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Introduction: Diabetic retinopathy (DR), a microvascular complication of type 2 diabetes mellitus (T2DM), is a leading cause of blindness and has detrimental effects on patients' quality of life. We compared the risk of DR diagnosis with sodium-glucose cotransporter-2 inhibitors (SGLT2i) versus dipeptidyl peptidase-4 inhibitors (DPP-4i) in patients with T2DM in Japan. Methods: This Japanese retrospective cohort study used the JMDC Claims Database (data collected from January 2015 to September 2022). Patients with T2DM and no record of microvascular or macrovascular diseases who were newly treated with an SGLT2i (23,061 patients) or a DPP-4i (53,986 patients) were matched 1:1 using propensity score (10,166 per matched group). Incidence rates (IRs) and cumulative IRs of DR diagnosis were calculated for each treatment group; hazard ratio (HR) and its 95% confidence interval (CI) were calculated using Cox proportional hazard models to compare the risk between the groups. Results: The IR of DR diagnosis was 46.23 and 57.12 per 1000 person-years in the SGLT2i and DPP-4i groups, respectively, with a significantly lower risk in the SGLT2i group than in the DPP-4i group (HR 0.83, 95% CI 0.75–0.92, P = 0.0003). Conclusions: In this study, the risk of DR diagnosis was lower with SGLT2i compared with DPP-4i in patients with T2DM without microvascular and macrovascular diseases in Japan. Findings suggest that early SGLT2i treatment may be beneficial in preventing DR development in early-stage T2DM. Graphical abstract available for this article. [ABSTRACT FROM AUTHOR]

Background: The ideal timing for initiating levodopa in newly diagnosed people with Parkinson's disease (PD) is uncertain due to limited data on the long‐term effects of levodopa. Objective: The aim was to investigate whether early levodopa initiation postpones mortality (primary outcome), the requirement of device‐aided therapies, and the incidence of PD‐related complications, such as fall‐induced injuries. Methods: Using nationwide claims data from Dutch hospitals (2012–2020), we grouped newly diagnosed PD individuals as "early initiators" (initiating levodopa within 2 years of diagnosis) or "nonearly initiators." We used the national death registry to assess mortality and health‐care claims to assess PD‐related complications and device‐aided therapies. We used marginal structural models to compare mortality and device‐aided therapy rates between groups, and a Poisson regression model to compare PD‐related complication rates. Results: Among 29,943 newly diagnosed PD individuals (mean age at diagnosis: 71.6, 38.5% female), there were 24,847 early and 5096 nonearly levodopa initiators. Over a median 4.25 years, 8109 (27.1%) died. The causal risk ratio for mortality was 1.04 (95% confidence interval [CI] 0.92–1.19) for early versus nonearly initiators. The risk ratio of receiving any device‐aided therapy was 3.19 (95% CI 2.56–5.80). No association was observed with incidence of PD‐related complications (incidence rate ratio: 1.00, 95% CI 0.96–1.05). Conclusions: Early levodopa initiation in PD does neither postpone nor accelerate mortality or PD‐related complications, nor does it precipitate earlier occurrence of PD‐related complications or mortality. However, we cannot exclude that the results were influenced by residual confounding due to unmeasured risk factors of mortality. [ABSTRACT FROM AUTHOR]

Purpose: Specialized pressure transducers for arterial pulse waveform analysis (S-APWA) devices are dedicated kits connected to an arterial pressure catheter that monitors hemodynamic parameters, such as cardiac output, pulse pressure variation, and stroke volume variation, less invasively. While the association between the use of S-APWA devices and clinical outcomes in perioperative patients has been previously evaluated, its assessment in patients with septic shock remains inadequate. Materials and Methods: This retrospective cohort study utilized a nationwide Diagnosis Procedure Combination database in Japan. Adult patients with septic shock admitted to the intensive care unit (ICU) with arterial pressure catheter placement on the admission day from August 2012 to February 2021 were included. Hospitalizations meeting the eligibility criteria were categorized into groups based on S-APWA device usage. The primary outcome, evaluated using Cox regression analysis, was 30-day all-cause mortality in the propensity score overlap-weighted population. Secondary outcomes included in-hospital mortality, ICU duration, and overall hospital stay. Results: Among 5130 eligible hospitalizations, 643 were in the S-APWA group and 4487 were in the conventional pressure transducer group. Cox regression analysis within the propensity score overlap-weighted population showed no significant difference in 30-day mortality (adjusted hazard ratio: 0.94; 95% confidence interval: 0.9-1.38; P =.58). Logistic regression analysis indicated no significant differences in the in-hospital mortality. While the S-APWA group had prolonged ICU stays, no significant difference in the overall hospital stay was observed according to linear regression analyses. Conclusions: Our study found no significant association between S-APWA use and 30-day mortality in patients with septic shock. These findings offer insights into optimizing monitoring systems in ICUs. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusionsLong-chain fatty acid oxidation disorders (LC-FAOD) are a group of rare genetic inborn errors of metabolism. Clinical manifestations may result in frequent healthcare visits, hospitalizations, and early death. This retrospective cohort study assessed manifestations, healthcare resource use (HRU), direct medical costs, and the impact of COVID-19 on HRU among patients with LC-FAOD.The IQVIA PharMetrics Plus database was searched for pediatric (0–17 years) and adult (≥18 years) patients with confirmed LC-FAOD (ICD-10-CM Diagnosis Code E71.310) and ≥12 months continuous enrollment (CE) between January 2016-February 2020. A non–LC-FAOD general population cohort was randomly selected and matched using 1:20 exact matching on age, gender, payer type, and CE start year. Manifestations were identified via ICD-10 diagnosis codes (any billing position). Overall HRU and attributable costs were stratified by care setting. Pre-COVID-19 (March 2019–February 2020) and during COVID-19 (March 2020-February 2021) HRU was assessed among a subgroup of patients and the general population. Outcomes were evaluated among children and adults, respectively.423 patients with LC-FAOD (47% female; 79.7% children) were included. The mean enrollment duration was 2.6 ± 1.2 years. 22.6% of children with LC-FAOD had at least one major clinical event (MCE), consisting of rhabdomyolysis (10.1%), hypoglycemia (9.8%), or cardiomyopathy (8.6%) versus 1.5% overall occurrence in the general population. Adults with LC-FAOD had a higher incidence of MCEs (37.2%) than children with LC-FAOD. Annualized all-cause HRU in all care settings and mean total annualized medical costs (children: $17,082 vs $4144; adults: $43,602 vs $3949) were higher in patients with LC-FAOD versus the general population. Patients with LC-FAOD had substantially fewer healthcare visits during COVID-19 across care settings than during the pre-COVID-19 period.LC-FAOD impart a high burden on patients. Extended hospital stays and increased outpatient management were especially pronounced for adults and for patients with ≥1 MCE, resulting in substantially higher medical costs than the general population. [ABSTRACT FROM AUTHOR]

Background: We aimed to evaluate the validity of self-administered questionnaire surveys and face-to-face interview surveys for the detection of Helicobacter pylori eradication therapy. Methods: Participants were a cohort, aged 40-74 years, living in three different locations of Japan, who took part in the baseline survey (2011-2012) of the Japan Public Health Center-based Prospective Study for the Next Generation (JPHC-NEXT). Five years after the baseline survey, a questionnaire and interview survey were independently conducted to determine the history of Helicobacter pylori eradication treatment over the 5-year period. Prescription of Helicobacter pylori eradication medications in national insurance claims data from the baseline survey to the 5-year survey was used as a reference standard. Results: In total, 15,760 questionnaire surveys and 8,006 interview surveys were included in the analysis. There were 3,471 respondents to the questionnaire and 2,398 respondents to the interview who reported having received Helicobacter pylori eradication treatment within the past 5 years. Comparison of the questionnaire survey to national insurance claims data showed a sensitivity of 95.1% (2,213/2,328), specificity of 90.6% (12,174/13,432), positive predictive value of 63.8% (2,213/3,471), negative predictive value of 99.1% (12,174/12,289), and Cohen's Kappa value of 0.71. Respective values of the interview survey were 94.4% (1,694/1,795), 88.7% (5,507/6,211), 70.6% (1,694/2,398), 98.2% (5,507/5,608), and 0.74. Conclusion: Both the questionnaire and the interview showed high sensitivity, high specificity, and good agreement with the insurance claim prescriptions data. Some participants may have received eradication treatment without going through the public insurance claim database, resulting in a low positive predictive value. [ABSTRACT FROM AUTHOR]

David Singer,1 Philippe Thompson-Leduc,2 Siyu Ma,1,3 Deepshekhar Gupta,4 Wendy Y Cheng,5 Selvam R Sendhil,6 Manasvi Sundar,6 Ella Hagopian,5 Nikita Stempniewicz,1 Mei Sheng Duh,5 Sara Poston1 1GSK, US Health Economics and Outcomes Research, Philadelphia, PA, USA; 2Analysis Group, Inc., Health Economics and Outcomes Research, Montreal, QC, Canada; 3Tufts Medical Center, Boston, MA, USA; 4Analysis Group, Inc., Health Economics and Outcomes Research, Menlo Park, CA, USA; 5Analysis Group, Inc., Health Economics and Outcomes Research, Boston, MA, USA; 6Analysis Group, Inc., Health Economics and Outcomes Research, Los Angeles, CA, USACorrespondence: Nikita Stempniewicz, GSK, US Health Economics and Outcomes Research, FMC Tower Suite 1700, 2929 Walnut Street, Philadelphia, PA, 19104, USA, Tel +1 203 803 9909, Email nikita.x.stempniewicz@gsk.comPurpose: Patients with psoriasis (PsO) and psoriatic arthritis (PsA) are at increased risk of herpes zoster (HZ), but healthcare resource use (HRU) and costs relating to HZ in adults with PsA are unknown. We aimed to estimate the incidence of HZ among adults with PsA vs without psoriatic disease and the additional HRU and costs among patients with PsA with vs without HZ.Patients and Methods: This retrospective, longitudinal, cohort study estimated HZ incidence in PsA+ vs PsO–/PsA– cohorts and HRU and medical/pharmacy costs among PsA+/HZ+ vs PsA+/HZ– cohorts comprised of adults from Optum’s de-identified Clinformatics Data Mart Database during 2015– 2020. For the HRU/cost analyses, index was the date of first HZ diagnosis (PsA+/HZ+ cohort) or was randomly assigned (PsA+/HZ– cohort). Generalized linear models were used for adjusted comparisons between cohorts.Results: HZ incidence was higher in the PsA+ (n = 57,126) vs PsO–/PsA– (n = 23,837,237) cohort (14.85 vs 7.67 per 1000 person-years; adjusted incidence rate ratio [aIRR]: 1.23; 95% confidence interval [CI]: 1.16– 1.30). Numbers of outpatient visits, emergency department visits, and inpatient admissions were significantly higher in the PsA+/HZ+ (n = 1045) vs PsA+/HZ– (n = 36,091) cohorts during the first month after HZ diagnosis (outpatient: aIRR: 1.74; 95% CI: 1.63– 1.86; emergency department: 3.14; 95% CI: 2.46– 4.02; inpatient: aIRR: 2.61; 95% CI: 1.89– 3.61). Mean all-cause per-patient costs were significantly higher in the PsA+/HZ+ vs PsA+/HZ– cohorts during the first month after index ($6493 vs $4521; adjusted cost difference: $2012; 95% CI: $1204–$3007). HRU and costs were numerically higher in the PsA+/HZ+ cohort during the first 3 and 12 months.Conclusion: These findings, which provide evidence on the increased incidence and HRU and economic burden associated with HZ among adults with PsA, could be used to inform clinical practice and decision-making.Plain Language Summary: Why was the study done?Psoriatic arthritis affects the joints of around 20% of patients with the skin condition, psoriasis.Patients with psoriatic arthritis are at increased risk of shingles, which can cause a painful skin rash and complications.This study aimed to provide information on how many patients with psoriatic arthritis get shingles and the healthcare use and costs of caring for patients with psoriatic arthritis and shingles.What did the researchers do and find?Using data from a large US health plan database, we estimated that for every 1000 patients with psoriatic arthritis observed for 1 year, 15 will develop shingles.Patients with psoriatic arthritis were 23% more likely to develop shingles than people without psoriatic disease.Patients with psoriatic arthritis and shingles had 2– 3 times as many healthcare visits in the month after a shingles diagnosis as patients with psoriatic arthritis but no shingles.This resulted in an average additional cost of approximately $2000 per patient.What do these results mean?Psoriatic arthritis increases the risk of shingles.The costs associated with shingles in patients with psoriatic arthritis are substantial.Measures to prevent shingles in this population could be beneficial. Keywords: claims database, costs, healthcare resource use, incidence, psoriatic arthritis, United States

