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Mehmet Asim Bilen,1 Ibrahim Khilfeh,2 Carmine Rossi,3 Erik Muser,2 Laura Morrison,3 Annalise Hilts,3 Lilian Diaz,3 Patrick Lefebvre,3 Dominic Pilon,3 Daniel J George4 1Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA, USA; 2Janssen Scientific Affairs, LLC, Horsham, PA, USA; 3Analysis Group, Inc., Montréal, QC, Canada; 4Department of Medicine, Duke University Cancer Center, Durham, NC, USACorrespondence: Carmine Rossi, Analysis Group, Inc., 1190 avenue des Canadiens-de-Montréal, Tour Deloitte, Suite 1500, Montréal, QC, H3B 0G7, Canada, Tel +1 514-871-4233, Email carmine.rossi@analysisgroup.comBackground: Alterations in DNA damage repair genes in advanced prostate cancer (PC) may impact responses to therapy and clinical outcomes. This study described homologous recombination repair (HRR) testing patterns and clinical outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) by HRR alteration status and race in the United States (US).Methods: Clinical data in the nationwide (US-based) Flatiron Health-Foundation Medicine, Inc. (FMI) Metastatic PC Clinico-Genomic Database were evaluated (01/01/2011– 12/31/2022). Patients initiating first-line (1L) mCRPC therapy on or after mCRPC diagnosis were included. Testing patterns, time-to-next treatment, overall survival (OS), and time-to-prostate specific antigen response were described.Results: Of the 1367 patients with mCRPC and at least one HRR panel test prior to or on the date of 1L mCRPC therapy initiation, 332 (24.3%) were HRR positive (White patients: n = 219 [66.0%]; Black patients: n = 37 [11.1%]) and 1035 (75.7%) were HRR negative (White patients: n = 702 [67.8%]; Black patients: n = 84 [8.1%]). The mean time between first positive test and 1L mCRPC therapy initiation date was 588 days (White patients: 589 days; Black patients: 639 days). Among HRR positive relative to negative patients, trends for faster progression (respective 12-month rate overall: 71.1% and 63.7%; White patients: 72.5% and 64.0%; Black patients: 65.4% and 56.4%), shorter OS (respective 24-month rate overall: 46.8% and 51.9%; White patients: 48.6% and 46.2%; Black patients: 52.8% and 54.1%), and decreased treatment response (respective 12-month rate overall: 24.3% and 37.9%; White patients: 24.5% and 35.2%; Black patients: 17.0% and 43.9%) were observed.Conclusion: Patients with mCRPC positive for HRR alterations tended to exhibit poorer treatment responses and clinical outcomes than those with a negative status. These findings highlight the importance of timely genetic testing in mCRPC, particularly among Black patients, and the need for improved 1L targeted therapies to address the unmet need in HRR positive mCRPC.Keywords: burden of illness, electronic health records, homologous recombination repair genes, metastatic castration-resistant prostate cancer, next-generation sequencing testing, precision therapy

Maryia Zhdanava,1 Sumesh Kachroo,2 Aditi Shah,1 Zhijie Ding,2 Patrick Lefebvre,1 Ruizhi Zhao,2 Caroline Kerner,2 Dominic Pilon1 1Analysis Group, Inc, Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Horsham, PA, USACorrespondence: Maryia Zhdanava, Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Suite 1500, Montréal, QC, H3B 0G7, Canada, Tel +1-514-394-4469, Fax +1-514-394-4461, Email Masha.Zhdanava@analysisgroup.comPurpose: To describe real-world persistence in bio-naïve and bio-experienced adults with ulcerative colitis (UC) treated with ustekinumab, a recently approved anti-interleukin 12/23 antibody, or adalimumab, an anti-TNF biologic.Methods: This is a descriptive, retrospective cohort study. Patients initiating ustekinumab or adalimumab (index date, between 10/21/2019 and 08/13/2021) were selected from the Komodo Health comprehensive dataset and stratified into bio-naïve and bio-experienced subgroups based on biologic use 12 months pre-index date. Endpoints evaluated at 12-months after maintenance phase start using Kaplan–Meier analysis included 1) persistence; 2) persistence while being corticosteroid-free (< 14 consecutive days of corticosteroid supply after day 90 post-index); and, 3) persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies).Results: Ustekinumab cohort included 778 patients (236 bio-naïve, 542 bio-experienced) and adalimumab cohort included 1693 patients (1517 bio-naive, 176 bio-experienced). At 12 months after maintenance phase start, 75.5% and 50.5% of bio-naïve patients persisted on ustekinumab and adalimumab and 72.3% and 56.9% of bio-experienced patients persisted on ustekinumab and adalimumab, respectively. Further, 55.1% and 38.2% of bio-naïve patients were persistent and corticosteroid-free with ustekinumab and adalimumab; 43.7% and 33.4% of bio-experienced patients were persistent and corticosteroid-free with ustekinumab and adalimumab, respectively. Moreover, 68.1% and 44.5% of bio-naïve patients were persistent and on monotherapy with ustekinumab and adalimumab; 61.6% and 47.9% of bio-experienced patients were persistent and on monotherapy with ustekinumab and adalimumab, respectively.Conclusion: At 12 months after maintenance phase start, patients with UC treated with ustekinumab had numerically higher persistence, including persistence while corticosteroid-free and persistence while on monotherapy, than patients treated with adalimumab.Keywords: biologics, inflammatory bowel disease, outcomes research

