Publications
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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
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
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
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
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
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
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
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
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
Kummar S, Berlin J, Mascarenhas L, van Tilburg CM, Geoerger B, Lassen UN, Schilder RJ, Turpin B, Nanda S, Keating K, Childs BH, Chirila C, Laetsch TW, Hyman DM, Drilon A, Hong DS. Quality of life in adult and pediatric patients with tropomyosin receptor kinase fusion cancer receiving larotrectinib. Curr Probl Cancer. 2021 Dec;45(6):100734. doi: 10.1016/j.currproblcancer.2021.100734
Smith MR, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Mohamed AF, Odom D, Bartsch J, Snapir A, Sarapohja T, Fizazi K. Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the phase III ARAMIS trial. Eur J Cancer. 2021 Jul 14;154:138-46.
Hofheinz RD, Bruix J, Demetri GD, Grothey A, Marian M, Bartsch J, Odom D. Effect of regorafenib in delaying definitive deterioration in health-related quality of life in patients with advanced cancer of three different tumor types. Cancer Manag Res. 2021 Jul 12;13:5523-33. doi: 10.2147/CMAR.S305939
Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, Andre F. Patient-reported outcomes in patients with PIK3CA-mutated hormone receptor-positive, human epidermal growth factor receptor 2–negative advanced breast cancer from SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-15. doi: 10.1200/JCO.20.01139
Samuelson TW, Singh IP, Williamson BK, Falvey H, Lee WC, Odom D, McSorley D, Katz LJ. Quality of life in primary open-angle glaucoma and cataract: an analysis of VFQ-25 and OSDI from the iStent inject® Pivotal Trial. Am J Ophthalmol. 2021 Mar 15;229:220-9. doi: 10.1016/j.ajo.2021.03.007
Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of remission endpoints with secukinumab over 3 years in active ankylosing spondylitis: pooled analysis of two phase 3 studies. Rheum Ther. 2021 Mar;8(1):273-88. doi: 10.1007/s40744-020-00269-6
Himmler S, Mueller M, Sherif B, Ostwald D. A case study applying a novel approach to estimate the social impact of a medical innovation - the use of secukinumab for psoriatic arthritis in Germany. Expert Rev Pharmacoecon Outcomes Res. 2019 Jul 29. doi: 10.1080/14737167.2019.1644169
Coates L, Gossec L, Kirkham B, Sherif B, Gaillez C, Mpofu S, Jugl SM, Karyekar C, Gandhi KK. Minimal disease activity among active psoriatic arthritis patients treated with Secukinumab: 2-year results from a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase III study. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1529-35. doi: 10.1002/acr.23537
Feldman SR, Zhao Y, Gilloteau I, Graham CN, Miles L, McBride D, Herrera V. Higher psoriasis skin clearance is associated with lower annual indirect costs in the United States: a post hoc analysis from the CLEAR Study. J Manag Care Spec Pharm. 2018 Jul;24(7):617-22. doi: 10.18553/jmcp.2018.24.7.617
Stull DE, Griffiths CEM, Gilloteau I, Zhao Y, Guana A, Finlay AY, Sherif B, Houghton K, Puig L. Differential effects of secukinumab vs. ustekinumab for treatment of psoriasis on quality of life, work productivity and activity impairment: a structural equation modelling analysis. Br J Dermatol. 2018 Jun;178(6):1297-307. doi: 10.1111/bjd.16366
Donohue IF, Bollu VK, Stull DE, Nelson LM, Williams VS, Stensland MD, Hanania NA. Long-term health-related quality-of-life and symptom response profiles with arformoterol in COPD: results from a 52-week trial. Int J Chron Obstruct Pulmon Dis. 2018 Feb 5;13:499-508.
Korman NJ, Sofen H, Fretzin S, Rich P, Zhao Y, Herrera V, Nyirady J, Williams N, Mordin M, Tyring S. Secukinumab provides better relief from the impact of psoriasis on daily activities and personal relationships than etanercept: results of two phase 3 placebo-controlled randomized clinical trials in moderate-to-severe psoriasis. J Dermatolog Trea. 2017 Aug;28(5):384-9.