Abstract Aims The use of large medical or healthcare claims databases is very useful for population‐based studies on the burden of heart failure (HF). Clinical characteristics and management of HF patients differ according to categories of left ventricular ejection fraction (LVEF), but this information is often missing in such databases. We aimed to develop and validate algorithms to identify LVEF in healthcare databases where the information is lacking. Methods and results Algorithms were built by machine learning with a random forest approach. Algorithms were trained and reinforced using the French national claims database [Système National des Données de Santé (SNDS)] and a French HF registry. Variables were age, gender, and comorbidities, which could be identified by medico‐administrative code‐based proxies, Anatomical Therapeutic Chemical codes for drug delivery, International Classification of Diseases (Tenth Revision) coding for hospitalizations, and administrative codes for any other type of reimbursed care. The algorithms were validated by cross‐validation and against a subset of the SNDS that includes LVEF information. The areas under the receiver operating characteristic curve were 0.84 for the algorithm identifying LVEF ≤ 40% and 0.79 for the algorithms identifying LVEF

Background: Ibrutinib is a Bruton's tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström's macroglobulinemia (WM) and mantle cell lymphoma (MCL). This study aimed to describe the characteristics of CLL patients treated with ibrutinib and its effectiveness, safety, and treatment pattern in real life. Methods: All patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS). An algorithm was developed to identify the disease (CLL, MCL or WM) for which ibrutinib was prescribed. This article focused on CLL patients. The time to next treatment (TTNT) was plotted using Kaplan‒Meier curves. Results: During this period, 6,083 patients initiated ibrutinib, among whom 2,771 (45.6%) patients had CLL (mean age of 74 years; 61% of men). At ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. Most patients (91.7%) were not hospitalized during the exposure period for one of the cardiovascular or bleeding events studied. Hospitalizations were more frequent in patients with a cardiovascular comorbidity (5.9% versus 11.0%, p-value < 0.0001) and aged over 70 (5.9% versus 9.4%, p-value < 0.0001). The median TTNT was not reached. Conclusion: This is one of the largest cohorts of ibrutinib-treated patients in the world. The profile of CLL patients treated with ibrutinib was in accordance with the marketing authorization and reimbursement. This study confirmed effectiveness and safety data. [ABSTRACT FROM AUTHOR]

Introduction: The association between sodium-glucose cotransporter-2 (SGLT2) inhibitors and the risk of urogenital infections remains controversial. This study aimed to investigate the association between SGLT2 inhibitors and the incidence of perineal soft tissue infections, including Fournier's gangrene (FG), genital bacterial infections, and urinary tract infections (UTIs), using administrative claims data in Japan. Methods: In this retrospective cohort study, we utilized the JMDC Claims Database. The study included patients aged 18 years or older diagnosed with type 2 diabetes mellitus, identified by a diagnostic code, who received new prescriptions for SGLT2 inhibitors or dipeptidyl peptidase 4 (DPP-4) inhibitors between April 2014 and August 2020. Using one-to-one propensity score (PS) matching, we compared the incidence of perineal soft tissue infections, including FG, genital bacterial infection, and UTIs between groups treated with SGLT2 and DPP-4 inhibitors. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using the Cox proportional hazards model. Results: We identified 34,897 patients in the SGLT2 inhibitor group and 135,311 patients in the DPP-4 inhibitor group. After one-to-one PS matching, 31,665 pairs were generated. The mean age of the patients was 51 years, with approximately 70% being male. The use of SGLT2 inhibitors was associated with a decreased risk of UTI (HR 0.90, 95% CI 0.83–0.98) and an increased risk of genital bacterial infection (HR 1.23, 95% CI 1.03–1.46) compared to DPP-4 inhibitors. However, no significant association was observed with perineal soft tissue infection (HR 1.05, 95% CI 0.61–1.81). Conclusions: SGLT2 inhibitors were associated with a reduced risk of UTI and an increased risk of genital bacterial infection. They showed no significant association with perineal soft tissue infection when compared to DPP-4 inhibitors. Future research should explore broader demographics, focusing on the elderly and achieving gender balance, to gain a comprehensive understanding of infection risks. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated treatment patterns and clinical outcomes among patients with metastatic triple-negative breast cancer (mTNBC) in real-world clinical settings in Japan. Methods: The treatment patterns, time to next treatment or death (TTNTD), time to treatment discontinuation, adverse events of interest, and medical costs of treating patients with mTNBC in first-, second-, and third-line settings were investigated using data of patients meeting the inclusion criteria between January 2017 and March 2022 in a Japanese medical claims database. The treatment regimens for mTNBC were defined according to the Japanese Breast Cancer Society Clinical Practice Guidelines. Results: In this study, 2236 patients with mTNBC (median age 66.0 years; 99.8% female) were included in the first-line cohort. Of these, 46.6% and 20.8% were included in the second- and third-line cohorts, respectively. The two most frequently used treatments were capecitabine (19.1%) and S-1 (tegafur–gimeracil–oteracil) (14.5%) in the first-line cohort, eribulin (18.3%) and bevacizumab/paclitaxel (14.4%) in the second-line cohort, and eribulin (19.4%) and bevacizumab/paclitaxel (17.5%) in the third-line cohort. The TTNTD shortened as the line of therapy progressed (median 8.0, 6.5, and 5.2 months for the first-, second-, and third-line treatments, respectively). Nausea/vomiting and neutropenia/leukopenia occurred in 62.8% and 18.3% of all patients, respectively. The medical total costs per day were 6.7, 10.2, and 12.9 thousand yen during the first-/second-/third-line treatments, respectively. Conclusion: This study provides insight into current treatment patterns for mTNBC in Japan. The cost–benefit balance worsens with later-line treatment and a high unmet need for mTNBC drug treatment remains. [ABSTRACT FROM AUTHOR]

Background and Aim: The number of older patients with ulcerative colitis is increasing; however, limited data exist regarding the differences between elderly‐ and non‐elderly‐onset ulcerative colitis. We aimed to compare the clinical practice and course of elderly‐onset ulcerative colitis with those of non‐elderly‐onset ulcerative colitis. Methods: We selected older patients with ulcerative colitis and divided them into the elderly‐ and non‐elderly‐onset ulcerative colitis groups according to their age at onset. We compared the cumulative systemic steroid‐free, molecular targeting drug‐free, and surgery‐free rates between the two groups. We performed a multivariate analysis to identify the clinical factors related to systemic steroid administration, the use of molecular targeting drugs, surgery, and death. Results: We collected data of 2669 and 277 elderly and non‐elderly‐onset ulcerative colitis patients, respectively. The cumulative systemic steroid‐free rate of elderly‐onset ulcerative colitis was significantly lower than that of non‐elderly‐onset ulcerative colitis. However, no difference was observed in the cumulative molecular targeting drugs and surgery‐free rates between the two groups. Elderly‐onset ulcerative colitis significantly increased the risk of systemic steroid administration and death but not the use of molecular targeting drugs and surgery. Conclusion: The disease severity of ulcerative colitis and clinical practice may not differ between the elderly‐ and non‐elderly‐onset groups. However, elderly‐onset ulcerative colitis was associated with increased mortality risk. Thus, we need to pay attention to the patients' condition and appropriate timing of surgery for patients with elderly‐onset ulcerative colitis. [ABSTRACT FROM AUTHOR]

Aims: The use of large medical or healthcare claims databases is very useful for population‐based studies on the burden of heart failure (HF). Clinical characteristics and management of HF patients differ according to categories of left ventricular ejection fraction (LVEF), but this information is often missing in such databases. We aimed to develop and validate algorithms to identify LVEF in healthcare databases where the information is lacking. Methods and results: Algorithms were built by machine learning with a random forest approach. Algorithms were trained and reinforced using the French national claims database [Système National des Données de Santé (SNDS)] and a French HF registry. Variables were age, gender, and comorbidities, which could be identified by medico‐administrative code‐based proxies, Anatomical Therapeutic Chemical codes for drug delivery, International Classification of Diseases (Tenth Revision) coding for hospitalizations, and administrative codes for any other type of reimbursed care. The algorithms were validated by cross‐validation and against a subset of the SNDS that includes LVEF information. The areas under the receiver operating characteristic curve were 0.84 for the algorithm identifying LVEF ≤ 40% and 0.79 for the algorithms identifying LVEF < 50% and ≥50%. For LVEF ≤ 40%, the reinforced algorithm identified 50% of patients in the validation dataset with a positive predictive value of 0.88 and a specificity of 0.96. The most important predictive variables were delivery of HF medication, sex, age, hospitalization, and testing for natriuretic peptides with different orders of positive or negative importance according to the LVEF category. Conclusions: The algorithms identify reduced or preserved LVEF in HF patients within a nationwide healthcare claims database with high positive predictive value and low rates of false positives. [ABSTRACT FROM AUTHOR]

Brentuximab vedotin (BV) monotherapy (BV-M) and combination (BV-C) therapies are safe and effective for classical Hodgkin lymphoma (cHL) and CD30-expressing peripheral T-cell lymphomas (PTCLs). Although the sample sizes have been small (12–29 patients), in clinical studies, response rates of 53–88% have been reported for BV retreatment in patients with an initial BV response. We evaluated the real-world characteristics and treatment patterns of cHL/PTCL patients who received BV and were retreated in the United States. Symphony Health Patient Claims (11/2013–1/2022) were retrospectively analyzed to identify cHL/PTCL patients treated with BV and retreated with BV-M, BV-C, or non-BV therapy. Patient characteristics were described by retreatment, and predictors of BV-M retreatment were identified. Among the cHL and PTCL patients treated with BV (n = 6442 and 2472, respectively), 13% and 12%, respectively, were retreated with BV; the median times from initial BV to BV-M retreatment were 5 and 7 months, respectively; and the numbers of BV-M retreatment doses were 4 and 5, respectively. Among cHL patients, the predictors of BV-M retreatment were age (18–39 vs. ≥60 years), sex (women vs. men), and previous stem cell transplantation (yes vs. no). Among PTCL patients, the only predictor of BV-M retreatment was systemic anaplastic large-cell lymphoma subtype (yes vs. no). Real-world data support clinical study results suggesting earlier BV treatment be considered, as BV retreatment may be an option.

