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1. A Novel Approach to Integrate Human Biomonitoring Data with Model Predicted Dietary Exposures: A Crop Protection Chemical Case Study Using Lambda-Cyhalothrin.

Author

Cuvelier, Nicholas, Avanasi, Raga, Grunenwald, Mark, Ramanarayanan, Tharacad, Wolf, Douglas, and Bartell, Scott

Subjects
National Health and Nutrition Examination Survey, agricultural chemicals, exposure modeling, human health risk assessment, pyrethroids, urinary biomarkers, Humans, Pyrethrins, Nitriles, Dietary Exposure, Biological Monitoring, Adult, Bayes Theorem, Male, Female, Middle Aged, Insecticides, Young Adult, Adolescent, Nutrition Surveys, Benzoates
Abstract

The appropriate use of human biomonitoring data to model population chemical exposures is challenging, especially for rapidly metabolized chemicals, such as agricultural chemicals. The objective of this study is to demonstrate a novel approach integrating model predicted dietary exposures and biomonitoring data to potentially inform regulatory risk assessments. We use lambda-cyhalothrin as a case study, and for the same representative U.S. population in the National Health and Nutrition Examination Survey (NHANES), an integrated exposure and pharmacokinetic model predicted exposures are calibrated to measurements of the urinary metabolite 3-phenoxybenzoic acid (3PBA), using an approximate Bayesian computing (ABC) methodology. We demonstrate that the correlation between modeled urinary 3PBA and the NHANES 3PBA measurements more than doubled as ABC thresholding narrowed the acceptable tolerance range for predicted versus observed urinary measurements. The median predicted urinary concentrations were closer to the median measured value using ABC than using current regulatory Monte Carlo methods.

Published
2024

8. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial

Author

Oliinyk, Oleksandr, Bilianskyi, Leonid, Gniady-Jastrzebska, Jadwiga, Petryka, Robert, Arlukowicz, Tomasz, Gietka, Piotr, Zmudzinski, Marcin, Mumtaz, Syed, Wolf, Douglas, Wojcik, Katarzyna, Duvall, George, Augustyn, Monika, Filip, Rafal, Tarabar, Dino, Tkachev, Alexander, Seidler, Ursula, Zittan, Eran, Pokrotnieks, Juris, Shchukina, Oksana, Machavariani, Andro, Loy, Laura, Abu-farsakh, Niazy, Marina, Pesegova, Sreckovic, Slobodan, Laclav, Martin, Wei, Shu-Chen, Suiter, Daniel, Borsuk, Aleksey, Hebuterne, Xavier, Buning, Carsten, Lahat-Zok, Adi, Danilkiewicz, Wit, Frysna, Bernadetta, Jovicic, Ivana, Datsenko, Olena, Guram, Maninder, Jain, Animesh, Rashid, Zahid, Heeren, Sonja, Shulga, Natallia, Timkin, Ivan, Gornjakovic, Srdjan, Lukas, Milan, Altwegg, Romain, Desjeux, Ariadne, Reimund, Jean-Marie, Giorgadze, Manana, Jochum, Christoph, Ito, Hiroaki, Nakai, Katsuhiko, Takagi, Tomohisa, Zaha, Osamu, Choi, Changhwan, Kim, Taeoh, Lee, Jonghun, Stundiene, Ieva, Hilmi, Ida Normiha, Hj Md Said, Rosaida, Leszczyszyn, Jaroslaw, Abdulganieva, Diana, Fominykh, Yulia, Maksyashina, Svetlana, Balaz, Jozef, Van Domselaar, Manuel, Kav, Taylan, Dennis, Patrick, Henry, Patricia, Holmes, Robert, Johnson, Christopher, McBride, Matthew, Sarles, Harry, Moore, Gregory, Yakubtsevich, Ruslan, Muls, Vinciane, Trbojevic, Stevan, Afif, Waqqas, Bernstein, Charles, Klarin, Ivo, Serclova, Zuzana, Volfova, Miroslava, Desreumaux, Pierre, Gilletta de Saint Joseph, Cyrielle, Roblin, Xavier, Vuitton, Lucine, Chelidze, Kakhaber, Kuehbacher, Tanja, Koutroubakis, Ioannis, Cicala, Michele, Fries, Walter, Gasbarrini, Antonio, Aoyama, Nobuo, Hayashi, Yoshito, Hirai, Fumihito, Horiki, Norkiyuki, Hoshi, Namiko, Inaba, Tomoki, Hiroyasu, Ishida, Maemoto, Atsuo, Matsumoto, Takayuki, Matsushima, Kayoko, Motoya, Satoshi, Taruishi, Masaki, Rashid, Mohammed, Chun, Jaeyoung, Kim, Young-Ho, Park, Dong Il, Sharara, Ala, Jonaitis, Laimas, Deriban, Gjorgi, Brooker, James, Gawdis-Wojnarska, Beata, Wozniak-Stolarska, Barbara, Andreev, Pavel, Simanenkov, Vladimir, Trofimov, Vasiliy, Jovanovic, Igor, Zdravkovic, Natasa, Aldeguer i Mante, Xavier, Hernandez Ramirez, Vicent, Akpinar, Hale, Celebi, Gurkan, Hamzaoglu, Hulya, Fernandez, Juan, Kamath, Jayaprakash, Palekar, Nicole, Pruthi, Jatinder S., Rausher, David, Ritter, Timothy, Danese, Silvio, Panaccione, Remo, Feagan, Brian G, Afzali, Anita, Rubin, David T, Sands, Bruce E, Reinisch, Walter, Panés, Julián, Sahoo, Aparna, Terry, Natalie A, Chan, Daphne, Han, Chenglong, Frustaci, Mary Ellen, Yang, Zijiang, Sandborn, William J, Hisamatsu, Tadakazu, Andrews, Jane M, and D'Haens, Geert R

