed until 2017. Thus, follow-up ranged from 2 years to 6 years. Patients were excluded if they presented with an index fracture occurring at a non-osteoporotic fracture site, their index fracture was associated with a trauma code, or they experienced a previous fracture within 5 years prior to their index fracture. This fracture cohort was matched 1:1 to controls within a non-fracture cohort by date, sex, age, geography and comorbidities. All-cause mortality risk was assessed. Results The survival probability for up to 6 years post-fracture was significantly reduced for the fracture cohort vs matched non-fracture controls (p < 0.0001; n = 101,773 per cohort), with the sharpest decline occurring within the first-year post-fracture. Crude relative risk of mortality (95% confidence interval) within 1-year post-fracture was 2.47 (2.38–2.56) in women and 3.22 (3.06–3.40) in men. In the fracture vs non-fracture cohort, the absolute mortality risk within one year after a fragility fracture occurring at any site was 12.5% vs 5.1% in women and 19.5% vs 6.0% in men. The absolute mortality risk within one year after a fragility fracture occurring at a non-hip vs hip site was 9.4% vs 21.5% in women and 14.4% vs 32.3% in men. Conclusions In this real-world cohort aged > 65 years, a fragility fracture occurring at any site was associated with reduced survival for up to 6 years post-fracture. The greatest reduction in survival occurred within the first-year post-fracture, where mortality risk more than doubled and deaths were observed in 1 in 11 women and 1 in 7 men following a non-hip fracture and in 1 in 5 women and 1 in 3 men following a hip fracture.


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