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1. Liposomes versus metallic nanostructures: differences in the process of knowledge translation in cancer

Author

Fajardo-Ortiz D, Duran L, Moreno L, Ochoa H, and Castaño VM

Subjects
Medicine (General), R5-920
Abstract

David Fajardo-Ortiz,1 Luis Duran,1 Laura Moreno,1 Héctor Ochoa,2 Víctor M Castaño1,3,41Faculty of Medicine of the National Autonomous University of Mexico, Mexico City, Mexico; 2El Colegio de la Frontera Sur, San Cristobal de las Casas, Mexico; 3Molecular Material Department, Applied Physics and Advanced Technology Center, National Autonomous University of Mexico, Juriquilla, Mexico; 4Advanced Technology Center, CIATEQ, Queretaro, MexicoAbstract: This research maps the knowledge translation process for two different types of nanotechnologies applied to cancer: liposomes and metallic nanostructures (MNs). We performed a structural analysis of citation networks and text mining supported in controlled vocabularies. In the case of liposomes, our results identify subnetworks (invisible colleges) associated with different therapeutic strategies: nanopharmacology, hyperthermia, and gene therapy. Only in the pharmacological strategy was an organized knowledge translation process identified, which, however, is monopolized by the liposomal doxorubicins. In the case of MNs, subnetworks are not differentiated by the type of therapeutic strategy, and the content of the documents is still basic research. Research on MNs is highly focused on developing a combination of molecular imaging and photothermal therapy.Keywords: nanotechnology, citation network analysis, basic research, clinics, health care

Published
2014

3. Health Equity Implications of Missing Data Among Youths With Childhood‐Onset Systemic Lupus Erythematosus: A Proof‐of‐Concept Study in the Childhood Arthritis and Rheumatology Research Alliance Registry

Author

Woo, Jennifer M. P., Simmonds, Faith, Dennos, Anne, Son, Mary Beth F., Lewandowski, Laura B., Rubinstein, Tamar B., Abel, N., Abulaban, K., Adams, A., Adams, M., Agbayani, R., Aiello, J., Akoghlanian, S., Alejandro, C., Allenspach, E., Alperin, R., Alpizar, M., Amarilyo, G., Ambler, W., Anderson, E., Ardoin, S., Armendariz, S., Baker, E., Balboni, I., Balevic, S., Ballenger, L., Ballinger, S., Balmuri, N., Barbar‐Smiley, F., Barillas‐Arias, L., Basiaga, M., Baszis, K., Becker, M., Bell‐Brunson, H., Beltz, E., Benham, H., Benseler, S., Bernal, W., Beukelman, T., Bigley, T., Binstadt, B., Black, C., Blakley, M., Bohnsack, J., Boland, J., Boneparth, A., Bowman, S., Bracaglia, C., Brooks, E., Brothers, M., Brown, A., Brunner, H., Buckley, M., Buckley, M., Bukulmez, H., Bullock, D., Cameron, B., Canna, S., Cannon, L., Carper, P., Cartwright, V., Cassidy, E., Cerracchio, L., Chalom, E., Chang, J., Chang‐Hoftman, A., Chauhan, V., Chira, P., Chinn, T., Chundru, K., Clairman, H., Co, D., Confair, A., Conlon, H., Connor, R., Cooper, A., Cooper, J., Cooper, S., Correll, C., Corvalan, R., Costanzo, D., Cron, R., Curiel‐Duran, L., Curington, T., Curry, M., Dalrymple, A., Davis, A., Davis, C., Davis, C., Davis, T., De Benedetti, F., De Ranieri, D., Dean, J., Dedeoglu, F., DeGuzman, M., Delnay, N., Dempsey, V., DeSantis, E., Dickson, T., Dingle, J., Donaldson, B., Dorsey, E., Dover, S., Dowling, J., Drew, J., Driest, K., Du, Q., Duarte, K., Durkee, D., Duverger, E., Dvergsten, J., Eberhard, A., Eckert, M., Ede, K., Edelheit, B., Edens, C., Edens, C., Edgerly, Y., Elder, M., Ervin, B., Fadrhonc, S., Failing, C., Fair, D., Falcon, M., Favier, L., Federici, S., Feldman, B., Fennell, J., Ferguson, I., Ferguson, P., Ferreira, B., Ferrucho, R., Fields, K., Finkel, T., Fitzgerald, M., Fleming, C., Flynn, O., Fogel, L., Fox, E., Fox, M., Franco, L., Freeman, M., Fritz, K., Froese, S., Fuhlbrigge, R., Fuller, J., George, N., Gerhold, K., Gerstbacher, D., Gilbert, M., Gillispie‐Taylor, M., Giverc, E., Godiwala, C., Goh, I., Goheer, H., Goldsmith, D., Gotschlich, E., Gotte, A., Gottlieb, B., Gracia, C., Graham, T., Grevich, S., Griffin, T., Griswold, J., Grom, A., Guevara, M., Guittar, P., Guzman, M., Hager, M., Hahn, T., Halyabar, O., Hammelev, E., Hance, M., Hanson, A., Harel, L., Haro, S., Harris, J., Harry, O., Hartigan, E., Hausmann, J., Hay, A., Hayward, K., Heiart, J., Hekl, K., Henderson, L., Henrickson, M., Hersh, A., Hickey, K., Hill, P., Hillyer, S., Hiraki, L., Hiskey, M., Hobday, P., Hoffart, C., Holland, M., Hollander, M., Hong, S., Horwitz, M., Hsu, J., Huber, A., Huggins, J., Hui‐Yuen, J., Hung, C., Huntington, J., Huttenlocher, A., Ibarra, M., Imundo, L., Inman, C., Insalaco, A., Jackson, A., Jackson, S., James, K., Janow, G., Jaquith, J., Jared, S., Johnson, N., Jones, J., Jones, J., Jones, J., Jones, K., Jones, S., Joshi, S., Jung, L., Justice, C., Justiniano, A., Karan, N., Kaufman, K., Kemp, A., Kessler, E., Khalsa, U., Kienzle, B., Kim, S., Kimura, Y., Kingsbury, D., Kitcharoensakkul, M., Klausmeier, T., Klein, K., Klein‐Gitelman, M., Kompelien, B., Kosikowski, A., Kovalick, L., Kracker, J., Kramer, S., Kremer, C., Lai, J., Lam, J., Lang, B., Lapidus, S., Lapin, B., Lasky, A., Latham, D., Lawson, E., Laxer, R., Lee, P., Lee, P., Lee, T., Lentini, L., Lerman, M., Levy, D., Li, S., Lieberman, S., Lim, L., Lin, C., Ling, N., Lingis, M., Lo, M., Lovell, D., Lowman, D., Luca, N., Lvovich, S., Madison, C., Madison, J., Manzoni, S. Magni, Malla, B., Maller, J., Malloy, M., Mannion, M., Manos, C., Marques, L., Martyniuk, A., Mason, T., Mathus, S., McAllister, L., McCarthy, K., McConnell, K., McCormick, E., McCurdy, D., Stokes, P. McCurdy, McGuire, S., McHale, I., McMonagle, A., McMullen‐Jackson, C., Meidan, E., Mellins, E., Mendoza, E., Mercado, R., Merritt, A., Michalowski, L., Miettunen, P., Miller, M., Milojevic, D., Mirizio, E., Misajon, E., Mitchell, M., Modica, R., Mohan, S., Moore, K., Moorthy, L., Morgan, S., Dewitt, E. Morgan, Moss, C., Moussa, T., Mruk, V., Murphy, A., Muscal, E., Nadler, R., Nahal, B., Nanda, K., Nasah, N., Nassi, L., Nativ, S., Natter, M., Neely, J., Nelson, B., Newhall, L., Ng, L., Nicholas, J., Nicolai, R., Nigrovic, P., Nocton, J., Nolan, B., Oberle, E., Obispo, B., OʼBrien, B., OʼBrien, T., Okeke, O., Oliver, M., Olson, J., OʼNeil, K., Onel, K., Orandi, A., Orlando, M., Osei‐Onomah, S., Oz, R., Pagano, E., Paller, A., Pan, N., Panupattanapong, S., Pardeo, M., Paredes, J., Parsons, A., Patel, J., Pentakota, K., Pepmueller, P., Pfeiffer, T., Phillippi, K., Phillippi, K., Marafon, D. Pires, Ponder, L., Pooni, R., Prahalad, S., Pratt, S., Protopapas, S., Puplava, B., Quach, J., Quinlan‐Waters, M., Rabinovich, C., Radhakrishna, S., Rafko, J., Raisian, J., Rakestraw, A., Ramirez, C., Ramsay, E., Ramsey, S., Randell, R., Reed, A., Reed, A., Reed, A., Reid, H., Remmel, K., Repp, A., Reyes, A., Richmond, A., Riebschleger, M., Ringold, S., Riordan, M., Riskalla, M., Ritter, M., Rivas‐Chacon, R., Robinson, A., Rodela, E., Rodriquez, M., Rojas, K., Ronis, T., Rosenkranz, M., Rosolowski, B., Rothermel, H., Rothman, D., Roth‐Wojcicki, E., Rouster‐Stevens, K., Rubinstein, T., Ruth, N., Saad, N., Sabbagh, S., Sacco, E., Sadun, R., Sandborg, C., Sanni, A., Santiago, L., Sarkissian, A., Savani, S., Scalzi, L., Schanberg, L., Scharnhorst, S., Schikler, K., Schlefman, A., Schmeling, H., Schmidt, K., Schmitt, E., Schneider, R., Schollaert‐Fitch, K., Schulert, G., Seay, T., Seper, C., Shalen, J., Sheets, R., Shelly, A., Shenoi, S., Shergill, K., Shirley, J., Shishov, M., Shivers, C., Silverman, E., Singer, N., Sivaraman, V., Sletten, J., Smith, A., Smith, C., Smith, J., Smith, J., Smitherman, E., Soep, J., Son, M., Spence, S., Spiegel, L., Spitznagle, J., Sran, R., Srinivasalu, H., Stapp, H., Steigerwald, K., Rakovchik, Y. Sterba, Stern, S., Stevens, A., Stevens, B., Stevenson, R., Stewart, K., Stingl, C., Stokes, J., Stoll, M., Stringer, E., Sule, S., Sumner, J., Sundel, R., Sutter, M., Syed, R., Syverson, G., Szymanski, A., Taber, S., Tal, R., Tambralli, A., Taneja, A., Tanner, T., Tapani, S., Tarshish, G., Tarvin, S., Tate, L., Taxter, A., Taylor, J., Terry, M., Tesher, M., Thatayatikom, A., Thomas, B., Tiffany, K., Ting, T., Tipp, A., Toib, D., Torok, K., Toruner, C., Tory, H., Toth, M., Tse, S., Tubwell, V., Twilt, M., Uriguen, S., Valcarcel, T., Van Mater, H., Vannoy, L., Varghese, C., Vasquez, N., Vazzana, K., Vehe, R., Veiga, K., Velez, J., Verbsky, J., Vilar, G., Volpe, N., von Scheven, E., Vora, S., Wagner, J., Wagner‐Weiner, L., Wahezi, D., Waite, H., Walker, J., Walters, H., Muskardin, T. Wampler, Waqar, L., Waterfield, M., Watson, M., Watts, A., Weiser, P., Weiss, J., Weiss, P., Wershba, E., White, A., Williams, C., Wise, A., Woo, J., Woolnough, L., Wright, T., Wu, E., Yalcindag, A., Yee, M., Yen, E., Yeung, R., Yomogida, K., Yu, Q., Zapata, R., Zartoshti, A., Zeft, A., Zeft, R., Zhang, Y., Zhao, Y., Zhu, A., and Zic, C.

