Employees Of AbbVie Research Articles

Abstract PO-006: ABBV-319: A CD19–targeting glucocorticoid receptor modulator antibody-drug conjugate therapy for B-cell malignancies

Abstract Glucocorticoids such as prednisone (P) and dexamethasone (D) are key components in standard-of-care immuno-chemotherapy regimens (e.g., R-CHOP, EPOCH-R, Hyper-CVAD) for the treatment of B-cell malignancy. However, prolonged systemic glucocorticoid treatment is associated with several adverse events that often result in dose reduction and reduced therapeutic efficacy. ABBV-319 is a CD19-targeting antibody-drug conjugate (ADC) with a glucocorticoid receptor modulator (GRM) payload engineered to reduce glucocorticoid-associated toxicities while possessing three distinct mechanisms of action (MOA) to increase therapeutic efficacy: (1) CD19 receptor-mediated delivery of potent glucocorticoid receptor modulator (GRM) payload to induce apoptosis, (2) inhibition of B-cell receptor (BCR) stimulated CD19 signaling, and (3) enhanced Fc-mediated effector function via afucosylation of the antibody backbone. ABBV-319 elicited potent GRM-driven anti-tumor activity against multiple malignant B-cell lines in vitro as well as in cell line-derived xenografts (CDXs) and patient-derived xenografts (PDXs) in vivo. Remarkably, a single-dose of ABBV-319 induced sustained tumor regression and enhanced anti-tumor activity compared to repeat dosing of systemic prednisolone at the maximum tolerated dose (MTD) in mice. The unconjugated CD19 monoclonal antibody (mAb) also displayed anti-proliferative activity on a subset of B-cell lymphoma cell lines through the inhibition of PI3K signaling. Moreover, afucosylation of the CD19 mAb enhanced Fc-mediated antibody-dependent cellular cytotoxicity (ADCC), and this activity was maintained after conjugation with GRM payload. Notably, ABBV-319 displayed superior efficacy compared to afucosylated CD19 mAb in human CD34+ PBMC-engrafted NSG-tg(Hu-IL15) transgenic mice, demonstrating enhanced anti-tumor activity in vivo when multiple MOAs are enabled concurrently. ABBV-319 also showed potent anti-tumor activity across multiple B-cell lymphoma models, including non-germinal center B-cell (GCB) DLBCL and relapsed lymphoma treated with R-CHOP treatment. Collectively, these data support the ongoing evaluation of ABBV-319 for the treatment of B-cell malignancy in Phase I clinical trial (NCT05512390). Disclosures: All authors are employees of AbbVie. The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication. Citation Format: Chewei (Anderson) Chang. ABBV-319: A CD19–targeting glucocorticoid receptor modulator antibody-drug conjugate therapy for B-cell malignancies [abstract]. In: Proceedings of the Fourth AACR International Meeting on Advances in Malignant Lymphoma: Maximizing the Basic-Translational Interface for Clinical Application; 2024 Jun 19-22; Philadelphia, PA. Philadelphia (PA): AACR; Blood Cancer Discov 2024;5(3_Suppl):Abstract nr PO-006.

Abstract ND01: ABBV-303: A novel NK and CD8 T cell engager specific for c-Met-expressing tumors