Brentuximab vedotin (BV) monotherapy (BV-M) and combination (BV-C) therapies are safe and effective for classical Hodgkin lymphoma (cHL) and CD30-expressing peripheral T-cell lymphomas (PTCLs). Although the sample sizes have been small (12–29 patients), in clinical studies, response rates of 53–88% have been reported for BV retreatment in patients with an initial BV response. We evaluated the real-world characteristics and treatment patterns of cHL/PTCL patients who received BV and were retreated in the United States. Symphony Health Patient Claims (11/2013–1/2022) were retrospectively analyzed to identify cHL/PTCL patients treated with BV and retreated with BV-M, BV-C, or non-BV therapy. Patient characteristics were described by retreatment, and predictors of BV-M retreatment were identified. Among the cHL and PTCL patients treated with BV (n = 6442 and 2472, respectively), 13% and 12%, respectively, were retreated with BV; the median times from initial BV to BV-M retreatment were 5 and 7 months, respectively; and the numbers of BV-M retreatment doses were 4 and 5, respectively. Among cHL patients, the predictors of BV-M retreatment were age (18–39 vs. ≥60 years), sex (women vs. men), and previous stem cell transplantation (yes vs. no). Among PTCL patients, the only predictor of BV-M retreatment was systemic anaplastic large-cell lymphoma subtype (yes vs. no). Real-world data support clinical study results suggesting earlier BV treatment be considered, as BV retreatment may be an option. [ABSTRACT FROM AUTHOR]

Purpose: Validated algorithms (VAs) in insurance claims databases are often used to estimate the prevalence and incidence of comorbidities and evaluate safety signals. However, although they are then used in different data sources or subpopulations from those in which they were developed the replicability of these VAs are rarely tested, making their application and performance in these settings potentially unknown. This paper describes testing multiple VAs used to identify incident breast cancer cases in a general population and in an indication‐specific population, patients with atopic dermatitis (AD). Methods: Two algorithms were tested in multiple insurance claims databases and four cohorts were created. Modifications were made to account for the US insurance setting. The resulting incidence rates (IRs) were then compared across algorithms and against surveillance, epidemiology, and end results (SEER) estimates to assess reliability. Results: Algorithm 1 produced low IRs compared to Algorithm 2. Algorithm 2 provided similar estimates to those of SEER. Individuals in the AD cohorts experienced lower incident breast cancer cases than those in the general population cohorts. Conclusion: Regardless of an algorithm's reported accuracy, the original study setting and targeted population for the VAs may matter when attempting to replicate the algorithm in an indication‐specific subpopulation or varying data sources. Investigators should use caution and conduct sensitivity analyses or use multiple algorithms when attempting to calculate incidence or prevalence estimates using VAs. [ABSTRACT FROM AUTHOR]

Objectives: Assess the relationship between public interest in ankyloglossia as determined by internet search volume and real‐world medical claims data. Study Design: Retrospective Cohort Study. Setting: This retrospective cohort study was conducted using claims data from the Merative™ Marketscan® Research Databases. The internet search data was collected from Google Trends. Methods: Annual Google Trends data were compiled using search terms associated with "ankyloglossia" and "frenotomy" for the years 2011 to 2021. We obtained incidence of ankyloglossia diagnoses and frenotomy procedures in children under 12 months from Marketscan relative to all infants enrolled. We compared associations between search and incidence data among US states and over time. Results: Google search correlated with ankyloglossia incidence (r = 0.4104, P =.0031) and with frenotomy incidence (r = 0.4062, P =.0034) per state. Ankyloglossia diagnoses increased with Google search index (coefficient = 0.336, 95% confidence interval [CI] 0.284, 0.388) and year (coefficient = 0.028, 95% CI 0.025, 0.031). Similarly, frenotomy procedures increased with Google search index (coefficient = 0.371, 95% CI 0.313, 0.429) and year (coefficient = 0.027, 95% CI 0.024, 0.030). Conclusions: Associations between online ankyloglossia search trends and both diagnosis and treatment rates, persist across US regions and timeframes. Internet search trends are pivotal in shaping pediatric health care decisions, driving clinical consensus, and disseminating evidence‐based information. [ABSTRACT FROM AUTHOR]

Introduction: Pulmonary hypertension (PH) is often complicated by chronic lung diseases (CLDs) such as chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). Differentiating between PH associated with CLD (group 3 PH) and pulmonary arterial hypertension (PAH) in CLD is often difficult and reporting on the efficacy of PAH-specific therapies is inconsistent as a result of the lack of understanding of the heterogeneity of patients with PH. Methods: A retrospective observational cohort study was conducted to understand the baseline characteristics, comorbidities, and treatment profiles of patients with PH in CLD in a real-world setting using a large-scale claims database (Medical Data Vision). Administrative and clinical data for patients admitted to acute-care hospitals in Japan between April 2008 and January 2021 were analyzed. Results: A total of 115,921 patients with CLD (109,578 with COPD and 6343 with ILD, of whom 569 and 176 had PH, respectively) were analyzed. This study found lower PH diagnosis rates among patients with COPD and patients with ILD than in previous studies. The majority of PH with CLD patients were elderly (mean age 75.7 years) and male (80.81%). Among patients with CLD prescribed PAH-specific therapies (105 patients with COPD; 64 patients with ILD), most received these as monotherapy (COPD, 84.76%; ILD, 75.56%); the most common were phosphodiesterase 5 inhibitors (COPD, 42.70%; ILD, 18.37%), prostacyclins (oral; COPD, 48.31%; ILD, 24.49%), and endothelin receptor antagonists (ERA) (COPD, 8.99%; ILD, 18.37%). Comorbidities (e.g., pulmonary, cardiac, kidney), home oxygen therapy (HOT), and echocardiography (ECHO) were factors associated with the diagnosis of PH. Conclusion: This is the first study using an administrative database that provides real-world data on patients with PH in CLD in Japan. Our results indicate that PH may be misdiagnosed or underdiagnosed in Japan which may lead to suboptimal treatment for patients, and supports the need for further evidence to guide appropriate treatment. Plain Language Summary: Pulmonary hypertension is a disorder affecting the arteries in the lungs and the right heart. It can be associated with a variety of heart and lung conditions, including many chronic lung diseases such as chronic obstructive pulmonary disease and interstitial lung disease. Patients with pulmonary hypertension with chronic lung disease and/or hypoxia can be hard to tell apart from patients with pulmonary arterial hypertension coinciding with chronic lung disease. In Japan, there is not enough data on patient demographics and their disease characteristics for patients with pulmonary hypertension and chronic lung disease, including treatment profiles, and disease management. We identified these patients from a large medical claims database in Japan and analyzed their data. Our study focused on the use of therapies for pulmonary arterial hypertension on patients with pulmonary hypertension and chronic lung disease. The diagnosis rates of pulmonary hypertension for patients with chronic obstructive pulmonary disease and interstitial lung disease were low compared to previous reports, meaning patients with pulmonary hypertension may be misdiagnosed or underdiagnosed which may be resulting in suboptimal treatments. Furthermore, the majority of patients with pulmonary hypertension treated with pulmonary arterial hypertension medication received a single drug as treatment, even though the guidelines recommend the use of combination therapies in certain situations. This study emphasizes the need for further evidence generation for improvements in diagnoses and treatment of patients with pulmonary hypertension in Japan. [ABSTRACT FROM AUTHOR]

Abstract Background and Aim The number of older patients with ulcerative colitis is increasing; however, limited data exist regarding the differences between elderly‐ and non‐elderly‐onset ulcerative colitis. We aimed to compare the clinical practice and course of elderly‐onset ulcerative colitis with those of non‐elderly‐onset ulcerative colitis. Methods We selected older patients with ulcerative colitis and divided them into the elderly‐ and non‐elderly‐onset ulcerative colitis groups according to their age at onset. We compared the cumulative systemic steroid‐free, molecular targeting drug‐free, and surgery‐free rates between the two groups. We performed a multivariate analysis to identify the clinical factors related to systemic steroid administration, the use of molecular targeting drugs, surgery, and death. Results We collected data of 2669 and 277 elderly and non‐elderly‐onset ulcerative colitis patients, respectively. The cumulative systemic steroid‐free rate of elderly‐onset ulcerative colitis was significantly lower than that of non‐elderly‐onset ulcerative colitis. However, no difference was observed in the cumulative molecular targeting drugs and surgery‐free rates between the two groups. Elderly‐onset ulcerative colitis significantly increased the risk of systemic steroid administration and death but not the use of molecular targeting drugs and surgery. Conclusion The disease severity of ulcerative colitis and clinical practice may not differ between the elderly‐ and non‐elderly‐onset groups. However, elderly‐onset ulcerative colitis was associated with increased mortality risk. Thus, we need to pay attention to the patients' condition and appropriate timing of surgery for patients with elderly‐onset ulcerative colitis.

Background: This cohort study aimed to estimate incidence rates of femoral shaft fracture in patients who were treated with antiresorptive drugs. Methods: We used data from the National Database of Health Insurance Claims of Japan from April 2009 and October 2016. All patients with new use of an antiresorptive drug, prescription-free period of ≥3 months, and no prior femoral fractures were included. Femoral shaft fractures were identified using a validated definition based on International Classification of Diseases, 10th revision (ICD-10) codes. Incidence rate ratios were estimated using Poisson regression, with adjustment for sex, age, and the Charlson Comorbidity Index. Results: We identified 7,958,655 patients (women: 88.4%; age ≥75 years: 51.2%). Femoral shaft fractures were identified in 22,604 patients. Incidence rates per 100,000 person-years were 74.8 for women, 30.1 for men, 30.1 for patients aged ≤64 years, 47.7 for patients aged 65–74 years, and 99.0 for patients aged ≥75 years. Adjusted incidence rate ratios in patients taking versus not taking each type of antiresorptive drug were 1.00 (95% confidence interval [CI], 0.98–1.03) for bisphosphonates, 0.46 (95% CI, 0.44–0.48) for selective estrogen receptor modulators, 0.24 (95% CI, 0.18–0.32) for estrogens, 0.75 (95% CI, 0.71–0.79) for calcitonins, and 0.93 (95% CI, 0.84–1.03) for denosumab. The adjusted incidence rate ratio for alendronate was 1.18 (95% CI, 1.14–1.22). Conclusion: The incidence rates of femoral shaft fracture varied across patients treated with different antiresorptive drugs. Further research on a specific antiresorptive drug can increase understanding of the risk of femoral shaft fracture.

