Real-world Treatment Patterns In Patients Research Articles

Real-world treatment patterns of patients with major depressive disorder treated with auvelity® in the United States

ABSTRACT Aims: Major depressive disorder (MDD) is a prevalent, chronic disorder. Auvelity® (dextromethorphan-bupropion) is a novel, oral, N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist approved (August 2022) by the FDA for treating MDD in adults. This is the first analysis on real-world Auvelity usage in the US. Methods: Adult patients initiating Auvelity in the Symphony IDV® databases by September 2023 were identified (index date: the first Auvelity claim). Patients had continuous eligibility over the 12-month pre-index period and ≥1 MDD diagnosis (ICD-10-CM codes: F32.*, F33.*) over the 5-year pre-index period. Demographic and clinical characteristics, comorbidities, prior MDD-related medications, and Auvelity initiation status were assessed. Results: This analysis included 22,288 patients with MDD treated with Auvelity (mean age 45.1 years; 68.1% women); 40.0% lived in the South and 58.5% had commercial insurance. Comorbidities included mental health disorders (53.5%; 47.6% had anxiety disorders). Overall, 83.7% of the patients had received treatment with selective serotonin reuptake inhibitors (SSRIs; 54.9%), norepinephrine-dopamine reuptake inhibitor (NDRI [bupropion]; 40.4%), and/or serotonin-norepinephrine reuptake inhibitors (SNRIs; 35.9%) over the 12-month pre-index period. The last MDD-related treatment prior to Auvelity comprised SSRIs (22.4%), SNRIs (13.2%), and NDRI (12.8%) monotherapies; 294 (1.3%) patients received esketamine. In total, 6,418 patients (28.8%) initiated Auvelity as monotherapy vs 15,870 (71.2%) as an add-on; Auvelity was most frequently added to an SSRI alone (10.7%) or SNRI alone (6.5%). A total of 2,254 (10.1%) patients initiated Auvelity without prior treatment in the 12-month pre-index period. Limitations: Incomplete data due to reporting; diagnoses captured subject to coding error; limited generalizability to other populations. Conclusions: Using a large demographically distributed claims database, 22,288 patients with MDD initiated Auvelity within a year of its approval; 10.1% were treatment-naïve and 28.8% initiated Auvelity as monotherapy. Most patients had mental health-related comorbidities and attempted various MDD-related treatments prior to Auvelity.

PP01.68 Real-World Treatment Patterns of Patients with EGFR Exon 20 Insertion-Mutated Advanced NSCLC Treated with Amivantamab or Mobocertinib after Platinum-Based Chemotherapy

PP01.68 Real-World Treatment Patterns of Patients with EGFR Exon 20 Insertion-Mutated Advanced NSCLC Treated with Amivantamab or Mobocertinib after Platinum-Based Chemotherapy

71P Real-world treatment patterns in patients with metastatic colorectal cancer in the Netherlands

71P Real-world treatment patterns in patients with metastatic colorectal cancer in the Netherlands

Real-world treatment patterns in patients with BRCA 1/2-positive (BRCA+) metastatic castration-resistant prostate cancer (mCRPC) initiating first-line (1L) therapy.

