Publications
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MacDonald SC, Rivero-Ferrer E, Bell EJ, Franklin J, Hardy J, Margulis AV, Seals R, Yang R, Seeger J, Straghan E, Asomaning K. A retrospective cohort database study to evaluate the safety of rimegepant exposure during pregnancy. Poster to be given at the 38th Annual Meeting of the Society for Pediatric and Perinatal Epidemiologic Research; June 9, 2025. Boston, MA.
Dellon ES, Goodwin B, Liu E, de los Santos B, Korgaonkar S, Meyers J, Schaeffer-Koziol CR, Terreri B, Shah ED. Eosinophilic esophagitis-related healthcare resource utilization and associated costs for payers and patients: a retrospective cohort study of US health insurance claims data. Poster presented at the ISPOR 2025; May 14, 2025. Montréal, Canada.
Layton JB, Lloyd PC, Peetluk LS, Jiao Y, Djibo DA, Gruber JF, Deng J, Bui C, Lo AC, Ogilvie RP, Parambi R, Miller M, Song J, Weatherby LB, Cho S, Wong HL, Clarke TC, Hervol JR, Illei D, Bell EJ, Yang GW, Seeger JD, Wernecke M, Richey MM, Forshee RA, Anderson SA, Chillarige Y, McMahill-Walraven CN, Amend KL, Anthony MS, Shoaibi A. Effectiveness over time of a primary series of the original monovalent COVID-19 vaccines in adults in the United States. PLoS One. 2025 May 6;20(5):e0320434. doi: 10.1371/journal.pone.0320434
Dellon ES, Goodwin B, Liu Y, de los Santos B, Korgaonkar S, Meyers J, Schaeffer-Koziol CR, Terreri B, Shah ED. Healthcare resource utilization and associated costs in patients with eosinophilic esophagitis: a retrospective cohort study of US health insurance claims data. Poster presented at the Digestive Disease Week (DDW) 2025; May 3, 2025. San Diego, CA.
Pladevall-Vila M, Ziemiecki R, Johannes CB, Khan AM, Mines D, Ebert N, Kovesdy CP, Thomsen RW, Baak BN, Garcia-Sempere A, Kanegae H, Coleman CI, Walsh M, Andersen IT, Bernal CR, Cabaninas CR, Christiansen CF, Farjat AE, Gay A, Gee P, Herings RMC, Hurtado I, Kashihara N, Kristensen FPB, Liu F, Okami S, Overbeek JA, Beest FJAP, Yamashita S, Yano Y, Layton JB, Vizcaya D, Oberprieler NG. Clinical profile and treatment patterns in individuals with type 2 diabetes and chronic kidney disease who initiate a GLP-1 receptor agonist: a multinational cohort study. Diabetes Ther. 2025 May;16(5):931-54. doi: 10.1007/s13300-025-01717-8
Rao S, McQuay LJ, Forns J, MacKay R, Danysh HE, Doshi D, Abler V, Anthony MS, Layton JB. Evaluation of mortality in users of pimavanserin compared with other atypical antipsychotics in patients with Parkinson's disease psychosis: an update. Drug Saf. 2025 Apr 9. doi: 10.1007/s40264-025-01543-8
Brufsky AM, Sandin R, Stergiopoulos S, Chen C, Karanth S, Li B, Esterberg E, Makari D, Candrilli SD, Goyal RK, Rugo HS. Overall survival with palbociclib and aromatase inhibitor versus aromatase inhibitor alone in older patients with HR+/HER2− metastatic breast cancer. Cancer Med. 2025 Apr;14(7):e70719. doi: 10.1002/cam4.70719
Layton JB, Anderson-Smits C, Huang Z, Ay H, Spalding W, Khokhar B, Zhou J, Bennett L, Anthony MS. A comparative real-world study evaluating the safety of immune globulin infusion (human) 10% solution and other intravenous immunoglobulin therapies for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy. Pharmacoepidemiol Drug Saf. 2025 Mar;34(3):e70124. doi: 10.1002/pds.70124
Greenhawt M, Bansal P, Goodwin B, Korgaonkar S, Liu Y, Meyers J, Shah E, Terreri B, Dellon E, Schaeffer-Koziol C. High incidence and prevalence of eosinophilic esophagitis in the USA identified: an analysis of US health insurance claims data. Poster presented at the 2025 American Academy of Allergy Asthma & Immunology (AAAAI)/WAO Joint Congress; February 28, 2025. San Diego, CA.
