Publications
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Nardoni V, Lippi M, Marinai S, Hyeraci G, Maccari M, Arana A, Lucenteforte E, Limoncella G, Mohammadi S, Roberto G, Dehghan Tarazjani A, Virgili G, Weibel D, Gini R. Comparing humans and large language models in filling clinical questionnaires. Presentation to be given at the 4th International Conference Series on Hybrid Human-Artificial Intelligence; June 9, 2025. Pisa, Italy.
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
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
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
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
Weibel D, de Luise C, Cid Royo A, Ryan O, Vaz T, Aguado J, Marsal J, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Pala E, Poblador-Plou B, Gimeno-Miguel A, Santos-Mejias A, Marconi E, Barbieri E, Stona L, Lysen T, Roy D, Hyeraci G, Girardi A, Lupattelli A, Desalegn AA, Villalobos F, Bissacco CA, Kendrick K, Garg R, Rubino H, Sturkenboom MCJM, Arana A. Interim results from the VAC4EU Post-Authorization Safety Study (PASS) among recipients of the Pfizer-BioNTech COVID-19 (Comirnaty®) vaccine in Europe. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
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
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
Viguerie A, Jacobson EU, Hicks KA, Bates L, Carrico J, Honeycutt A, Lyles C, Farnham PG. Assessing the impact of COVID-19 on HIV outcomes in the United States: a modeling study. Sex Transm Dis. 2024 Apr 1;51(4):299-304. doi: 10.1097/OLQ.0000000000001935
Jacobson E, Viguerie A, Hicks K, Bates L, Honeycutt A, Carrico J, Farnham P. Strategies for eliminating racial/ethnic disparities in HIV incidence in the United States. Poster presented at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI); March 5, 2024. Denver, CO.
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
Djibo DA, Margulis AV, McMahill-Walraven CN, Saltus CW, Shuminski P, Kaye JA, Johannes CB, Libertin M, Graham S. Validation of an ICD-10 case-finding algorithm for endometrial cancer in US insurance claims. Pharmacoepidemiol Drug Saf. 2024 Jan;33(1):E5690. doi: 10.1002/pds.5690
Hamadani M, Spira AI, Zhou X, Liao L, Chen L, Radford J, Ai WZ, Solh MM, Ardeshna KM, Hess BT, Caimi PF, Stathis A, Carlo Stella C, Alderuccio JP, Kahl BS, Wang Y, Qin YG, Xu ZC, Zinzani PL. Clinical outcomes of older and younger patients treated with loncastuximab tesirine in the LOTIS-2 clinical trial. Blood Adv. 2024 Jan;9(1):93-8. doi: 10.1182/bloodadvances.2023010636
Sherif B, Burke M, Besse B, Solomon B, Bazhenova L, Kim DW, Lin JJ, Wolf J, Popat S, Goto K, de Langen AJ, Springfeld C, Reynolds M, Odom D, Yuan Y, Lee A, Blum SI, Thamake S, Ades F, Drilon A. Health-related quality-of-life of patients treated with repotrectinib for neurotrophic tyrosine receptor kinase (NTRK)-positive advanced solid tumors: results From TRIDENT-1. Poster presented at the ISPOR Europe 2023; November 14, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S484. doi: 10.1016/j.jval.2023.09.2619
Yee KS, Chirila C, Davenport E, Mladsi D, Barnett C, Kronenberger WG. A post hoc analysis of Projected Retained Ability Scores (PRAS) for the longitudinal assessment of cognitive functioning in patients with neuronopathic mucopolysaccharidosis II receiving intrathecal idursulfase-IT. Orphanet J Rare Dis. 2023 Nov 2;18(1):343. doi: 10.1186/s13023-023-02957-2
Perrone RD, Nunna S, Gandhi HK, Fernandes AW, Garbinsky D, Zhou X. Kidney function decline in autosomal dominant polycystic kidney disease (ADPKD) patients: assessment of real world effectiveness of tolvaptan. Poster presented at the Kidney Week 2023; November 2, 2023. Philadelphia, PA.