Published
2024
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9. Surgery for Crohn’s Disease Is Associated With a Dysbiotic Microbiome and Metabolome: Results From Two Prospective Cohorts

Author

Wolf, Douglas C., Hron, Bridget, Hanson, John S., Mohanty, Sanjib P., Fogel, Ronald P., Levy, L. Campbell, Iskandar, Heba N., Fischer, Monika, Cohen, Benjamin, Swaminath, Arun, Kane, Sunanda, McCabe, Robert P., Jr., Yen, Eugene F., Hanauer, Stephen B., Hudesman, David P., Afzali, Anita, Kelly, Colleen, Weber, John R., Mahadevan, Uma, Herfarth, Hans, Katz, Jeffery, Taleban, Sasha, Rubin, David T., Yachyshyn, Bruce, Reynolds, Gorman J., Gerich, Mark, Dryden, Gerald W., Quezada, Sandra, Higgins, Peter D.R., Shmidt, Eugenia, Lewis, James D., Schwartz, Marc B., Flynn, Ann D., Saha, Sumona, Horst, Sara N., Chiorean, Michael, Green, Patrick D., Scherl, Ellen J., Sandler, Robert, Brotherton, Carol, Albenberg, Lindsey, Valentine, John F., Suskind, David, Meyer, Andrea, Compher, Charlene W., Bewtra, Meenakshi, Kaur, Manreet, Dassopoulos, Themistocles, Snapper, Scott B., Korzenik, Joshua R., Bohm, Matthew, Raffals, Laura, Beniwal-Patel, Poonam, Hudesman, David, Russ, Kirk, Brook, Loren, Pekow, Joel, Cross, Raymond, Wong, Uni, Bishu, Shrinivas, Duerr, Richard, Caldera, Freddy, Scoville, Elizabeth, Deepak, Parakkal, Ciorba, Matthew, Daniel, Scott G., Li, Hongzhe, Hao, Fuhua, Patterson, Andrew D., Hecht, Aaron L., Brensinger, Colleen M., Wu, Gary D., and Bittinger, Kyle

Published
2024
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13. Surgery for Crohn’s Disease Is Associated with a Dysbiotic Microbiome and Metabolome: Results from Two Prospective Cohorts