Layton JB, Forns J, McQuay LJ, Danysh HE, Dempsey C, Anthony MS, Turner ME. Plain language summary of mortality rates of patients with Parkinson's disease psychosis who were treated either with pimavanserin or with different second-generation (atypical) antipsychotics. Futur Neurol. 2025 Feb 28;20(1). doi: 10.1080/14796708.2025.2463315
Perrone RD, Garbinsky D, Nunna S, Gandhi HK, Fernandes AW, Burgos G, Olopoenia A, DeCongelio M, Maculaitis MC, Zhou X. Effectiveness of tolvaptan for autosomal dominant polycystic kidney disease in US clinical practice with comparison to historical control data. Kidney Med. 2025 Feb 27;7(5):100988. doi: 10.1016/j.xkme.2025.100988
Kovesdy CP, Ebert N, Vizcaya D, Walsh M, Kosiborod MN, Layton JB, Ziemiecki R, Johannes CB, Pladevall-Vila M, Gee PO, Jefferson N, Chicoye A, Lopes M, Thapa BB, Curhan G, Rangel L, Bhartia M, Liu F, Farjat AE, Oberprieler NG. Change in urine albumin-creatinine ratio and occurrence of hyperkalemia in patients initiating finerenone in the United States: a cohort study from the FOUNTAIN platform. Nephron. 2025 Feb 27;1-26. doi: 10.1159/000543923
Johannes CB, Ziemiecki R, Pladevall-Vila M, Ebert N, Kovesdy CP, Thomsen RW, Baak BN, Garcia-Sempere A, Kanegae H, Coleman CI, Walsh M, Andersen IT, Rodriguez Bernal C, Robles Cabaninas C, Christiansen CF, Farjat AE, Gay A, Gee P, Herings RMC, Hurtado I, Kashihara N, Kristensen FPB, Liu F, Okami S, Overbeek JA, Penning-van Beest FJA, Yamashita S, Yano Y, Layton JB, Vizcaya D, Oberprieler NG. Clinical profile and treatment adherence in patients with type 2 diabetes and chronic kidney disease who initiate an SGLT2 inhibitor: a multi-cohort study. Diabetes Ther. 2025 Feb;16(2):205-26. doi: 10.1007/s13300-024-01671-x
Chebib FT, Dahl N, Zhou X, Garbinsky D, Wang J, Nunna S, Oberdhan D, Fernandes AW. Tolvaptan and autosomal dominant polycystic kidney disease progression in individuals aged 18–35 years: a pooled database analysis. Kidney Med. 2025 Jan;7(1):100935. doi: 10.1016/j.xkme.2024.100935
Cappellini MD, Glassberg MB, Meyers J, Jimenez M, Nham T, Bueno L, Sieluk J, Yucel A, Alashkar F. Demographics, clinical characteristics, and real-world treatment patterns among patients with beta-thalassemia: a retrospective medical record abstraction study. Ther Adv Hematol. 2024 Dec 15;15. doi: 0.1177/20406207241298088
Rao S, McQuay L, Forns J, MacKay R, Aquilina T, Doshi D, Abler V, Anthony MS, Layton B. Mortality in patients with Parkinson's disease psychosis using pimavanserin versus other antipsychotics. Poster presented at the 2024 Parkinson Study Group (PSG) 33rd Annual Meeting; December 5, 2024. Nashville, TN. Previously presented at the Neuroscience Education Institute (NEI) Congress 2024.
Rao S, Forns J, Danysh HE, Calingaert B, Dempsey C, Aquilina T, Pathak S, Anthony MS, Layton JB. Natural history and clinical outcomes in patients with Alzheimer's disease-related psychosis by antipsychotic treatment status in the United States. J Alzheimers Dis. 2024 Dec;102(4):1260-70. doi: 10.1177/13872877241297361
Rao S, McQuay L, Forns J, MacKay R, Aquilina T, Doshi D, Abler V, Anthony MS, Layton B. Mortality in patients with Parkinson's disease psychosis using pimavanserin versus other antipsychotics. Poster presented at the Neuroscience Education Institute (NEI) Congress 2024; November 8, 2024. Colorado Springs, CO.