52 Background: Patients with BRCA+ mCRPC have an aggressive disease course. Recently, they have been shown to be responsive to treatment with poly ADP-ribose polymerase inhibitors, such as niraparib, olaparib, and rucaparib, used in combination with abiraterone acetate and prednisone or prednisolone, or as monotherapy. This study aimed to describe real-world treatment patterns and outcomes among patients with BRCA+ mCRPC. Methods: De-identified electronic health records from the Flatiron Health – Foundation Medicine Inc. (FMI) Metastatic PC Clinico-Genomic Database (01/01/2011 – 06/30/2022) were used to select BRCA+ mCRPC patients initiating 1L therapy on or after 01/01/2019 or monotherapy with androgen deprivation therapy (ADT). Patients were classified as recipients of ADT monotherapy if they used ADT at mCRPC diagnosis and did not initiate any subsequent advanced PC therapy. Distribution, line of therapy (LOT) sequences, and reasons for censoring were described in 1L, and among patients who advanced to second-line (2L) therapy. Flatiron Health and FMI did not participate in data analyses. Results: A total of 98 treated patients with BRCA+ mCRPC were included (mean age 72 years, 58% White, 15% Black, 55% Medicare-insured), 19 of whom received ADT monotherapy (mean age 70 years, 53% White, 26% Black, 47% Medicare-insured). The top five treatment regimens for mCRPC were ADT monotherapy (19%), enzalutamide (ENZ; 14%), olaparib (OLA; 13%), abiraterone acetate (AA; 11%), and docetaxel (DOC; 10%), with 14% of patients receiving ≥1 medication. The main reasons for censoring in patients with ADT monotherapy were death (52.6%), loss to follow-up (26.3%), and end of data availability (21.1%). Among the 79 patients treated with other than ADT monotherapy in 1L, 43.0% (n=34) did not advance to 2L, of which 35.3% were lost to follow-up, 29.4% died (median time-to-death: 2.25 months), 29.4% were censored at the end of data availability, and 5.9% initiated a clinical trial drug. The most prescribed 2L therapies were DOC (22.2%), OLA (20.0%), AA (13.3%), and ENZ (11.1%). In those who advanced to 2L (n=45), the most common 1L → 2L treatment sequences were OLA → DOC (11.1%), ENZ → DOC (6.7%), AA → ENZ (6.7%), and AA → OLA (6.7%). In patients receiving 2L, 51.1% (n=23) did not advance to third-line therapy, of which 34.8% died, 34.8% were lost to follow-up, 26.1% were censored at the end of data availability, and 4.3% initiated a clinical trial drug. Conclusions: Among treated patients with BRCA+ mCRPC, ADT monotherapy, ENZ, OLA, AA, and DOC were most commonly used. The majority of ADT monotherapy patients died, while a substantial proportion of patients initiating 1L therapy died or initiated a clinical trial drug and did not advance to 2L, suggesting unmet need for more effective 1L treatment for patients with BRCA+ mCRPC.

Real-world treatment patterns for patients with high-risk biochemically recurrent nonmetastatic castration-sensitive prostate cancer.

299 Background: Patients with biochemically recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC) who are identified as high-risk of developing metastases may benefit from earlier treatment. This study analyzed treatment patterns in these patients. Methods: The Adelphi Real World nmCSPC retrospective survey was completed by urologists and radiation oncologists in the US. For this analysis, data from medical charts for patients diagnosed with high-risk BCR nmCSPC from Jan 2021–Jul 2023 were extracted; physicians completed a chart for their last 6–8 patients. Data were analyzed descriptively for first line (1L) treatment received (regardless of time) since high-risk BCR diagnosis for the total patient sample and subgroups of interest. Physicians documented those with no treatment as on observation. Results: Aggregated data were analyzed for 376 patients with high-risk BCR nmCSPC; 252 (67%) had prostate-specific antigen doubling time (PSADT) ≤9 months after BCR and initial definitive therapy of radiotherapy (RT) and/or radical prostatectomy (RP). Overall, 84% were treated by urologists and 16% by radiation oncologists. Median age was 70 years; 64% were White, 31% were Black/African American. Median PSA at high-risk BCR diagnosis was 5 ng/mL. Median follow-up after high-risk BCR diagnosis was 249 days. Median time between high-risk BCR diagnosis and initiation of 1L treatment was 17 days. Most common 1L treatments were androgen deprivation therapy (ADT) alone, salvage RT, novel hormonal therapy (NHT) + ADT, and observation alone. For patients on observation alone, median follow-up after high-risk BCR diagnosis was 181 days. Few numerical differences were seen in treatment patterns depending on how patients were determined as high-risk (Table). Patients treated by urologists rather than radiation oncologists had numerically higher proportions of 1L treatment with NHT + ADT (21% / 2%) and observation alone (17% / 8%), and numerically lower proportions of ADT alone (27% / 34%) and salvage RT (12% / 44%). Conclusions: First line treatments were typically initiated rapidly following high-risk BCR nmCSPC diagnosis, with only 15% of patients receiving observation alone during available follow-up. [Table: see text]