Layton JB, Anderson-Smits C, Huang Z, Ay H, Spalding W, Khokhar B, Zhou J, Bennett L, Anthony M. A comparative real-world study evaluating the safety of gammagard liquid and other intravenous immunoglobulin therapies for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy. Poster presented at the 2023 AANEM Annual Meeting; November 2023. Phoenix, AZ.
Viguerie A, Jacobson EU, Hicks K, Bates L, Carrico J, Honeycutt A, Lyles C, Farnham PG. Assessing the impact of COVID-19 on HIV outcomes: a modeling study. Poster presented at the 2023 INFORMS Annual Meeting; October 16, 2023. Phoenix, AR.
Weibel D, de Luise C, Elbers R, van den Bor R, Martin I, Cid-Royo A, Plana E, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Poblador-Plou B, Marconi E, Barbieri E, Stona L, Swart KMA, Roy D, Hyeraci G, Bartolini C, Lupattelli A, Villalobos F, Kendrick K, Garg R, Rubino H, Eijkemans R, Sturkenboom M, Arana A. Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):173-4. doi: 10.1002/pds.5687
Anderson-Smits C, Ritchey ME, Huang Z, Chavan S, Souayah N, Ay H, Layton BJ. Intravenous immunoglobulin treatment patterns and outcomes in patients with chronic inflammatory demyelinating polyradiculoneuropathy: a US claims database analysis. Neurol Ther. 2023 Aug;12(4):1119-32. doi: 10.1007/s40120-023-00478-5
Layton JB, Ritchey ME, Huang Z, Chavan S, Ay H, Souayah N, Anderson-Smits C. Intravenous immunoglobulin initiation in patients with chronic inflammatory demyelinating polyradiculoneuropathy: a US claims-based cohort study. Neurol Ther. 2023 Aug;12(4):1171-86. doi: 10.1007/s40120-023-00479-4
Chebib FT, Dahl N, Zhou X, Garbinsky D, Wang J, Nunna S, Oberdhan D, Fernandes AW. Pooled data analysis of the effect of tolvaptan in patients aged 18-35 years with autosomal dominant polycystic kidney disease. Poster presented at the PKD Connect Conference 2023; June 23, 2023. Denver, CO.
Lioudis M, Zhou X, Davenport E, Nunna S, Krasa HB, Oberdhan D, Fernandes AW. Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis. BMC Neurol. 2023 Jun 22;24:182. doi: 10.1186/s12882-023-03247-6
Gnanasakthy A, Norcross L, Fitzgerald K. Editorial - Assessment of patient-reported outcomes in industry-sponsored phase 1 oncology studies: considerations for translating theory into practice. Value Health. 2023 Jun 21;26(10):1440-3. doi: 10.1016/j.jval.2023.06.006
Davenport E, Zhou X, Wang J, Nunna S, Oberdhan D, Fernandes A, Mekahli D. Disease burden and disease progression of young adult patients with autosomal dominant polycystic kidney disease (ADPKD). Poster presented at the 51st Annual Meeting of the European Working Group on Psychosocial Aspects of Children; June 8, 2023. Leuven, Belgium. Previously presented at the National Kidney Foundation 2023 Spring Clinical Meeting.
Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and kidney function decline in older individuals with autosomal dominant polycystic kidney disease: a pooled analysis of randomized clinical trials and observational studies. Kidney Med. 2023 Jun;5(6):100639. doi: 10.1016/j.xkme.2023.100639
Levintow SN, Nielson CM, Hernandez RK, Breskin A, Pritchard D, Lash TL, Rothman KJ, Gilbertson D, Muntner P, Critchlow C, Brookhart MA, Bradbury BD. Pragmatic considerations for negative control outcome studies to guide non-randomized comparative analyses: a narrative review. Pharmacoepidemiol Drug Saf. 2023 Jun;32(6):599-606. doi: 10.1002/pds.5623
Maeda-Chubachi T, McLeod L, Cartwright M. Meaningful change in children's dermatology life quality index (DLQI) and lesion counts in patients with molluscum contagiosum. Poster presented at the First International Societies for Investigative Dermatology (ISID2023) Meeting; May 10, 2023. Tokyo, Japan. [abstract] J Invest Dermatol. 2023 May; 143(5 Suppl):S105. doi: 10.1016/j.jid.2023.03.622
Wolf J, Garon EB, Groen HJM, Tan DSW, Gilloteau I, Le Mouhaer S, Hampe M, Cai C, Chassot-Agostinho C, Reynolds M, Sherif B, Heist RS. Patient-reported outcomes in capmatinib-treated patients with METex14-mutated advanced NSCLC: results from the GEOMETRY mono-1 study. Eur J Cancer. 2023 Apr;183:98-108. doi: 10.1016/j.ejca.2022.10.030
Davenport E, Zhou X, Wang J, Nunna S, Oberdhan D, Fernandes A, Mekahli D. Disease burden and disease progression of young adult patients with autosomal dominant polycystic kidney disease. Poster presented at the National Kidney Foundation 2023 Spring Clinical Meeting; April 11, 2023. Austin, TX. [abstract] Am J Kidney Dis. 2023 Apr 1; 81(4, Supple 1):S102. doi: 10.1053/j.ajkd.2023.01.349
Cotter SP, Schwartz L, Strong TV, Bender RH, Fehnel S. The Prader-Willi syndrome anxiousness and distress behaviors questionnaire: development and psychometric validation. Value Health. 2023 Feb 1;26(2):243-50. doi: 10.1016/j.jval.2022.08.004
Bergerot C, Young Rha S, Pal S, Koralewski P, Stroyakovskiy D, Alekseev B, Parnis F, Castellano D, Lyun Lee J, Sunela K, Ciuleanu T, Heng D, Glen H, Wang J, Bennett L, Pan J, O'Hara K, Puente J. Health-related quality of life outcomes with two different starting doses of lenvatinib in combination with everolimus for previously treated renal cell carcinoma. Oncologist. 2023 Jan 18;28(1):59-71. doi: 10.1093/oncolo/oyac142
Forsythe E, Haws RM, Argente J, Beales P, Martos-Moreno GA, Dollfus H, Chirila C, Gnanasakthy A, Buckley BC, Mallya UG, Clement K, Haqq AM. Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results. Orphanet J Rare Dis. 2023 Jan 16;18(1):12. doi: 10.1186/s13023-022-02602-4
Carrigan G, Bradbury BD, Brookhart MA, Capra WB, Chia V, Rothman KJ, Sarsour K, Taylor MD, Brown JS. External comparator groups derived from real-world data used in support of regulatory decision making: use cases and challenges. Curr Epidemiol Rep. 2022 Dec;9:326-37. doi: 10.1007/s40471-022-00305-9
Spira A, Zhou X, Liao L, Yu E, Chen L, Lau A, Wang Y, Gnanasakthy A, Radford J, Hamadani M. Health-related quality of life and tolerability in patients with/without skin toxicity during loncastuximab tesirine treatment in a phase 2 clinical trial (LOTIS-2). Poster presented at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022); September 28, 2022. Houston, TX.
Bell T, Fernandez M, Khan S, Tumminello B, Bektas M, Heyes CE, Oton AB. Patient burden of illness associated with desmoid tumors. Poster presented at the 2022 Desmond Tumor Research Foundation (DTRF) Annual Meeting; September 24, 2022. Philadelphia, PA.
Weibel D, Sturkenboom M, Eijkemans R, van den Bor R, Elbers R, Plana E, Garcia de Albeniz X, Weinrib R, Yefimenko N, Bianchini E, Stona L, Poblador-Plou B, Swart-Polinder K, Bartolini C, Hyeraci RG, Roy D, Lupattelli A, Villalobos F, Barbieri E, Garg RK, Rubino H, de Luise C, Arana A. VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in five European countries: study design and first results. Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8. doi: 10.1002/pds.5518
Wainberg ZA, Enzinger PC, Qin S, Yamaguchi K, Gnanasakthy A, Taylor K, Jamotte A, Majer I, Kang YK. Health-related quality of life (HRQoL) in FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer (G/GEJC): results from the FIGHT trial comparing bemarituzumab (BEMA) + modified FOLFOX6 (mFOLFOX6) to placebo (PBO) + mFOLFOX6. Poster presented at the 2022 ESMO Annual Conference; September 9, 2022. Paris, France.