Published
2023
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5. Childhood‐Onset Lupus Nephritis in the Childhood Arthritis and Rheumatology Research Alliance Registry: Short‐Term Kidney Status and Variation in Care

Author

Smitherman, Emily A., Chahine, Rouba A., Beukelman, Timothy, Lewandowski, Laura B., Rahman, A. K. M. Fazlur, Wenderfer, Scott E., Curtis, Jeffrey R., Hersh, Aimee O., Abel, N., Abulaban, K., Adams, A., Adams, M., Agbayani, R., Aiello, J., Akoghlanian, S., Alejandro, C., Allenspach, E., Alperin, R., Alpizar, M., Amarilyo, G., Ambler, W., Anderson, E., Ardoin, S., Armendariz, S., Baker, E., Balboni, I., Balevic, S., Ballenger, L., Ballinger, S., Balmuri, N., Barbar‐Smiley, F., Barillas‐Arias, L., Basiaga, M., Baszis, K., Becker, M., Bell‐Brunson, H., Beltz, E., Benham, H., Benseler, S., Bernal, W., Beukelman, T., Bigley, T., Binstadt, B., Black, C., Blakley, M., Bohnsack, J., Boland, J., Boneparth, A., Bowman, S., Bracaglia, C., Brooks, E., Brothers, M., Brown, A., Brunner, H., Buckley, M., Buckley, M., Bukulmez, H., Bullock, D., Cameron, B., Canna, S., Cannon, L., Carper, P., Cartwright, V., Cassidy, E., Cerracchio, L., Chalom, E., Chang, J., Chang‐Hoftman, A., Chauhan, V., Chira, P., Chinn, T., Chundru, K., Clairman, H., Co, D., Confair, A., Conlon, H., Connor, R., Cooper, A., Cooper, J., Cooper, S., Correll, C., Corvalan, R., Costanzo, D., Cron, R., Curiel‐Duran, L., Curington, T., Curry, M., Dalrymple, A., Davis, A., Davis, C., Davis, C., Davis, T., De Benedetti, F., De Ranieri, D., Dean, J., Dedeoglu, F., DeGuzman, M., Delnay, N., Dempsey, V., DeSantis, E., Dickson, T., Dingle, J., Donaldson, B., Dorsey, E., Dover, S., Dowling, J., Drew, J., Driest, K., Du, Q., Duarte, K., Durkee, D., Duverger, E., Dvergsten, J., Eberhard, A., Eckert, M., Ede, K., Edelheit, B., Edens, C., Edens, C., Edgerly, Y., Elder, M., Ervin, B., Fadrhonc, S., Failing, C., Fair, D., Falcon, M., Favier, L., Federici, S., Feldman, B., Fennell, J., Ferguson, I., Ferguson, P., Ferreira, B., Ferrucho, R., Fields, K., Finkel, T., Fitzgerald, M., Fleming, C., Flynn, O., Fogel, L., Fox, E., Fox, M., Franco, L., Freeman, M., Fritz, K., Froese, S., Fuhlbrigge, R., Fuller, J., George, N., Gerhold, K., Gerstbacher, D., Gilbert, M., Gillispie‐Taylor, M., Giverc, E., Godiwala, C., Goh, I., Goheer, H., Goldsmith, D., Gotschlich, E., Gotte, A., Gottlieb, B., Gracia, C., Graham, T., Grevich, S., Griffin, T., Griswold, J., Grom, A., Guevara, M., Guittar, P., Guzman, M., Hager, M., Hahn, T., Halyabar, O., Hammelev, E., Hance, M., Hanson, A., Harel, L., Haro, S., Harris, J., Harry, O., Hartigan, E., Hausmann, J., Hay, A., Hayward, K., Heiart, J., Hekl, K., Henderson, L., Henrickson, M., Hersh, A., Hickey, K., Hill, P., Hillyer, S., Hiraki, L., Hiskey, M., Hobday, P., Hoffart, C., Holland, M., Hollander, M., Hong, S., Horwitz, M., Hsu, J., Huber, A., Huggins, J., Hui‐Yuen, J., Hung, C., Huntington, J., Huttenlocher, A., Ibarra, M., Imundo, L., Inman, C., Insalaco, A., Jackson, A., Jackson, S., James, K., Janow, G., Jaquith, J., Jared, S., Johnson, N., Jones, J., Jones, J., Jones, J., Jones, K., Jones, S., Joshi, S., Jung, L., Justice, C., Justiniano, A., Karan, N., Kaufman, K., Kemp, A., Kessler, E., Khalsa, U., Kienzle, B., Kim, S., Kimura, Y., Kingsbury, D., Kitcharoensakkul, M., Klausmeier, T., Klein, K., Klein‐Gitelman, M., Kompelien, B., Kosikowski, A., Kovalick, L., Kracker, J., Kramer, S., Kremer, C., Lai, J., Lam, J., Lang, B., Lapidus, S., Lapin, B., Lasky, A., Latham, D., Lawson, E., Laxer, R., Lee, P., Lee, P., Lee, T., Lentini, L., Lerman, M., Levy, D., Li, S., Lieberman, S., Lim, L., Lin, C., Ling, N., Lingis, M., Lo, M., Lovell, D., Lowman, D., Luca, N., Lvovich, S., Madison, C., Madison, J., Manzoni, S. Magni, Malla, B., Maller, J., Malloy, M., Mannion, M., Manos, C., Marques, L., Martyniuk, A., Mason, T., Mathus, S., McAllister, L., McCarthy, K., McConnell, K., McCormick, E., McCurdy, D., Stokes, P. McCurdy, McGuire, S., McHale, I., McMonagle, A., McMullen‐Jackson, C., Meidan, E., Mellins, E., Mendoza, E., Mercado, R., Merritt, A., Michalowski, L., Miettunen, P., Miller, M., Milojevic, D., Mirizio, E., Misajon, E., Mitchell, M., Modica, R., Mohan, S., Moore, K., Moorthy, L., Morgan, S., Dewitt, E. Morgan, Moss, C., Moussa, T., Mruk, V., Murphy, A., Muscal, E., Nadler, R., Nahal, B., Nanda, K., Nasah, N., Nassi, L., Nativ, S., Natter, M., Neely, J., Nelson, B., Newhall, L., Ng, L., Nicholas, J., Nicolai, R., Nigrovic, P., Nocton, J., Nolan, B., Oberle, E., Obispo, B., OʼBrien, B., OʼBrien, T., Okeke, O., Oliver, M., Olson, J., OʼNeil, K., Onel, K., Orandi, A., Orlando, M., Osei‐Onomah, S., Oz, R., Pagano, E., Paller, A., Pan, N., Panupattanapong, S., Pardeo, M., Paredes, J., Parsons, A., Patel, J., Pentakota, K., Pepmueller, P., Pfeiffer, T., Phillippi, K., Marafon, D. Pires, Phillippi, K., Ponder, L., Pooni, R., Prahalad, S., Pratt, S., Protopapas, S., Puplava, B., Quach, J., Quinlan‐Waters, M., Rabinovich, C., Radhakrishna, S., Rafko, J., Raisian, J., Rakestraw, A., Ramirez, C., Ramsay, E., Ramsey, S., Randell, R., Reed, A., Reed, A., Reed, A., Reid, H., Remmel, K., Repp, A., Reyes, A., Richmond, A., Riebschleger, M., Ringold, S., Riordan, M., Riskalla, M., Ritter, M., Rivas‐Chacon, R., Robinson, A., Rodela, E., Rodriquez, M., Rojas, K., Ronis, T., Rosenkranz, M., Rosolowski, B., Rothermel, H., Rothman, D., Roth‐Wojcicki, E., Rouster – Stevens, K., Rubinstein, T., Ruth, N., Saad, N., Sabbagh, S., Sacco, E., Sadun, R., Sandborg, C., Sanni, A., Santiago, L., Sarkissian, A., Savani, S., Scalzi, L., Schanberg, L., Scharnhorst, S., Schikler, K., Schlefman, A., Schmeling, H., Schmidt, K., Schmitt, E., Schneider, R., Schollaert‐Fitch, K., Schulert, G., Seay, T., Seper, C., Shalen, J., Sheets, R., Shelly, A., Shenoi, S., Shergill, K., Shirley, J., Shishov, M., Shivers, C., Silverman, E., Singer, N., Sivaraman, V., Sletten, J., Smith, A., Smith, C., Smith, J., Smith, J., Smitherman, E., Soep, J., Son, M., Spence, S., Spiegel, L., Spitznagle, J., Sran, R., Srinivasalu, H., Stapp, H., Steigerwald, K., Rakovchik, Y. Sterba, Stern, S., Stevens, A., Stevens, B., Stevenson, R., Stewart, K., Stingl, C., Stokes, J., Stoll, M., Stringer, E., Sule, S., Sumner, J., Sundel, R., Sutter, M., Syed, R., Syverson, G., Szymanski, A., Taber, S., Tal, R., Tambralli, A., Taneja, A., Tanner, T., Tapani, S., Tarshish, G., Tarvin, S., Tate, L., Taxter, A., Taylor, J., Terry, M., Tesher, M., Thatayatikom, A., Thomas, B., Tiffany, K., Ting, T., Tipp, A., Toib, D., Torok, K., Toruner, C., Tory, H., Toth, M., Tse, S., Tubwell, V., Twilt, M., Uriguen, S., Valcarcel, T., Van Mater, H., Vannoy, L., Varghese, C., Vasquez, N., Vazzana, K., Vehe, R., Veiga, K., Velez, J., Verbsky, J., Vilar, G., Volpe, N., von Scheven, E., Vora, S., Wagner, J., Wagner‐Weiner, L., Wahezi, D., Waite, H., Walker, J., Walters, H., Muskardin, T. Wampler, Waqar, L., Waterfield, M., Watson, M., Watts, A., Weiser, P., Weiss, J., Weiss, P., Wershba, E., White, A., Williams, C., Wise, A., Woo, J., Woolnough, L., Wright, T., Wu, E., Yalcindag, A., Yee, M., Yen, E., Yeung, R., Yomogida, K., Yu, Q., Zapata, R., Zartoshti, A., Zeft, A., Zeft, R., Zhang, Y., Zhao, Y., Zhu, A., and Zic, C.