Treatment patterns of patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitor-based regimens: a cohort study in the French nationwide healthcare database

PurposeTo assess real-world treatment patterns in patients diagnosed with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (mBC) who received cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in combination with an aromatase inhibitor (AI) or fulvestrant at first line.MethodsPatient characteristics, treatment history, and outcomes data were extracted from the French ‘Système National des Données de Santé’ (SNDS) database for patients diagnosed with HR+/HER2- mBC between January 2014 and June 2019 and who received combination therapy with a CDK4/6 inhibitor and endocrine therapy. Kaplan-Meier methodology was used to assess time to next treatment (TTNT) and time to treatment discontinuation (TTTD).ResultsThe cohort comprised 6061 patients including 4032 patients who received CDK4/6 inhibitors + AIs and 2029 patients who received CDK4/6 inhibitors + fulvestrant. Median follow-up was 13.5 months (IQR 9.5–18.1). The median TTTD of first line treatment with CDK4/6 inhibitors + AIs and CDK4/6 inhibitors + fulvestrant was 17.3 months (95% CI 16.8–17.9) and 9.7 months (95% CI 9.0–10.2), respectively. Chemotherapy was the most common second line therapy. Median TTTD of subsequent treatment lines was progressively shorter following first line treatment with CDK4/6 inhibitors + AIs (2nd line: 4.6 months (95% CI 4.4–4.9) and with CDK4/6 inhibitors + fulvestrant (2nd line: 4.7 months (95% CI 4.3–5.1). TTNT was longer than TTTD across lines of therapy.ConclusionThis real-world analysis confirms the effectiveness of CDK4/6 inhibitor-based regimens in French patients and highlights the frequent use of chemotherapy as second line therapy.

Understanding the real-world treatment patterns in patients using migraine preventive medications in Ontario, Canada

Understanding the real-world treatment patterns in patients using migraine preventive medications in Ontario, Canada

Understanding the real-world treatment patterns for patients with migraine-specific acute medications in Ontario, Canada

Understanding the real-world treatment patterns for patients with migraine-specific acute medications in Ontario, Canada

Machine Learning Approach to Understand Real-World Treatment in Patients with Higher-Risk Myelodysplastic Syndromes

Background: Higher-risk myelodysplastic syndromes (HR-MDS) is a severe and aggressive form of MDS that represents a group of rare and heterogeneous hematologic disorders that primarily affect the bone marrow and blood cells. Treatment typically involves a combination of supportive care and active treatment with targeted therapies, hypomethylating agents, chemotherapy, and hematopoietic stem cell transplant. In this study, we have evaluated real-world treatment patterns in patients with HR-MDS with machine-learning (ML) models to identify clinical and demographic features that may impact decisions about which patients receive systemic therapies and when the therapies are implemented. Methods: We identified 821 patients aged ≥18 years with HR-MDS diagnosed between January 2015 and April 2022, using ConcertAI's RWD360 database linked with open claims data. RWD360 consists of structured records from US-based oncology electronic health record systems. Demographic and clinical data up to 1 year prior to the date of HR-MDS diagnosis were used to develop a family of XGBoost-based ML models to investigate drivers of treatment. We created five models: a time-to-therapy model that predicts patient-level hazard ratios and four classification models that predict likelihood of therapy in the first 2, 3, 6, and 12 months, respectively, following HR-MDS diagnosis (therapy yes/no models). Model performance was evaluated using Harrell's concordance index (C-index) and Akaike information criterion (AIC) for the time-to-therapy model and area under curve (AUC) for the therapy yes/no models. Key features included laboratory values, Charlson comorbidity index (CCI), and prescribed medications. To better capture the temporal characteristics of a patient's disease state evolution, clinical features were organized into time windows alongside the variations within them. We used recursive feature elimination to bring the total features used in the model to 50 to enhance the interpretability and compactness. Five-fold cross-validation (data was split 5 ways; for each fold, a different 20% is left out for validation, while 80% of the data was used to train the model) on the full 821-patient cohort was performed to train and evaluate the model. Results: The median age in this patient cohort was 73 years (range = 21-88 years); approximately 60% were male, and 66% patients were treated in community oncology practices. Only 42.5% patients were recorded to ever receive systemic active therapy, and of those, the median time to therapy was 4.2 months (Figure 1). Patients had a median hemoglobin concentration of 9.4 g/dL (range = 4.4-18.9 g/dL), median CCI of 1 (range = 0-10), and median polypharmacy of 10 (computed on patients who had at least 1 concomitant medication (49%); range = 1-93) around time of diagnosis (assessed 1 year prior, and up to 30 days after diagnosis date). Model performance for the time-to-therapy model (C-index = 0.78; AIC = 3314.2) and for the therapy yes/no models (AUC = 0.7-0.74) were evaluated. A key predictive feature across models was the minimum laboratory value of white blood cell (WBC) count near the point of diagnosis; low WBC values around time of diagnosis was consistently a strong predictor for receiving systemic therapy and receiving it earlier. Two other top predictors of systemic therapy and its timing were the rate of fall in measurements of blood glucose and the rate of fall of hemoglobin during the 180 to 30 days before diagnosis. Table 1 details model performance and the top 3 features impacting time and likelihood of therapy for all 5 models. Conclusion: We have built a family of data-driven ML models for patients with HR-MDS, based on data collected in routine clinical practice, towards predicting time-to and probability-of first-line systemic therapy with reasonable accuracy driven by patient characteristics. A majority of patients diagnosed with HR-MDS in this study appeared to receive delayed or no systemic therapy in their treatment journey. To bridge gaps in care and facilitate timely treatment in eligible patients, data-driven predictive modeling that take into account detailed patient-level factors is critical. Further analysis on outcomes of untreated patients linked with their key clinical characteristics identified using these models may provide opportunities to improve clinical care by implementing strategies for treatments based on patient-level factors.