Brufsky A, Kwan ML, Sandin R, Stergiopoulos S, Karanth S, Cha-Silva AS, Makari D, Goyal RK. Trends in HR+ metastatic breast cancer survival before and after CDK4/6 inhibitor introduction in the United States: a SEER registry analysis of patients with HER2− and HER2+ metastatic breast cancer. Breast Cancer Res Treat. 2024 Nov;208(2):223-35. doi: 10.1007/s10549-024-07469-6
Oberprieler NG, Pladevall-Vila M, Johannes C, Layton JB, Golozar A, Lavallee M, Liu F, Kubin M, Vizcaya D. FOUNTAIN: a modular research platform for integrated real-world evidence generation. BMC Med Res Methodol. 2024 Oct 1;24(1):224. doi: 10.1186/s12874-024-02344-w
Keogh KA, Dolin P, Kielar D, Shavit A, Rowell J, Edmonds C, Meyers J, Esterberg E, Nham T, Chen SY. Pulmonary and cardiovascular involvement and persistent damage in eosinophilic granulomatosis with polyangiitis: a retrospective analysis of US health insurance claims data. Poster presented at the CHEST 2024; October 9, 2024. Boston, MA. [abstract] Chest. 2024 Oct; 166(4, Suppl):A5373-A57.
Kovesdy CP, Layton JB, Thapa BB, Curhan GC, Rangel LM, Farjat AE, Liu F, Johannes CB, Vizcaya D, Oberprieler NG. Reduction in Urinary Albumin-to-Creatinine Ratio (UACR) in people with CKD and type 2 diabetes initiating finerenone: a CKD stage subgroup analysis from the FOUNTAIN platform. Poster presented at the American Society of Nephrology (ASN) Kidney Week 2024; October 25, 2024. San Diego, CA. [abstract] J Am Soc Nephrol. 2024 Oct; 35(Suppl v1):559.
Kovesdy CP, Layton JB, Thapa BB, Curhan GC, Rangel LM, Farjat AE, Liu F, Johannes CB, Vizcaya D, Oberprieler NG. Reduction in Urinary Albumin-to-Creatinine Ratio (UACR) in people with CKD and type 2 diabetes initiating finerenone: a comedication subgroup analysis from the FOUNTAIN platform. Poster presented at the American Society of Nephrology (ASN) Kidney Week 2024; October 24, 2024. San Diego, CA. [abstract] J Am Soc Nephrol. 2024 Oct; 35(Suppl v1):559.
Gitomer BY, Chonchol M, Zhou X, Garbinsky D, Wang J, Nunna S, Fernandes AW, Oberdhan D. Kidney stone disease and progression risk in autosomal dominant polycystic kidney disease: a post hoc analysis of OVERTURE. Kidney360. 2024 Sep;5(9):1364-6. doi: 10.34067/KID.0000000000000524
Mody FV, Goyal RK, Ajmera M, Davis KL, Amin AN. Exploring the association between heart rate control and rehospitalization: a real-world analysis of patients hospitalized with heart failure with reduced ejection fraction. Drugs Real World Outcomes. 2024 Sep;11(3):501-11. doi: 10.1007/s40801-024-00436-z
Danysh HE, Gilsenan A, Kaye JA, Garcia de Albeniz Martinez X, Schmid R, Bartsch J, Calingaert B, Rahman S, Layton JB, Gutierrez L. Validation of algorithms to identify breast cancer and bladder cancer among patients with type 2 diabetes mellitus in United States medicare administrative claims. Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Layton JB, Muthuri S, Lindaas A, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski LS, McKillop M, Fisher S, Lyu H, Cheng A, Bui CL, Duenas PF, Chen Y, Forshee RA, Anderson SA, Beers JB, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States. Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Layton JB, Lindaas A, Muthuri S, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski L, McKillop M, Fisher S, Lyu H, Cheng A, Bui C, Duenas PF, Chen Y, Beers JB, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Risk of cardiovascular adverse events after COVID-19 diagnosis in the United States. Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Peetluk LS, Djibo DA, Layton JB, Deng J, Deshazo J, Richey MM, Ogilvie RP, Parambi RJ, Miller M, Song J, Tarazi W, Weatherby LB, Bell EJ, Anthony MS, McMahill-Walraven CN, Yang GW, Seeger JD, Amend KL. Considerations for negative control outcome analyses in vaccine effectiveness studies: post-hoc analyses from an adult vaccine effectiveness study conducted within the FDA BEST initiative. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB, Peetluk LS, Lloyd PC, Jiao Y, Djibo DA, Deng J, Gruber JF, Ogilvie RP, Parambi R, Miller M, Song J, Weatherby LB, Bell EJ, Lo AC, Hervol JR, Wernecke M, Cho S, Wong H-L, Clarke TC, Bui CL, Stone A, Tarazi W, Deshazo J, Forshee RA, Anderson SA, Seeger JD, Amend KL, MaMahill-Walraven CN, Chillarige Y, Yang GW, Anthony MS, Shoaibi A. Effectiveness over time of a complete primary series of the original, monovalent COVID-19 vaccines among adults aged 18-64 years in the United States. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB, Richey M, Lindaas A, Muthuri S, Lloyd PC, Gruber JF, Bui C, McKillop M, Kowarski L, Lyu H, Cheng A, Wan Z, Clarke TC, Kawai AT, Beers J, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Events on day zero of follow-up: considerations for cohort studies of adverse events after COVID-19 diagnosis. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Johannes CB, Ziemiecki R, Pladevall-Vila M, Kosvesdy CP, Ebert N, Thomsen RWW, Christiansen CF, Baak B, Cabaninas CR, Kashihara N, Yano Y, Kanegae H, Coleman CI, Okami S, Li u F, Layton JB, Vizcaya D, Oberprieler NG. Use of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease: a multicountry report from the FOUNTAIN platform. Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Weinrib R, Fortuny J, Martinez D, Kollhorst B, Haug U, Kousholt A, Ehrenstein V, Iversen P, Mortensen J, Bosch D, Kuppen M, Pisa F, Vassiley Z. Drug utilisation of radium-223 under routine clinical practice (DIRECT) in Europe: a post-authorisation safety study. Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Gini R, Pajouheshnia R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Commentary - Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): lessons learnt from the MINERVA project in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5884. doi: 10.1002/pds.5884
Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): development and pilot of a metadata list and catalogue in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871
Slota C, Norcross L, Comerford E, Sasane M, Zheng Y, Gnanasakthy A. Critical comments by Food and Drug Administration Reviewers on patient-reported outcomes in Food and Drug Administration Regulatory Submissions (2018-2021) [Editor's Choice]. Value Health. 2024 Jun;27(6):755-66. doi: 10.1016/j.jval.2024.02.011
Brufsky A, Sandin R, Stergiopoulos S, Chen C, Karanth S, Li B, Esterberg L, Makari D, Candrilli S, Goyal R, Rugo H. Overall survival with palbociclib (PAL) plus an aromatase inhibitor (AI) versus AI alone in older patients (pts) with de novo, HR+/HER2− metastatic breast cancer: a SEER-Medicare analysis. Poster presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31, 2024. Chicago, IL.
Shavit A, Dolin P, Kielar D, Keogh KA, Rowell J, Edmonds C, Meyers J, Esterberg L, Nham T, Chen SY. Pulmonary involvement and persistent pulmonary damage in eosinophilic granulomatosis with polyangiitis (EGPA): a retrospective analysis of US health insurance claims data. Poster presented at the American Thoracic Society (ATS) 2024 Meeting; May 19, 2024. San Diego, CA.
Oberprieler NG, Kovesdy CP, Layton JB, Thapa B, Curhan G, Farjat AE, Liu F, Johannes C, Vizcaya D. Clinical outcomes in US patients initiating finerenone – a report from the FOUNTAIN platform. Poster presented at the 61st European Renal Association (ERA) Congress; May 2024. Stockholm, Germany. [abstract] Nephrol Dial Transplant. 2024 May; 39(Suppl 1):i2271.