Published
2023
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12. A Randomized Trial of an Elementary School Mathematics Software Intervention: Spatial-Temporal Math

Author

Rutherford, T, Farkas, G, Duncan, G, Burchinal, M, Kibrick, M, Graham, J, Richland, L, Tran, N, Schneider, S, Duran, L, and Martinez, ME

Subjects
Elementary mathematics, experimental design, computer-assisted instruction, Clinical Research
Abstract

Abstract: Fifty-two low performing schools were randomly assigned to receive Spatial-Temporal (ST) Math, a supplemental mathematics software and instructional program, in second/third or fourth/fifth grades or to a business-as-usual control. Analyses reveal a negligible effect of ST Math on mathematics scores, which did not differ significantly across subgroups defined by prior math proficiency and English Language Learner status. Two years of program treatment produced a nonsignificant effect. Publication of evaluation results from large-scale real-world supplemental mathematics instructional implementations such as this one can provide a realistic view of the possibilities, costs, and limitations of this and other computer aided instruction supplemental interventions.

Published
2014

13. The Accuracy of CARB (COVID ASSESSMENT AND REVIEW BOARD) Screening Tool in diagnosing patients with COVID 19 from March 2020 to March 2022 in Silliman Medical Center Foundation Incorporated; A retrospective descriptive cross sectional study

Author

Duran, L. Angelique Gene, primary, Cuyacot, Dehuel, additional, Calinawagan, Brian Joseph, additional, Garcia, Gamaliel, additional, Tindoc, John Anthony, additional, and Catacutan, Hannah Candace, additional

Published
2023
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14. Comparing The Efficacy Of An Anti-Human VEGF-A Neutralizing Antibody Versus Bevacizumab On A Laser-Induced Choroidal Neovascularization (CNV) Rhesus Monkey Model

Author

Olvera-Montaño O, Baiza-Duran L, Quintana-Hau JD, Quiñonez-Alvarado MG, Zeng W, Gong L, and Muñoz-Villegas P

Subjects
age-related macular degeneration, monoclonal antibodies, fundus fluorescein angiography, optical coherence tomography., Therapeutics. Pharmacology, RM1-950
Abstract

Oscar Olvera-Montaño,1 Leopoldo Baiza-Duran,1 Juan D Quintana-Hau,2 Mayra G Quiñonez-Alvarado,2 Wen Zeng,3 Li Gong,3 Patricia Muñoz-Villegas1 1Clinical Research Department, Laboratorios Sophia, SA De CV, Zapopan, Jalisco, Mexico; 2Research and Development Department (CIS), Zapopan, Jalisco, Mexico; 3Sichuan Primed Shines Bio-Tech Co, Ltd, Chengdu, Sichuan, People’s Republic of ChinaCorrespondence: Patricia Muñoz-VillegasLaboratorios Sophia, SA de CV, Paseo del Norte 5255, Guadalajara Technology Park, Zapopan 45010, Jalisco, MexicoTel +52 3301 4200, Ext: 1018Fax +52 3301 4200Email patricia.munoz@sophia.com.mxPurpose: To evaluate the efficacy of a therapy on improving characteristics of laser-induced choroidal neovascularization (CNV) via single intravitreal injection of a humanized anti-human VEGF monoclonal antibody (PRO-169) versus bevacizumab in a rhesus monkey model.Methods: To induce experimental CNV, small high-energy laser spots were used to treat several areas, around the macula in the retinas of monkeys at Day −21. Eighteen rhesus monkeys were used for CNV induction. The efficacy endpoints were fluorescein leakage by FFA and retinal thickness by OCT. FFA examinations were performed 19 days after induction. Appropriate animals were enrolled for treatment and randomly divided into 3 groups: bevacizumab (n=5, 7 eyes), PRO-169 (n=5, 7 eyes), and vehicle controls (n=4, 7 eyes).Results: In 25 of 36 (69.4%) eyes, CNV lesions were identified. The average percent change of retinal thickness in the eyes of bevacizumab group was −159.3±62.2% and −154.0±45.1% (p

Published
2019

15. Juvenile Spondyloarthritis in the Childhood Arthritis and Rheumatology Research Alliance Registry: High Biologic Use, Low Prevalence of HLA–B27, and Equal Sex Representation in Sacroiliitis

