Objective: To describe the prevalence and costs of anxiety and depression among moderate-to-sever... more Objective: To describe the prevalence and costs of anxiety and depression among moderate-to-severe psoriasis (PsO) patients in a commercially-insured US population. Methods: The IBM MarketScan Commercial database was used to select adults with moderate-tosevere PsO (!1 PsO diagnosis and !1 systemic or biologic medication) within each calendar year from 2014 to 2016. Adults with no diagnosis of PsO or similar disorders were randomly selected (2014-2016) and matched 1:1 to PsO patients to compare the prevalence of anxiety and depression each year. Moderate-to-severe PsO patients identified in 2014 with continuous enrollment through 2015 were stratified into those with treated anxiety and/or depression (!1 anxiety or depression diagnosis plus any anxiolytics, antidepressants, or antipsychotics within 30 days) vs those without anxiety/ depression, and then matched 1:1 to determine the incremental burden of treated anxiety/depression among PsO patients. All-cause and PsO-related healthcare costs were compared between the matched cohorts using generalized linear models. Results: In total, 69,644 matched PsO and non-PsO patients were identified in 2014, 61,478 in 2015, and 66,880 in 2016. The prevalence of anxiety/depression among PsO patients increased more than for matched controls, from 18.2% vs 12.2% in 2014 (p < 0.01) to 19.6% vs 13.1% in 2016 (p < 0.01). Prevalence of treated anxiety/depression followed the same trend, with increases from 14.5% vs 8.9% in 2014 (p < 0.01) to 15.9% vs 9.9% in 2016 (p < 0.01). For patients with moderate-to-severe PsO, unadjusted incremental all-cause healthcare costs associated with treated anxiety/depression were $8,077 (p < 0.01); 91% was due to utilization of medical services such as hospitalizations, ER visits, office visits, and other outpatient services (all p < 0.01). Conclusions: The prevalence of psychiatric disorders is higher among PsO patients than the general population, and the incremental burden of treated anxiety/depression is substantial. Further research is needed, but PsO treatments that improve psychiatric symptoms such as anxiety/depression may benefit patients and reduce their economic burden.
65 Background: CR is an important clinical indicator of disease progression and worsening overall... more 65 Background: CR is an important clinical indicator of disease progression and worsening overall survival among pts with mCSPC. This study describes real-world time-to-CR progression in an oncology setting among pts with mCSPC who initiated APA, ENZ, or ABI in the United States. Methods: Clinical data from the Flatiron Metastatic Prostate Cancer (PC) Core Registry Electronic DataMart (1/1/2013 – 07/31/2022) were evaluated. Metastatic pts without evidence of CR before initiating a next-generation androgen inhibitor (AAI) were classified into exclusive treatment cohorts based on the start date (index date) for APA, ENZ, or ABI. CR was identified by a Flatiron algorithm searching for: 1) mention of CR in patient charts, 2) rising prostate-specific antigen (PSA) levels documented from laboratory testing, or 3) mention of rising PSA while on hormonal therapy from unstructured data sources. Pts had ≥12 months (mo) of clinical data pre-index date and were followed from the index date unti...
80 Background: Several recurrent mutations that interfere with the HRR DNA damage signaling respo... more 80 Background: Several recurrent mutations that interfere with the HRR DNA damage signaling response pathway have been recently identified as novel biomarkers that may help optimize treatment for patients with mCRPC. There is limited real-world information on clinical outcomes, including TTNT and OS, among patients with mCRPC who initiate 1L, overall and by HRR mutation status in the United States. Methods: This study used the nationwide (de-identified) Flatiron Health – Foundation Medicine Inc. (FMI) Metastatic Prostate Cancer Clinico-Genomic Database (1/1/2011–12/31/2021). The de-identified data originated from approximately 280 US cancer clinics (~800 care sites). Patients who initiated 1L therapy (index date) on or after mCRPC diagnosis and had ≥1 HRR mutation test any time prior to or on the index date were included. Patients were excluded if they initiated a clinical trial drug in 1L or had <12 months of clinical activity before the index date. Patients were classified as H...