Chirila C, Nuamah I, Woodruff K. Health care resource use analysis of paliperidone palmitate 3 month injection from two phase 3 clinical trials. Curr Med Res Opin. 2017 Jun;33(6):1083-90. doi: 10.1080/03007995.2017.1300144
Strober B, Gottlieb AB, Sherif B, Mollon P, Gilloteau I, McLeod L, Fox T, Mordin M, Gnanasakthy A, Papavassilis C, Lebwohl MG. Secukinumab sustains early patient-reported outcome benefits through 1 year: results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept. J Am Acad Dermatol. 2017 Apr;76(4):655-61. doi: 10.1016/j.jaad.2016.11.043
Donohue JF, Ganapathy V, Bollu V, Stensland MD, Nelson LM. Health status of patients with moderate to severe COPD after treatment with nebulized arformoterol tartrate or placebo for 1 year. Clin Ther. 2017 Jan;39(1):66-74. doi: 10.1016/j.clinthera.2016.11.021
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski BE, Gottlieb AB, Zhao Y, Tran MH, Karpov A, McLeod LD, Mordin M, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials. Int J Dermatol. 2016 Apr;55(4):401-7. doi: 10.1111/ijd.13236
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski BE, Gottlieb AB, Zhao Y, Herrera V, Mordin M, Odom D, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab provides clearer skin and better control on patient-reported psoriasis symptoms of itching, pain, and scaling than placebo and etanercept. J Psoriasis and Psoriatic Arthritis. 2016;1(4):167-75.
Zhou X, Wang J, Zhang J, Copley-Merriman C, Torigoe Y, Reyes C, Seymour JF, Offner FC, Trneny M, Salles GA. Symptoms and toxicity of rituximab maintenance relative to observation following immunochemotherapy in patients with follicular lymphoma. Hematology. 2015 Apr;129(36). doi: 10.1179/1607845414Y.0000000179
Martin P, Byrtek M, Dawson K, Ziemiecki RM, Friedberg JW, Cerhan JR, Flowers CR, Link BK. Patterns of delivery of chemoimmunotherapy to patients with follicular lymphoma in the United States: results of the National Lymphocare Study. Cancer. 2013 Dec 1;119(23):4129-36. doi: 10.1002/cncr.28350
Messiah SE, Lopez-Mitnik G, Winegar D, Sherif BN, Arheart KL, Reichard KW, Michalsky MP, Lipshultz SE, Miller TL, Livingstone AS, de la Cruz-Muñoz N. Effect of ethnicity on weight loss among adolescents 1 year after bariatric surgery. World J Diabetes. 2013 Oct 15;4(5):202-9. doi: 10.4239/wjd.v4.i5.202
Hahn KA, Wise LA, Riis AH, Mikkelsen EM, Rothman KJ, Banholzer K, Hatch EE. Correlates of menstrual cycle characteristics among nulliparous Danish women. Clin Epidemiol. 2013 Aug 19;5(1):311-9.
Harrison CN, Mesa RA, Kiladjian J-J, Al-Ali H-K, Gisslinger H, Knoops L, Squier M, Sirulnik A, Mendelson E, Zhou X, Copley-Merriman C, Hunter DS, Levy RS, Cervantes F, Passamonti F, Barbui T, Barosi G, Vannucchi AM. Health-related quality of life and symptoms in patients with myelofibrosis treated with ruxolitinib versus best available therapy. Br J Haematol. 2013 Jul;162(2):229-39. doi: 10.1111/bjh.12375
Nooka AK, Nabhan C, Zhou X, Taylor MD, Byrtek M, Miller TP, Friedberg JW, Zelenetz AD, Link BK, Cerhan JR, Sinha R, Shenoy PJ, Levy D, Dawson K, Hirata JH, Flowers CR. Examination of the follicular lymphoma international prognostic index (FLIPI) in the National LymphoCare study (NLCS): a prospective US patient cohort treated predominantly in community practices. Ann Oncol. 2013 Feb 1;24(2):441-8.
