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3. Describing the Patient Journey of Women with Claims for Uterine Fibroids and Heavy Menstrual Bleeding Using a Commercial Database (2011–2020)

Author

Agarwal,Sanjay K, Stokes,Michael, Kung,Tiffany, Tilney,Rong, Lickert,Cassandra, Agarwal,Sanjay K, Stokes,Michael, Kung,Tiffany, Tilney,Rong, and Lickert,Cassandra

Abstract

Sanjay K Agarwal,1 Michael Stokes,2 Tiffany Kung,3 Rong Tilney,2 Cassandra Lickert3 1UC San Diego, La Jolla, CA, USA; 2Evidera, St. Laurent, Quebec, Canada; 3Myovant Sciences, Inc (now known as Sumitomo Pharma America, Inc), Marlborough, MA, USACorrespondence: Cassandra Lickert, Sumitomo Pharma America, Inc, 4 Waterford Drive, Marlborough, MA, 01752, USA, Tel +1 (708) 214-1007, Email Cassandra.lickert@us.sumitomo-pharma.comIntroduction: This retrospective database claims analysis describes the clinical characteristics and treatment patterns of commercially insured United States women with uterine fibroids (UF) and heavy menstrual bleeding (HMB).Methods: Women age 18– 55 years with an incident UF diagnosis (index date) between 1/1/2012 and 12/31/2019 and ≥ 1 claim for HMB (UF-HMB), were identified from the Optum® Clinformatics® database. Outcomes included clinical characteristics, pharmacologic therapy use, and surgeries/procedures. Regression models were used to identify factors associated with time to post-diagnosis hormonal therapy and hysterectomy.Results: A total of 85,428 women had UF-HMB (mean [SD] age, 43.7 [6.4] years). The median follow-up was 3.2 years. After HMB, the most common symptoms were pelvic pressure/pain (27.6%) and backache (17.5%). Within 6 months of UF diagnosis, 40.2% of patients had received only pharmacologic therapy; 25.5% had received no treatment; 24.3% had a hysterectomy, and 10.0% had other procedures. By the end of follow-up, 50.0% had received a hysterectomy. Multiple factors were predictive of a higher likelihood of receiving hormonal therapy (geographic region, infertility, pre-index pregnancy) or hysterectomy (older age, prior hormonal treatment, specific bulk symptoms, White race).Conclusion: Within 6 months of UF diagnosis, fewer than one-half of women with UF-HMB had received hormonal therapy, one-quarter received no treatment, and one-quarter had received a hysterectomy or another gynecologic procedure. Patients who rece

Published
2023

5. Erratum. Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis. Diabetes Care 2020;43:90–97

Author

Hampp, Christian, primary, Swain, Richard S., additional, Horgan, Casie, additional, Dee, Elizabeth, additional, Qiang, Yandong, additional, Dutcher, Sarah K., additional, Petrone, Andrew, additional, Tilney, Rong Chen, additional, Maro, Judith C., additional, and Panozzo, Catherine A., additional

Published
2020
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6. The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines

Author

Baker, Meghan A., primary, Jankosky, Christopher, additional, Yih, W. Katherine, additional, Gruber, Susan, additional, Li, Lingling, additional, Cocoros, Noelle M., additional, Lipowicz, Hana, additional, Coronel-Moreno, Claudia, additional, DeLuccia, Sandra, additional, Lin, Nancy D., additional, McMahill-Walraven, Cheryl N., additional, Menschik, David, additional, Selvan, Mano S., additional, Selvam, Nandini, additional, Chen Tilney, Rong, additional, Zichittella, Lauren, additional, Lee, Grace M., additional, and Kawai, Alison Tse, additional

Published
2020
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9. Use of Sodium-Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis.