Goyal RK, Zhang J, Davis KL, Sluga-O'Callaghan M, Kaufman PA. Real-world treatment patterns and clinical outcomes in patients treated with eribulin after prior phosphoinositide 3-kinase inhibitor treatment for metastatic breast cancer. Breast Cancer Res Treat. 2024 May;205(1):201-10. doi: 10.1007/s10549-023-07080-1
de Vogel S, Seeger J, Arana A, Margulis AV, McQuay LJ, Perez-Gutthann S, Hallas J, Kristiansen NS, Linder M, Odsbu I, Suehs B, Xu Y, Uribe C, Appenteng K, Robinson NJ. Lessons learned from a multi-data source research collaboration: the mirabegron post-authorization safety study program. Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5799. doi: 10.1002/pds.5799
Ogilvie RP, Layton JB, Lloyd PC, Jiao Y, Djibo DA, Wong HL, Gruber JF, Parambi R, Deng J, Miller M, Song J, Weatherby LB, Peetluk L, Lo A, Matuska K, Wernecke M, Bui CL, Clarke TC, Cho S, Bell EJ, Yang G, Amend KL, Forshee RA, Anderson SA, McMahill-Walraven CN, Chillarige Y, Anthony MS, Seeger JD, Shoaibi A. Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study. BMC Pediatr. 2024 Apr 26;24(1):276. doi: 10.1186/s12887-024-04756-5
Comerford E, Norcross L, Sasane M, Zheng Y, Gnanasakthy A. Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): a review of criticism and concerns in comments from regulators. Poster presented at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference; April 5, 2024. Orlando, FL. [abstract] J Natl Compr Canc Netw. 2024 Apr 5; 22(2.5). doi: 10.6004/jnccn.2023.7146
Rebordosa C, Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D, Garcia-Esteban R, Plana E, Tormos A, Farsani SF, Perez-Gutthann S, Pladevall-Vila M. Liver, renal, genitourinary, and diabetic ketoacidosis risks among new users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes: post-authorisation safety study based on multinational cohorts. Diabetes Obes Metab. 2024 Apr;26(4):1291-304. doi: 10.1111/dom.15429
Anthony MS, Aroda VR, Parlett LE, Djebarri L, Berreghis S, Calingaert B, Beachler DC, Crowe CL, Johannes CB, Juhaeri J, Lanes S, Pan C, Rothman KJ, Saltus CW, Walsh KE. Risk of anaphylaxis among new users of glp-1 receptor agonists: a cohort study. Diabetes Care. 2024 Apr 1;47(4):712-9. doi: 10.2337/dc23-1911
Rao S, Forns J, Danysh HE, Calingaert B, Dempsey C, Aquilina T, Pathak S, Anthony MS, Layton JB. Natural history and clinical outcomes in patients with Alzheimer's disease-related psychosis in the United States. Presented at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) 2024; March 5, 2024. Lisbon, Portugal.
Ayodele O, Parikh RC, Esterberg E, Ajmera M, Goodwin B, Williams J, Desai NK, Katzka DA. Treatment patterns and persistent disease activity in patients with eosinophilic esophagitis: a retrospective cohort study. Gastro Hep Adv. 2024 Mar 2;3(5):659-70. doi: 10.1016/j.gastha.2024.02.007
Mladsi D, Zhou X, Mader G, Sanon M, Wang J, Barnett C, Willey C, Seliger S. Mortality risk in patients with autosomal dominant polycystic kidney disease. BMC Nephrol. 2024 Feb 16;25(1):56. doi: 10.1186/s12882-024-03484-3
Maeda-Chubachi T, McLeod L, Enloe C, Cartwright M, Siegfried E, Hebert AA, Silverberg N. Defining clinically meaningful improvement in molluscum contagiosum. J Am Acad Dermatol. 2024 Feb;90(2):443-5. doi: 10.1016/j.jaad.2023.10.033
Dolin P, Kielar D, Shavit A, Koegh K, Rowell J, Edmonds C, Meyers J, Esterberg E, Nham T, Chen S. Comorbidities in patients with eosinophilic granulomatosis with polyangiitis versus severe uncontrolled asthma: a retrospective analysis of US health insurance claims data. Poster presented at the 2024 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting; February 23, 2024. Washington, DC. [abstract] J Allergy Clin Immunol. 2024 Feb; 153(2):AB53.