Author

Lewis, James D., primary, Daniel, Scott G., additional, Li, Hongzhe, additional, Hao, Fuhua, additional, Patterson, Andrew D., additional, Hecht, Aaron, additional, Brensinger, Colleen M., additional, Wu, Gary D., additional, Bittinger, Kyle, additional, Wolf, Douglas C., additional, Hron, Bridget, additional, Hanson, John S., additional, Mohanty, Sanjib P., additional, Fogel, Ronald P., additional, Levy, L. Campbell, additional, Iskandar, Heba N., additional, Fischer, Monika, additional, Cohen, Benjamin, additional, Swaminath, Arun, additional, Kane, Sunanda, additional, McCabe, Robert P., additional, Yen, Eugene F., additional, Hanauer, Stephen B., additional, Hudesman, David P., additional, Afzali, Anita, additional, Kelly, Colleen, additional, Weber, John R., additional, Mahadevan, Uma, additional, Herfarth, Hans, additional, Katz, Jeffery, additional, Taleban, Sasha, additional, Rubin, David T., additional, Yachyshyn, Bruce, additional, Reynolds, Gorman J., additional, Gerich, Mark, additional, Dryden, Gerald W., additional, Quezada, Sandra, additional, Higgins, Peter D.R., additional, Shmidt, Eugenia, additional, Lewis, James D., additional, Schwartz, Marc B., additional, Flynn, Ann D., additional, Saha, Sumona, additional, Horst, Sara N., additional, Chiorean, Michael, additional, Green, Patrick D., additional, Scherl, Ellen J., additional, Sandler, Robert, additional, Brotherton, Carol, additional, Albenberg, Lindsey, additional, Valentine, John F., additional, Suskind, David, additional, Meyer, Andrea, additional, Compher, Charlene W., additional, Bewtra, Meenakshi, additional, Kaur, Manreet, additional, Dassopoulos, Themistocles, additional, Snapper, Scott B., additional, Korzenik, Joshua R., additional, Bohm, Matthew, additional, Raffals, Laura, additional, Beniwal-Patel, Poonam, additional, Hudesman, David, additional, Russ, Kirk, additional, Brook, Loren, additional, Pekow, Joel, additional, Cross, Raymond, additional, Wong, Uni, additional, Bishu, Shrinivas, additional, Duerr, Richard, additional, Caldera, Freddy, additional, Scoville, Elizabeth, additional, Deepak, Parakkal, additional, and Ciorba, Matthew, additional

Published
2024
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14. Removal of urban-use insecticides in a large-scale constructed wetland

Author

Cryder, Zachary, Wolf, Douglas, Carlan, Craig, and Gan, Jay

Subjects
Environmental Sciences, Pollution and Contamination, Clean Water and Sanitation, Amphipoda, Animals, Geologic Sediments, Humans, Insecticides, Pyrethrins, Water Pollutants, Chemical, Wetlands, Fipronil, Pyrethroids, Constructed wetland, Water treatment, Invertebrate toxicity
Abstract

Water treatment and reuse initiatives are essential to combat declining water supplies in a changing climate, especially in arid and semi-arid regions. Pollution of water resources intensifies the search for strategies to provide water for potable and non-potable reuse that mitigates detrimental ecological and human health effects. Fipronil and synthetic pyrethroids are common urban-use insecticides that exert aquatic toxicity at trace levels and have been often found in urban surface streams. In this study, samples were collected from the 182 ha Prado Wetlands in Southern California for seven months to assess the occurrence of fipronil and its degradation products as well as pyrethroids (bifenthrin and cyfluthrin) in water, sediment, and plants in a 4.45 ha vegetated surface flow constructed wetland (CW). Concentration-based removal values and changes in mass flux were calculated to determine the efficacy of CW treatment. Observed water concentrations were further used to calculate toxic units for the invertebrates Hyalella azteca and Chironomus dilutus. Pesticide concentrations in water, sediment, and plant samples consistently decreased during passage through the CW at all time points. Removal values for fipronil desulfinyl, fipronil sulfide, fipronil, fipronil sulfone, bifenthrin, and cyfluthrin were 100%, 99.7-100%, 57.8-88.1%, 75.6-100%, 74.7-100%, and 36.6-82.2%, respectively, and there was a general net deposition of pesticides into CW compartments. Toxic unit values decreased in every instance for both aquatic invertebrates. Settling of contaminated particles, adsorption to sediment, plant uptake or adsorption, and subsequent degradation contributed to the effective removal of these urban-use insecticides, which highlights the potential of CWs for protecting urban water quality.