69 Background: For patients with nmCRPC, APA with androgen deprivation therapy is an important th... more 69 Background: For patients with nmCRPC, APA with androgen deprivation therapy is an important therapeutic option with demonstrated efficacy in improving metastasis-free survival (MFS), and other clinical outcomes. However, there is limited real-world information on these outcomes among patients with nmCRPC treated with APA. This study describes PSA response and MFS among patients with nmCRPC treated with APA in the United States as compared to the SPARTAN registrational trial. Methods: Clinical data from 2/2017 to 4/2022 collected from 77 community-based urology practices were used to evaluate patients with nmCRPC who received ≥1 APA dispensation (index date being the date of first dispensation). Patients were excluded if they had previously used another next-generation antiandrogen or had <12 months of pre-index clinical activity. PSA response was evaluated while on treatment and was defined as a post-index ≥90% decline (PSA90) in PSA from baseline (using the closest PSA value ...
43 Background: Deep prostate-specific antigen (PSA) response, defined as a ≥90% decline in PSA (P... more 43 Background: Deep prostate-specific antigen (PSA) response, defined as a ≥90% decline in PSA (PSA90), is an important early prognostic factor for achieving radiographic progression free survival and overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with a next generation androgen receptor inhibitor (ARI) or androgen biosynthesis inhibitor. This study compared PSA90 responses among patients with mCSPC at first use of a next generation ARI. Methods: Clinical data from 69 community urology practices in the United States were evaluated. Patients with mCSPC were classified into treatment cohorts based on their first filled prescription (index date) for apalutamide (APA) or enzalutamide (ENZ) after 12/16/2019. Patients were followed from index date until the earliest of index regimen discontinuation, treatment switch, end of clinical activity or end of data availability (03/05/2021). Included patients had ≥12 months of clinical activity to...
BACKGROUND Treatment of Crohn’s disease (CD) may require biologics. Dose escalation may be necess... more BACKGROUND Treatment of Crohn’s disease (CD) may require biologics. Dose escalation may be necessary to maintain efficacy, while adverse events or non-response may lead to treatment discontinuation. This analysis aimed to generate real-world evidence of persistence to ustekinumab versus adalimumab while on labeled maintenance dose (United States [US] prescribing information) among bio-naïve patients with CD in the US. METHODS Adults with CD initiated on ustekinumab or adalimumab from 09/23/2016 (approval of ustekinumab for CD in the US) to 08/01/2019 were selected from a de-identified health insurance claims database (IQVIA PharMetrics® Plus). Patients who used other biologics indicated for CD or had diagnoses for other autoimmune disorders in the 12 months before the initiation of the index agent (baseline) were excluded. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence to the index agent while on labeled maintenance dose...
INTRODUCTION: We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patien... more INTRODUCTION: We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD). METHODS: This study used a retrospective, multicenter, multinational consortium of UST-treated CD patients. Data included patient demographics, disease phenotype, disease activity, treatment history, and concomitant medications. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions were assessed using time-to-event analysis, and clinical predictors were assessed by using multivariate Cox proportional hazard analyses. Serious infections and adverse events were defined as those requiring hospitalization or treatment discontinuation. RESULTS: A total of 1,113 patients (51.8% female, 90% prior antitumor necrosis factor exposure) were included, with a median follow-up of 386 days. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions at 12 months were 40%, 32%, 39%, and 30%, respectively. Biologic-na...
410 Background: As use of oral therapies in prostate cancer treatment increases, IOD of oral medi... more 410 Background: As use of oral therapies in prostate cancer treatment increases, IOD of oral medication has become more common. The objective of this study was to describe clinical surveillance practices and PSA outcomes in nmCRPC patients (pts) treated in clinics with or without IOD. Methods: nmCRPC pts with ≥1 ARI prescription (Rx) were identified in data from 95 US urology practices between 2018-2021. Pts were categorized into 3 groups: (1) Treated in IOD clinic and received ARI onsite within 14 days of Rx (IOD+), (2) Treated in IOD clinic but no onsite ARI receipt within 14 days of Rx (IOD-), and (3) Treated in a clinic without IOD (non-IOD). Descriptive analyses were conducted on pt characteristics, PSA and imaging data. PSA response, reported using Kaplan-Meier rates, was defined as ≥50% reduction in post-index (PI; index date = 14 days after 1st ARI Rx) PSA compared to baseline PSA (measured within 13 weeks before 1st ARI prescription). PSA progression was defined as ≥25% inc...