Real-World Patterns of Care and Financial Burden of Patients with Follicular Lymphoma in the United States

Introduction: Follicular lymphoma (FL) is the most common indolent non-Hodgkin lymphoma and accounts for nearly a quarter of cases. As a heterogenous disease with an estimated 20% having progression of disease within 24 months of first FL therapy, FL often quickly becomes relapsed or refractory (R/R) to current therapy. The objective of this study was to evaluate the real-world treatment patterns, time to next treatment, and associated costs and healthcare resource utilization (HCRU) in patients with FL in the United States. Methods: A retrospective observational study was conducted using an integrated real-world database including linked data from the Symphony Integrated Dataverse (IDV ®), electronic medical records, specialty pharmacy, and in-office dispensing datasets. Patients were included in the study if they were ≥ 18 years old and initiated a first-line (1L), second-line (2L), third-line (3L), or fourth-line (4L) of therapy for FL between 1/1/2019 and 12/31/2022. Patients were categorized by line of therapy into non-mutually exclusive cohorts based on the date of initiation of their treatment regimen. Each line of therapy cohort was followed for a minimum of 90 days through lost to follow-up or end of the study period (3/31/2023). Patients were also required to have continuous pre-index enrollment of 365 days to record baseline comorbidities. Demographics, clinical characteristics, and treatment regimens were examined for each line of therapy cohort. Within each line of therapy, patients were categorized into 6 mutually exclusive subgroups based on their treatment regimens: bendamustine + rituximab (BR), rituximab monotherapy (R-mono), cyclophosphamide, doxorubicin, prednisone, rituximab + vincristine (R-CHOP), bendamustine + obinutuzumab (BO), lenalidomide + rituximab (R2), and other treatments for all other regimens. Advancement to the next line of therapy, treatment regimen distribution, and switching for each cohort and subgroup were evaluated during the follow-up period. Treatment duration, time to next treatment (TTNT), HCRU and pharmacy costs were measured for each cohort and treatment regimen during the follow-up period. HCRU included outpatient visits and hospital claims, reported as per patient per month (PPPM) over the time on each treatment regimen. Results: The study population included 9,579 patients initiating 1L, and then 3,061, 952 and 263 patients who received 2L, 3L, and 4L, respectively. The median follow-up was 719 days (1L), 652 days (2L), 578 days (3L), and 468 (4L). Mean age at index was similar across treatment lines, ranging from 66.7 years (1L) to 67.9 years (4L). Males represented a little under half (47.3%) in 1L cohort but increased slightly with subsequent lines (49.3%, 2L; 54.9%, 3L; 70% 4L). The most common baseline comorbidities across treatment lines were hypertension (1L=35.2%; 2L=32.3%; 3L=29.8%; and 4L=28.1%) and gastrointestinal disease (1L=23.9%; 2L=22.2%; 3L=22.2%; and 4L=22.1%). Across all treatment lines, R-mono was the most common regimen (1L=34.1%; 2L=29.0%; 3L=23.8%; and 4L=18.6%) followed by BR (1L=32.8%; 2L=17.3%; 3L=12.0%; and 4L=11.4%), and R-CHOP (1L=14.5%; 2L=12.8%; 3L=10.1%; and 4L=9.5%). Median TTNT across all regimens was 417 days (159, 691) in 1L, 444.5 days (225, 661) in 2L, 414 days (174, 784) in 3L, and 382.5 days (200.5, 599.5) in 4L (Figure 1). Mean (standard deviation; SD) of all-cause outpatient visits PPPM were 5.99 (4.86) in 1L, 6.06 (5.42) in 2L, 6.27 (6.04) in 3L, and 6.25 (5.95) in 4L. Mean (SD) of FL-specific outpatient visits PPPM were 4.59 (4.00) in 1L, 4.49 (4.31) in 2L, 4.57 (4.93) in 3L, and 4.42 (4.65) in 4L. The mean all-cause hospitalizations PPPM were 0.35 (1.72) in 1L, 0.79 (3.36) in 2L, 1.94 (6.29) in 3L, and 1.85 (5.00) in 4L. The mean FL-related hospitalizations PPPM were 0.13 (0.76) in 1L, 0.18 (1.02) in 2L, 0.36 (1.56) in 3L, and 0.45 (2.12) in 4L (Figure 2). Average pharmacy costs PPPM increased from $1,033 ($3,963.8) in 1L to $2,166.6 ($6,001.1) in 2L, and $2,943.7 ($6,413.1) to $3,374.1 ($7,361.3) in 3L and 4L, respectively. Conclusions: Real-world treatment patterns for patients with FL were shown to be mostly consistent with clinical guidelines. This study highlighted that TTNT decreased while hospitalizations and pharmacy costs increased as line of therapy progressed, suggesting high financial burden and unmet need for better treatment options for R/R FL patients.

Response to letter to editor on the article: Ge W, Chen C, Wu N et al. Hedgehog pathway inhibitor real-world treatment patterns in patients with basal cell carcinoma: a claims-based analysis. Fut. Oncol. 18(23), 2561-2572 (2022).

Response to letter to editor on the article: Ge W, Chen C, Wu N et al. Hedgehog pathway inhibitor real-world treatment patterns in patients with basal cell carcinoma: a claims-based analysis. Fut. Oncol. 18(23), 2561-2572 (2022).

Nationwide Study of Real-World Treatment Patterns and Clinical Outcomes in Patients with Metastatic Urothelial Carcinoma in Hungary.

Data describing real-world treatment patterns in patients with metastatic urothelial carcinoma (mUC) in Central-Eastern Europe are scarce, and data from Hungary have not been published. This retrospective, nationwide, real-world study investigated patient characteristics, treatment patterns, comorbidities, and clinical outcomes in patients with mUC in Hungary. Adults diagnosed with mUC from January 2016 through June2021 were identified using the National Health Insurance Fund Administration database. Overall survival (OS) was estimated using the Kaplan-Meier method. In total, 2523 patients with mUC were identified. Median follow-up was 7.1months. Overall, 50% of patients received an identified systemic anticancer treatment; within this subgroup, first-line treatment was platinum-based chemotherapy (PBC) in 86%, non-PBC in 8%, and immune checkpoint inhibitor (ICI) in 6%. The proportion of patients receiving treatment increased from 41% in 2016 to 59% in 2020, driven by increased use of first-line PBC or first-line ICI treatment. Comorbidities were more common in patients receiving first-line ICI treatment vs PBC or non-PBC and in patients receiving carboplatin + gemcitabine vs cisplatin + gemcitabine. Overall, only 24% received a second-line treatment. Unadjusted median OS from the start of first-line treatment in the PBC, non-PBC, and ICI subgroups was 12.8, 7.5, and 6.3months, respectively. Median OS from date of diagnosis in untreated patients was 7.8months. OS comparisons adjusted for differences in baseline characteristics between subgroups could not be performed. To our knowledge, this is the first study to assess treatment patterns in patients with mUC in clinical practice in Hungary, using the national health insurance database. Rates of first- and second-line treatment were consistent with those observed in other countries. Avelumab first-line maintenance treatment became available for reimbursement in Hungary in late 2022, after the study period. Given the evolving landscape of reimbursed treatments in Hungary, further analyses are warranted.