Background: Myocardial infarction (MI), stroke, peripheral arterial disease (PAD), heart failure (HF) and chronic kidney disease (CKD) are common cardiovascular renal diseases (CVRD) manifestations for type 2 diabetes. The objective was to estimate the incidence of the first occurring CVRD manifestation and cumulative hospitalization costs of each CVRD manifestation for type 2 diabetes without CVRD history. Methods: A cohort study of all type 2 diabetes free of CVRD as of January 1st 2014, was identified and followed-up for 5 years within the French SNDS nationwide claims database. The cumulative incidence of the first occurring CVRD manifestation was estimated using the cumulative incidence function, with death as a competing risk. Cumulative hospitalization costs of each CVRD manifestations were estimated from the perspective of all payers. Results: From 2,079,089 type 2 diabetes without cancer or transplantation, 76.5% were free of CVRD at baseline with a mean age of 65 years, 52% of women and 7% with microvascular complications history. The cumulative incidence of a first CVRD manifestation was 15.3% after 5 years of follow-up with a constant linear increase over time for all CVRD manifestations: The most frequent was CKD representing 40.6% of first occurred CVRD manifestation, followed by HF (23.0%), then PAD (13.5%), stroke (13.2%) and MI (9.7%). HF and CKD together reached about one patient out of ten after 5 years and represented 63.6% of first CVRD manifestations. The 5-year global cost of all CVRD hospitalizations was 3.9 billion euros (B€), i.e. 2,450€ per patient of the whole cohort, with an exponential increase over time for each specific CVRD manifestation. The costliest was CKD (2.0 B€), followed by HF (1.2 B€), then PAD (0.7 B€), stroke (0.6 B€) and MI (0.3 B€). Conclusions/interpretation: While MI, stroke and PAD remain classic major risks of complications for CVRD-free type 2 diabetes, HF and CKD nowadays represent individually a higher risk and cost than each of these classic manifestations, and jointly represents a risk and a cost twice as high as these three classic manifestations all together. This should encourage the development of specific HF and CKD preventive strategies. [ABSTRACT FROM AUTHOR]

Background Although thyroid eye disease (TED) can impact social and psychological well-being, the epidemiological evidence of TED is lacking in Japan. Methods Nationwide claims databases provided by JMDC Inc. and Medical Data Vision Co. Ltd. and national population statistics are used. Three TED definitions ranging from a strict definition only including a TED diagnosis to a broad definition including a TED diagnosis and considering ocular symptoms are considered. The proportion of patients by severity and disease activity are estimated based on definitions that would allow identification of those patients within the claims data. Results The incidence rate per 100 000 person-years ranged from 7.3 to 11.1 for the strict and broad TED definitions, respectively. For fiscal year 2020 (April 2020 to March 2021) the prevalence rate ranged between 24.65 (strict TED) and 37.58 (broad TED) per 100 000 persons. These correspond to 25 383 and 38 697 patients for the strict and broad TED definitions, respectively. Regardless of the definition used, a predominance of female patients was observed, and the highest burden of the disease was seen in the age group of 35 to 59. Mild and inactive forms of TED were predominant (about 85% and 74%, respectively). Conclusion The incidence and prevalence of TED in Japan were 7.3 to 11.1 per 100 000 person-years and 24.65 to 37.58 per 100 000 persons, respectively. The robust results of this database study add valuable real-world evidence on the incidence and prevalence of TED in Japan. [ABSTRACT FROM AUTHOR]

Purpose: Chemotherapy-induced peripheral neuropathy (CIPN) has been reported to reduce patients’ quality of life and impair cancer treatment by causing anticancer drug withdrawal or interruption. However, there are currently no effective methods for the prevention of CIPN. Renin–angiotensin–aldosterone system (RAAS) inhibitors may be associated with a reduced risk of developing oxaliplatin-induced peripheral neuropathy, and it would be valuable to examine whether they have the same effect on CIPN caused by other anticancer drugs. Our study explored the potential preventive effects of RAAS inhibitors on preventing paclitaxel-induced peripheral neuropathy (PIPN). Methods: An exploratory cohort study was conducted using commercially available administrative claims data on lung cancer patients treated with paclitaxel-based chemotherapy. Cumulative paclitaxel doses, RAAS inhibitor prescriptions, and incidences of PIPN were identified using patient medical records. Fine–Gray analyses with death as a competing risk were performed. A propensity score approach was applied to address the problem of confounding. Results: Patients with lung cancer who received paclitaxel-based chemotherapy were classified into users of RAAS inhibitor (n = 1320) and non-users of RAAS inhibitor (n = 4566). The doses of RAAS inhibitors in our study were similar to those commonly used to treat hypertension. The PIPN incidence was significantly lower in users of RAAS inhibitor than in the non-users of RAAS inhibitor (sub-distribution hazard ratio, 0.842; 95% confidence interval, 0.762–0.929). The result was consistent in various sensitivity analyses and important subgroup analyses. Conclusions: RAAS inhibitors at doses commonly used for hypertension were associated with a reduced incidence of PIPN in patients with lung cancer. [ABSTRACT FROM AUTHOR]

Abstract Introduction Pulmonary hypertension (PH) is often complicated by chronic lung diseases (CLDs) such as chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). Differentiating between PH associated with CLD (group 3 PH) and pulmonary arterial hypertension (PAH) in CLD is often difficult and reporting on the efficacy of PAH-specific therapies is inconsistent as a result of the lack of understanding of the heterogeneity of patients with PH. Methods A retrospective observational cohort study was conducted to understand the baseline characteristics, comorbidities, and treatment profiles of patients with PH in CLD in a real-world setting using a large-scale claims database (Medical Data Vision). Administrative and clinical data for patients admitted to acute-care hospitals in Japan between April 2008 and January 2021 were analyzed. Results A total of 115,921 patients with CLD (109,578 with COPD and 6343 with ILD, of whom 569 and 176 had PH, respectively) were analyzed. This study found lower PH diagnosis rates among patients with COPD and patients with ILD than in previous studies. The majority of PH with CLD patients were elderly (mean age 75.7 years) and male (80.81%). Among patients with CLD prescribed PAH-specific therapies (105 patients with COPD; 64 patients with ILD), most received these as monotherapy (COPD, 84.76%; ILD, 75.56%); the most common were phosphodiesterase 5 inhibitors (COPD, 42.70%; ILD, 18.37%), prostacyclins (oral; COPD, 48.31%; ILD, 24.49%), and endothelin receptor antagonists (ERA) (COPD, 8.99%; ILD, 18.37%). Comorbidities (e.g., pulmonary, cardiac, kidney), home oxygen therapy (HOT), and echocardiography (ECHO) were factors associated with the diagnosis of PH. Conclusion This is the first study using an administrative database that provides real-world data on patients with PH in CLD in Japan. Our results indicate that PH may be misdiagnosed or underdiagnosed in Japan which may lead to suboptimal treatment for patients, and supports the need for further evidence to guide appropriate treatment.

Abstract Introduction Patients with psoriasis (PsO) are at increased risk of herpes zoster (HZ), but recent data on the incidence of HZ among patients with PsO and the impact of HZ on healthcare resource use (HRU) and costs for patients with PsO have not been described. Methods This retrospective, longitudinal, cohort study estimated HZ incidence in cohorts of adults with vs without PsO (PsO + vs PsO–) and HRU and costs among those with PsO, with vs without HZ (PsO + /HZ + vs PsO + /HZ–) using Optum’s de-identified Clinformatics Data Mart Database during 2015–2020. Patients with psoriatic arthritis were excluded from all four cohorts. Comparisons between cohorts used generalized linear models to adjust outcomes based on various baseline characteristics. Results The incidence rate of HZ was significantly higher in the PsO + (n = 144,115) vs PsO– (n = 23,837,237) cohorts at 11.35 vs 7.67 per 1000 patient-years; adjusted incidence rate ratio (aIRR): 1.21, 95% confidence interval (CI): 1.16–1.25. HRU (outpatient, emergency department, and inpatient) was significantly higher in the PsO + /HZ + (n = 1859) vs PsO + /HZ– (n = 78,664) cohorts during 1 month and 3 months after HZ diagnosis (e.g., outpatient visits during month: 2.83 vs 1.30 per patient; aIRR: 1.96; 95% CI 1.86–2.06). Mean all-cause costs were also significantly higher in the PsO + /HZ + vs PsO + /HZ– cohort during both month ($5020 vs $2715 per patient; adjusted cost difference: $1390; 95% CI $842–$1964) and 3 months ($12,305 vs $8256; adjusted cost difference: $1422; 95% CI $280–$2889) after HZ diagnosis. Conclusion These findings show the increased incidence of HZ among patients with PsO and the clinical and economic burdens of HZ in this population. Considering the high prevalence of PsO, insights into the impact of HZ in these patients provide valuable evidence to inform clinical decision-making. Graphical abstract

Abstract Background Sickle cell disease (SCD) is a major public health concern in sub-Saharan Africa, accounting for nearly 75% of the global disease burden. The current analysis evaluated patient characteristics, treatment patterns, healthcare resource utilization (HCRU) and associated costs in patients with SCD based on a Private Medical Insurance Database in Ghana. Methods This retrospective longitudinal cohort study was conducted using an e-claims database from Ghana (01 January 2015 to 31 March 2021). Patients were stratified by age (0 month to

Compared with notifiable disease surveillance, claims-based algorithms estimate higher Lyme disease incidence, but their accuracy is unknown. We applied a previously developed Lyme disease algorithm (diagnosis code plus antimicrobial drug prescription dispensing within 30 days) to an administrative claims database in Massachusetts, USA, to identify a Lyme disease cohort during July 2000–June 2019. Clinicians reviewed and adjudicated medical charts from a cohort subset by using national surveillance case definitions. We calculated positive predictive values (PPVs). We identified 12,229 Lyme disease episodes in the claims database and reviewed and adjudicated 128 medical charts. The algorithmʼs PPV for confirmed, probable, or suspected cases was 93.8% (95% CI 88.1%–97.3%); the PPV was 66.4% (95% CI 57.5%–74.5%) for confirmed and probable cases only. In a high incidence setting, a claims-based algorithm identified cases with a high PPV, suggesting it can be used to assess Lyme disease burden and supplement traditional surveillance data.