Abstract Natural killer (NK) cell redirecting therapies are emerging as promising “off the shelf” treatments for cancer without the safety issues associated with T cell directed therapies. ABBV-303 is a novel c-Met targeted multispecific NK cell engager based on Dragonfly Therapeutics’ TriNKET® technology. ABBV-303 includes three functional arms: (1) a c-Met binding scFv based on ABT-700, common to c-Met-targeting antibody-drug conjugates ABBV-400 and Teliso-V; (2) a Fab arm that binds NKG2D, a stimulatory receptor expressed by NK cells and activated CD8+ T cells; and (3) a heterodimeric IgG1 Fc which binds CD16a on NK cells and links the other two binding moieties. ABBV-303 binding to NKG2D and CD16a results in redirection of both innate (NK cells) and adaptive (CD8+ T cells) immune cells to lyse c-Met expressing tumor cells. Treatment of peripheral blood mononuclear cells (PBMCs) from healthy donors and cancer patients with ABBV-303 in the presence of c-Met+ tumor cells stimulates NK and CD8+ T cells as demonstrated by modulation of activation-associated surface proteins and release of soluble factors. ABBV-303 drives sub-nanomolar redirected killing potency against tumor cells expressing a broad range of c-Met. Additionally, anti-tumor activity of ABBV-303 has been demonstrated against established xenografts in CD34 humanized NSG mice. NK and CD8+ T cell activity in response to ABBV-303 has been observed in c-Met-expressing fresh patient tumor explants. A benign safety profile was observed in non-human primates through three repeat doses up to 150 mg/kg given every two weeks, with antibody-like exposures and a serum half-life around 8 days. Based on these findings, the First in Human ABBV-303 study will initiate in 1H 2024 in solid tumors as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor. All authors are current employees of AbbVie. The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication. Citation Format: Jennifer Stone, Kamonwan Pear Fish, Devika Ashok, Laura McKay, Saeed Akhand, Weilong Zhao, Si Wu, Amani Makkouk, Cormac Cosgrove, Paul Ellis, David Peetz, Stephanie Shee, Richard Peterson II, Shelby Anderson, Adam Chervin, Claudina Stevenson, Tamar Uziel, Edward Reilly. ABBV-303: A novel NK and CD8 T cell engager specific for c-Met-expressing tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr ND01.

Safety and Effectiveness in Treatment Naive CLL Patients with or without High Risk Features Treated with Veno Under Real-World Conditions in Austria, Germany, and Switzerland

Background In chronic lymphocytic leukemia (CLL), the association of genetic markers such as del(17p), TP53 and IGHV status with disease prognosis is well established. In clinical trials, treatment with Venetoclax in combination with Obinutzumab (VenO) has shown promising efficacy and good tolerability in all subgroups 1. However, there is limited real-world data in specific genetic subgroups. Aim Effectiveness and safety data were analyzed for therapy naive patients treated with VenO focusing on CLL patients with or without the genetic risk factors TP53 mut and/or del(17p) as well as IGHV status. Methods VeRVe is a non-interventional, observational, prospective study with 60 study sites in Germany, Austria, and Switzerland. CLL patients treated with VenO according to the local label 2 were included. Study documentation is possible at baseline, weekly during ramp-up, monthly until the end of month 6 and quarterly afterwards up to a maximum of 2 years. Response assessment was documented after ramp-up, 3, 12 and 24 months. Results Until April 12 th, 2023, 101 patients were enrolled and received at least one dose of Venetoclax, 42 % were IGHV unmutated. Baseline characteristics were balanced between the genetic risk groups. Patients with TP53 aberrations were older compared TP53 wildtype patients (71 vs. 66 a). 70% of patients with TP53 aberration, 68% of patients with wt TP53, 74% of patients with IGHVunmutated and 71% of patients with IGHVmut had at least 1 comorbidity. The best overall response rate after 12 months for 88 evaluable patients is shown in the figure. Estimated PFS-rate after 1 year was 93% in the total population, 100% in patients with TP53 aberrations, 91% in patients with wt TP53 95.1% of patients with IGHVunmutated and 82.5% of patients with IGHVmut. Estimated OS -rate after 1 year was identical to the estimated PFS. CTCAE grade AEs 3-5 were reported in 35% of the total population, in 21% in the TP53 aberrant, in 35% in the TP53 wt, in 33% in the IGHVunmutated and 10% in the IGHVmut population. A total of 3 patients had laboratory TLS. No new safety signals were detected. Conclusion In summary, both patients with or without TP53 aberration and with mutated or unmutated IGHV had high rates of best ORR, estimated PFS, and OS. Reassuringly, CR/CRi rates were high in patients with TP53 aberration or IGHV unmutated patients. Treatment was well tolerated. Disclosures DR has received honoraria or research grants from AbbVie, AstraZeneca, Gilead, Janssen, Verastem, Roche, Cellestia. IS has received honoraria from AbbVie, Amgen, AstraZeneca, BeiGene, Janssen, Roche, Servier. HH received speaker or consulting fees from AbbVie, AstraZeneca, Celgene, Janssen, Roche, and Beigene. CL received consulting fees from AbbVie, Amgen. TW received honaria or research funding from Novartis, Celgene, Roche, Bayer, Teva and Abbvie. CL and JH are employees of AbbVie and may own AbbVie stock. BS received speaker or consulting fees from AbbVie, Alexion, Amgen, AstraZeneca, BeiGene, BMS, Hexal, Janssen, Novartis, Pfizer, Sanofi-Aventis and SOBI. PP has received honoraria from Amgen, Gilead, Janssen, Sanofi-Aventis, Takeda. Honorarium paid by AbbVie was not related to authorship of this abstract. No honoraria or payments were made for authorship. AbbVie sponsored this study and contributed to the design, study conduct. AbbVie participated in the interpretation of data, review, and approval of the publication. All authors had access to all relevant data. Statistical support was provided by Daniela Giesder and Anna Eisen of GermanOncology GmbH, which was funded by AbbVie.