Author

Rumsey, Dax G., Lougee, Aimee, Matsouaka, Roland, Collier, David H., Schanberg, Laura E., Schenfeld, Jennifer, Shiff, Natalie J., Stoll, Matthew L., Stryker, Scott, Weiss, Pamela F., Beukelman, Timothy, Abel, N., Abulaban, K., Adams, A., Adams, M., Agbayani, R., Aiello, J., Akoghlanian, S., Alejandro, C., Allenspach, E., Alperin, R., Alpizar, M., Amarilyo, G., Ambler, W., Anderson, E., Ardoin, S., Armendariz, S., Baker, E., Balboni, I., Balevic, S., Ballenger, L., Ballinger, S., Balmuri, N., Barbar‐Smiley, F., Barillas‐Arias, L., Basiaga, M., Baszis, K., Becker, M., Bell‐Brunson, H., Beltz, E., Benham, H., Benseler, S., Bernal, W., Bigley, T., Binstadt, B., Black, C., Blakley, M., Bohnsack, J., Boland, J., Boneparth, A., Bowman, S., Bracaglia, C., Brooks, E., Brothers, M., Brown, A., Brunner, H., Buckley, M., Buckley, M., Bukulmez, H., Bullock, D., Cameron, B., Canna, S., Cannon, L., Carper, P., Cartwright, V., Cassidy, E., Cerracchio, L., Chalom, E., Chang, J., Chang‐Hoftman, A., Chauhan, V., Chira, P., Chinn, T., Chundru, K., Clairman, H., Co, D., Confair, A., Conlon, H., Connor, R., Cooper, A., Cooper, J., Cooper, S., Correll, C., Corvalan, R., Costanzo, D., Cron, R., Curiel‐Duran, L., Curington, T., Curry, M., Dalrymple, A., Davis, A., Davis, C., Davis, C., Davis, T., De Benedetti, F., De Ranieri, D., Dean, J., Dedeoglu, F., DeGuzman, M., Delnay, N., Dempsey, V., DeSantis, E., Dickson, T., Dingle, J., Donaldson, B., Dorsey, E., Dover, S., Dowling, J., Drew, J., Driest, K., Du, Q., Duarte, K., Durkee, D., Duverger, E., Dvergsten, J., Eberhard, A., Eckert, M., Ede, K., Edelheit, B., Edens, C., Edens, C., Edgerly, Y., Elder, M., Ervin, B., Fadrhonc, S., Failing, C., Fair, D., Falcon, M., Favier, L., Federici, S., Feldman, B., Fennell, J., Ferguson, I., Ferguson, P., Ferreira, B., Ferrucho, R., Fields, K., Finkel, T., Fitzgerald, M., Fleming, C., Flynn, O., Fogel, L., Fox, E., Fox, M., Franco, L., Freeman, M., Fritz, K., Froese, S., Fuhlbrigge, R., Fuller, J., George, N., Gerhold, K., Gerstbacher, D., Gilbert, M., Gillispie‐Taylor, M., Giverc, E., Godiwala, C., Goh, I., Goheer, H., Goldsmith, D., Gotschlich, E., Gotte, A., Gottlieb, B., Gracia, C., Graham, T., Grevich, S., Griffin, T., Griswold, J., Grom, A., Guevara, M., Guittar, P., Guzman, M., Hager, M., Hahn, T., Halyabar, O., Hammelev, E., Hance, M., Hanson, A., Harel, L., Haro, S., Harris, J., Harry, O., Hartigan, E., Hausmann, J., Hay, A., Hayward, K., Heiart, J., Hekl, K., Henderson, L., Henrickson, M., Hersh, A., Hickey, K., Hill, P., Hillyer, S., Hiraki, L., Hiskey, M., Hobday, P., Hoffart, C., Holland, M., Hollander, M., Hong, S., Horwitz, M., Hsu, J., Huber, A., Huggins, J., Hui‐Yuen, J., Hung, C., Huntington, J., Huttenlocher, A., Ibarra, M., Imundo, L., Inman, C., Insalaco, A., Jackson, A., Jackson, S., James, K., Janow, G., Jaquith, J., Jared, S., Johnson, N., Jones, J., Jones, J., Jones, J., Jones, K., Jones, S., Joshi, S., Jung, L., Justice, C., Justiniano, A., Karan, N., Kaufman, K., Kemp, A., Kessler, E., Khalsa, U., Kienzle, B., Kim, S., Kimura, Y., Kingsbury, D., Kitcharoensakkul, M., Klausmeier, T., Klein, K., Klein‐Gitelman, M., Kompelien, B., Kosikowski, A., Kovalick, L., Kracker, J., Kramer, S., Kremer, C., Lai, J., Lam, J., Lang, B., Lapidus, S., Lapin, B., Lasky, A., Latham, D., Lawson, E., Laxer, R., Lee, P., Lee, P., Lee, T., Lentini, L., Lerman, M., Levy, D., Li, S., Lieberman, S., Lim, L., Lin, C., Ling, N., Lingis, M., Lo, M., Lovell, D., Lowman, D., Luca, N., Lvovich, S., Madison, C., Madison, J., Magni Manzoni, S., Malla, B., Maller, J., Malloy, M., Mannion, M., Manos, C., Marques, L., Martyniuk, A., Mason, T., Mathus, S., McAllister, L., McCarthy, K., McConnell, K., McCormick, E., McCurdy, D., McCurdy Stokes, P., McGuire, S., McHale, I., McMonagle, A., McMullen‐Jackson, C., Meidan, E., Mellins, E., Mendoza, E., Mercado, R., Merritt, A., Michalowski, L., Miettunen, P., Miller, M., Milojevic, D., Mirizio, E., Misajon, E., Mitchell, M., Modica, R., Mohan, S., Moore, K., Moorthy, L., Morgan, S., Morgan Dewitt, E., Moss, C., Moussa, T., Mruk, V., Murphy, A., Muscal, E., Nadler, R., Nahal, B., Nanda, K., Nasah, N., Nassi, L., Nativ, S., Natter, M., Neely, J., Nelson, B., Newhall, L., Ng, L., Nicholas, J., Nicolai, R., Nigrovic, P., Nocton, J., Nolan, B., Oberle, E., Obispo, B., O’Brien, B., O’Brien, T., Okeke, O., Oliver, M., Olson, J., O’Neil, K., Onel, K., Orandi, A., Orlando, M., Osei‐Onomah, S., Oz, R., Pagano, E., Paller, A., Pan, N., Panupattanapong, S., Pardeo, M., Paredes, J., Parsons, A., Patel, J., Pentakota, K., Pepmueller, P., Pfeiffer, T., Phillippi, K., Pires Marafon, D., Phillippi, K., Ponder, L., Pooni, R., Prahalad, S., Pratt, S., Protopapas, S., Puplava, B., Quach, J., Quinlan‐Waters, M., Rabinovich, C., Radhakrishna, S., Rafko, J., Raisian, J., Rakestraw, A., Ramirez, C., Ramsay, E., Ramsey, S., Randell, R., Reed, A., Reed, A., Reed, A., Reid, H., Remmel, K., Repp, A., Reyes, A., Richmond, A., Riebschleger, M., Ringold, S., Riordan, M., Riskalla, M., Ritter, M., Rivas‐Chacon, R., Robinson, A., Rodela, E., Rodriquez, M., Rojas, K., Ronis, T., Rosenkranz, M., Rosolowski, B., Rothermel, H., Rothman, D., Roth‐Wojcicki, E., Rouster – Stevens, K., Rubinstein, T., Ruth, N., Saad, N., Sabbagh, S., Sacco, E., Sadun, R., Sandborg, C., Sanni, A., Santiago, L., Sarkissian, A., Savani, S., Scalzi, L., Scharnhorst, S., Schikler, K., Schlefman, A., Schmeling, H., Schmidt, K., Schmitt, E., Schneider, R., Schollaert‐Fitch, K., Schulert, G., Seay, T., Seper, C., Shalen, J., Sheets, R., Shelly, A., Shenoi, S., Shergill, K., Shirley, J., Shishov, M., Shivers, C., Silverman, E., Singer, N., Sivaraman, V., Sletten, J., Smith, A., Smith, C., Smith, J., Smith, J., Smitherman, E., Soep, J., Son, M., Spence, S., Spiegel, L., Spitznagle, J., Sran, R., Srinivasalu, H., Stapp, H., Steigerwald, K., Sterba Rakovchik, Y., Stern, S., Stevens, A., Stevens, B., Stevenson, R., Stewart, K., Stingl, C., Stokes, J., Stringer, E., Sule, S., Sumner, J., Sundel, R., Sutter, M., Syed, R., Syverson, G., Szymanski, A., Taber, S., Tal, R., Tambralli, A., Taneja, A., Tanner, T., Tapani, S., Tarshish, G., Tarvin, S., Tate, L., Taxter, A., Taylor, J., Terry, M., Tesher, M., Thatayatikom, A., Thomas, B., Tiffany, K., Ting, T., Tipp, A., Toib, D., Torok, K., Toruner, C., Tory, H., Toth, M., Tse, S., Tubwell, V., Twilt, M., Uriguen, S., Valcarcel, T., Van Mater, H., Vannoy, L., Varghese, C., Vasquez, N., Vazzana, K., Vehe, R., Veiga, K., Velez, J., Verbsky, J., Vilar, G., Volpe, N., von Scheven, E., Vora, S., Wagner, J., Wagner‐Weiner, L., Wahezi, D., Waite, H., Walker, J., Walters, H., Wampler Muskardin, T., Waqar, L., Waterfield, M., Watson, M., Watts, A., Weiser, P., Weiss, J., Wershba, E., White, A., Williams, C., Wise, A., Woo, J., Woolnough, L., Wright, T., Wu, E., Yalcindag, A., Yee, M., Yen, E., Yeung, R., Yomogida, K., Yu, Q., Zapata, R., Zartoshti, A., Zeft, A., Zeft, R., Zhang, Y., Zhao, Y., Zhu, A., and Zic, C.

Published
2021
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27. Conventional Joystick vs. Wiimote for Holonomic Wheelchair Control

Author

Duran, L., Fernandez-Carmona, M., Urdiales, C., Peula, J. M, Sandoval, F., Hutchison, David, Series editor, Kanade, Takeo, Series editor, Kittler, Josef, Series editor, Kleinberg, Jon M., Series editor, Mattern, Friedemann, Series editor, Mitchell, John C., Series editor, Naor, Moni, Series editor, Nierstrasz, Oscar, Series editor, Pandu Rangan, C., Series editor, Steffen, Bernhard, Series editor, Sudan, Madhu, Series editor, Terzopoulos, Demetri, Series editor, Tygar, Doug, Series editor, Vardi, Moshe Y., Series editor, Weikum, Gerhard, Series editor, Cabestany, Joan, editor, Sandoval, Francisco, editor, Prieto, Alberto, editor, and Corchado, Juan M., editor

Published
2009
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28. Health Equity Implications of Missing Data Among Youths With Childhood‐OnsetSystemic Lupus Erythematosus: A Proof‐of‐ConceptStudy in the Childhood Arthritis and Rheumatology Research Alliance Registry