Abstract Introduction Prior research has demonstrated that early treatment with high-efficacy disease-modifying therapies (DMTs), including ocrelizumab (OCR), can reduce relapses and delay disease progression among persons with multiple sclerosis (pwMS) compared with escalation from low-/moderate-efficacy DMTs. However, there is a lack of research examining the impact of early use of OCR on real-world clinical and economic outcomes. This study aimed to evaluate differences in events often associated with a relapse (EOAR) as well as non-DMT healthcare resource use (HCRU) and costs among pwMS who received OCR as a first-line treatment compared with later-line treatment after diagnosis. Methods Newly diagnosed adult pwMS were selected from deidentified Optum Market Clarity claims data (study period: January 1, 2015–June 30, 2021). All pwMS were required to have initiated OCR after diagnosis and have 12 months of continuous eligibility prior to diagnosis. The index date was the date of initiation of the first-line DMT after diagnosis. pwMS who initiated OCR as first-line (1L OCR cohort) or a second- or later-line treatment (2L + OCR cohort) were matched 1:1 based on length of continuous eligibility after the first-line DMT and weighted using stabilized inverse probability of treatment. In the follow-up period, differences in outcomes, including annualized EOAR, non-DMT HCRU and costs, were evaluated for pwMS in the 1L vs. 2L + OCR cohorts. Results The sample included 748 pwMS. During the follow-up period, pwMS in the 1L OCR cohort had a significantly lower annual rate of EOAR compared with pwMS in the 2L + OCR cohort (0.37 vs. 0.56; difference: 0.20 [95% CI 0.08, 0.32]). pwMS in the 1L OCR cohort had a significantly lower probability of any hospitalization within 1 year, fewer non-DMT outpatient visits and lower all-cause and MS-related, non-DMT costs compared with pwMS in the 2L + OCR cohort. Conclusions First-line initiation OCR was associated with improvements in clinical and non-DMT economic outcomes compared with later-line initiation of OCR, suggesting that early initiation may benefit both patients and the healthcare system.

Abstract Background Medications influencing the risk of fall-related injuries (FRIs) in older adults have been inconsistent in previous guidelines. This study employed case–control design to assess the association between FRIs and medications, and an additional case-crossover design was conducted to examine the consistency of the associations and the transient effects of the medications on FRIs. Methods This study was conducted using a national claims database (2002–2015) in Korea. Older adults (≥ 65 years) who had their first FRI between 2007 and 2015 were matched with non-cases in 1:2 ratio. Drug exposure was examined for 60 days prior to the date of the first FRI (index date) in the case–control design. The hazard period (1–60 days) and two control periods (121–180 and 181–240 days prior to the index date) were investigated in the case-crossover design. The risk of FRIs with 32 medications was examined using conditional logistic regression after adjusting for other medications that were significant in the univariate analysis. In the case-crossover study, the same conditional model was applied. Results In the case–control design, the five medications associated with the highest risk of FRIs were muscle relaxants (adjusted odd ratio(AOR) = 1.35, 95% confidence interval (CI) = 1.31–1.39), anti-Parkinson agents (AOR = 1.30, 95%CI = 1.19–1.40), opioids (AOR = 1.23, 95%CI = 1.19–1.27), antiepileptics (AOR = 1.19, 95%CI = 1.12–1.26), and antipsychotics (AOR = 1.16, 95%CI = 1.06–1.27). In the case-crossover design, the five medications associated with the highest risk of FRIs were angiotensin II antagonists (AOR = 1.87, 95%CI = 1.77–1.97), antipsychotics (AOR = 1.63, 95%CI = 1.42–1.83), anti-Parkinson agents (AOR = 1.58, 95%CI = 1.32–1.85), muscle relaxants (AOR = 1.42, 95%CI = 1.35–1.48), and opioids (AOR = 1.35, 95%CI = 1.30–1.39). Conclusions Anti-Parkinson agents, opioids, antiepileptics, antipsychotics, antidepressants, hypnotics and sedatives, anxiolytics, muscle relaxants, and NSAIDs/antirheumatic agents increased the risk of FRIs in both designs among older adults. Medications with a significant risk only in the case-crossover analysis, such as antithrombotic agents, calcium channel blockers, angiotensin II antagonists, lipid modifying agents, and benign prostatic hypertrophy agents, may have transient effects on FRIs at the time of initiation. Corticosteroids, which were only associated with risk of FRIs in the case–control analysis, had more of cumulative than transient effects on FRIs.

Background/purpose: As the occurrence of second primary cancers (SPCs) is strongly related to the survival rate of patients with oral and pharyngeal cancers, early detection and treatment are important. Therefore, this study aimed to clarify the incidence of SPCs and their risk factors in patients with oral and pharyngeal cancer. Materials and methods: This observational study was conducted using data from the administrative claims database of 21,736 participants with oral and pharyngeal cancer from January 2005 to December 2020. We evaluated the cumulative incidence of SPCs among patients with oral and pharyngeal cancers using the Kaplan–Meier method. The Cox proportional-hazard model was used for multivariate analysis. Results: Of the 1633 patients with oral and pharyngeal cancer who qualified for analysis, 388 developed SPCs (incidence rate, 7.994/1000 person-months). The multivariate analysis showed that the risk of developing SPCs was affected by age at diagnosis of oral and pharyngeal cancer, cancer treatment, and anatomical site of the primary cancer. Conclusion: Patients with oral and pharyngeal cancers are at a high risk of developing SPCs. The data from this study may be useful in providing accurate information to patients with oral and oropharyngeal cancer.

Background: Evidence of factors associated with Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from population-based studies is scarce. Objective: We aimed to identify the incidence, risk factors, and drugs that trigger the development of SJS/TEN in the general population. Methods: A regional, population-based, longitudinal cohort with 2,398,393 Japanese individuals was analyzed using the Shizuoka Kokuho Database from 2012 to 2020. Results: Among 1,909,570 individuals, 223 (0.01%, 2.3 cases/100,000 person-years) patients were diagnosed with SJS/TEN during the observational period of a maximum of 7.5 years. In a multivariable analysis, the risks of SJS/TEN were an older age, and the presence of type 2 diabetes, peripheral vascular disease, and systemic autoimmune diseases. The administration of drugs, such as immune checkpoint inhibitors, insulin, and type 2 diabetes agents, triggered the onset of SJS/TEN. Limitations: The results may apply only to the Japanese population. Conclusion: In this cohort population from a database representing the general population, the risks of developing SJS/TEN were old age and a history of type 2 diabetes, peripheral vascular disease, and systemic autoimmune disease. Furthermore, in addition to previously reported drugs, the administration of immune checkpoint inhibitors, insulin, and type 2 diabetes agents, may trigger the development of SJS/TEN.

Introduction: Patients with psoriasis (PsO) are at increased risk of herpes zoster (HZ), but recent data on the incidence of HZ among patients with PsO and the impact of HZ on healthcare resource use (HRU) and costs for patients with PsO have not been described. Methods: This retrospective, longitudinal, cohort study estimated HZ incidence in cohorts of adults with vs without PsO (PsO + vs PsO–) and HRU and costs among those with PsO, with vs without HZ (PsO + /HZ + vs PsO + /HZ–) using Optum's de-identified Clinformatics Data Mart Database during 2015–2020. Patients with psoriatic arthritis were excluded from all four cohorts. Comparisons between cohorts used generalized linear models to adjust outcomes based on various baseline characteristics. Results: The incidence rate of HZ was significantly higher in the PsO + (n = 144,115) vs PsO– (n = 23,837,237) cohorts at 11.35 vs 7.67 per 1000 patient-years; adjusted incidence rate ratio (aIRR): 1.21, 95% confidence interval (CI): 1.16–1.25. HRU (outpatient, emergency department, and inpatient) was significantly higher in the PsO + /HZ + (n = 1859) vs PsO + /HZ– (n = 78,664) cohorts during 1 month and 3 months after HZ diagnosis (e.g., outpatient visits during month: 2.83 vs 1.30 per patient; aIRR: 1.96; 95% CI 1.86–2.06). Mean all-cause costs were also significantly higher in the PsO + /HZ + vs PsO + /HZ– cohort during both month ($5020 vs $2715 per patient; adjusted cost difference: $1390; 95% CI $842–$1964) and 3 months ($12,305 vs $8256; adjusted cost difference: $1422; 95% CI $280–$2889) after HZ diagnosis. Conclusion: These findings show the increased incidence of HZ among patients with PsO and the clinical and economic burdens of HZ in this population. Considering the high prevalence of PsO, insights into the impact of HZ in these patients provide valuable evidence to inform clinical decision-making. Plain Language Summary: Psoriasis is an inflammatory condition that causes flaky, scaly skin. Herpes zoster (shingles) causes a painful rash, usually on the abdomen. However, recent data on the proportion of patients with psoriasis who develop herpes zoster is lacking. Furthermore, little is known about the healthcare resources that are used or the costs of care for patients with psoriasis who develop herpes zoster. We found that patients with psoriasis were 21% more likely to have herpes zoster than patients without psoriasis. Among patients with psoriasis, those who developed herpes zoster had twice as many doctor's visits, 3 times as many emergency department visits, and twice as many inpatient hospital stays during the month after a herpes zoster diagnosis as patients without herpes zoster. This resulted in an additional cost of $1390 per patient with psoriasis and herpes zoster compared with those with psoriasis but without herpes zoster. Overall, patients with psoriasis are at increased risk of developing herpes zoster and the healthcare resource use and associated cost of treating herpes zoster in patients with psoriasis is substantial. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study was to present the first nation‐wide, systematic, repeated assessment of doctor‐shopping (i.e. visiting multiple physicians to be prescribed the same drug) during 10 years for more than 200 psychoactive prescription drugs in the 67 million inhabitants in France. Design: This was a nation‐wide, repeated cross‐sectional study. Setting and Participants: Data are from the French National Health Data System in 2010, 2015 and 2019 for 214 psychoactive prescription drugs (i.e. anaesthetics, analgesics, antiepileptics, anti‐Parkinson drugs, psycholeptics, psychoanaleptics, other nervous system drugs and antihistamines for systemic use). Measurements The detection and quantification of doctor‐shopping relied upon an algorithm that detects overlapping prescriptions from repeated visits to different physicians. We used two doctor‐shopping indicators aggregated at population level for each drug dispensed to more than 5000 patients: (i) the quantity doctor‐shopped, expressed in defined daily doses (DDD), which measures the total quantity doctor‐shopped by the study population for a given drug; and (ii) the proportion doctor‐shopped, expressed as a percentage, which standardizes the quantity doctor‐shopped according to the use level of the drug. Findings The analyses included approximately 200 million dispensings to approximately 30 million patients each year. Opioids (e.g. buprenorphine, methadone, morphine, oxycodone and fentanyl), benzodiazepines and non‐benzodiazepine hypnotics (Z‐drugs) (e.g. diazepam, oxazepam, zolpidem and clonazepam) had the highest proportions doctor‐shopped during the study period. In most cases, the proportion and the quantity doctor‐shopped increased for opioids and decreased for benzodiazepines and Z‐drugs. Pregabalin had the sharpest increase in the proportion doctor‐shopped (from 0.28 to 1.40%), in parallel with a sharp increase in the quantity doctor‐shopped (+843%, from 0.7 to 6.6 DDD/100 000 inhabitants/day). Oxycodone had the sharpest increase in the quantity doctor‐shopped (+1000%, from 0.1 to 1.1 DDD/100 000 inhabitants/day), in parallel with a sharp increase in the proportion doctor‐shopped (from 0.71 to 1.41%). Detailed results for all drugs during the study period can be explored interactively at: https://soeiro.gitlab.io/megadose/. Conclusions: In France, doctor‐shopping occurs for many drugs from many pharmacological classes, and mainly involves opioid maintenance drugs, some opioids analgesics, some benzodiazepines and Z‐drugs and pregabalin. [ABSTRACT FROM AUTHOR]