Published
2021

16. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies

Author

Sandborn, William J, Vermeire, Séverine, Peyrin-Biroulet, Laurent, Dubinsky, Marla C, Panes, Julian, Yarur, Andres, Ritter, Timothy, Baert, Filip, Schreiber, Stefan, Sloan, Sheldon, Cataldi, Fabio, Shan, Kevin, Rabbat, Christopher J, Chiorean, Michael, Wolf, Douglas C, Sands, Bruce E, D'Haens, Geert, Danese, Silvio, Goetsch, Martina, and Feagan, Brian G

Published
2023
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20. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial

Author

Danese, Silvio, primary, Panaccione, Remo, additional, Feagan, Brian G, additional, Afzali, Anita, additional, Rubin, David T, additional, Sands, Bruce E, additional, Reinisch, Walter, additional, Panés, Julián, additional, Sahoo, Aparna, additional, Terry, Natalie A, additional, Chan, Daphne, additional, Han, Chenglong, additional, Frustaci, Mary Ellen, additional, Yang, Zijiang, additional, Sandborn, William J, additional, Hisamatsu, Tadakazu, additional, Andrews, Jane M, additional, D'Haens, Geert R, additional, Oliinyk, Oleksandr, additional, Bilianskyi, Leonid, additional, Gniady-Jastrzebska, Jadwiga, additional, Petryka, Robert, additional, Arlukowicz, Tomasz, additional, Gietka, Piotr, additional, Zmudzinski, Marcin, additional, Mumtaz, Syed, additional, Wolf, Douglas, additional, Wojcik, Katarzyna, additional, Duvall, George, additional, Augustyn, Monika, additional, Filip, Rafal, additional, Tarabar, Dino, additional, Tkachev, Alexander, additional, Seidler, Ursula, additional, Zittan, Eran, additional, Pokrotnieks, Juris, additional, Shchukina, Oksana, additional, Machavariani, Andro, additional, Loy, Laura, additional, Abu-farsakh, Niazy, additional, Marina, Pesegova, additional, Sreckovic, Slobodan, additional, Laclav, Martin, additional, Wei, Shu-Chen, additional, Suiter, Daniel, additional, Borsuk, Aleksey, additional, Hebuterne, Xavier, additional, Buning, Carsten, additional, Lahat-Zok, Adi, additional, Danilkiewicz, Wit, additional, Frysna, Bernadetta, additional, Jovicic, Ivana, additional, Datsenko, Olena, additional, Guram, Maninder, additional, Jain, Animesh, additional, Rashid, Zahid, additional, Heeren, Sonja, additional, Shulga, Natallia, additional, Timkin, Ivan, additional, Gornjakovic, Srdjan, additional, Lukas, Milan, additional, Altwegg, Romain, additional, Desjeux, Ariadne, additional, Reimund, Jean-Marie, additional, Giorgadze, Manana, additional, Jochum, Christoph, additional, Ito, Hiroaki, additional, Nakai, Katsuhiko, additional, Takagi, Tomohisa, additional, Zaha, Osamu, additional, Choi, Changhwan, additional, Kim, Taeoh, additional, Lee, Jonghun, additional, Stundiene, Ieva, additional, Hilmi, Ida Normiha, additional, Hj Md Said, Rosaida, additional, Leszczyszyn, Jaroslaw, additional, Abdulganieva, Diana, additional, Fominykh, Yulia, additional, Maksyashina, Svetlana, additional, Balaz, Jozef, additional, Van Domselaar, Manuel, additional, Kav, Taylan, additional, Dennis, Patrick, additional, Henry, Patricia, additional, Holmes, Robert, additional, Johnson, Christopher, additional, McBride, Matthew, additional, Sarles, Harry, additional, Moore, Gregory, additional, Yakubtsevich, Ruslan, additional, Muls, Vinciane, additional, Trbojevic, Stevan, additional, Afif, Waqqas, additional, Bernstein, Charles, additional, Klarin, Ivo, additional, Serclova, Zuzana, additional, Volfova, Miroslava, additional, Desreumaux, Pierre, additional, Gilletta de Saint Joseph, Cyrielle, additional, Roblin, Xavier, additional, Vuitton, Lucine, additional, Chelidze, Kakhaber, additional, Kuehbacher, Tanja, additional, Koutroubakis, Ioannis, additional, Cicala, Michele, additional, Fries, Walter, additional, Gasbarrini, Antonio, additional, Aoyama, Nobuo, additional, Hayashi, Yoshito, additional, Hirai, Fumihito, additional, Horiki, Norkiyuki, additional, Hoshi, Namiko, additional, Inaba, Tomoki, additional, Hiroyasu, Ishida, additional, Maemoto, Atsuo, additional, Matsumoto, Takayuki, additional, Matsushima, Kayoko, additional, Motoya, Satoshi, additional, Taruishi, Masaki, additional, Rashid, Mohammed, additional, Chun, Jaeyoung, additional, Kim, Young-Ho, additional, Park, Dong Il, additional, Sharara, Ala, additional, Jonaitis, Laimas, additional, Deriban, Gjorgi, additional, Brooker, James, additional, Gawdis-Wojnarska, Beata, additional, Wozniak-Stolarska, Barbara, additional, Andreev, Pavel, additional, Simanenkov, Vladimir, additional, Trofimov, Vasiliy, additional, Jovanovic, Igor, additional, Zdravkovic, Natasa, additional, Aldeguer i Mante, Xavier, additional, Hernandez Ramirez, Vicent, additional, Akpinar, Hale, additional, Celebi, Gurkan, additional, Hamzaoglu, Hulya, additional, Fernandez, Juan, additional, Kamath, Jayaprakash, additional, Palekar, Nicole, additional, Pruthi, Jatinder S., additional, Rausher, David, additional, and Ritter, Timothy, additional