Journal of the American Academy of Dermatology, 2020
Gene TarGeTinG and Gene CorreCTion i mutation and correction of SMN2 aberrant splicing, by exploi... more Gene TarGeTinG and Gene CorreCTion i mutation and correction of SMN2 aberrant splicing, by exploiting the non-homologous end-joining (NHEJ) pathway. Plasmids encoding Cas9-GFP under the control of CMV promoter, and selected gRNAs downstream to the Pol-III U6 promoter (Addgene) were transfected in HEK-293T cell line and in immortalized myoblasts derived from either healthy donors or SMA patients. Transfection efficiency was estimated as percentage of GFP-expressing cells (20-50% and 1-10%, respectively) and nuclease activity detected by Surveyor assay and target site sequencing. In particular, in SMA patient-derived myoblasts we detected mutations (indels) at the level of the induced DNA double-strand break at ~30% frequency. Levels of SMN restoration will be investigated by qPCR of the different species of SMN transcripts and by western blotting of SMN protein. The goal of this study is to provide an in vitro proof of principle of effective gene correction in SMA patient-derived cells. In the context of a multisystemic, complicated disease such as SMA, targeted genome editing strategy could represent an additional therapeutic tool.
Background: Psoriasis (PsO) is a chronic inflammatory skin disorder that may be associated with c... more Background: Psoriasis (PsO) is a chronic inflammatory skin disorder that may be associated with comorbidities, including inflammatory bowel disease (IBD), given common immunopathogenic mechanisms. Whether PsO patients are more likely to suffer from gastrointestinal (GI) signs and symptoms has not been well-characterized. Understanding their prevalence in PsO patients may inform strategies to evaluate for GI signs and symptoms, screen for those at risk for IBD, and guide choice of therapy. Objective: To assess the prevalence of GI signs and symptoms in patients with moderate-to-severe PsO. Methods: An Internet-based survey was conducted to evaluate GI signs and symptoms in patients with self-reported moderate-to-severe PsO and non-PsO controls. The impact of PsO severity and presence of psoriatic arthritis (PsA) [self-reported and/or screened positive on the Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire] on prevalence of GI signs and symptoms was also assessed. Th...
Abstract Aims To quantify the long-term direct and indirect costs among patients with Crohn’s dis... more Abstract Aims To quantify the long-term direct and indirect costs among patients with Crohn’s disease (CD) and specific subgroups of these patients in the United States from the private payer’s perspective. Materials and methods This retrospective study used the OptumHealth Care Solutions, Inc database (01 January 1999–31 March 2017) to match (1:5) adult patients with ≥2 claims for CD to patients without inflammatory bowel disease (IBD). Patterns observed during follow-up (i.e. biologics, opioids, or steroids; CD-related surgery; moderate-to-severe disease; and comorbidities) were used to identify CD subgroups. Comparisons of healthcare resource utilization, work loss days, and direct and indirect work loss-related costs were made between matched cohorts. Descriptive analyses of costs were conducted within each CD subgroup. Results There were 6,715 and 33,575 patients in the CD and non-IBD cohorts, respectively. The direct burden was significantly higher in the CD cohort compared to the non-IBD cohort, with 0.34 inpatient admissions per patient per year (PPPY) versus 0.12 (217% increase; p < .001), and $24,500 direct healthcare costs PPPY versus $7,037 ($17,463 increase; p < .001). The trend was similar for the indirect burden, with work loss–related costs PPPY of $5,490 in the CD cohort versus $3,322 in the non-IBD cohort ($2,168 increase; p < .001). The burden was numerically higher in the CD subgroups, with direct healthcare costs reaching $101,013 PPPY in the surgery subgroup. Limitations Severity of CD was determined based on claims-based algorithms due to the lack of access to medical files. Absenteeism was imputed based on claims data, and presenteeism was not assessed. Conclusions The direct healthcare and indirect work loss–related costs of patients with CD was significantly higher compared to patients without IBD over an average follow-up of 5 years.