Author

Woo, Jennifer M. P., Simmonds, Faith, Dennos, Anne, Son, Mary Beth F., Lewandowski, Laura B., Rubinstein, Tamar B., Abel, N., Abulaban, K., Adams, A., Adams, M., Agbayani, R., Aiello, J., Akoghlanian, S., Alejandro, C., Allenspach, E., Alperin, R., Alpizar, M., Amarilyo, G., Ambler, W., Anderson, E., Ardoin, S., Armendariz, S., Baker, E., Balboni, I., Balevic, S., Ballenger, L., Ballinger, S., Balmuri, N., Barbar‐Smiley, F., Barillas‐Arias, L., Basiaga, M., Baszis, K., Becker, M., Bell‐Brunson, H., Beltz, E., Benham, H., Benseler, S., Bernal, W., Beukelman, T., Bigley, T., Binstadt, B., Black, C., Blakley, M., Bohnsack, J., Boland, J., Boneparth, A., Bowman, S., Bracaglia, C., Brooks, E., Brothers, M., Brown, A., Brunner, H., Buckley, M., Buckley, M., Bukulmez, H., Bullock, D., Cameron, B., Canna, S., Cannon, L., Carper, P., Cartwright, V., Cassidy, E., Cerracchio, L., Chalom, E., Chang, J., Chang‐Hoftman, A., Chauhan, V., Chira, P., Chinn, T., Chundru, K., Clairman, H., Co, D., Confair, A., Conlon, H., Connor, R., Cooper, A., Cooper, J., Cooper, S., Correll, C., Corvalan, R., Costanzo, D., Cron, R., Curiel‐Duran, L., Curington, T., Curry, M., Dalrymple, A., Davis, A., Davis, C., Davis, C., Davis, T., De Benedetti, F., De Ranieri, D., Dean, J., Dedeoglu, F., DeGuzman, M., Delnay, N., Dempsey, V., DeSantis, E., Dickson, T., Dingle, J., Donaldson, B., Dorsey, E., Dover, S., Dowling, J., Drew, J., Driest, K., Du, Q., Duarte, K., Durkee, D., Duverger, E., Dvergsten, J., Eberhard, A., Eckert, M., Ede, K., Edelheit, B., Edens, C., Edens, C., Edgerly, Y., Elder, M., Ervin, B., Fadrhonc, S., Failing, C., Fair, D., Falcon, M., Favier, L., Federici, S., Feldman, B., Fennell, J., Ferguson, I., Ferguson, P., Ferreira, B., Ferrucho, R., Fields, K., Finkel, T., Fitzgerald, M., Fleming, C., Flynn, O., Fogel, L., Fox, E., Fox, M., Franco, L., Freeman, M., Fritz, K., Froese, S., Fuhlbrigge, R., Fuller, J., George, N., Gerhold, K., Gerstbacher, D., Gilbert, M., Gillispie‐Taylor, M., Giverc, E., Godiwala, C., Goh, I., Goheer, H., Goldsmith, D., Gotschlich, E., Gotte, A., Gottlieb, B., Gracia, C., Graham, T., Grevich, S., Griffin, T., Griswold, J., Grom, A., Guevara, M., Guittar, P., Guzman, M., Hager, M., Hahn, T., Halyabar, O., Hammelev, E., Hance, M., Hanson, A., Harel, L., Haro, S., Harris, J., Harry, O., Hartigan, E., Hausmann, J., Hay, A., Hayward, K., Heiart, J., Hekl, K., Henderson, L., Henrickson, M., Hersh, A., Hickey, K., Hill, P., Hillyer, S., Hiraki, L., Hiskey, M., Hobday, P., Hoffart, C., Holland, M., Hollander, M., Hong, S., Horwitz, M., Hsu, J., Huber, A., Huggins, J., Hui‐Yuen, J., Hung, C., Huntington, J., Huttenlocher, A., Ibarra, M., Imundo, L., Inman, C., Insalaco, A., Jackson, A., Jackson, S., James, K., Janow, G., Jaquith, J., Jared, S., Johnson, N., Jones, J., Jones, J., Jones, J., Jones, K., Jones, S., Joshi, S., Jung, L., Justice, C., Justiniano, A., Karan, N., Kaufman, K., Kemp, A., Kessler, E., Khalsa, U., Kienzle, B., Kim, S., Kimura, Y., Kingsbury, D., Kitcharoensakkul, M., Klausmeier, T., Klein, K., Klein‐Gitelman, M., Kompelien, B., Kosikowski, A., Kovalick, L., Kracker, J., Kramer, S., Kremer, C., Lai, J., Lam, J., Lang, B., Lapidus, S., Lapin, B., Lasky, A., Latham, D., Lawson, E., Laxer, R., Lee, P., Lee, P., Lee, T., Lentini, L., Lerman, M., Levy, D., Li, S., Lieberman, S., Lim, L., Lin, C., Ling, N., Lingis, M., Lo, M., Lovell, D., Lowman, D., Luca, N., Lvovich, S., Madison, C., Madison, J., Manzoni, S. Magni, Malla, B., Maller, J., Malloy, M., Mannion, M., Manos, C., Marques, L., Martyniuk, A., Mason, T., Mathus, S., McAllister, L., McCarthy, K., McConnell, K., McCormick, E., McCurdy, D., Stokes, P. McCurdy, McGuire, S., McHale, I., McMonagle, A., McMullen‐Jackson, C., Meidan, E., Mellins, E., Mendoza, E., Mercado, R., Merritt, A., Michalowski, L., Miettunen, P., Miller, M., Milojevic, D., Mirizio, E., Misajon, E., Mitchell, M., Modica, R., Mohan, S., Moore, K., Moorthy, L., Morgan, S., Dewitt, E. Morgan, Moss, C., Moussa, T., Mruk, V., Murphy, A., Muscal, E., Nadler, R., Nahal, B., Nanda, K., Nasah, N., Nassi, L., Nativ, S., Natter, M., Neely, J., Nelson, B., Newhall, L., Ng, L., Nicholas, J., Nicolai, R., Nigrovic, P., Nocton, J., Nolan, B., Oberle, E., Obispo, B., O'Brien, B., O'Brien, T., Okeke, O., Oliver, M., Olson, J., O'Neil, K., Onel, K., Orandi, A., Orlando, M., Osei‐Onomah, S., Oz, R., Pagano, E., Paller, A., Pan, N., Panupattanapong, S., Pardeo, M., Paredes, J., Parsons, A., Patel, J., Pentakota, K., Pepmueller, P., Pfeiffer, T., Phillippi, K., Phillippi, K., Marafon, D. Pires, Ponder, L., Pooni, R., Prahalad, S., Pratt, S., Protopapas, S., Puplava, B., Quach, J., Quinlan‐Waters, M., Rabinovich, C., Radhakrishna, S., Rafko, J., Raisian, J., Rakestraw, A., Ramirez, C., Ramsay, E., Ramsey, S., Randell, R., Reed, A., Reed, A., Reed, A., Reid, H., Remmel, K., Repp, A., Reyes, A., Richmond, A., Riebschleger, M., Ringold, S., Riordan, M., Riskalla, M., Ritter, M., Rivas‐Chacon, R., Robinson, A., Rodela, E., Rodriquez, M., Rojas, K., Ronis, T., Rosenkranz, M., Rosolowski, B., Rothermel, H., Rothman, D., Roth‐Wojcicki, E., Rouster‐Stevens, K., Rubinstein, T., Ruth, N., Saad, N., Sabbagh, S., Sacco, E., Sadun, R., Sandborg, C., Sanni, A., Santiago, L., Sarkissian, A., Savani, S., Scalzi, L., Schanberg, L., Scharnhorst, S., Schikler, K., Schlefman, A., Schmeling, H., Schmidt, K., Schmitt, E., Schneider, R., Schollaert‐Fitch, K., Schulert, G., Seay, T., Seper, C., Shalen, J., Sheets, R., Shelly, A., Shenoi, S., Shergill, K., Shirley, J., Shishov, M., Shivers, C., Silverman, E., Singer, N., Sivaraman, V., Sletten, J., Smith, A., Smith, C., Smith, J., Smith, J., Smitherman, E., Soep, J., Son, M., Spence, S., Spiegel, L., Spitznagle, J., Sran, R., Srinivasalu, H., Stapp, H., Steigerwald, K., Rakovchik, Y. Sterba, Stern, S., Stevens, A., Stevens, B., Stevenson, R., Stewart, K., Stingl, C., Stokes, J., Stoll, M., Stringer, E., Sule, S., Sumner, J., Sundel, R., Sutter, M., Syed, R., Syverson, G., Szymanski, A., Taber, S., Tal, R., Tambralli, A., Taneja, A., Tanner, T., Tapani, S., Tarshish, G., Tarvin, S., Tate, L., Taxter, A., Taylor, J., Terry, M., Tesher, M., Thatayatikom, A., Thomas, B., Tiffany, K., Ting, T., Tipp, A., Toib, D., Torok, K., Toruner, C., Tory, H., Toth, M., Tse, S., Tubwell, V., Twilt, M., Uriguen, S., Valcarcel, T., Van Mater, H., Vannoy, L., Varghese, C., Vasquez, N., Vazzana, K., Vehe, R., Veiga, K., Velez, J., Verbsky, J., Vilar, G., Volpe, N., Scheven, E., Vora, S., Wagner, J., Wagner‐Weiner, L., Wahezi, D., Waite, H., Walker, J., Walters, H., Muskardin, T. Wampler, Waqar, L., Waterfield, M., Watson, M., Watts, A., Weiser, P., Weiss, J., Weiss, P., Wershba, E., White, A., Williams, C., Wise, A., Woo, J., Woolnough, L., Wright, T., Wu, E., Yalcindag, A., Yee, M., Yen, E., Yeung, R., Yomogida, K., Yu, Q., Zapata, R., Zartoshti, A., Zeft, A., Zeft, R., Zhang, Y., Zhao, Y., Zhu, A., and Zic, C.

Abstract

Health disparities in childhood‐onset systemic lupus erythematosus (SLE) disproportionately impact marginalized populations. Socioeconomically patterned missing data can magnify existing health inequities by supporting inferences that may misrepresent populations of interest. Our objective was to assess missing data and subsequent health equity implications among participants with childhood‐onset SLE enrolled in a large pediatric rheumatology registry. We evaluated co‐missingness of 12 variables representing demographics, socioeconomic position, and clinical factors (e.g., disease‐related indices) using Childhood Arthritis and Rheumatology Research Alliance Registry childhood‐onset SLE enrollment data (2015–2022; n = 766). We performed logistic regression to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs) for missing disease‐related indices at enrollment (Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI‐2K] and/or Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI]) associated with data missingness. We used linear regression to assess the association between socioeconomic factors and SLEDAI‐2K at enrollment using 3 analytic methods for missing data: complete case analysis, multiple imputation, and nonprobabilistic bias analyses, with missing values imputed to represent extreme low or high disadvantage. On average, participants were missing 6.2% of data, with over 50% of participants missing at least 1 variable. Missing data correlated most closely with variables within data categories (i.e., demographic). Government‐assisted health insurance was associated with missing SLEDAI‐2K and/or SDI scores compared to private health insurance (OR 2.04 [95% CI 1.22, 3.41]). The different analytic approaches resulted in varying analytic sample sizes and fundamentally conflicting estimated associations. Our results support intentional evaluation of missing data to inform effect estimate interpretation and critical assessment of causal statements that might otherwise misrepresent health inequities.