Aim: Intravenous tocilizumab (TCZ‐IV) was approved for the treatment of adult Still's disease (ASD) in Japan in May 2019 based on its efficacy and safety in a phase III randomized controlled trial. This study determined treatment patterns in patients with ASD and assessed oral glucocorticoid (GC) dose changes after TCZ‐IV administration in Japanese clinical practice. Methods: Patients in the Medical Data Vision database aged 16 years or older with one or more of International Classification of Diseases, 10th revision codes M061 (ASD) or M082 (systemic juvenile idiopathic arthritis) during January 2017–March 2021 (cohort 1) and those initiating TCZ‐IV during May 2019–March 2021 (cohort 2) were included. Results: In cohort 1, the proportion of patients who were prescribed interleukin‐6 inhibitors (mainly TCZ‐IV) increased from 10.8% (January–April 2019 [before TCZ‐IV approval]; n = 2002) to 18.3% (January–March 2021 [after TCZ‐IV approval]; n = 2008). In cohort 2 (n = 193), 84.5% of patients were on oral GCs (≤5 mg/day: 23.8%) at index date (initial TCZ‐IV prescription date); 46/70 (65.7%) were on oral GC at 5 mg/day or higher 12 months after TCZ‐IV treatment (primary outcome). After 12 months of treatment, the TCZ‐IV retention rate was 73.6% and the TCZ‐IV administration interval was every 4 weeks and every 2 weeks in 31.9% and 27.7% of patients, respectively. Conclusion: The use of interleukin‐6 inhibitors increased by 7.5% points in Japanese patients with ASD ~2 years after TCZ‐IV approval, suggesting that an unmet medical need existed. This study suggests the potential GC‐sparing effect of TCZ‐IV in patients with ASD in clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: Prior research has demonstrated that early treatment with high-efficacy disease-modifying therapies (DMTs), including ocrelizumab (OCR), can reduce relapses and delay disease progression among persons with multiple sclerosis (pwMS) compared with escalation from low-/moderate-efficacy DMTs. However, there is a lack of research examining the impact of early use of OCR on real-world clinical and economic outcomes. This study aimed to evaluate differences in events often associated with a relapse (EOAR) as well as non-DMT healthcare resource use (HCRU) and costs among pwMS who received OCR as a first-line treatment compared with later-line treatment after diagnosis. Methods: Newly diagnosed adult pwMS were selected from deidentified Optum Market Clarity claims data (study period: January 1, 2015–June 30, 2021). All pwMS were required to have initiated OCR after diagnosis and have 12 months of continuous eligibility prior to diagnosis. The index date was the date of initiation of the first-line DMT after diagnosis. pwMS who initiated OCR as first-line (1L OCR cohort) or a second- or later-line treatment (2L + OCR cohort) were matched 1:1 based on length of continuous eligibility after the first-line DMT and weighted using stabilized inverse probability of treatment. In the follow-up period, differences in outcomes, including annualized EOAR, non-DMT HCRU and costs, were evaluated for pwMS in the 1L vs. 2L + OCR cohorts. Results: The sample included 748 pwMS. During the follow-up period, pwMS in the 1L OCR cohort had a significantly lower annual rate of EOAR compared with pwMS in the 2L + OCR cohort (0.37 vs. 0.56; difference: 0.20 [95% CI 0.08, 0.32]). pwMS in the 1L OCR cohort had a significantly lower probability of any hospitalization within 1 year, fewer non-DMT outpatient visits and lower all-cause and MS-related, non-DMT costs compared with pwMS in the 2L + OCR cohort. Conclusions: First-line initiation OCR was associated with improvements in clinical and non-DMT economic outcomes compared with later-line initiation of OCR, suggesting that early initiation may benefit both patients and the healthcare system. [ABSTRACT FROM AUTHOR]

Background: Sickle cell disease (SCD) is a major public health concern in sub-Saharan Africa, accounting for nearly 75% of the global disease burden. The current analysis evaluated patient characteristics, treatment patterns, healthcare resource utilization (HCRU) and associated costs in patients with SCD based on a Private Medical Insurance Database in Ghana. Methods: This retrospective longitudinal cohort study was conducted using an e-claims database from Ghana (01 January 2015 to 31 March 2021). Patients were stratified by age (0 month to < 2 years, ≥ 2 years to ˂6 years, ≥ 6 years to < 12 years, ≥ 12 years to < 16 years; ≥16 years), vaso-occlusive crisis (VOC) (< 1, ≥ 1 to < 3, and ≥ 3 per year), and continuous enrolment. Study outcomes related to patient characteristics, comorbidities, treatment pattern, HCRU were evaluated for pre- and post-index period (index period was between July 2015 to March 2020). Descriptive analysis was used to analyse different study variables. Results: The study included 2,863 patients (mean age: 20.1 years; Min age: 0; Max age: 83; females 56.1%). Overall, 52.2% (n = 1,495) of SCD patients were ≥ 16 years and 17.0% (n = 486) were in the ≥ 2 to ˂6-years age group. The majority of patients aged ≥ 16 years (62.5%) in the database did not have reported VOC episodes, 35.9% of patients had 1 to 3 VOCs per year and 1.5% had ≥ 3 VOCs per year during the follow-up period. Consultation-based prevalence of SCD was 0.5% [95% confidence interval (CI): 0-1.3%] − 1.4% [CI: 0.6-2.2%]. Malaria, upper respiratory tract infection (URTI) and sepsis were the common complications of SCD. Analgesics were the most frequently prescribed medications followed by anti-infectives, hematinics, and antimalarials. Hydroxyurea, a routine standard of care for SCD was under-utilized. SCD patients had median cost incurred for consultation/hospital services of $11.3 (Interquartile range [IQR] $6.2 - $27.2). For patients with VOC, maximum median cost was incurred for medications ($10.9 [IQR $5.0-$32.6]). Overall median healthcare cost was highest for individuals with ≥ 3 VOCs per year during the follow-up period ($166.8 [IQR $70.3-$223.5]). Conclusion: In this retrospective private insurance claims database analysis, SCD imposes a significant healthcare burden, especially in patients with VOC. There is a need for reimbursed treatment options that could reduce the long-term burden associated with SCD and VOC. [ABSTRACT FROM AUTHOR]

Abstract Introduction Intravenous immunoglobulin (IVIG) is recommended as first-line therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), an immune-mediated neuropathy. The clinical profile of patients with CIDP newly initiating IVIG is poorly characterized. This claims-based cohort study describes characteristics of US patients with CIDP initiating IVIG treatment. Methods Adult immunoglobulin (IG)-naïve patients with CIDP diagnosed between 2008 and 2018 and a subgroup of patients subsequently initiating IVIG were identified in the Merative MarketScan Research Databases. Demographics, clinical characteristics, and diagnostic procedures were described for patients initiating IVIG. Results Of 32,090 patients with CIDP identified, 3975 (mean age 57 years) subsequently initiated IVIG. In the 6 months prior to IVIG initiation, diagnoses of comorbidities including neuropathy (75%), hypertension (62%), and diabetes (33%) were frequent, as were CIDP features/symptoms/markers of functional status including chronic pain (80%), difficulty walking (30%), and weakness (30%). CIDP-related laboratory/diagnostic procedures were performed in approximately 20– > 40% of patients in the 3 months prior to IVIG initiation (63.7% underwent electrodiagnostic/nerve conduction testing in the 6 months prior to IVIG initiation). Patient characteristics by initial IVIG product differed only in IVIG initiation year, US geographic region, and insurance type. Comorbidities, CIDP severity or functional status markers, and other clinical variables were generally well balanced across initial IVIG product groups. Conclusion A heavy burden of symptoms, comorbidities, and diagnostic testing exists in patients with CIDP initiating IVIG. Characteristics of patients with CIDP initiating different IVIG products are well balanced, suggesting an absence of clinical or demographic determinants underlying IVIG selection.

Abstract Introduction Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare progressive or relapsing inflammatory disease. Intravenous immunoglobulin (IVIG) is recommended as a first-line therapy. The aim of this study was to describe real-world treatment patterns and outcomes of patients with CIDP in the Define initiating IVIG treatment. Methods This cohort study used health insurance claims data from the Merative MarketScan Research Databases (2008–2018). Adult patients (≥ 18 years old) with CIDP without prior immunoglobulin treatment were identified using International Statistical Classification of Diseases and Related Health Problems (ICD) codes, and patients subsequently initiating IVIG were included in the analysis. Real-world IVIG treatment patterns and treatment and safety outcomes (assessed via ICD codes) were described. Results In total, 3975 patients (median age 58 years) with CIDP who initiated IVIG were identified. After the initial IVIG loading period, patients received IVIG at a median dosing interval of 21 days (quartile [Q]1, Q3: 7, 28), and continued treatment for a median of 129 days (Q1, Q3: 85, 271). After the 2-year follow-up period, 55% of patients had discontinued all IVIG treatment; more than one-half of these discontinuations occurred within 4 months. Diagnoses of impaired functional status were evident in more than 30% of patients at baseline, but at lower rates during follow-up. Rates of new-onset safety outcomes after IVIG treatment were low. Conclusion This real-world analysis of IVIG treatment patterns and treatment and safety outcomes of patients with CIDP who initiated IVIG highlights the unmet need for improved long-term management. Further research is needed to evaluate the use of functional status measures as endpoints for immunoglobulin treatment effectiveness.