Published
2024
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22. Fiproles in urban surface runoff: Understanding sources and causes of contamination

Author

Cryder, Zachary, Greenberg, Les, Richards, Jaben, Wolf, Douglas, Luo, Yuzhou, and Gan, Jay

Subjects
Environmental Sciences, Pollution and Contamination, Animals, California, Cities, Dust, Environmental Monitoring, Insecticides, Invertebrates, Pyrazoles, Soil, Water Pollutants, Chemical, Fipronil, Urban use pesticides, Runoff, Risk mitigation, Water quality
Abstract

Urban-use pesticides present a unique risk to non-target organisms in surface aquatic systems because impervious pavement facilitates runoff that may lead to serious contamination and ensuing aquatic toxicity. Fipronil is an insecticide used at high rates in urban environments, especially in regions such as California. This compound and its biologically active degradation products have been detected in urban runoff drainage and downstream surface water bodies at concentrations exceeding toxicity thresholds for sensitive aquatic invertebrates, necessitating a better understanding of the runoff sources and causes of this contamination at sites of application. In this study, we evaluated sorption of fipronil, fipronil desulfinyl, fipronil sulfide, and fipronil sulfone in urban dust, soil, and concrete, matrices commonly associated with the perimeter of a residential home. Samples were also collected from five single family homes treated with fipronil in Riverside, California, for five months to determine the occurrence of fipronil and its degradates in runoff water, urban dust, soil, and on concrete surfaces. Statistical analysis was performed to determine which urban matrices contributed more significantly to the contaminant levels in runoff water. Freundlich sorption coefficients for fipronil and its degradation products in dust were 3- to 9-fold greater than their values in soil. Fipronil and its degradates were detected in 100% of runoff samples and their presence was observed in dust, soil, and concrete wipe samples for 153 d after the treatment. Linear regression analysis showed that concrete surfaces were a primary source of all four compounds to runoff, and loose dust on concrete pavement also served as an important contributor. This study represents the first comprehensive investigation of the sources and causes for surface runoff contamination by fipronil and its degradation products. Findings highlight the importance to reduce fipronil residues on concrete surfaces through improved application methods and other mitigation practices.