Author

Hampp, Christian, Swain, Richard S., Horgan, Casie, Dee, Elizabeth, Yandong Qiang, Dutcher, Sarah K., Petrone, Andrew, Rong Chen Tilney, Maro, Judith C., Panozzo, Catherine A., Qiang, Yandong, and Chen Tilney, Rong

Subjects
RESEARCH, RESEARCH methodology, TYPE 1 diabetes, HYPOGLYCEMIC agents, GLYCOSIDES, DISEASE incidence, EVALUATION research, MEDICAL cooperation, COMPARATIVE studies, DISEASE prevalence, DIABETIC acidosis, ALGORITHMS, DISEASE complications
Abstract

Objective: To estimate real-world off-label use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with type 1 diabetes, estimate rates of diabetic ketoacidosis (DKA), and compare them with DKA rates observed in sotagliflozin clinical trials.Research Design and Methods: We identified initiators of SGLT2 inhibitors in the Sentinel System from March 2013 to June 2018, determined the prevalence of type 1 diabetes using a narrow and a broad definition, and measured rates of DKA using administrative claims data. Standardized incidence ratios (SIRs) were calculated using age- and sex-specific follow-up time in Sentinel and age- and sex-specific DKA rates from sotagliflozin trials 309, 310, and 312.Results: Among 475,527 initiators of SGLT2 inhibitors, 0.50% and 0.92% met narrow and broad criteria for type 1 diabetes, respectively. Rates of DKA in the narrow and broad groups were 7.3/100 person-years and 4.5/100 person-years, respectively. Among patients who met narrow criteria for type 1 diabetes, rates of DKA were highest for patients aged 25-44 years, especially females aged 25-44 years (19.7/100 person-years). More DKA events were observed during off-label use of SGLT2 inhibitors in Sentinel than would be expected based on sotagliflozin clinical trials (SIR = 1.83; 95% CI 1.45-2.28).Conclusions: Real-world off-label use of SGLT2 inhibitors among patients with type 1 diabetes accounted for a small proportion of overall SGLT2 inhibitor use. However, the risk for DKA during off-label use was notable, especially among young, female patients. Although real-word rates of DKA exceeded the expectation based on clinical trials, results should be interpreted with caution due to differences in study methods, patient samples, and study drugs. [ABSTRACT FROM AUTHOR]

Published
2020
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10. The Risk of Febrile Seizures Following Influenza and 13-Valent Pneumococcal Conjugate Vaccines

Author

Baker, Meghan, primary, Jankosky, Christopher, additional, Yih, Katherine, additional, Gruber, Susan, additional, Li, Lingling, additional, Cocoros, Noelle, additional, Lipowicz, Hana, additional, Coronel-Moreno, Claudia, additional, Feibelmann, Sandra, additional, Lin, Nancy, additional, McMahill-Walraven, Cheryl, additional, Menschik, David, additional, Selvan, Mano, additional, Selvam, Nandini, additional, Tilney, Rong Chen, additional, Zichittella, Lauren, additional, Lee, Grace, additional, and Kawai, Alison Tse, additional

Published
2017
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11. Real -World Outcomes for Relapsed or Refractory Multiple Myeloma Patients Treated with Lenalidomide and Daratumumab Sparing Triplet Regimens: A United States Retrospective Cohort Study

Author

Braunlin, Megan, Najdi, Rani, Arora, Mukta, Kimball, Amy, Tilney, Rong, and McFadden, Ian

Abstract

Background:Current frontline treatment of multiple myeloma (MM) often includes lenalidomide (Len) and the anti-CD38 monoclonal antibody daratumumab (Dara), with treatment administered until disease progression. There is no singular standard of care for patients (pts) refractory to these drugs at time of relapse. With the rising need for regimens that incorporate alternate agents in relapsed and/or refractory MM (RRMM), we evaluated subsequent treatment regimens that exclude Len and Dara RRMM. This study describes the most frequent real-world use of such regimens in early RRMM and patient outcomes.

Published
2023
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12. Use of Intrauterine Devices and Risk of Human Immunodeficiency Virus Acquisition Among Insured Women in the United States.

Author

Marcus, Julia L, Snowden, Jonathan M, Horwitz, Mara E Murray, Toh, Sengwee, Horgan, Casie, Tilney, Rong Chen, Rajbhandari, Rajani, Back, Soowoo, and Westreich, Daniel J

Subjects
HIV infection risk factors, AMERICAN women, COPPER, HEALTH insurance, INTRAUTERINE contraceptives, SYNTHETIC progestagens, RISK assessment, LEVONORGESTREL
Abstract

Concerns have been raised about progestin-containing contraceptives and the risk of human immunodeficiency virus (HIV) acquisition. Based on health insurance data from women in the United States with intrauterine device (IUD) insertions during 2011–2018, there was no increased risk of incident HIV diagnosis for levonorgestrel-releasing IUDs versus copper IUDs. [ABSTRACT FROM AUTHOR]

Published
2020
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