Macdonald TM, Mackenzie IS, Wei L, Hawkey CJ, Ford I, Perez-Gutthann S. Methodology of a large prospective, randomised, open, blinded endpoint streamlined safety study of celecoxib versus traditional non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis: protocol of the Standard care versus Celocoxib Outcome Trial (SCOT). BMJ Open. 2013 Jan 29;3(1):e002295. doi: 10.1136/bmjopen-2012-002295
Stull DE, Houghton KF, Petrillo J. Innovative data analysis for demonstrating product value: analysis of heterogeneity in treatment response in clinical trials. Ispor Connections. 2013;19(1):5-8.
Reau N, Hamzeh FM, Lentz E, Zhou X, Jensen D. Characterization of nonrapid virologic response patients infected with HCV genotype 1 who may relapse after standard therapy with peginterferon plus ribavirin. J Viral Hepat. 2012 Feb;19(2):94-102.
Hareendran A, Gnanasakthy A, Winnette RM, Revicki D. Capturing patients' perspectives of treatment in clinical trials/drug development. Contemp Clin Trials. 2012 Jan;33(1):23-8.
Bennett L, Zhao Z, Barber B, Zhou X, Peeters M, Zhang J, Xu F, Wiezorek J, Douillard JY. Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment. Br J Cancer. 2011 Nov 1;105(10):1495-502.
Schmidt M, Christiansen CF, Mehnert F, Rothman KJ, Sorensen HT. Non-steroidal anti-inflammatory drug use and risk of atrial fibrillation or flutter: population based case-control study. Br Med J. 2011 Jul 4;343:d3450. doi: 10.1136/bmj.d3450
McLeod LD, Coon CD, Martin SA, Fehnel SE, Hays RD. Interpreting patient-reported outcome results: uS FDA guidance and emerging methods. Expert Rev Pharmacoecon Outcomes Res. 2011 Apr 1;11(2):163-9.
Baldwin M, Spong A, Doward LC, Gnanasakthy A. Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond. Patient. 2011 Jan;4(1):11-7. doi: 10.2165
Chung RT, Poordad FF, Hassanein T, Zhou X, Lentz E, Prabhakar A, Di Bisceglie AM. Association of host pharmacodynamic effects with virologic response to pegylated interferon alfa-2a/ribavirin in chronic hepatitis C. Hepatology. 2010 Dec 1;52(6):1906-14. doi: 10.1002/hep.23947
Pockros PJ, Hamzeh FM, Martin P, Lentz E, Zhou X, Govindarajan S, Lok AS. Histologic outcomes in hepatitis C–infected patients with varying degrees of virologic response to interferon-based treatments. Hepatology. 2010 Oct 1;52(4):1193-200.
Turk DC, Dworkin RH, McDermott MP, Bellamy N, Burke LB, Chandler JM, Cleeland CS, Cowan P, Dimitrova R, Farrar JT, Hertz S, Heyse JF, Iyengar S, Jadad AR, Jay GW, Jermano JA, Katz NP, Manning DC, Martin SA, Max MB, McGrath P, McQuay HJ, Quessy S, Rappaport BA, Revicki DA, Rothman M, Stauffer JW, Svensson O, White RE, Witter J. Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations. Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials. Pain. 2008 Oct;139(3):485-93. doi: 10.1016/j.pain.2008.06.025.
Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP, Martin SA, Sharma U. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol. 2008 Mar;35(3):502-14.
Schneeweiss S, Patrick AR, Sturmer T, Brookhart MA, Avorn J, Maclure M, Rothman KJ, Glynn RJ. Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results. Med Care. 2007 Oct 1;45(10 - Suppl 2):S131-42.
Camilleri M, Mangel AW, Fehnel SE, Drossman DA, Mayer EA, Talley NJ. Primary endpoints for irritable bowel syndrome trials: a review of performance of endpoints. Clin Gastroenterol Hepatol. 2007 May 1;5(5):534-40.