MALT1 Protease Inhibition Overcomes BTK Inhibitor Resistance and Shows Synergistic Activity with Venetoclax in Models of B Cell Lymphoma and Leukemia

Background Specific B cell malignancies, including the aggressive non-germinal center B cell-like (GCB) subtype of diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL), are driven by constitutive activation of the transcription factor NF-kB. Chronic signaling resulting from mutations or antigen-induced activation of the B cell receptor (BCR) pathway drives NF-kB activity in these tumors resulting in sustained proliferation and survival pathways. Mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) represents a key mediator of the BCR/NF-kB signal transduction pathway responsible for maintaining survival and driving proliferation of NF-kB-addicted B cell tumors by proteolytically cleaving NF-kB antagonists. Aims Pharmacological inhibition of MALT1 protease activity may provide an attractive treatment option for patients with these cancers. Further, as combination therapy is often required for the treatment of aggressive B cell malignancies, the identification of therapies that synergistically combine with MALT1 inhibitors could afford additional and promising treatment options. Methods A highly potent and orally bioavailable MALT1 protease inhibitor (ABBV-MALT1) was used to test the hypothesis that MALT1 inhibition will abrogate the proliferation of preclinical models of B cell malignancies in vitro and in vivo. Tumors treated with ABBV-MALT1 were subjected to transcriptomic and functional proteomic assays to elucidate molecular mechanisms of action and rational combination partners. Results ABBV-MALT1 potently inhibits MALT1 activity in vitro while showing high selectivity against a panel of proteases, kinases and other types of receptors and enzymes. Mechanistic studies reveal that ABBV-MALT1 effectively inhibits signal transduction of the BCR pathway and reduces NF-kB gene activation in non-GCB DLBCL cell lines resulting in cell cycle arrest and diminished viability. In vivo, oral administration of this compound demonstrates robust tumor growth inhibition in several models of B cell tumors, including non-GCB DLBCL models that are resistant to Bruton's tyrosine kinase (BTK) inhibitors. NF-kB target genes include the pro-survival family members BCL-XL and BCL2-A1, which aid in regulation of the intrinsic apoptosis pathway. As ABBV-MALT1-induced inhibition of the NF-kB pathway resulted in downregulation of these genes, we hypothesized that the associated tumor models would become increasingly dependent on the pro-survival family member BCL-2. To test this hypothesis, combination studies of ABBV-MALT1 and the selective BCL-2 inhibitor venetoclax were performed in both cell line and patient-derived xenograft models of DLBCL. Herein we show that concomitant administration of ABBV-MALT1 and venetoclax results in dramatic antitumor activity in all models tested in vivo. This efficacy also translates to primary patient CLL cells in vitro where the combination confers greater levels of apoptosis compared to either agent alone. Summary/Conclusion: ABBV-MALT1 demonstrates robust single agent anti-tumor activity in malignant B cell models that are resistant to BTK inhibitors. Moreover, combination of ABBV-MALT1 with the BCL-2 inhibitor venetoclax shows synergistic cell killing of B cell tumors in vitro and dramatic tumor regression in vivo. Together, these data indicate that MALT1 inhibition may overcome BTK inhibitor resistance and combine with venetoclax to effectively treat patients with DLBCL, CLL and other B cell malignancies. Disclosures All authors are employees of AbbVie. The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.

Place of care and costs associated with acute episodes and remission in schizophrenia.