Marvel J, Goransson O, Clark M, Romano (DeMuro) C, Olayinka-Amao O, Whalley D, Crawford R, Brindicci C, Garg K, Kordy K, Everhard F, Patalano F, Roesler Z, Landles R, Naujoks C, Gutzwiller FS. Interactive tablet application for self-report of asthma symptoms and impacts in young children. Poster presented at the ERS International Congress 2022; September 6, 2022. Barcelona, Spain. [abstract] Eur Respir J. 2022 Sep 4; 60(Suppl 66):2127. doi: 10.1183/13993003.congress-2022.2127
Spira A, Liao L, Zhou X, Gnanasakthy A, Chen L, Ungar D, Yu E, Kilavuz T, Radford J, Hamadani M. Health-related quality of life and tolerability of loncastuximab tesirine in high-risk patients with relapsed/refractory diffuse large B-cell lymphoma treated in a phase 2 clinical trial (LOTIS 2). Poster presented at the 2022 EHA Congress; June 9, 2022. Vienna, Austria.
Johannes CB, Saltus CW, Kaye JA, Calingaert B, Kaplan S, Gordon MF, Andrews EB. The risk of melanoma with rasagiline compared with other antiparkinsonian medications: a retrospective cohort study in the United States Medicare database. Pharmacoepidemiol Drug Saf. 2022 Jun;31(6):643-51. doi: 10.1002/pds.5422
Motzer R, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Bennett L, Wang J, Pan JJ, Saretsky TL, Perini RF, He CS, Mody K, Cella D. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study. Lancet Oncol. 2022 Jun;23(6):768-80. doi: 10.1016/S1470-2045(22)00212-1
Jacobson EU, Hicks KA, Carrico J, Purcell DW, Green TA, Mermin JH, Farnham PG. Optimizing HIV prevention efforts to achieve EHE incidence targets. J Acquir Immune Defic Syndr. 2022 Apr;89(4):373-80. doi: 10.1097/QAI.0000000000002885
Spira A, Liao L, Zhou X, Sherif B, Chen L, Ungar D, Yu E, Radford J, Hamadani M. Health-related quality of life, symptoms, and tolerability of Loncastuximab Tesirine in older versus younger patients with relapsed/refractory diffuse large b-cell lymphoma treated in a phase 2 clinical trial (LOTIS-2). Poster presented at the National Comprehensive Cancer Network (NCCN) 2022 Virtual Annual Conference; March 31, 2022.
Anderson-Smits C, Orange J, Park M, Huang Z, Layton JB, Ritchey ME. Immunoglobulin initiation among patients with primary immunodeficiency diseases: a retrospective claims-based United States cohort study. Presented at the AMCP 2022 Meeting; March 29, 2022. Chicago, IL.
Spira A, Zhou X, Chen L, Gnanasakthy A, Wang L, Ungar D, Curiel R, Liao L, Radford J, Kahl B. Health-related quality of life, symptoms, and tolerability of Loncastuximab Tesirine in patients with relapsed or refractory diffuse large b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2022 Mar;22(3):158-68. doi: 10.1016/j.clml.2021.09.001
Chen YH, Farnham PG, Hicks KA, Sansom SL. Estimating the HIV effective reproduction number in the United States and evaluating HIV elimination strategies. J Public Health Manag Pract. 2022 Mar;28(2). doi: 10.1097/PHH.0000000000001397
Zhou X, Davenport E, Ouyang J, Hoke ME, Garbinsky D, Agarwal I, Krasa HB, Oberdhan D. Pooled data analysis of the long-term treatment effects of tolvaptan in ADPKD. Kidney Int Rep. 2022 Feb 19;7(5):1037-48. doi: 10.1016/j.ekir.2022.02.009
Kuhnen P, Wabitsch M, von Schnurbein J, Chirila C, Mallya UG, Callahan P, Gnanasakthy A, Poitou C, Krabusch PM, Stewart M, Clement K. Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency. Orphanet J Rare Dis. 2022 Feb 5;17(1):38. doi: 10.1186/s13023-022-02186-z
Herring WL, Zhang Y, Shinde V, Stoddard J, Talbird SE, Rosen B. Clinical and economic outcomes associated with respiratory syncytial virus vaccination in older adults in the United States. Vaccine. 2022 Jan 24;40(3):483-93. doi: 10.1016/j.vaccine.2021.12.002