Published
2023
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29. Pharmacokinetics and Safety of an Intravitreal Humanized Anti-VEGF-A Monoclonal Antibody (PRO-169), a Biosimilar Candidate to Bevacizumab

Author

Muñoz-Villegas P, Sanchez-Rios A, Quinonez-Alvarado MG, Olvera-Montaño O, Quintana-Hau JD, and Baiza-Duran L

Subjects
safety, vascular endothelial growth factor, Therapeutics. Pharmacology, RM1-950, bevacizumab, ranibizumab, pharmacokinetics
Abstract

Patricia Muñoz-Villegas,1 Alejandra Sanchez-Rios,1 Mayra G Quinonez-Alvarado,2 Oscar Olvera-Montaño,1 Juan D Quintana-Hau,2 Leopoldo Baiza-Duran1 1Medical Affairs Department, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, México; 2Research and Development Department (CIS), Zapopan, Jalisco, MéxicoCorrespondence: Patricia Muñoz-VillegasMedical Affairs Department, Laboratorios Sophia, S.A. de C.V., Paseo del Norte 5255, Guadalajara Technology Park. Zapopan, 45010, Jalisco, MéxicoEmail patricia.munoz@sophia.com.mxBackground: PRO-169 is a biosimilar candidate to bevacizumab (BEV), a monoclonal antibody (mAb) that inhibits vascular endothelial growth factor-A (VEGF-A) developed for intravitreal use. The current study demonstrates the intraocular pharmacokinetics (PK) of PRO-169 and its safety using New Zealand white (NZW) rabbits.Methods: Intraocular concentration was evaluated in thirty-six rabbits at 1h, 1, 2, 5, 14 and 30 days after a single bilateral injection of PRO-169 or BEV (1.25 mg/0.05 mL). In a secondary experiment, safety was evaluated after three consecutive unilateral injections at 30-day intervals in twenty-four rabbits (PRO-169: 1.25 mg/0.05 mL or ranibizumab [RZB]: 0.5 mg/0.05 mL), by liver-associated enzymes (LAE), ophthalmological examination and adverse event (AE) incidence. Primary endpoints were vitreous maximum concentration (Cmax), time to attain maximum concentration (tmax), area under curve (AUC0-t), half-life (t1/2) and LAE. Secondary endpoints included aqueous humor (AH) and plasma pharmacokinetics, clinical examination and AEs.Results: The Cmax in the vitreous was 593.75 ± 45.63 (PRO-169) vs 644.79 ± 62.65 μg/mL (BEV) (p= 0.136). Tmax was 0.53 ± 0.82 vs 0.85 ± 0.73 days (p= 0.330). The AUC0-t was 3837.72 ± 465.91 vs 4247.31 ± 93.99 days*μg/mL (p= 0.052) and the half-life was 4.99 ± 0.89 vs 5.18 ± 0.88 days (p= 0.711). LAEs were normal in 92% of NZW rabbits; no differences between groups were observed (p> 0.05). The AH and plasma PKs were also similar. Finally, clinical examinations found no alterations. AEs were observed in 25% of PRO-169 rabbits, without differences vs RZB (p=0.399).Conclusion: PRO-169 can be efficiently diffused and distributed in ocular compartments, showing vitreous pharmacokinetics analogous to BEV. The safety experiment did not find evidence of clinical alterations from a repeated injection of PRO-169. These results provide scientific justification supporting that PRO-169 should be evaluated in future clinical trials to confirm its safety and efficacy.Keywords: bevacizumab, pharmacokinetics, ranibizumab, safety, vascular endothelial growth factor

Published
2021

31. Childhood‐OnsetLupus Nephritis in the Childhood Arthritis and Rheumatology Research Alliance Registry: Short‐TermKidney Status and Variation in Care

Author

Smitherman, Emily A., Chahine, Rouba A., Beukelman, Timothy, Lewandowski, Laura B., Rahman, A. K. M. Fazlur, Wenderfer, Scott E., Curtis, Jeffrey R., Hersh, Aimee O., Abel, N., Abulaban, K., Adams, A., Adams, M., Agbayani, R., Aiello, J., Akoghlanian, S., Alejandro, C., Allenspach, E., Alperin, R., Alpizar, M., Amarilyo, G., Ambler, W., Anderson, E., Ardoin, S., Armendariz, S., Baker, E., Balboni, I., Balevic, S., Ballenger, L., Ballinger, S., Balmuri, N., Barbar‐Smiley, F., Barillas‐Arias, L., Basiaga, M., Baszis, K., Becker, M., Bell‐Brunson, H., Beltz, E., Benham, H., Benseler, S., Bernal, W., Beukelman, T., Bigley, T., Binstadt, B., Black, C., Blakley, M., Bohnsack, J., Boland, J., Boneparth, A., Bowman, S., Bracaglia, C., Brooks, E., Brothers, M., Brown, A., Brunner, H., Buckley, M., Buckley, M., Bukulmez, H., Bullock, D., Cameron, B., Canna, S., Cannon, L., Carper, P., Cartwright, V., Cassidy, E., Cerracchio, L., Chalom, E., Chang, J., Chang‐Hoftman, A., Chauhan, V., Chira, P., Chinn, T., Chundru, K., Clairman, H., Co, D., Confair, A., Conlon, H., Connor, R., Cooper, A., Cooper, J., Cooper, S., Correll, C., Corvalan, R., Costanzo, D., Cron, R., Curiel‐Duran, L., Curington, T., Curry, M., Dalrymple, A., Davis, A., Davis, C., Davis, C., Davis, T., De Benedetti, F., De Ranieri, D., Dean, J., Dedeoglu, F., DeGuzman, M., Delnay, N., Dempsey, V., DeSantis, E., Dickson, T., Dingle, J., Donaldson, B., Dorsey, E., Dover, S., Dowling, J., Drew, J., Driest, K., Du, Q., Duarte, K., Durkee, D., Duverger, E., Dvergsten, J., Eberhard, A., Eckert, M., Ede, K., Edelheit, B., Edens, C., Edens, C., Edgerly, Y., Elder, M., Ervin, B., Fadrhonc, S., Failing, C., Fair, D., Falcon, M., Favier, L., Federici, S., Feldman, B., Fennell, J., Ferguson, I., Ferguson, P., Ferreira, B., Ferrucho, R., Fields, K., Finkel, T., Fitzgerald, M., Fleming, C., Flynn, O., Fogel, L., Fox, E., Fox, M., Franco, L., Freeman, M., Fritz, K., Froese, S., Fuhlbrigge, R., Fuller, J., George, N., Gerhold, K., Gerstbacher, D., Gilbert, M., Gillispie‐Taylor, M., Giverc, E., Godiwala, C., Goh, I., Goheer, H., Goldsmith, D., Gotschlich, E., Gotte, A., Gottlieb, B., Gracia, C., Graham, T., Grevich, S., Griffin, T., Griswold, J., Grom, A., Guevara, M., Guittar, P., Guzman, M., Hager, M., Hahn, T., Halyabar, O., Hammelev, E., Hance, M., Hanson, A., Harel, L., Haro, S., Harris, J., Harry, O., Hartigan, E., Hausmann, J., Hay, A., Hayward, K., Heiart, J., Hekl, K., Henderson, L., Henrickson, M., Hersh, A., Hickey, K., Hill, P., Hillyer, S., Hiraki, L., Hiskey, M., Hobday, P., Hoffart, C., Holland, M., Hollander, M., Hong, S., Horwitz, M., Hsu, J., Huber, A., Huggins, J., Hui‐Yuen, J., Hung, C., Huntington, J., Huttenlocher, A., Ibarra, M., Imundo, L., Inman, C., Insalaco, A., Jackson, A., Jackson, S., James, K., Janow, G., Jaquith, J., Jared, S., Johnson, N., Jones, J., Jones, J., Jones, J., Jones, K., Jones, S., Joshi, S., Jung, L., Justice, C., Justiniano, A., Karan, N., Kaufman, K., Kemp, A., Kessler, E., Khalsa, U., Kienzle, B., Kim, S., Kimura, Y., Kingsbury, D., Kitcharoensakkul, M., Klausmeier, T., Klein, K., Klein‐Gitelman, M., Kompelien, B., Kosikowski, A., Kovalick, L., Kracker, J., Kramer, S., Kremer, C., Lai, J., Lam, J., Lang, B., Lapidus, S., Lapin, B., Lasky, A., Latham, D., Lawson, E., Laxer, R., Lee, P., Lee, P., Lee, T., Lentini, L., Lerman, M., Levy, D., Li, S., Lieberman, S., Lim, L., Lin, C., Ling, N., Lingis, M., Lo, M., Lovell, D., Lowman, D., Luca, N., Lvovich, S., Madison, C., Madison, J., Manzoni, S. Magni, Malla, B., Maller, J., Malloy, M., Mannion, M., Manos, C., Marques, L., Martyniuk, A., Mason, T., Mathus, S., McAllister, L., McCarthy, K., McConnell, K., McCormick, E., McCurdy, D., Stokes, P. McCurdy, McGuire, S., McHale, I., McMonagle, A., McMullen‐Jackson, C., Meidan, E., Mellins, E., Mendoza, E., Mercado, R., Merritt, A., Michalowski, L., Miettunen, P., Miller, M., Milojevic, D., Mirizio, E., Misajon, E., Mitchell, M., Modica, R., Mohan, S., Moore, K., Moorthy, L., Morgan, S., Dewitt, E. Morgan, Moss, C., Moussa, T., Mruk, V., Murphy, A., Muscal, E., Nadler, R., Nahal, B., Nanda, K., Nasah, N., Nassi, L., Nativ, S., Natter, M., Neely, J., Nelson, B., Newhall, L., Ng, L., Nicholas, J., Nicolai, R., Nigrovic, P., Nocton, J., Nolan, B., Oberle, E., Obispo, B., O'Brien, B., O'Brien, T., Okeke, O., Oliver, M., Olson, J., O'Neil, K., Onel, K., Orandi, A., Orlando, M., Osei‐Onomah, S., Oz, R., Pagano, E., Paller, A., Pan, N., Panupattanapong, S., Pardeo, M., Paredes, J., Parsons, A., Patel, J., Pentakota, K., Pepmueller, P., Pfeiffer, T., Phillippi, K., Marafon, D. Pires, Phillippi, K., Ponder, L., Pooni, R., Prahalad, S., Pratt, S., Protopapas, S., Puplava, B., Quach, J., Quinlan‐Waters, M., Rabinovich, C., Radhakrishna, S., Rafko, J., Raisian, J., Rakestraw, A., Ramirez, C., Ramsay, E., Ramsey, S., Randell, R., Reed, A., Reed, A., Reed, A., Reid, H., Remmel, K., Repp, A., Reyes, A., Richmond, A., Riebschleger, M., Ringold, S., Riordan, M., Riskalla, M., Ritter, M., Rivas‐Chacon, R., Robinson, A., Rodela, E., Rodriquez, M., Rojas, K., Ronis, T., Rosenkranz, M., Rosolowski, B., Rothermel, H., Rothman, D., Roth‐Wojcicki, E., Rouster – Stevens, K., Rubinstein, T., Ruth, N., Saad, N., Sabbagh, S., Sacco, E., Sadun, R., Sandborg, C., Sanni, A., Santiago, L., Sarkissian, A., Savani, S., Scalzi, L., Schanberg, L., Scharnhorst, S., Schikler, K., Schlefman, A., Schmeling, H., Schmidt, K., Schmitt, E., Schneider, R., Schollaert‐Fitch, K., Schulert, G., Seay, T., Seper, C., Shalen, J., Sheets, R., Shelly, A., Shenoi, S., Shergill, K., Shirley, J., Shishov, M., Shivers, C., Silverman, E., Singer, N., Sivaraman, V., Sletten, J., Smith, A., Smith, C., Smith, J., Smith, J., Smitherman, E., Soep, J., Son, M., Spence, S., Spiegel, L., Spitznagle, J., Sran, R., Srinivasalu, H., Stapp, H., Steigerwald, K., Rakovchik, Y. Sterba, Stern, S., Stevens, A., Stevens, B., Stevenson, R., Stewart, K., Stingl, C., Stokes, J., Stoll, M., Stringer, E., Sule, S., Sumner, J., Sundel, R., Sutter, M., Syed, R., Syverson, G., Szymanski, A., Taber, S., Tal, R., Tambralli, A., Taneja, A., Tanner, T., Tapani, S., Tarshish, G., Tarvin, S., Tate, L., Taxter, A., Taylor, J., Terry, M., Tesher, M., Thatayatikom, A., Thomas, B., Tiffany, K., Ting, T., Tipp, A., Toib, D., Torok, K., Toruner, C., Tory, H., Toth, M., Tse, S., Tubwell, V., Twilt, M., Uriguen, S., Valcarcel, T., Van Mater, H., Vannoy, L., Varghese, C., Vasquez, N., Vazzana, K., Vehe, R., Veiga, K., Velez, J., Verbsky, J., Vilar, G., Volpe, N., Scheven, E., Vora, S., Wagner, J., Wagner‐Weiner, L., Wahezi, D., Waite, H., Walker, J., Walters, H., Muskardin, T. Wampler, Waqar, L., Waterfield, M., Watson, M., Watts, A., Weiser, P., Weiss, J., Weiss, P., Wershba, E., White, A., Williams, C., Wise, A., Woo, J., Woolnough, L., Wright, T., Wu, E., Yalcindag, A., Yee, M., Yen, E., Yeung, R., Yomogida, K., Yu, Q., Zapata, R., Zartoshti, A., Zeft, A., Zeft, R., Zhang, Y., Zhao, Y., Zhu, A., and Zic, C.