Introduction: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare progressive or relapsing inflammatory disease. Intravenous immunoglobulin (IVIG) is recommended as a first-line therapy. The aim of this study was to describe real-world treatment patterns and outcomes of patients with CIDP in the Define initiating IVIG treatment. Methods: This cohort study used health insurance claims data from the Merative MarketScan Research Databases (2008–2018). Adult patients (≥ 18 years old) with CIDP without prior immunoglobulin treatment were identified using International Statistical Classification of Diseases and Related Health Problems (ICD) codes, and patients subsequently initiating IVIG were included in the analysis. Real-world IVIG treatment patterns and treatment and safety outcomes (assessed via ICD codes) were described. Results: In total, 3975 patients (median age 58 years) with CIDP who initiated IVIG were identified. After the initial IVIG loading period, patients received IVIG at a median dosing interval of 21 days (quartile [Q]1, Q3: 7, 28), and continued treatment for a median of 129 days (Q1, Q3: 85, 271). After the 2-year follow-up period, 55% of patients had discontinued all IVIG treatment; more than one-half of these discontinuations occurred within 4 months. Diagnoses of impaired functional status were evident in more than 30% of patients at baseline, but at lower rates during follow-up. Rates of new-onset safety outcomes after IVIG treatment were low. Conclusion: This real-world analysis of IVIG treatment patterns and treatment and safety outcomes of patients with CIDP who initiated IVIG highlights the unmet need for improved long-term management. Further research is needed to evaluate the use of functional status measures as endpoints for immunoglobulin treatment effectiveness. Plain Language Summary: Chronic inflammatory demyelinating polyradiculoneuropathy, also called CIDP, is a rare disease that causes the body's immune system to attack its nerves. Treatments for CIDP include antibodies, which are also called immunoglobulins. Immunoglobulins may be given intravenously, meaning they are administered into a vein. Intravenous immunoglobulin, also called IVIG, is recommended as one of the first treatments that patients with CIDP receive in their therapy and involves giving antibodies through a drip into a vein. This study aimed to gather information on the day-to-day use of IVIG by patients with CIDP. Information from 2008 to 2018 was collected from a large health insurance database in the USA. Information was taken from the records of patients aged 18 years or older who had received IVIG during the information collection period. In total, records from 3975 patients with an average age of 58 years were included in the study. On average, patients received IVIG every 21 days for 129 days. By 2 years, 55% of patients had stopped receiving IVIG; most of those patients had stopped within 4 months of first receiving the treatment. In the 6 months before receiving IVIG, over 30% of patients experienced limitations owing to their CIDP that affected their daily lives, although this percentage became smaller once patients started to receive IVIG. In addition, a low number of patients experienced side effects because of their IVIG treatment. This study highlights that improved long-term care for patients with CIDP is needed. Further research into ways of measuring the impact of CIDP on patients' daily lives is required, which may help doctors to work out how effective IVIG is at treating CIDP. [ABSTRACT FROM AUTHOR]

Introduction: Intravenous immunoglobulin (IVIG) is recommended as first-line therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), an immune-mediated neuropathy. The clinical profile of patients with CIDP newly initiating IVIG is poorly characterized. This claims-based cohort study describes characteristics of US patients with CIDP initiating IVIG treatment. Methods: Adult immunoglobulin (IG)-naïve patients with CIDP diagnosed between 2008 and 2018 and a subgroup of patients subsequently initiating IVIG were identified in the Merative MarketScan Research Databases. Demographics, clinical characteristics, and diagnostic procedures were described for patients initiating IVIG. Results: Of 32,090 patients with CIDP identified, 3975 (mean age 57 years) subsequently initiated IVIG. In the 6 months prior to IVIG initiation, diagnoses of comorbidities including neuropathy (75%), hypertension (62%), and diabetes (33%) were frequent, as were CIDP features/symptoms/markers of functional status including chronic pain (80%), difficulty walking (30%), and weakness (30%). CIDP-related laboratory/diagnostic procedures were performed in approximately 20– > 40% of patients in the 3 months prior to IVIG initiation (63.7% underwent electrodiagnostic/nerve conduction testing in the 6 months prior to IVIG initiation). Patient characteristics by initial IVIG product differed only in IVIG initiation year, US geographic region, and insurance type. Comorbidities, CIDP severity or functional status markers, and other clinical variables were generally well balanced across initial IVIG product groups. Conclusion: A heavy burden of symptoms, comorbidities, and diagnostic testing exists in patients with CIDP initiating IVIG. Characteristics of patients with CIDP initiating different IVIG products are well balanced, suggesting an absence of clinical or demographic determinants underlying IVIG selection. Plain Language Summary: Intravenous immunoglobulin, also called IVIG, involves giving antibodies through a drip into a vein. IVIG is recommended as one of the first treatments that patients receive if they have chronic inflammatory demyelinating polyradiculoneuropathy, also called CIDP, which is a rare disease that causes the body's immune system to attack its nerves. Our study described the characteristics of patients with CIDP who received IVIG in the USA. Information was collected from a large health insurance database and included records of patients aged ≥ 18 years who were diagnosed with CIDP between 2008 and 2018. Overall, 3975 patients with CIDP who received IVIG were included in the study. In the 6 months before starting IVIG, patients frequently had diagnoses of other diseases in addition to their CIDP; these included neuropathy (75% of patients), hypertension (62%), and diabetes (33%). CIDP features and symptoms that affected patients' daily lives were also frequently reported in these 6 months, including long-lasting pain (80%), difficulty walking (30%), and weakness (30%). In the 3 months before starting IVIG treatment, 20% to > 40% of patients underwent diagnostic procedures related to their CIDP. Different IVIG products were used similarly, but the year of IVIG initiation, geographic region, and insurance type all differed by IVIG product. In conclusion, patients with CIDP who receive IVIG experience a heavy burden caused by their symptoms, other diseases, and CIDP-related procedures. Patient characteristics were generally similar between patients receiving different IVIG products, suggesting that no specific characteristics are factored in when doctors select an IVIG product. [ABSTRACT FROM AUTHOR]

Background: Medications influencing the risk of fall-related injuries (FRIs) in older adults have been inconsistent in previous guidelines. This study employed case–control design to assess the association between FRIs and medications, and an additional case-crossover design was conducted to examine the consistency of the associations and the transient effects of the medications on FRIs. Methods: This study was conducted using a national claims database (2002–2015) in Korea. Older adults (≥ 65 years) who had their first FRI between 2007 and 2015 were matched with non-cases in 1:2 ratio. Drug exposure was examined for 60 days prior to the date of the first FRI (index date) in the case–control design. The hazard period (1–60 days) and two control periods (121–180 and 181–240 days prior to the index date) were investigated in the case-crossover design. The risk of FRIs with 32 medications was examined using conditional logistic regression after adjusting for other medications that were significant in the univariate analysis. In the case-crossover study, the same conditional model was applied. Results: In the case–control design, the five medications associated with the highest risk of FRIs were muscle relaxants (adjusted odd ratio(AOR) = 1.35, 95% confidence interval (CI) = 1.31–1.39), anti-Parkinson agents (AOR = 1.30, 95%CI = 1.19–1.40), opioids (AOR = 1.23, 95%CI = 1.19–1.27), antiepileptics (AOR = 1.19, 95%CI = 1.12–1.26), and antipsychotics (AOR = 1.16, 95%CI = 1.06–1.27). In the case-crossover design, the five medications associated with the highest risk of FRIs were angiotensin II antagonists (AOR = 1.87, 95%CI = 1.77–1.97), antipsychotics (AOR = 1.63, 95%CI = 1.42–1.83), anti-Parkinson agents (AOR = 1.58, 95%CI = 1.32–1.85), muscle relaxants (AOR = 1.42, 95%CI = 1.35–1.48), and opioids (AOR = 1.35, 95%CI = 1.30–1.39). Conclusions: Anti-Parkinson agents, opioids, antiepileptics, antipsychotics, antidepressants, hypnotics and sedatives, anxiolytics, muscle relaxants, and NSAIDs/antirheumatic agents increased the risk of FRIs in both designs among older adults. Medications with a significant risk only in the case-crossover analysis, such as antithrombotic agents, calcium channel blockers, angiotensin II antagonists, lipid modifying agents, and benign prostatic hypertrophy agents, may have transient effects on FRIs at the time of initiation. Corticosteroids, which were only associated with risk of FRIs in the case–control analysis, had more of cumulative than transient effects on FRIs. [ABSTRACT FROM AUTHOR]

Introduction: Although the prevalence and burden of asthma are continuously increasing, there is a lack of evidence on the landscape of moderate-to-severe asthma in Japan. Here, we report the prevalence of moderate-to-severe asthma and describe patient's demographics and clinical characteristics from 2010 to 2019 using the JMDC claims database. Methods: Patients (≥12 years) from the JMDC database with ≥2 asthma diagnoses in 2 different months in each index year were stratified as moderate-to-severe asthma based on the definition of asthma prevention and management guideline (Japanese Guidelines for Asthma, JGL) or Global Initiative for Asthma (GINA). Primary objective: 10-year trend (2010–2019) in the prevalence of moderate-to-severe asthma. Secondary objective: Demographics and clinical characteristics of patients from 2010 to 2019. Results: Of 7,493,027 patients from the JMDC database, 38,089 and 133,557 were included in JGL and GINA cohorts, respectively, by 2019. Both cohorts presented an increasing trend in the prevalence rate of moderate-to-severe asthma from 2010 to 2019, irrespective of age groups. Demographics and clinical characteristics were consistent across the cohorts in each calendar year. Majority of patients were in the age group of 18–60 years in both JGL (86.6%) and GINA (84.2%) cohorts. Allergic rhinitis was the most frequent comorbidity and anaphylaxis the least frequent comorbidity reported in both the cohorts. Conclusions: In Japan, the prevalence rate of patients with moderate-to-severe asthma, as per JGL or GINA in the JMDC database, increased from 2010 to 2019. The demographics and clinical characteristics were similar in both cohorts over the assessment duration. [ABSTRACT FROM AUTHOR]

As the occurrence of second primary cancers (SPCs) is strongly related to the survival rate of patients with oral and pharyngeal cancers, early detection and treatment are important. Therefore, this study aimed to clarify the incidence of SPCs and their risk factors in patients with oral and pharyngeal cancer. This observational study was conducted using data from the administrative claims database of 21,736 participants with oral and pharyngeal cancer from January 2005 to December 2020. We evaluated the cumulative incidence of SPCs among patients with oral and pharyngeal cancers using the Kaplan–Meier method. The Cox proportional-hazard model was used for multivariate analysis. Of the 1633 patients with oral and pharyngeal cancer who qualified for analysis, 388 developed SPCs (incidence rate, 7.994/1000 person-months). The multivariate analysis showed that the risk of developing SPCs was affected by age at diagnosis of oral and pharyngeal cancer, cancer treatment, and anatomical site of the primary cancer. Patients with oral and pharyngeal cancers are at a high risk of developing SPCs. The data from this study may be useful in providing accurate information to patients with oral and oropharyngeal cancer. [ABSTRACT FROM AUTHOR]