Maryia Zhdanava,1 H Lynn Starr,2 Todor I Totev,3 Patrick Lefebvre,1 Aditi Shah,1 Kristy Sheng,4 Dominic Pilon1 1Analysis Group, Inc., Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Analysis Group, Inc., Boston, MA, USA; 4Analysis Group, Inc., Menlo Park, CA, USACorrespondence: Maryia Zhdanava, Manager at Analysis Group, Inc, 1190 Avenue des Canadiens-de-Montréal, Suite, 1500, Montréal, QC, H3B 0G7, Canada, Tel +1 514-394-4469, Email Masha.Zhdanava@analysisgroup.comPurpose: To describe changes due to the COVID-19 pandemic in the prescribing of long-acting antipsychotics (LAI) for schizophrenia, patient outcomes, and patient and healthcare provider (HCP) attitudes regarding COVID-19 vaccination in the United States (US).Methods: An anonymous online survey was administered to US-based LAI prescribers with a psychiatry specialty in May 2021. Information on prescriber and clinical practice characteristics, LAI prescribing, patient outcomes, and attitudes toward COVID-19 vaccination was collected and described.Results: Of the 401 LAI prescribers meeting survey criteria, 64.6% reported that LAI prescribing remained unchanged (increase: 19.2%, decrease: 14.0%). The majority did not switch patients from LAIs to oral antipsychotics (OAP; 63.3%) or to LAI formulations with lower frequency of administration (68.1%); most prescribers switched the same number of patients from OAPs to LAIs during the pandemic as in previous practice (65.1%). Half of LAI prescribers (50.1%) reported antipsychotic adherence as unchanged among most patients; 44.6% reported symptom control/relapse frequency as unchanged. Most prescribers believed their patients with schizophrenia should be prioritized for COVID-19 vaccination (74.1%) and encouraged all patients to obtain a COVID-19 vaccine (84.0%). However, 64.1% of prescribers reported hesitancy among some patients about vaccines’ safety; 51.4% reported that some patients were willing to be vaccinated despite the hesitancy, 48.6% indicated that some patients perceived COVID-19 vaccines as safe, effective, and important.Conclusion: LAI prescribing and prescriber-reported antipsychotic adherence in patients with schizophrenia remained largely unchanged approximately one year after the start of COVID-19. Focused efforts to overcome patients’ COVID-19 vaccine hesitancy are warranted.Keywords: adherence, antipsychotics, COVID-19, physician survey, prescribing habits, schizophrenia