Objective: To describe the prevalence and costs of anxiety and depression among moderate-to-sever... more Objective: To describe the prevalence and costs of anxiety and depression among moderate-to-severe psoriasis (PsO) patients in a commercially-insured US population. Methods: The IBM MarketScan Commercial database was used to select adults with moderate-tosevere PsO (!1 PsO diagnosis and !1 systemic or biologic medication) within each calendar year from 2014 to 2016. Adults with no diagnosis of PsO or similar disorders were randomly selected (2014-2016) and matched 1:1 to PsO patients to compare the prevalence of anxiety and depression each year. Moderate-to-severe PsO patients identified in 2014 with continuous enrollment through 2015 were stratified into those with treated anxiety and/or depression (!1 anxiety or depression diagnosis plus any anxiolytics, antidepressants, or antipsychotics within 30 days) vs those without anxiety/ depression, and then matched 1:1 to determine the incremental burden of treated anxiety/depression among PsO patients. All-cause and PsO-related healthcare costs were compared between the matched cohorts using generalized linear models. Results: In total, 69,644 matched PsO and non-PsO patients were identified in 2014, 61,478 in 2015, and 66,880 in 2016. The prevalence of anxiety/depression among PsO patients increased more than for matched controls, from 18.2% vs 12.2% in 2014 (p < 0.01) to 19.6% vs 13.1% in 2016 (p < 0.01). Prevalence of treated anxiety/depression followed the same trend, with increases from 14.5% vs 8.9% in 2014 (p < 0.01) to 15.9% vs 9.9% in 2016 (p < 0.01). For patients with moderate-to-severe PsO, unadjusted incremental all-cause healthcare costs associated with treated anxiety/depression were $8,077 (p < 0.01); 91% was due to utilization of medical services such as hospitalizations, ER visits, office visits, and other outpatient services (all p < 0.01). Conclusions: The prevalence of psychiatric disorders is higher among PsO patients than the general population, and the incremental burden of treated anxiety/depression is substantial. Further research is needed, but PsO treatments that improve psychiatric symptoms such as anxiety/depression may benefit patients and reduce their economic burden.
65 Background: CR is an important clinical indicator of disease progression and worsening overall... more 65 Background: CR is an important clinical indicator of disease progression and worsening overall survival among pts with mCSPC. This study describes real-world time-to-CR progression in an oncology setting among pts with mCSPC who initiated APA, ENZ, or ABI in the United States. Methods: Clinical data from the Flatiron Metastatic Prostate Cancer (PC) Core Registry Electronic DataMart (1/1/2013 – 07/31/2022) were evaluated. Metastatic pts without evidence of CR before initiating a next-generation androgen inhibitor (AAI) were classified into exclusive treatment cohorts based on the start date (index date) for APA, ENZ, or ABI. CR was identified by a Flatiron algorithm searching for: 1) mention of CR in patient charts, 2) rising prostate-specific antigen (PSA) levels documented from laboratory testing, or 3) mention of rising PSA while on hormonal therapy from unstructured data sources. Pts had ≥12 months (mo) of clinical data pre-index date and were followed from the index date unti...
80 Background: Several recurrent mutations that interfere with the HRR DNA damage signaling respo... more 80 Background: Several recurrent mutations that interfere with the HRR DNA damage signaling response pathway have been recently identified as novel biomarkers that may help optimize treatment for patients with mCRPC. There is limited real-world information on clinical outcomes, including TTNT and OS, among patients with mCRPC who initiate 1L, overall and by HRR mutation status in the United States. Methods: This study used the nationwide (de-identified) Flatiron Health – Foundation Medicine Inc. (FMI) Metastatic Prostate Cancer Clinico-Genomic Database (1/1/2011–12/31/2021). The de-identified data originated from approximately 280 US cancer clinics (~800 care sites). Patients who initiated 1L therapy (index date) on or after mCRPC diagnosis and had ≥1 HRR mutation test any time prior to or on the index date were included. Patients were excluded if they initiated a clinical trial drug in 1L or had <12 months of clinical activity before the index date. Patients were classified as H...