Published
2019

23. Rethinking chronic toxicity and carcinogenicity assessment for agrochemicals project (ReCAAP): A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays

Author

Hilton, Gina M., Adcock, Catherine, Akerman, Gregory, Baldassari, James, Battalora, Michael, Casey, Warren, Clippinger, Amy J., Cope, Rhian, Goetz, Amber, Hayes, A. Wallace, Papineni, Sabitha, Peffer, Richard C., Ramsingh, Deborah, Williamson Riffle, Brandy, Sanches da Rocha, Mitscheli, Ryan, Natalia, Scollon, Edward, Visconti, Nicolo, Wolf, Douglas C., Yan, Zhongyu, and Lowit, Anna

Published
2022
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25. State COVID-19 Policies and Drug Overdose Mortality Among Working-Age Adults in the United States, 2020.

Author

Wolf, Douglas A., Monnat, Shannon M., Wiemers, Emily E., Sun, Yue, Zhang, Xue, Grossman, Elyse R., and Montez, Jennifer Karas

Subjects
*DRUG overdose, *DEATH, *GOVERNMENT policy, *RESEARCH funding, *STATE governments, *DESCRIPTIVE statistics, *MULTIVARIATE analysis, *DATA analysis software, *CONFIDENCE intervals, *POISONING, *COVID-19 pandemic, *EMPLOYMENT
Abstract

Objectives. To identify relationships between US states' COVID-19 in-person activity limitation and economic support policies and drug overdose deaths among working-age adults in 2020. Methods. We used county-level data on 140 435 drug overdoses among adults aged 25 to 64 years during January 2019 to December 2020 from the National Vital Statistics System and data on states' COVID-19 policies from the Oxford COVID-19 Government Response Tracker to assess US trends in overdose deaths by sex in 3138 counties. Results. Policies limiting in-person activities significantly increased, whereas economic support policies significantly decreased, overdose rates. A 1-unit increase in policies restricting activities predicted a 15% average monthly increase in overdose rates for men (incident rate ratio [IRR] = 1.15; 95% confidence interval [CI] = 1.09, 1.20) and a 14% increase for women (IRR = 1.14; 95% CI = 1.09, 1.20). A 1-unit increase in economic support policies predicted a 3% average monthly decrease for men (IRR = 0.97; 95% CI = 0.95, 1.00) and a 4% decrease for women (IRR = 0.96; 95% CI = 0.93, 0.99). All states' policy combinations are predicted to have increased drug-poisoning mortality. Conclusions. The economic supports that states enacted were insufficient to fully mitigate the adverse relationship between activity limitations and drug overdoses. (Am J Public Health. 2024;114(7):714–722. https://doi.org/10.2105/AJPH.2024.307621) [ABSTRACT FROM AUTHOR]

Published
2024
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26. Decreased Antibody Responses to Ad26.COV2.S Relative to SARS-CoV-2 mRNA Vaccines in Patients With Inflammatory Bowel Disease

Author

Pozdnyakova, VALERIYA, Botwin, GREGORY J., Sobhani, KIMIA, Prostko, JOHN, Braun, JONATHAN, Mcgovern, DERMOT P.B., Melmed, GIL Y., Appel, Keren, Banty, Andrea, Feldman, Edward, Ha, Christina, Kumar, Rashmi, Lee, Susie, Rabizadeh, Shervin, Stein, Theodore, Syal, Gaurav, Targan, Stephan, Vasiliauskas, Eric, Ziring, David, Debbas, Philip, Hampton, Melissa, Mengesha, Emebet, Stewart, James L., Frias, Edwin C., Cheng, Susan, Ebinger, Joseph, Figueiredo, Jane C., Boland, Brigid, Charabaty, Aline, Chiorean, Michael, Cohen, Erica, Flynn, Ann, Valentine, John, Fudman, David, Horizon, Arash, Hou, Jason, Hwang, Caroline, Lazarev, Mark, Lum, Donald, Fausel, Rebecca, Reddy, Swapna, Mattar, Mark, Metwally, Mark, Ostrov, Arthur, Parekh, Nimisha, Raffals, Laura, Sheibani, Sarah, Siegel, Corey, Wolf, Douglas, and Younes, Ziad