Abstract

The goal was to characterize short‐term kidney status and describe variation in early care utilization in a multicenter cohort of patients with childhood‐onset systemic lupus erythematosus (cSLE) and nephritis. We analyzed previously collected prospective data from North American patients with cSLE with kidney biopsy‐proven nephritis enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry from March 2017 through December 2019. We determined the proportion of patients with abnormal kidney status at the most recent registry visit and applied generalized linear mixed models to identify associated factors. We also calculated frequency of medication use, both during induction and ever recorded. We identified 222 patients with kidney biopsy–proven nephritis, with 64% class III/IV nephritis on initial biopsy. At the most recent registry visit at median (interquartile range) of 17 (8–29) months from initial kidney biopsy, 58 of 106 patients (55%) with available data had abnormal kidney status. This finding was associated with male sex (odds ratio [OR] 3.88, 95% confidence interval [95% CI] 1.21–12.46) and age at cSLE diagnosis (OR 1.23, 95% CI 1.01–1.49). Patients with class IV nephritis were more likely than class III to receive cyclophosphamide and rituximab during induction. There was substantial variation in mycophenolate, cyclophosphamide, and rituximab ever use patterns across rheumatology centers. In this cohort with predominately class III/IV nephritis, male sex and older age at cSLE diagnosis were associated with abnormal short‐term kidney status. We also observed substantial variation in contemporary medication use for pediatric lupus nephritis between pediatric rheumatology centers. Additional studies are needed to better understand the impact of this variation on long‐term kidney outcomes.

Published
2023
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35. Disease Recapture Rates After Medication Discontinuation and Flare in Juvenile Idiopathic Arthritis: An Observational Study Within the Childhood Arthritis and Rheumatology Research Alliance Registry

Author

Ringold, Sarah, Dennos, Anne C., Kimura, Yukiko, Beukelman, Timothy, Shrader, Peter, Phillips, Thomas A., Kohlheim, Melanie, Schanberg, Laura E., Yeung, Rae S. M., Horton, Daniel B., Abel, N., Abulaban, K., Adams, A., Adams, M., Agbayani, R., Aiello, J., Akoghlanian, S., Alejandro, C., Allenspach, E., Alperin, R., Alpizar, M., Amarilyo, G., Ambler, W., Anderson, E., Ardoin, S., Armendariz, S., Baker, E., Balboni, I., Balevic, S., Ballenger, L., Ballinger, S., Balmuri, N., Barbar‐Smiley, F., Barillas‐Arias, L., Basiaga, M., Baszis, K., Becker, M., Bell‐Brunson, H., Beltz, E., Benham, H., Benseler, S., Bernal, W., Beukelman, T., Bigley, T., Binstadt, B., Black, C., Blakley, M., Bohnsack, J., Boland, J., Boneparth, A., Bowman, S., Bracaglia, C., Brooks, E., Brothers, M., Brown, A., Brunner, H., Buckley, M., Buckley, M., Bukulmez, H., Bullock, D., Cameron, B., Canna, S., Cannon, L., Carper, P., Cartwright, V., Cassidy, E., Cerracchio, L., Chalom, E., Chang, J., Chang‐Hoftman, A., Chauhan, V., Chira, P., Chinn, T., Chundru, K., Clairman, H., Co, D., Confair, A., Conlon, H., Connor, R., Cooper, A., Cooper, J., Cooper, S., Correll, C., Corvalan, R., Costanzo, D., Cron, R., Curiel‐Duran, L., Curington, T., Curry, M., Dalrymple, A., Davis, A., Davis, C., Davis, C., Davis, T., De Benedetti, F., De Ranieri, D., Dean, J., Dedeoglu, F., DeGuzman, M., Delnay, N., Dempsey, V., DeSantis, E., Dickson, T., Dingle, J., Donaldson, B., Dorsey, E., Dover, S., Dowling, J., Drew, J., Driest, K., Du, Q., Duarte, K., Durkee, D., Duverger, E., Dvergsten, J., Eberhard, A., Eckert, M., Ede, K., Edelheit, B., Edens, C., Edens, C., Edgerly, Y., Elder, M., Ervin, B., Fadrhonc, S., Failing, C., Fair, D., Falcon, M., Favier, L., Federici, S., Feldman, B., Fennell, J., Ferguson, I., Ferguson, P., Ferreira, B., Ferrucho, R., Fields, K., Finkel, T., Fitzgerald, M., Fleming, C., Flynn, O., Fogel, L., Fox, E., Fox, M., Franco, L., Freeman, M., Fritz, K., Froese, S., Fuhlbrigge, R., Fuller, J., George, N., Gerhold, K., Gerstbacher, D., Gilbert, M., Gillispie‐Taylor, M., Giverc, E., Godiwala, C., Goh, I., Goheer, H., Goldsmith, D., Gotschlich, E., Gotte, A., Gottlieb, B., Gracia, C., Graham, T., Grevich, S., Griffin, T., Griswold, J., Grom, A., Guevara, M., Guittar, P., Guzman, M., Hager, M., Hahn, T., Halyabar, O., Hammelev, E., Hance, M., Hanson, A., Harel, L., Haro, S., Harris, J., Harry, O., Hartigan, E., Hausmann, J., Hay, A., Hayward, K., Heiart, J., Hekl, K., Henderson, L., Henrickson, M., Hersh, A., Hickey, K., Hill, P., Hillyer, S., Hiraki, L., Hiskey, M., Hobday, P., Hoffart, C., Holland, M., Hollander, M., Hong, S., Horwitz, M., Hsu, J., Huber, A., Huggins, J., Hui‐Yuen, J., Hung, C., Huntington, J., Huttenlocher, A., Ibarra, M., Imundo, L., Inman, C., Insalaco, A., Jackson, A., Jackson, S., James, K., Janow, G., Jaquith, J., Jared, S., Johnson, N., Jones, J., Jones, J., Jones, J., Jones, K., Jones, S., Joshi, S., Jung, L., Justice, C., Justiniano, A., Karan, N., Kaufman, K., Kemp, A., Kessler, E., Khalsa, U., Kienzle, B., Kim, S., Kimura, Y., Kingsbury, D., Kitcharoensakkul, M., Klausmeier, T., Klein, K., Klein‐Gitelman, M., Kompelien, B., Kosikowski, A., Kovalick, L., Kracker, J., Kramer, S., Kremer, C., Lai, J., Lam, J., Lang, B., Lapidus, S., Lapin, B., Lasky, A., Latham, D., Lawson, E., Laxer, R., Lee, P., Lee, P., Lee, T., Lentini, L., Lerman, M., Levy, D., Li, S., Lieberman, S., Lim, L., Lin, C., Ling, N., Lingis, M., Lo, M., Lovell, D., Lowman, D., Luca, N., Lvovich, S., Madison, C., Madison, J., Magni Manzoni, S., Malla, B., Maller, J., Malloy, M., Mannion, M., Manos, C., Marques, L., Martyniuk, A., Mason, T., Mathus, S., McAllister, L., McCarthy, K., McConnell, K., McCormick, E., McCurdy, D., Stokes, P. McCurdy, McGuire, S., McHale, I., McMonagle, A., McMullen‐Jackson, C., Meidan, E., Mellins, E., Mendoza, E., Mercado, R., Merritt, A., Michalowski, L., Miettunen, P., Miller, M., Milojevic, D., Mirizio, E., Misajon, E., Mitchell, M., Modica, R., Mohan, S., Moore, K., Moorthy, L., Morgan, S., Dewitt, E. Morgan, Moss, C., Moussa, T., Mruk, V., Murphy, A., Muscal, E., Nadler, R., Nahal, B., Nanda, K., Nasah, N., Nassi, L., Nativ, S., Natter, M., Neely, J., Nelson, B., Newhall, L., Ng, L., Nicholas, J., Nicolai, R., Nigrovic, P., Nocton, J., Nolan, B., Oberle, E., Obispo, B., O'Brien, B., O'Brien, T., Okeke, O., Oliver, M., Olson, J., O'Neil, K., Onel, K., Orandi, A., Orlando, M., Osei‐Onomah, S., Oz, R., Pagano, E., Paller, A., Pan, N., Panupattanapong, S., Pardeo, M., Paredes, J., Parsons, A., Patel, J., Pentakota, K., Pepmueller, P., Pfeiffer, T., Phillippi, K., Marafon, D. Pires, Phillippi, K., Ponder, L., Pooni, R., Prahalad, S., Pratt, S., Protopapas, S., Puplava, B., Quach, J., Quinlan‐Waters, M., Rabinovich, C., Radhakrishna, S., Rafko, J., Raisian, J., Rakestraw, A., Ramirez, C., Ramsay, E., Ramsey, S., Randell, R., Reed, A., Reed, A., Reed, A., Reid, H., Remmel, K., Repp, A., Reyes, A., Richmond, A., Riebschleger, M., Ringold, S., Riordan, M., Riskalla, M., Ritter, M., Rivas‐Chacon, R., Robinson, A., Rodela, E., Rodriquez, M., Rojas, K., Ronis, T., Rosenkranz, M., Rosolowski, B., Rothermel, H., Rothman, D., Roth‐Wojcicki, E., Rouster – Stevens, K., Rubinstein, T., Ruth, N., Saad, N., Sabbagh, S., Sacco, E., Sadun, R., Sandborg, C., Sanni, A., Santiago, L., Sarkissian, A., Savani, S., Scalzi, L., Schanberg, L., Scharnhorst, S., Schikler, K., Schlefman, A., Schmeling, H., Schmidt, K., Schmitt, E., Schneider, R., Schollaert‐Fitch, K., Schulert, G., Seay, T., Seper, C., Shalen, J., Sheets, R., Shelly, A., Shenoi, S., Shergill, K., Shirley, J., Shishov, M., Shivers, C., Silverman, E., Singer, N., Sivaraman, V., Sletten, J., Smith, A., Smith, C., Smith, J., Smith, J., Smitherman, E., Soep, J., Son, M., Spence, S., Spiegel, L., Spitznagle, J., Sran, R., Srinivasalu, H., Stapp, H., Steigerwald, K., Rakovchik, Y. Sterba, Stern, S., Stevens, A., Stevens, B., Stevenson, R., Stewart, K., Stingl, C., Stokes, J., Stoll, M., Stringer, E., Sule, S., Sumner, J., Sundel, R., Sutter, M., Syed, R., Syverson, G., Szymanski, A., Taber, S., Tal, R., Tambralli, A., Taneja, A., Tanner, T., Tapani, S., Tarshish, G., Tarvin, S., Tate, L., Taxter, A., Taylor, J., Terry, M., Tesher, M., Thatayatikom, A., Thomas, B., Tiffany, K., Ting, T., Tipp, A., Toib, D., Torok, K., Toruner, C., Tory, H., Toth, M., Tse, S., Tubwell, V., Twilt, M., Uriguen, S., Valcarcel, T., Van Mater, H., Vannoy, L., Varghese, C., Vasquez, N., Vazzana, K., Vehe, R., Veiga, K., Velez, J., Verbsky, J., Vilar, G., Volpe, N., Scheven, E., Vora, S., Wagner, J., Wagner‐Weiner, L., Wahezi, D., Waite, H., Walker, J., Walters, H., Muskardin, T. Wampler, Waqar, L., Waterfield, M., Watson, M., Watts, A., Weiser, P., Weiss, J., Weiss, P., Wershba, E., White, A., Williams, C., Wise, A., Woo, J., Woolnough, L., Wright, T., Wu, E., Yalcindag, A., Yee, M., Yen, E., Yeung, R., Yomogida, K., Yu, Q., Zapata, R., Zartoshti, A., Zeft, A., Zeft, R., Zhang, Y., Zhao, Y., Zhu, A., and Zic, C.