BACKGROUND: Schizophrenia imposes significant economic burden on patients, families, caregivers, and society. To our knowledge, place of care and associated costs of acute schizophrenia episodes have not been well characterized. OBJECTIVE: To describe the care settings and costs associated with likely acute episodes and untreated remission periods among patients with schizophrenia. METHODS: Adults with schizophrenia were identified using the IBM MarketScan Commercial and Medicare Supplemental databases (2009-2018); claims for capitated benefits plans were excluded. Acute episode index date was defined as at least 1 inpatient schizophrenia claim or outpatient schizophrenia claim (frequency of claim dependent on visit type, such as hospitalization, emergency department, private practice, clinic, urgent care, or laboratory). Mental health-related medical costs (health plan+patient) associated with acute episodes were collected over a 2-month follow-up period and stratified by setting (inpatient vs outpatient); acute episode data were reported in subgroups of patients without or with prior clozapine use, as an indication of disease severity. Remission index date was defined as at least 1 outpatient claim with a schizophrenia diagnosis with no acute episode and no oral or injectable antipsychotic therapy. Remission costs were assessed over a 3-month period. All data were analyzed descriptively. RESULTS: A total of 14,824 patients with schizophrenia met criteria for an acute episode (12,896 [87.0%] without prior clozapine use; 1,427 [9.6%] with prior clozapine use). Most acute episodes were treated in an outpatient setting (all patients, 76.3%; without prior clozapine use, 74.5%; with prior clozapine use, 87.1%). When treated inpatient, mean (SD) episode medical costs were $17,045 ($28,101) for all patients, $16,060 ($22,786) for those without prior clozapine use, and $22,827 ($55,860) for those with prior clozapine use. When treated outpatient, mean (SD) medical costs for acute episodes were $2,478 ($6,961) for all patients, $2,609 ($7,068) for those without prior clozapine use, and $1,770 ($6,560) for those with prior clozapine use. For all patients with acute episodes, regardless of clozapine use, patient-incurred out-of-pocket costs were approximately 30% of total medical costs. For an untreated period of remission, 6,950 patients with schizophrenia met criteria. Total medical costs were $2,399 for these patients over a 3-month period. CONCLUSIONS: The majority of acute schizophrenia episodes were treated in the outpatient setting. For episodes that required inpatient care, inpatient episodes were approximately 7 times more costly than episodes treated in outpatient-only settings. For acute episodes and remission periods, health plans covered most costs; however, there were additional patient-incurred out-of-pocket costs. DISCLOSURES: All authors met the International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship. Dr McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, Atai Life Sciences. Dr McIntyre is a CEO of Braxia Scientific Corp. Mr Doan, Dr Amari, and Mr Mercer are employees of Genesis Research, which was funded to perform the study. Ms Higa, Dr Gillard, and Dr Harrington were employees of AbbVie at the time of the study and may hold stock. This study was sponsored by AbbVie.

HARBOR: ABBV-916 In Subjects With Early Alzheimer’s Disease Combined Multiple-Ascending Dose/Proof-Of-Concept Study Design (P7-6.008)

<h3>Objective:</h3> This study evaluates safety, tolerability, pharmacokinetics, immunogenicity, and amyloid reduction associated with ABBV-916, a recombinant humanized immunoglobulin G1 monoclonal antibody, in subjects with early AD. <h3>Background:</h3> Alzheimer’s disease (AD) is the most common cause of dementia in the elderly. <h3>Design/Methods:</h3> Approximately 163 subjects will be enrolled in this Phase 1b/2 multicenter, randomized, placebo-controlled, double-blind, dose-finding study (NCT05291234), which consists of 2 stages: multiple-ascending dose (MAD; Phase 1b; Stage A) and proof-of-concept (POC; Phase 2; Stage B). Each stage has a 60-day screening period, 24-week double-blind period (ABBV-916 or placebo administered intravenously once every 4 weeks) and a 16-week safety follow-up period, with the option of a 2-year open-label extension. Subjects must meet the following inclusion criteria: be between 50 and 90 years of age, diagnosis of Stage 3 or 4 AD, as defined by the 2018 NIA-AA Research Framework, a Mini-Mental State Examination score between 20 and 28, a positive Precivity AD-Aβ blood test, and an amyloid PET scan consistent with amyloid pathology. <h3>Results:</h3> Safety evaluations include adverse events reports, clinical laboratory tests, MRI, vital signs, electrocardiograms, and the Columbia-Suicide Severity Rating Scale. Cerebrospinal fluid collection is required for subjects in Stage A and optional for subjects in Stage B. Change from baseline in brain amyloid plaque deposition is measured by amyloid PET scan in Stage B. <h3>Conclusions:</h3> This study tests the hypothesis that ABBV-916 will lead to rapid and robust removal of amyloid plaques from the brain of subjects with AD. <b>Disclosure:</b> Dr. Watson has nothing to disclose. Shau Yu Lynch has received personal compensation for serving as an employee of AbbVie. Shau Yu Lynch has received personal compensation for serving as an employee of Eisai. Shau Yu Lynch has stock in AbbVie. Hana Florian has received personal compensation for serving as an employee of AbbVie. Hana Florian has stock in AbbVie. Dr. Wang has received personal compensation for serving as an employee of AbbVie Inc.. Dr. Wang has stock in AbbVie Inc.. Mr. Bachhav has received personal compensation for serving as an employee of AbbVie Inc, USA. Mr. Bachhav has stock in AbbVie Inc. USA. Dr. Boiser has received personal compensation for serving as an employee of AbbVie. Dr. Boiser has stock in AbbVie. Dr. Bannon has received personal compensation for serving as an employee of AbbVie. Dr. Bannon has stock in AbbVie. Dr. Stage has received personal compensation for serving as an employee of AbbVie. Dr. Stage has stock in AbbVie.. Dr. Graff has received personal compensation for serving as an employee of AbbVie. Dr. Graff has stock in AbbVie.

