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Cost of Refractory Crohn's Disease Before and After Ustekinumab Utilization.

ABSTRACT: Background:Crohn's disease (CD) is associated with major health services utilization and costs. Between 2012 and 2015, ustekinumab was used off-label in Quebec, Canada for treatment of refractory CD. Aims:We assessed the direct medical cost of adult CD patients in the 1-year pre- and 1-year postustekinumab initiation. Methods:Data were obtained from the provincial administrative databases. CD patients dispensed subcutaneous ustekinumab in 2012 to 2014 were followed for 1 year from the date of initiation (index-date). Kaplan Meier plots were used to display time to ustekinumab discontinuation and factors associated with discontinuation were identified using multivariate Cox regression models. Direct medical costs and 95% confidence interval (CI) of gastrointestinal-related health services were calculated for the 1-year pre- and 1-year post-index-date. Results:Thirty-four CD patients (mean age ± standard deviation, 44 ± 14 years, 59% women and 41% with low income) were included. Of these, 14 (41%) discontinued ustekinumab during the postperiod. Discontinuation was less likely among older patients: hazard ratio (95% CI) per 5-year age increase, 0.77 (0.61 to 0.96). The total $CAN direct medical cost (mean, 95% CI) was higher in the post- versus preperiod: $1,681,239 ($49,448; $42,265 to $57,160) versus $880,060 ($25,884; $20,391 to 31,596), while the total costs of GI-related health services were similar: $250,206 ($7359, $3536 to $11,674), versus $213,446 ($6278, $3609 to $9423). Conclusion:In patients with severe refractory CD on off-label ustekinumab, approximately 60% remained on treatment beyond 1 year. The cost of gastrointestinal services did not increase during that year as compared to that of the year preceding ustekinumab use.

SUBMITTER: Rahme E

PROVIDER: S-EPMC7678737 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Cost of Refractory Crohn's Disease Before and After Ustekinumab Utilization.

Rahme Elham E Nedjar Hacene H Afif Waqqas W

Journal of the Canadian Association of Gastroenterology 20190801 6

<h4>Background</h4>Crohn's disease (CD) is associated with major health services utilization and costs. Between 2012 and 2015, ustekinumab was used off-label in Quebec, Canada for treatment of refractory CD.<h4>Aims</h4>We assessed the direct medical cost of adult CD patients in the 1-year pre- and 1-year postustekinumab initiation.<h4>Methods</h4>Data were obtained from the provincial administrative databases. CD patients dispensed subcutaneous ustekinumab in 2012 to 2014 were followed for 1 ye ...[more]

PMID: 33241178

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Project description:BackgroundThe effectiveness of ustekinumab in patients with refractory Crohn's disease (CD) has been investigated in several real-world studies. However, very few data concerning the real-life experience in Italy have been reported. Therefore, this study assessed the effectiveness of ustekinumab in a large cohort of Italian patients with refractory CD.MethodsAll patients who had started on ustekinumab after failure of or intolerance to antitumour necrosis factor-α (TNF-α) treatment at five tertiary centres between November 2018 and February 2020 were retrospectively enrolled. The coprimary outcome was corticosteroid-free clinical remission, defined as a Harvey-Bradshaw Index (HBI) score of ⩽4, at weeks 26 and 52. The secondary outcomes were changes in the HBI and C-reactive protein (CRP) values at weeks 8, 26, and 52 from baseline and the normalization of CRP in patients with initially abnormal values.ResultsTotally, 140 patients who had previously received at least one anti-TNF-α agent were enrolled; 40.0% received two anti-TNF-α agents and 20.0% received vedolizumab. At baseline, 108 patients (77.1%) had HBI scores of >4; of these, 56.5% and 58.3% achieved corticosteroid-free clinical remission at weeks 26 and 52, respectively. Significant decreases in HBI and CRP values were observed at weeks 8, 26, and 52 in the entire study cohort (all p < 0.0001). The CRP values were normalized in 34.9%, 37.8%, and 49.3% of the patients by weeks 8, 26, and 52, respectively. The baseline HBI score of ⩾8 was a negative predictor of corticosteroid-free clinical remission at week 52 (odds ratio: 0.21, 95% confidence interval: 0.08-0.56, p = 0.002). The probability of remaining on ustekinumab after 52 weeks was 92.1%. Eleven (7.9%) patients discontinued ustekinumab (three for adverse events).ConclusionOur study findings confirm the effectiveness and safety of ustekinumab in patients with CD after failure of or intolerance to anti-TNF-α therapy.

Project description:BackgroundUstekinumab (UST), a newly-used biologic targeting p40 subunit of IL12 and IL23 in China, exerts a confirmed therapeutic effect on the induction and maintenance therapies for refractory Crohn's disease (CD). Therapeutic drug monitoring based on trough and antibody concentration is of core importance when treating patients who lose response to UST. We aimed to analyze the UST exposure-response relationship in CD treatment in the real-world setting.MethodsWe retrospectively enrolled patients with CD who received UST between March 1, 2020 and May 31, 2021, at the inflammatory bowel disease (IBD) center of the Sun Yat-Sun Affiliated Sixth Hospital. Baseline characteristic information, biomarker examination, clinical outcomes determined by the Crohn's disease activity index (CDAI), and endoscopic outcomes evaluated using a simple endoscopic score for Crohn's disease (SES-CD) at week 16/20 were collected. The optimal UST cut-off trough concentration was identified using receiver operating characteristic curve (ROC) analysis.ResultsNineteen eligible patients were included in the study, the mean age was 29.1 ± 9.1 years and the mean disease duration was 5.5 ± 4.7 years. At the initiation of the study, 89.5% of the patients had been exposed to prior biologics, 42.1% had previous CD-related surgeries, and 52.6% had perianal diseases. At week 16/20 after the UST initiation, clinical response, clinical remission, endoscopic response, and endoscopic remission were 89.5%, 84.2%, 42.2%, and 73.7%, respectively. The cut-off optimal trough concentration for UST was 1.12 μg/mL, as determined by the ROC with an area under the curve (AUC) of 0.78, sensitivity of 87.5%, and specificity of 72.7%. Patients with a UST trough concentration > 1.12 μg/mL had a significantly higher rate of endoscopic remission than those without (70.0% vs. 11.1%, P = 0.02).ConclusionsUST is an effective therapeutic option for refractory CD treatment. A UST trough concentration above 1.12 μg/mL was associated with endoscopic remission at week 16/20 after UST initiation. Trial registration This study was approved and retrospectively registered by the Ethics Committee of Sun Yat-Sen University (2021ZSLYEC-066, March 29, 2021) and the Clinical Trial Registry (NCT04923100, June 10, 2021).

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Cost of Refractory Crohn's Disease Before and After Ustekinumab Utilization.

Publications

Cost of Refractory Crohn's Disease Before and After Ustekinumab Utilization.

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