Background: Statins are expected to have beneficial effects on nonalcoholic fatty liver disease (NAFLD); however, evidence remains insufficient. Objective: In this study, we aim to investigate the association between statin adherence and NAFLD development. Methods: We conducted a nested case-control study of statin users using the Japan Medical Data Center administrative claims database (January 2005 to January 2020). Individuals who developed NAFLD were designated as cases. For each case, we randomly selected a maximum of 10 controls using risk set sampling. Good adherence was defined as the proportion of days covered (PDC) of ≥0.80. Higher intensity was defined as the median or higher of a cumulative defined daily dose (cDDD) per day covered by statin prescription. Conditional logistic regression analysis was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Results: In this study, 253 383 patients with the first statin prescription were identified. Of them, 7080 were selected and matched to 70 734 controls. The medians of PDC and intensity were 0.88 (interquartile range [IQR], 0.61-0.96) and 0.32 (IQR, 0.25-0.50) cDDD/day, respectively. Good adherence was significantly associated with a reduced risk of NAFLD development (adjusted OR, 0.82; 95% CI, 0.78-0.86). Higher intensity was not significantly associated with a reduced risk of NAFLD development (adjusted OR, 1.02; 95% CI, 0.97-1.08). Conclusion and Relevance: Good adherence to statins is associated with a reduced risk of NAFLD development, regardless of the statin intensity. Appropriate statin therapy could reduce the risk of NAFLD development. [ABSTRACT FROM AUTHOR]

We aimed to evaluate the adverse birth outcomes of anticancer drug prescription during pregnancy using a Japanese claims database from 2005 to 2019. We applied validated claims-based algorithms to identify pregnant women with birth outcomes, and evaluated drug prescription during pregnancy. The causal relationship between anticancer drugs and adverse birth outcomes was evaluated using the Council for International Organizations of Medical Sciences Working Group VI criteria. Thirteen women with anticancer drugs prescription during pregnancy were identified (mean age: 34.6 years). Atrial/ventricular septal defect was observed in one infant after exposure to cyclophosphamide and doxorubicin for breast cancer in the second and third trimesters. One woman on several anticancer drugs (cyclophosphamide, cytarabine, daunorubicin, l-asparaginase, methotrexate, nelarabine, and vincristine) for acute lymphoblastic leukemia, one on imatinib for chronic myeloid leukemia, and one on cisplatin and fluorouracil for cervical cancer had miscarriages after exposure in the first trimester. A relationship between those anticancer drugs and miscarriage could not be ruled out, while no relationship was identified regarding the atrial/ventricular septal defect considering the period of exposure and organogenesis. Our results suggest increased risk of miscarriage with the use of several anticancer drugs such as methotrexate, imatinib, cisplatin, and fluorouracil in the first trimester.

ABSTRACT Aims/Introduction This study was designed and carried out to investigate the association of dipeptidyl peptidase‐4 inhibitor (DPP‐4i) use with pancreatic cancer (PC) in individuals with diabetes in Japan. Materials and Methods The JMDC Claims Database, which contains the medical and prescription information of Japanese employment‐based health insurance programs, was used. The primary outcome was duration to the first occurrence of PC (International Classification of Diseases 10th Revision code C25), both all and hospitalized, from prescription of DPP‐4is or other oral glucose‐lowering agents (GLAs). Results Individuals with diabetes who received DPP‐4is (n = 61,430) or other oral GLAs (n = 83,304) were analyzed. Follow‐up periods (median [interquartile range]) were 17 months (8–33) for DPP‐4is and 14 months (7–28) for other oral GLAs. Kaplan–Meier curve analysis to determine the duration of first use of DPP4i or other oral GLA to diagnosis of PC disclosed no differences between the two groups in duration to all or hospitalized PC (log‐rank test: all, P = 0.7140; hospitalized, P = 0.3446). Cox proportional hazards models showed that use of DPP‐4is did not affect the PC risk adjusted for medications, age, sex and risk comorbidities (all, hazard ratio 1.1, 95% confidence interval 0.8–1.3, P = 0.6518; hospitalized, hazard ratio 1.1, 95% confidence interval 0.8–1.4, P = 0.6662). Similar results were obtained when individuals with ≥2 years oral GLA treatment and those with medical checkup data (e.g., smoking or drinking habit) available were analyzed. Conclusion This database study shows that there is not a significant PC risk due to DPP‐4i treatment in individuals with diabetes in Japan, but larger studies with longer follow up are required to confirm these findings.

Abstract Background The epidemiology and payer costs for ankle fractures are not well documented. This study evaluated: (1) the incidence of ankle fracture and ankle surgery following fracture in the US population; and (2) the clinical presentation of patients presenting with ankle fractures requiring surgery, their complication rates, and payer costs. Methods Patients in the IBM® MarketScan® Commercial and Medicare Supplemental databases with an inpatient/outpatient diagnosis of ankle fracture from 2016 to 2019 were stratified by age group and gender, and rates of fracture per 10,000 enrollees were estimated. Surgically-treated patients between January 2016 – October 2021 were further analyzed. One-year post-surgical outcomes evaluated complication rates (e.g., infection, residual pain), reoperations, and 1-year payments. Standard descriptive statistics were calculated for all variables and outcomes. Generalized linear models were designed to estimate payments for surgical care and incremental payments associated with postoperative complications. Results Fracture cases affected 0.14% of the population; 23.4% of fractures required surgery. Pediatric and elderly patients were at increased risk. From 3 weeks to 12 months following index ankle surgery, 5.5% (5.3% - 5.7%) of commercially insured and 5.9% (5.1% - 6.8%) of Medicare patients required a new surgery. Infection was observed in 4.4% (4.2% - 4.6%) commercially insured and 9.8% (8.8% - 10.9%) Medicare patients, and residual pain 3 months post-surgery was observed in 29.5% (28.7% - 30.3%) commercially-insured and 39.3% (36.0% - 42.6%) Medicare patients. Commercial payments for index surgery ranged from $9,821 (95% CI: $9,697 - $9,945) in the ambulatory surgical center to $28,169 (95% CI: $27,780 - $28,559) in the hospital inpatient setting, and from $16,775 (95% CI: $16,668 - $16,882) in patients with closed fractures, to $41,206 (95% CI: $38,795 - $43,617) in patients with Gustilo III fractures. Incremental commercial payments for pain and infection averaged $5,200 (95% CI: $4,261 - $6,139) and $27,510 (95% CI: $21,759 - $33,261), respectively. Conclusion Ankle fracture has a high incidence and complication rate. Residual pain affects more than one-third of all patients. Ankle fracture thus presents a significant societal impact in terms of patient outcomes and payer burden.

Abstract Aims/Introduction This study aimed to investigate the effects of sodium–glucose cotransporter 2 inhibitors (SGLT2i) on new prescriptions of drugs, including antihypertensives, antigout/antihyperuricemics and antidyslipidemics, for the treatment of lifestyle‐related diseases in Japanese patients with diabetes mellitus using the JMDC Claims Database. Materials and Methods Patients with type 2 diabetes mellitus who were newly treated with SGLT2i or other oral antidiabetic drugs and had not been prescribed any antihypertensives, antigout/antihyperuricemics or antidyslipidemics for at least 1 year were extracted from the database. Using propensity score calibration matching (1:1), we assessed the proportion of patients who started the aforementioned concomitant medications within 2 years, and the risk ratio of SGLT2i to other antidiabetic medication groups was calculated. Results In 856,796 patients with diabetes mellitus, 734, 1,197 and 703 propensity score calibration‐matched patients in each group were analyzed for the prescription of antihypertensives, antigout/antihyperuricemics and antidyslipidemics, respectively. The new prescriptions of antihypertensives and antigout/antihyperuricemics were lower in the SGLT2i group than those in the other oral antidiabetic drug group (risk ratio 0.66 and 0.37, respectively), whereas those of antidyslipidemics were more common in the SGLT2i group (risk ratio 1.43). Conclusions New prescriptions of antihypertensives or antigout/antihyperuricemics were lower for patients taking SGLT2i than those taking other oral antidiabetic drugs, probably due to a reduction of blood pressure and uric acid levels by SGLT2i. The more frequent prescriptions of antidyslipidemics might partially reflect a moderate increase in low‐density lipoprotein cholesterol levels as a result of sodium–glucose cotransporter 2 inhibition.

Abstract Background Multiple inhaler triple therapy (MITT), comprising inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA), has been used as an escalation treatment for patients with chronic obstructive pulmonary disease (COPD). However, real-world use of MITT has not been investigated in Asia, including South Korea. This study reports baseline characteristics of patients with COPD initiated on MITT in South Korea, and their treatment patterns. Healthcare resource utilization (HRU) and costs associated with COPD exacerbations following MITT initiation were also assessed. Methods This was a retrospective cohort study using the South Korea National Health Insurance database (2014–2018). Included patients were ≥ 40 years, had a COPD diagnosis, were newly initiated on MITT and had ≥ 12 months’ data both before (baseline) and after index date (the first day with overlapping supply of all MITT components). Treatment immediately before initiation and immediately following discontinuation of MITT were identified, and proportion of days covered (PDC) by MITT was calculated. HRU and costs (per person per year [PPPY]) associated with exacerbations were identified following MITT initiation; costs were calculated using the average 2020 exchange rate (0.0008 USD/KRW). Results Among 37,400 patients, the mean age was 69 (SD 10) years and 73% were males; 56% had ≥ 1 COPD exacerbation during the baseline period, with a mean of 2 (SD 5) events/year. ICS/LABA was the most frequent regimen prescribed immediately before initiation (37%) and immediately following discontinuation (41% of 34,264 patients) of MITT. At 3, 6, and 12 months from treatment initiation, mean PDC was 81%, 63% and 49%, respectively; median treatment duration was 102 days. The mean (95% confidence interval [CI]) number of total visits for severe COPD exacerbations was 0.77 PPPY (0.75–0.78); mean PPPY total healthcare costs were 2093 USD. Conclusions Patients with COPD in South Korea experienced frequent exacerbations prior to MITT, and PDC by MITT was low. Patients may benefit from early optimization of COPD therapy, and greater emphasis on adherence to inhaled COPD therapy. Severe exacerbations were found to incur substantial costs; treatment alternatives that can reduce the rate of severe exacerbations are likely to minimize healthcare costs.

In pediatric patients with neurogenic bladder (NGB), urinary tract evaluation, early diagnosis, and individualized management are important. We aimed to clarify the current status of diagnosis and treatment of NGB in Japanese children. This descriptive, observational, retrospective cohort study using the JMDC claims database included NGB patients aged ≤17 years over a 12-month follow-up period. Of the 1065 pediatric NGB patients, 38.9% had spina bifida. Dermatological and gastrointestinal comorbidities were common in the baseline period. Renal/bladder ultrasound was a commonly performed investigation (38.3%), but urodynamics was infrequently used (3.0%). Of all the overactive bladder medications, anticholinergics were used commonly (17.9% patients), and most patients used anticholinergics alone (without combination therapy). Clean intermittent catheterization (CIC; alone or in combination with medications) was performed in 9.3% of patients, and 3.9% of patients were concomitantly treated with medications. The most common incident complication was lower urinary tract infection (18.1%), which was especially common in patients with open spina bifida (54.1%). Despite guideline recommendations, lower urinary tract dysfunction is not thoroughly evaluated. Adequate understanding of patient status is critical to optimal patient management (behavioral therapy, CIC, and medication) in clinical practice. [ABSTRACT FROM AUTHOR]