Maryia Zhdanava,1 H Lynn Starr,2 Patrick Lefebvre,1 Todor I Totev,3 Aditi Shah,1 Kristy Sheng,4 Dominic Pilon1 1Analysis Group, Inc, Montréal, Quebec, Canada; 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Analysis Group, Inc, Boston, MA, USA; 4Analysis Group, Inc, Menlo Park, CA, USACorrespondence: Maryia Zhdanava, Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Suite 1500, Montréal, Quebec, H3B 0G7, Canada, Tel +1 514-394-4469, Email Masha.Zhdanava@analysisgroup.comPurpose: To describe factors that enable the routine use of long-acting injectable antipsychotics (LAIs) for appropriate patients in the current clinical practice, including changes in LAI prescribing due to the COVID-19 pandemic and expectations for prescribing in 2021 in the United States (US).Methods: Frequent LAI prescribers recruited from a nationwide panel in 2020 completed an online survey regarding practice characteristics, perspectives on healthcare system conditions enabling routine use of LAIs, and prescribing patterns and changes in patterns during the COVID-19 pandemic.Results: Of 408 prescribers who completed the survey, 77.7% were physicians and 59.1% had ≥ 10 years of psychiatry practice. More than half of frequent prescribers (57.1%) reported treating > 20% of their patients with schizophrenia with LAIs. The American Psychiatric Association (APA) guideline was followed by 64.0% of prescribers. Most prescribers identified poor adherence to antipsychotics as a circumstance when LAIs are recommended (94.9%) and patient/caregiver involvement in treatment decisions as a key factor impacting the decision to prescribe LAIs (97.3%). Most prescribers reported that LAI prescribing rates were unchanged in 2020 (59.8%). Similar proportions of prescribers expected no change (44.1%) or an increase (42.9%) in LAI prescribing rates in 2021. The number of patients followed, cost of treatment, and availability of staff to administer LAIs were the main driving factors identified by prescribers expecting an increase in LAI prescribing rates.Conclusion: LAIs were commonly recommended to patients with poor adherence, and patient/caregiver involvement was an important factor affecting prescribers’ treatment decisions. LAI prescribing rates remained unchanged during the COVID-19 pandemic in 2020.Keywords: COVID-19, healthcare providers, long-acting injectable antipsychotics, prescribing patterns, schizophrenia

Douglas Mapel,1 François Laliberté,2 Melissa H Roberts,1,3 Susan R Sama,4 Devi Sundaresan,4 Dominic Pilon,2 Patrick Lefebvre,2 Mei Sheng Duh,5 Jeetvan Patel6 1Health Services Research Division, Lovelace Clinic Foundation, Albuquerque, NM, USA; 2Groupe d’analyse, Montreal, QC, Canada; 3Department of Pharmacy Practice and Administrative Sciences, University of New Mexico, College of Pharmacy, University of New Mexico, Albuquerque, NM, 4Research Department, Reliant Medical Group, Worcester, MA, 5Analysis Group, Boston, MA, 6US Health Outcomes, GlaxoSmithKline, Research Triangle Park, NC, USA Introduction: An incremental approach using open-triple therapy may improve outcomes in patients with chronic obstructive pulmonary disease (COPD). However, there is little sufficient, real-world evidence available identifying time to open-triple initiation.Methods: This retrospective study of patients with COPD, newly initiated on long-acting muscarinic antagonist (LAMA) monotherapy or inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination therapy, assessed baseline demographics, clinical characteristics, and exacerbations during 12 months prior to first LAMA or ICS/LABA use. Time to initiation of open-triple therapy was assessed for 12 months post-index date. Post hoc analyses were performed to assess the subsets of patients with pulmonary-function test (PFT) information and patients with and without comorbid asthma.Results: Demographics and clinical characteristics were similar between cohorts in the prespecified and post hoc analyses. In total, 283 (19.3%) and 160 (10.9%) patients had moderate and severe exacerbations at baseline, respectively, in the LAMA cohort, compared with 482 (21.3%) and 289 (12.8%) patients in the ICS/LABA cohort. Significantly more patients initiated open-triple therapy in the LAMA cohort compared with the ICS/LABA cohort (226 [15.4%] versus 174 [7.7%]; P

Dominic Pilon,1 Kruti Joshi,2 Neeta Tandon,2 Marie-Hélène Lafeuille,1 Rhiannon L Kamstra,1 Bruno Emond,1 Patrick Lefebvre2 1Groupe d’analyse, Ltée, Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA Background: Poor antipsychotic (AP) adherence is a key issue in patients with schizophrenia. First-generation antipsychotic (FGA) and second-generation antipsychotic (SGA) long-acting injectable therapies (LAI) may improve adherence compared to oral antipsychotics (OAP). The objective of the study was to compare treatment adherence and persistence in Medicaid patients with schizophrenia initiated on first-generation long-acting injectable therapies (FGA-LAI) or second-generation long-acting injectable therapies (SGA-LAI) versus OAP.Methods: Adults with schizophrenia initiated on FGA-LAI, SGA-LAI, or OAP on or after January 2010 were identified using a six-state Medicaid database (January 2009– March 2015). Outcomes were assessed during the 12 months following treatment initiation. Index medication adherence was assessed using the proportion of days covered ≥80%, while persistence was assessed as no gap of ≥30, ≥60, or ≥90 days between days of supply. Outcomes were compared between FGA/SGA-LAI and OAP cohorts using chi-squared tests and adjusted odds ratios (OR).Results: During follow-up, AP polypharmacy was more common in FGA-LAI patients (N=1,089; 36%; P=0.029) and less common in SGA-LAI patients (N=2,209; 27%; P