Improvement in Patient-Reported Outcomes When Ubrogepant Is Administered During the Migraine Prodrome (Premonitory Phase): Results From the PRODROME Trial (P9-12.001)

Improvement in Patient-Reported Outcomes When Ubrogepant Is Administered During the Migraine Prodrome (Premonitory Phase): Results From the PRODROME Trial (P9-12.001)

A Phase 1 First-in-human Study to Investigate the Safety, Tolerability and Food Effect of ABBV-CLS-7262 (P6-4.002)

<h3>Objective:</h3> To evaluate the first-in-human safety, tolerability and food effect of ABBV-CLS-7262 in healthy subjects. <h3>Background:</h3> ABBV-CLS-7262 is in development as a CNS-penetrant small molecule activator of eIF2B, which is the guanine nucleotide exchange factor for eukaryotic translation initiation factor 2 (eIF2). eIF2 is an important node in the Integrated Stress Response, which is believed to be persistently activated in various neurological diseases, including amyotrophic lateral sclerosis. By activating eIF2B, ABBV-CLS-7262 may attenuate the Integrated Stress Response and restore protein translation. <h3>Design/Methods:</h3> This multi-part Phase 1 study enrolled healthy male and female subjects between 18 and 65 years of age. A total of 125 subjects received ABBV-CLS-7262 and 33 received placebo. <h3>Results:</h3> ABBV-CLS-7262 was well-tolerated following oral administration of single and multiple ascending doses for up to 14 days. All adverse events (AEs) were mild to moderate in severity, and no dose-dependent patterns of AEs or laboratory abnormalities were identified. Following administration with a high-fat meal, the safety, tolerability, and pharmacokinetics were similar when compared to the fasting state. <h3>Conclusions:</h3> The observed safety, tolerability, and clinical pharmacology profile of ABBV-CLS-7262 support investigation of the product in further studies. <b>Disclosure:</b> Dr. Cho has received personal compensation for serving as an employee of Calico. Dr. Cho has stock in Roche. Dr. Jeong has received personal compensation for serving as an employee of AbbVie. An immediate family member of Dr. Jeong has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for Stryker. Dr. Jeong has stock in AbbVie. Dr. Malik has received personal compensation for serving as an employee of AbbVie. Dr. Malik has received personal compensation for serving as an employee of Calico Life Sciences. Dr. Boiser has received personal compensation for serving as an employee of AbbVie. Dr. Boiser has stock in AbbVie. Dr. Huang has received personal compensation for serving as an employee of AbbVie. Dr. Rosebraugh has received personal compensation for serving as an employee of AbbVie Inc. Dr. Rosebraugh has stock in AbbVie Inc..