125P Real-world treatment patterns in patients with biliary tract cancer (BTC): Retrospective chart review survey in Europe (GARNET-2)

125P Real-world treatment patterns in patients with biliary tract cancer (BTC): Retrospective chart review survey in Europe (GARNET-2)

Real-World Treatment Patterns in Patients with Vitiligo in the United States.

Vitiligo is an autoimmune disorder resulting in skin depigmentation, with limited approved treatment options. This study evaluated medication utilization and treatment patterns among patients in the first year following vitiligo diagnosis. This retrospective analysis of claims data from the Merative® MarketScan Research Databases included patients aged ≥ 12years newly diagnosed with vitiligo. Patients were identified between October 1, 2016, and April 30, 2021, and had ≥ 12months of continuous enrollment pre- and post-vitiligo diagnosis. Medication use, treatment line of therapy, time to and number of medication claims, and length of therapy were reported in the 12months post-vitiligo diagnosis. Results are reported separately for treatment initiators post-vitiligo diagnosis, patients with moderate-to-severe vitiligo, and adolescents (aged 12-17years). A total of 19,335 patients were included in the analysis, with half (N = 9648, 49.9%) not receiving any treatment during the 12-month follow-up. Switching was minimal among treatment initiators (N = 5845) in the 12months post-vitiligo diagnosis, with the most frequent first-line treatments being high-potency topical corticosteroids (25.4%), oral corticosteroids (23.1%), and topical calcineurin inhibitors (TCI, 14.7%). Adolescents initiating treatment (N = 486) most frequently received TCI (30.9%) as first-line therapy. Patients with moderate-to-severe vitiligo (N = 3462) were very likely to receive treatment during follow-up, with only 1.5% not receiving treatment. Among patients with no vitiligo treatment prior to diagnosis, time to first medication claim ranged from 51.9days (standard deviation [SD], 84.0) for TCI to 178.6days (SD 116.0) for systemic immunosuppressants; mean total days supplied ranged from 14.4days (SD 27.1) for oral corticosteroids to 121.0 (SD 114.0) for immunosuppressants. In this real-world study, a high proportion of patients did not receive any treatment. Among those receiving treatment, most were unlikely to switch or use a combination of treatments within the first year of vitiligo diagnosis.

Hedgehog inhibitors for basal cell carcinoma: real-world treatment patterns

This video presents a study of Hedgehog pathway inhibitor real-world treatment patterns in patients with basal cell carcinoma.

Burden of disease and real-world treatment patterns of patients with systemic lupus erythematosus in the Australian OPAL dataset