Abstract

Children with well‐controlled juvenile idiopathic arthritis (JIA) frequently experience flares after medication discontinuation, but the outcomes of these flares have not been well described. The objective of this study was to characterize the rates and predictors of disease recapture among children with JIA who restarted medication to treat disease flare. Children with JIA who discontinued conventional synthetic or biologic disease‐modifying antirheumatic drugs for well‐controlled disease but subsequently experienced a flare and restarted medication were identified from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry. The primary outcome was inactive disease (ID) (physician global assessment <1 and active joint count = 0) 6 months after flare. A total of 333 patients had complete data for ID at 6 months after flare. The recapture rate for the cohort was 55%, ranging from 47% (persistent oligoarthritis) to 69% (systemic arthritis) (P= 0.4). Approximately 67% of children achieved ID by 12 months. In the multivariable model, history and reinitiation of biologic drugs were associated with increased odds of successful recapture (odds ratio [OR] 4.79 [95% confidence interval (95% CI) 1.22–18.78] and OR 2.74 [95% CI 1.62–4.63], respectively). Number of joints with limited range of motion was associated with decreased odds (OR 0.83 per 1 joint increase [95% CI 0.72–0.95]). Approximately half of JIA flares post‐discontinuation were recaptured within 6 months, but rates of recapture varied across JIA categories. These findings inform shared decision‐making for patients, families, and clinicians regarding the risks and benefits of medication discontinuation. Better understanding of biologic predictors of successful recapture in JIA are needed.

Published
2023
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36. Efficacy and safety of bromfenac 0.09% and sodium hyaluronate 0.4% combination therapy, versus placebo in patients with pterygium I–III for clinical signs on ocular inflammation

Author

Chávez-Mondragón E, Palacio C, Soto-Gómez A, Villanueva-Nájera M, De Wit-Carter G, Suárez-Velasco R, Baiza-Duran L, Olvera-Montaño O, and Muñoz-Villegas P

Subjects
conjunctival hyperemia, Ophthalmology, Nonsteroidal anti-inflammatory drug, RE1-994, ocular lubricant, Ocular Surface Disease Index
Abstract

Eduardo Chávez-Mondragón,1 Claudia Palacio,2 Abraham Soto-Gómez,3 Miguel Villanueva-Nájera,4 Guillermo De Wit-Carter,5 Ruben Suárez-Velasco,6 Leopoldo Baiza-Duran,7 Oscar Olvera-Montaño,7 Patricia Muñoz-Villegas71Fundación de Asistencia Privada Conde de Valenciana, IAP, CDMX, Mexico; 2Fundación Hospital Nuestra Señora de la Luz, IAP, CDMX, Mexico; 3Catarata y Glaucoma de Occidente, SA de CV, Guadalajara, Jalisco, Mexico; 4Private Office, CDMX, Mexico; 5Asociación para Evitar la Ceguera en Mexico IAP, CDMX, Mexico; 6Novam y Vita, Guadalajara, Jalisco, Mexico; 7Clinical Research Department, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, MexicoPurpose: This study evaluated the clinical efficacy and safety of bromfenac 0.09%, sodium hyaluronate 0.4% (SH) combination therapy, versus placebo and SH in a clinical model of pterygium I–III.Methods: A total of 166 eyes (99 patients) with pterygium grade I–III were randomized to bromfenac 0.09% ophthalmic solution+SH 0.4% or placebo+SH 0.4%. This was a Phase IV, prospective, parallel, double-masked, multicenter clinical trial. One drop of bromfenac or placebo was instilled two times a day (BID) for 20 days, both groups accompanied treatments with one drop of SH three times a day (TID). The primary efficacy endpoints were the conjunctival hyperemia and the Ocular Surface Disease Index (OSDI) score. Other results measured included burning, foreign body sensation, and photophobia. The safety was assessed by the tear break-up time (TBUT), visual acuity (VA), IOP, lissamine green, fluorescein stains, and the incidence of adverse events (AEs).Results: Compared with baseline, there was a significant reduction in the conjunctival hyperemia (p=0.0001) and OSDI score in both groups (p=0.0001). There was a significant improvement in ocular symptomatology for both, placebo/SH and bromfenac/SH groups (p=0.0001), the decrement in the ocular burning was 41.1% vs 24.6%, the foreign body sensation was 31.5% vs 36.2% and, for photophobia was 23.3% vs 30.5%, respectively. A statistically significant difference was observed in TBUT for bromfenac/SH (p=0.045), at day 20. There were no significant alterations in IOP (p=0.068) or VA (p=0.632). Similar improvements were observed in the fluorescein and green lissamine staining. Finally, the incidence of AE was similar between groups.Conclusion: The treatment with bromfenac 0.09% ophthalmic solution and SH 0.4% combination therapy for 3 weeks reduced clinical signs, in patients with pterygium I–III. The results suggest that bromfenac 0.09% can improve the symptomatology, reduce the presentation of clinical signs associated with superficial ocular inflammation.Keywords: nonsteroidal anti-inflammatory drug, Ocular Surface Disease Index, conjunctival hyperemia, ocular lubricant

Published
2019

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