Benefit-Risk Assessment of Atogepant: A Post Hoc Analysis of the ADVANCE Trial (P12-12.001)

Benefit-Risk Assessment of Atogepant: A Post Hoc Analysis of the ADVANCE Trial (P12-12.001)

Real-world Adherence to Subsequent CGRP mAb Treatment Among Chronic Migraine (CM) Patients Initially Treated with OnabotulinumtoxinA: A Retrospective Claims Analysis (P10-12.004)

<h3>Objective:</h3> To examine adherence to calcitonin gene–related peptide monoclonal antibody (CGRP mAb) treatment among patients who initiated onabotulinumtoxinA (OnabotA) and subsequently added on or switched to a CGRP mAb. <h3>Background:</h3> The 2021 American Headache Society consensus statement and emerging clinical reports suggest that the combination of a CGRP mAb and OnabotA in patients with migraine is probably effective. However, real-world utilization of combination treatments relative to monotherapies among patients with chronic migraine (CM) has not been examined previously. <h3>Design/Methods:</h3> In this retrospective cohort study, adult patients with CM (ICD-10-CM G43.7X) treated with OnabotA and subsequently with a CGRP mAb were identified from IBM MarketScan® claims databases (05/17/2018 – 06/30/2021). The index date was the first CGRP mAb prescription. Patients were categorized into two cohorts: “addition” (concomitant OnabotA and index CGRP mAb usage ≥28 days) and “switch” (otherwise). Adherence (≥80% of days covered on medication) over a 6-month follow-up period was assessed using logistic regression to adjust for baseline characteristics during the 6-month pre-index period. <h3>Results:</h3> The study sample included 610 patients in the addition cohort and 680 in the switch cohort. Lower adherence to index CGRP mAb was observed in the addition versus switch cohorts (38.9% vs 48.2%; <i>P</i>&lt;0.001). After controlling for baseline characteristics, the switch cohort had 41% (95% CI: 1.12–1.77; <i>P</i>=0.003) higher odds of adherence versus the addition cohort. In the addition cohort, 60.2% (n=367) of patients were adherent to OnabotA alone or in combination with a CGRP mAb, and 19.3% (n=118) were adherent to combination use of the index CGRP mAb and OnabotA. <h3>Conclusions:</h3> During follow-up, patients who added a CGRP mAb to OnabotA had significantly lower adherence to the CGRP mAb versus patients who switched to a CGRP mAb. These findings suggest that usage of CGRP mAb as add-on to OnabotA occurs for a limited duration. <b>Disclosure:</b> Ms. DONG has received personal compensation for serving as an employee of AbbVie. Ms. DONG has stock in AbbVie. Ms. DONG has received research support from National Institutes of Health. Ms. Gusovsky has nothing to disclose. Ms. Shah has received personal compensation for serving as an employee of AbbVie. Ms. Shah has stock in AbbVie Inc. An immediate family member of Ms. Shah has received research support from National Institutes of Health. Mr. Park has received personal compensation for serving as an employee of AbbVie. Mr. Park has stock in AbbVie. Changgeng Zhao has received personal compensation for serving as an employee of AbbVie. Changgeng Zhao has stock in AbbVie.

SYNCHRONIZE: Real-World Retrospective Review of Safety in Patients Treated With OnabotulinumtoxinA for More Than 1 Therapeutic Indication: An Epidemiologic Perspective (P12-11.006)

SYNCHRONIZE: Real-World Retrospective Review of Safety in Patients Treated With OnabotulinumtoxinA for More Than 1 Therapeutic Indication: An Epidemiologic Perspective (P12-11.006)

Real-world Adherence to Subsequent Prophylactic Therapy Among Chronic Migraine (CM) Patients Initially Treated With a Calcitonin Gene–related Peptide Monoclonal Antibody (CGRP mAb) (P6-12.009)