ObjectiveTo describe the demographics, disease burden and real-world management of patients with systemic lupus erythematosus (SLE) in Australian community practice.MethodsPatients with a physician diagnosis of SLE and at least 1 visit between 1 January 2009 and 31 March 2021 were identified in the OPAL dataset, an aggregated collection of data extracted from the electronic medical records of patients managed by 112 Australian rheumatologists. Demographics, basic clinical features and prescribed medications were described, with medication combinations used as a surrogate of disease severity.ResultsOf 5133 patients with a diagnosis of lupus, 4260 (83%) had SLE. Of these SLE patients, almost 90% of patients were female, with a median age of 49 years [IQR 37–61] at first-recorded visit. Of the 2285 SLE patients whose most recent visit was between 1 January 2019 and 31 March 2021, 52.5% had mild disease, 29.9% had moderate-severe disease and 7.4% had very severe disease. Visit frequency increased with disease severity. Most patients (85.8%) were treated with hydroxychloroquine, typically prescribed as first line-of-therapy.ConclusionIn this large real-world Australian cohort of patients with SLE, a substantial burden of disease was identified, with a significant proportion (almost one-third of patients) considered to have moderate to severe disease based on medication use. This study provides a greater understanding of the path from symptom onset to treatment and the heterogeneous presentation of patients with SLE who are treated in community practice in Australia.Key messages• Most published studies describing patients with SLE are derived from specialist lupus centres, typically in the hospital setting, therefore little is known about the characteristics of patients with SLE who are receiving routine care in community clinics.• The OPAL dataset is a large collection of clinical data from the electronic medical records of rheumatologists predominantly practising in private community clinics, which is where the majority (73–80%) of adult rheumatology services are conducted in Australia [1–3] . Since data from community care has not been widely available for SLE research, this study contributes important insight into this large and under-reported patient population.• To improve access to care and effective treatments, and reduce the burden of SLE in Australia, a greater understanding of the characteristics and unmet needs of patients with SLE managed in the community setting is required.

Real-World Treatment Patterns and Switching Following Moderate/Severe Chronic Obstructive Pulmonary Disease Exacerbation in Patients with Commercial or Medicare Insurance in the United States.

There is limited literature regarding real-world treatment patterns of patients with COPD, particularly since the introduction of once-daily single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol in 2017. Here, we evaluated treatment patterns of patients with COPD before and after a COPD exacerbation. Retrospective, descriptive study using medical and pharmacy claims data and enrollment information from the Optum® Clinformatics® Data Mart database. Patients aged ≥40 years with ≥1 COPD exacerbation on or after September 18, 2017 were included. The index date was the last day of the first COPD exacerbation (ie day of visit for a moderate exacerbation or discharge date for a severe exacerbation). The baseline period was 12 months prior to index and the follow-up period (≥3 months) spanned from index until the earliest of health plan disenrollment, end of data availability (September 30, 2020), or death. Treatment patterns were evaluated during baseline and follow-up, with a focus on medication switching in the 90 days pre- and post-index. COPD exacerbations were identified in 307,727 patients (125,942 severe; 181,785 moderate). Mean age at index was 72.8 years; 56.3% were female. Before and after first exacerbation, 37.7% and 48.2% of patients used ≥1 controller medication, respectively. In the 90 days pre-index, ICS, LABA, and LAMA medications were used by 27.5% of patients. Of these users, 64.3% remained on the same medication class, 21.7% discontinued, and 14.1% switched medication in the 90 days post-index. Among switchers, 44.0% switched to triple therapy. Most common switches were ICS/LABA to ICS/LABA/LAMA (20.7%) and LAMA to ICS/LABA/LAMA (16.4%). Many COPD exacerbations occur among patients not on controller medications. Although the percentage of patients receiving a controller medication increased following a first exacerbation, it remained below 50%. Of patients receiving controller medications pre-exacerbation, only a small proportion escalated to triple therapy post-exacerbation.

Real-world treatment patterns in patients with nontuberculous mycobacterial lung disease in the Netherlands based on medication dispensing data

PurposeReal-world data on antibiotic management of nontuberculous mycobacterial lung disease (NTM-LD) is limited for many countries. This study aimed to evaluate real-world treatment practices of NTM-LD in the Netherlands using medication dispensing data.MethodsA retrospective longitudinal real-world study was conducted using IQVIA’s Dutch pharmaceutical dispensing database. The data are collected monthly and include approximately 70% of all outpatient prescriptions in the Netherlands. Patients initiated on specific NTM-LD treatment regimens between October 2015 and September 2020 were included. The main areas of investigation were initial treatment regimens, persistence on treatment, treatment switching, treatment compliance in terms of medication possession rate (MPR) and restarts of treatment.ResultsThe database included 465 unique patients initiated on triple- or dual-drug regimens for the treatment of NTM-LD. Treatment switches were common and occurred approximately 1.6 per quarter throughout the treatment period. The average MPR of patients initiated on triple-drug therapy was 90%. The median time on therapy for these patients was 119 days; after six months and one year, 47% and 20% of the patients, respectively, were still on antibiotic therapy. Of 187 patients initiated on triple-drug therapy, 33 (18%) patients restarted antibiotic therapy after the initial treatment had been stopped.ConclusionWhen on therapy, patients were compliant with the NTM-LD treatment; however, many patients stopped their therapy prematurely, treatment switches often occurred, and part of patients had to restart their therapy after a longer treatment gap. NTM-LD management should be improved through greater guideline adherence and appropriate involvement of expert centers.