69 Background: For patients with nmCRPC, APA with androgen deprivation therapy is an important th... more 69 Background: For patients with nmCRPC, APA with androgen deprivation therapy is an important therapeutic option with demonstrated efficacy in improving metastasis-free survival (MFS), and other clinical outcomes. However, there is limited real-world information on these outcomes among patients with nmCRPC treated with APA. This study describes PSA response and MFS among patients with nmCRPC treated with APA in the United States as compared to the SPARTAN registrational trial. Methods: Clinical data from 2/2017 to 4/2022 collected from 77 community-based urology practices were used to evaluate patients with nmCRPC who received ≥1 APA dispensation (index date being the date of first dispensation). Patients were excluded if they had previously used another next-generation antiandrogen or had <12 months of pre-index clinical activity. PSA response was evaluated while on treatment and was defined as a post-index ≥90% decline (PSA90) in PSA from baseline (using the closest PSA value ...
43 Background: Deep prostate-specific antigen (PSA) response, defined as a ≥90% decline in PSA (P... more 43 Background: Deep prostate-specific antigen (PSA) response, defined as a ≥90% decline in PSA (PSA90), is an important early prognostic factor for achieving radiographic progression free survival and overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with a next generation androgen receptor inhibitor (ARI) or androgen biosynthesis inhibitor. This study compared PSA90 responses among patients with mCSPC at first use of a next generation ARI. Methods: Clinical data from 69 community urology practices in the United States were evaluated. Patients with mCSPC were classified into treatment cohorts based on their first filled prescription (index date) for apalutamide (APA) or enzalutamide (ENZ) after 12/16/2019. Patients were followed from index date until the earliest of index regimen discontinuation, treatment switch, end of clinical activity or end of data availability (03/05/2021). Included patients had ≥12 months of clinical activity to...
BACKGROUND Treatment of Crohn’s disease (CD) may require biologics. Dose escalation may be necess... more BACKGROUND Treatment of Crohn’s disease (CD) may require biologics. Dose escalation may be necessary to maintain efficacy, while adverse events or non-response may lead to treatment discontinuation. This analysis aimed to generate real-world evidence of persistence to ustekinumab versus adalimumab while on labeled maintenance dose (United States [US] prescribing information) among bio-naïve patients with CD in the US. METHODS Adults with CD initiated on ustekinumab or adalimumab from 09/23/2016 (approval of ustekinumab for CD in the US) to 08/01/2019 were selected from a de-identified health insurance claims database (IQVIA PharMetrics® Plus). Patients who used other biologics indicated for CD or had diagnoses for other autoimmune disorders in the 12 months before the initiation of the index agent (baseline) were excluded. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence to the index agent while on labeled maintenance dose...
INTRODUCTION: We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patien... more INTRODUCTION: We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD). METHODS: This study used a retrospective, multicenter, multinational consortium of UST-treated CD patients. Data included patient demographics, disease phenotype, disease activity, treatment history, and concomitant medications. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions were assessed using time-to-event analysis, and clinical predictors were assessed by using multivariate Cox proportional hazard analyses. Serious infections and adverse events were defined as those requiring hospitalization or treatment discontinuation. RESULTS: A total of 1,113 patients (51.8% female, 90% prior antitumor necrosis factor exposure) were included, with a median follow-up of 386 days. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions at 12 months were 40%, 32%, 39%, and 30%, respectively. Biologic-na...
410 Background: As use of oral therapies in prostate cancer treatment increases, IOD of oral medi... more 410 Background: As use of oral therapies in prostate cancer treatment increases, IOD of oral medication has become more common. The objective of this study was to describe clinical surveillance practices and PSA outcomes in nmCRPC patients (pts) treated in clinics with or without IOD. Methods: nmCRPC pts with ≥1 ARI prescription (Rx) were identified in data from 95 US urology practices between 2018-2021. Pts were categorized into 3 groups: (1) Treated in IOD clinic and received ARI onsite within 14 days of Rx (IOD+), (2) Treated in IOD clinic but no onsite ARI receipt within 14 days of Rx (IOD-), and (3) Treated in a clinic without IOD (non-IOD). Descriptive analyses were conducted on pt characteristics, PSA and imaging data. PSA response, reported using Kaplan-Meier rates, was defined as ≥50% reduction in post-index (PI; index date = 14 days after 1st ARI Rx) PSA compared to baseline PSA (measured within 13 weeks before 1st ARI prescription). PSA progression was defined as ≥25% inc...