<h3>Objective:</h3> To examine adherence to branded preventive chronic migraine (CM) treatments among patients who initiated calcitonin gene–related peptide monoclonal antibody (CGRP mAb) treatment and subsequently added on or switched to another branded preventive treatment. <h3>Background:</h3> OnabotulinumtoxinA (OnabotA) and CGRP mAbs treat CM prophylactically. CM patients treated with a CGRP mAb may introduce a subsequent treatment, but little is known about adherence to the subsequent CM treatment. <h3>Design/Methods:</h3> This retrospective cohort study included adult CM patients (ICD-10-CM G43.7XX) treated with a CGRP mAb and a subsequent CM treatment from IBM MarketScan® claims databases (05/17/2018 – 06/30/2021). The index date was the first claim date of subsequent treatment. Patients were categorized into three cohorts: switch to another CGRP mAb, switch to OnabotA, and add-on OnabotA (concomitant with CGRP mAb ≥28 days immediately following index). Baseline characteristics were assessed during the 6-month pre-index period. Adherence was defined as ≥80% of days covered on index treatment over the 6-month follow-up period. Difference in adherence between cohorts was compared using a Chi-square test and adjusted for baseline characteristics using logistic regression. <h3>Results:</h3> A total of 1315 patients were included; 745 switched to a CGRP mAb, 449 switched to OnabotA, and 121 added OnabotA. Mean age was 41.9, 39.8, and 41.3 years, respectively, and all cohorts were ≥86% female. Adherence was highest for add-on OnabotA, followed by switch to OnabotA, and, lastly, switch to CGRP mAb (68.6% vs 61.5% vs 33.2%, respectively; <i>P</i>&lt;0.0001). After adjustment, switch to OnabotA and add-on OnabotA cohorts had 3.3 (95% CI: 2.5–4.2) and 4.6 (95% CI: 3.0–7.0) times higher odds of adherence compared with the switch to CGRP mAb cohort. <h3>Conclusions:</h3> Following a CGRP mAb, adding on or switching to OnabotA as a subsequent CM treatment was associated with significantly higher adherence over 6 months compared with switching to another CGRP mAb. <b>Disclosure:</b> Ms. Gusovsky has nothing to disclose. Ms. DONG has received personal compensation for serving as an employee of AbbVie. Ms. DONG has stock in AbbVie. Ms. DONG has received research support from National Institutes of Health. Changgeng Zhao has received personal compensation for serving as an employee of AbbVie. Changgeng Zhao has stock in AbbVie. Mr. Park has received personal compensation for serving as an employee of AbbVie. Mr. Park has stock in AbbVie. Ms. Shah has received personal compensation for serving as an employee of AbbVie. Ms. Shah has stock in AbbVie Inc. An immediate family member of Ms. Shah has received research support from National Institutes of Health.

Evaluation of the Clinical Outcomes and Disease Burden in Advanced Parkinson’s Disease Patients: PROSPECT Study Preliminary Results (P10-11.009)

Evaluation of the Clinical Outcomes and Disease Burden in Advanced Parkinson’s Disease Patients: PROSPECT Study Preliminary Results (P10-11.009)

Characterizing the Patient Experience During the Prodrome Phase of Migraine: A Qualitative Study of Symptoms and Their Timing (P7-12.002)

Characterizing the Patient Experience During the Prodrome Phase of Migraine: A Qualitative Study of Symptoms and Their Timing (P7-12.002)

Atogepant for the preventive treatment of chronic migraine: results from the PROGRESS phase 3 trial (S47.005)

Atogepant for the preventive treatment of chronic migraine: results from the PROGRESS phase 3 trial (S47.005)

Efficacy of Ubrogepant for the Treatment of Migraine Symptoms During the Prodrome (Premonitory Phase): Results From the PRODROME Trial (S47.002)

Efficacy of Ubrogepant for the Treatment of Migraine Symptoms During the Prodrome (Premonitory Phase): Results From the PRODROME Trial (S47.002)

Ubrogepant for the Acute Treatment of Migraine When Administered During the Prodrome (Premonitory Phase): Results From a Phase 3, Randomized, Double-blind, Placebo-Controlled, Crossover Study (S47.001)

Ubrogepant for the Acute Treatment of Migraine When Administered During the Prodrome (Premonitory Phase): Results From a Phase 3, Randomized, Double-blind, Placebo-Controlled, Crossover Study (S47.001)

Post Hoc Analysis of PROGRESS: Evaluating the Safety of Atogepant in Participants With Chronic Migraine and Cardiovascular Risk Factors (P10-12.012)

Post Hoc Analysis of PROGRESS: Evaluating the Safety of Atogepant in Participants With Chronic Migraine and Cardiovascular Risk Factors (P10-12.012)

Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period (S41.009)

Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period (S41.009)

Exploring the Experience of Neck Pain in Individuals With Episodic Migraine (P3-12.004)

Exploring the Experience of Neck Pain in Individuals With Episodic Migraine (P3-12.004)