Real-world treatment patterns in patients with HER2+ unresectable or metastatic breast cancer: Interim results from HER2 REAL Asia cohort.

1047 Background: HER2 REAL (NCT04857619) is the first multi-country, retrospective study exploring the treatment practices and outcomes in patients (pts) with HER2+ locally advanced, unresectable (u)/metastatic (m) breast cancer (BC) from routine clinical care in the APAC and LATAM. Methods: Adult HER2+ u/mBC pts diagnosed since reimbursement or wider access of trastuzumab emtansine (T-DM1) or 01 Jan 2017, whichever was earlier with ≥12 months (mo) of follow-up data from index date (u/mBC diagnosis) and treated with ≥1-line of therapy (LOT) were enrolled per medical chart review from 6 countries. Here we present interim descriptive analyses (cut-off 30 June 2022) on demographics, clinical characteristics, and treatment patterns. Results: Of the 763 enrolled pts, 370 with median (range) age of 55 (20–81) yrs from Hong Kong, Korea, Singapore, and Taiwan were eligible for interim analyses; 368 (99.5%) were female with 210 (57.1%) postmenopausal. A total of 210 (57.1%) pts with reported data had a median time of 2 (0–18) yrs from initial BC diagnosis to u/mBC relapse. At index date, majority had ductal carcinoma (227/254 [89.4%]), visceral (255/355 [71.8%]), and non-visceral (258/355 [72.3%]) metastases; 80/355 (22.5%) had CNS metastases. Family history of BC was reported by 45/370 (12.2%) pts completing the questionnaire; 209/370 (56.5%) had hormone receptor-positive BC. Treatments reported in the first to fifth line were quite variable. HER2-directed therapy was received by 323/367 (88.0%) in LOT1 (mainly trastuzumab [TRA] and pertuzumab [PTZ]-based) and 298/343 (86.9%) in LOT2 (mainly T-DM1). Median duration of LOT1 and LOT2 were 7.8 (0–130) and 5.0 (0–100) mo, respectively, that decreased to 2.3 (0–30) mo in LOT5. The prime reason for treatment discontinuation was disease progression (LOT1: 294 [80.1%]; LOT2: 273 [79.6%]; LOT3: 187 [68.5%]). Serious adverse effects from treatments were rare (LOT1: 7 [1.9%]; LOT2: 10 [2.9%]; LOT3: 5 [1.8%]). Conclusions: The interim analyses show heterogeneous treatment patterns in real-world among pts with HER2+ u/mBC progressing on HER2-directed therapies possibly due to access disparity in these 4 Asian countries. Clinical trial information: NCT04857619 . [Table: see text]

PCR136 A Retrospective Analysis of Real-World Treatment Patterns in Patients over Age 64 with Dry Eye Disease Receiving OTX-101 Ophthalmic Solution 0.09%, Cyclosporine Ophthalmic Emulsion 0.05%, or Lifitegrast Ophthalmic Solution 5%

Dry eye disease (DED) causes chronic ocular surface inflammation and damage. DED prevalence increases with age. Cyclosporine ophthalmic solution 0.09% (CEQUA®; OTX-101), cyclosporine ophthalmic emulsion 0.05% (Restasis®; CsA), and lifitegrast ophthalmic solution 5% (Xiidra®; LFT) are anti-inflammatory agents indicated for DED treatment. We compared treatment patterns in patients >64 years with DED receiving OTX-101, CsA, or LFT.