Journal of the American Academy of Dermatology, 2020
Gene TarGeTinG and Gene CorreCTion i mutation and correction of SMN2 aberrant splicing, by exploi... more Gene TarGeTinG and Gene CorreCTion i mutation and correction of SMN2 aberrant splicing, by exploiting the non-homologous end-joining (NHEJ) pathway. Plasmids encoding Cas9-GFP under the control of CMV promoter, and selected gRNAs downstream to the Pol-III U6 promoter (Addgene) were transfected in HEK-293T cell line and in immortalized myoblasts derived from either healthy donors or SMA patients. Transfection efficiency was estimated as percentage of GFP-expressing cells (20-50% and 1-10%, respectively) and nuclease activity detected by Surveyor assay and target site sequencing. In particular, in SMA patient-derived myoblasts we detected mutations (indels) at the level of the induced DNA double-strand break at ~30% frequency. Levels of SMN restoration will be investigated by qPCR of the different species of SMN transcripts and by western blotting of SMN protein. The goal of this study is to provide an in vitro proof of principle of effective gene correction in SMA patient-derived cells. In the context of a multisystemic, complicated disease such as SMA, targeted genome editing strategy could represent an additional therapeutic tool.
Background: Psoriasis (PsO) is a chronic inflammatory skin disorder that may be associated with c... more Background: Psoriasis (PsO) is a chronic inflammatory skin disorder that may be associated with comorbidities, including inflammatory bowel disease (IBD), given common immunopathogenic mechanisms. Whether PsO patients are more likely to suffer from gastrointestinal (GI) signs and symptoms has not been well-characterized. Understanding their prevalence in PsO patients may inform strategies to evaluate for GI signs and symptoms, screen for those at risk for IBD, and guide choice of therapy. Objective: To assess the prevalence of GI signs and symptoms in patients with moderate-to-severe PsO. Methods: An Internet-based survey was conducted to evaluate GI signs and symptoms in patients with self-reported moderate-to-severe PsO and non-PsO controls. The impact of PsO severity and presence of psoriatic arthritis (PsA) [self-reported and/or screened positive on the Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire] on prevalence of GI signs and symptoms was also assessed. Th...
Abstract Aims To quantify the long-term direct and indirect costs among patients with Crohn’s dis... more Abstract Aims To quantify the long-term direct and indirect costs among patients with Crohn’s disease (CD) and specific subgroups of these patients in the United States from the private payer’s perspective. Materials and methods This retrospective study used the OptumHealth Care Solutions, Inc database (01 January 1999–31 March 2017) to match (1:5) adult patients with ≥2 claims for CD to patients without inflammatory bowel disease (IBD). Patterns observed during follow-up (i.e. biologics, opioids, or steroids; CD-related surgery; moderate-to-severe disease; and comorbidities) were used to identify CD subgroups. Comparisons of healthcare resource utilization, work loss days, and direct and indirect work loss-related costs were made between matched cohorts. Descriptive analyses of costs were conducted within each CD subgroup. Results There were 6,715 and 33,575 patients in the CD and non-IBD cohorts, respectively. The direct burden was significantly higher in the CD cohort compared to the non-IBD cohort, with 0.34 inpatient admissions per patient per year (PPPY) versus 0.12 (217% increase; p < .001), and $24,500 direct healthcare costs PPPY versus $7,037 ($17,463 increase; p < .001). The trend was similar for the indirect burden, with work loss–related costs PPPY of $5,490 in the CD cohort versus $3,322 in the non-IBD cohort ($2,168 increase; p < .001). The burden was numerically higher in the CD subgroups, with direct healthcare costs reaching $101,013 PPPY in the surgery subgroup. Limitations Severity of CD was determined based on claims-based algorithms due to the lack of access to medical files. Absenteeism was imputed based on claims data, and presenteeism was not assessed. Conclusions The direct healthcare and indirect work loss–related costs of patients with CD was significantly higher compared to patients without IBD over an average follow-up of 5 years.
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