Published
2021
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30. A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals

Author

Luijten, Mirjam, Corvi, Raffaella, Mehta, Jyotigna, Corvaro, Marco, Delrue, Nathalie, Felter, Susan, Haas, Bodo, Hewitt, Nicola J., Hilton, Gina, Holmes, Thomas, Jacobs, Miriam N., Jacobs, Abigail, Lamplmair, Franz, Lewis, Dick, Madia, Federica, Manou, Irene, Melching-Kollmuss, Stephanie, Schorsch, Frederic, Schütte, Katrin, Sewell, Fiona, Strupp, Christian, van der Laan, Jan Willem, Wolf, Douglas C., Wolterink, Gerrit, Woutersen, Ruud, Zvonar, Zvonimir, Heusinkveld, Harm, and Braakhuis, Hedwig

Published
2020
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32. Developing a modern approach to assess ecological risk from pesticides without unnecessary vertebrate animal testing.

Author

Dreier, David A., Picard, Christian, Kabler, Kent, Ryan, Natalia, Lu, Haitian, Alexander-Watkins, Odette, Abbott, John, Currie, Richard A., Wolf, Douglas C., and Ramanarayanan, Tharacad

Subjects
ANIMAL experimentation, ECOLOGICAL risk assessment, HERBICIDE resistance, PESTICIDES, ENVIRONMENTAL protection, ENVIRONMENTAL chemistry, ENVIRONMENTAL toxicology
Abstract

Environmental context: Pesticides are critical to agriculture and food production but require ecological risk assessments. Although most risk assessments require data from vertebrate animal testing, we have developed an approach to assess risk to fish, birds and mammals using other means. This approach could help to ensure protection of the environment while minimising animal testing. Rationale: Recent directives to reduce animal testing have implications for ecological risk assessment, as several vertebrate tests are used to support these assessments. Therefore, a modern approach was devised to address these key knowledge needs without the use of chemical-specific vertebrate testing. Methodology: An ecological risk assessment for a novel acetyl-coenzyme A carboxylase (ACCase) inhibitor herbicide was conducted using alternative lines of evidence. For fish, chemical toxicity distributions were constructed to quantify the probability of effects, and these distributions were compared with exposure estimates for a representative use in soybeans. The effect distributions were further refined based on invertebrate toxicity and partitioning behaviour. For birds and mammals, a joint probability curve was constructed by integrating chemical toxicity distributions and Kenaga exposure distributions. Results: The lines of evidence presented in this predictive risk assessment suggest the intended use of a new ACCase inhibitor is unlikely to affect fish, birds, or mammals. Exposure was unlikely to exceed effect estimates, regardless of whether they were derived based on chemical-read across, invertebrate toxicity, or partitioning behaviour. Discussion: Key knowledge needs for ecological risk assessment can be informed by lines of evidence that do not require animal testing. The present study demonstrates such an approach by comparing predicted exposure and effects, which are expected to be protective. This predictive approach can be extended to other active ingredients and chemical classes, as well as other taxonomic groups of interest. Future research should aim to integrate new approach methods in a predictive risk assessment framework. Environmental context. Pesticides are critical to agriculture and food production but require ecological risk assessments. Although most risk assessments require data from vertebrate animal testing, we have developed an approach to assess risk to fish, birds and mammals using other means. This approach could help to ensure protection of the environment while minimising animal testing. This article belongs to the collection NAMs in Environmental Chemistry and Toxicology. [ABSTRACT FROM AUTHOR]

Published
2024
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33. The Changing Demography of Late-Life Family Caregiving: A Research Agenda to Understand Future Care Networks for an Aging U.S. Population.

Author

Freedman, Vicki A, Agree, Emily M, Seltzer, Judith A, Birditt, Kira S, Fingerman, Karen L, Friedman, Esther M, Lin, I-Fen, Margolis, Rachel, Park, Sung S, Patterson, Sarah E, Polenick, Courtney A, Reczek, Rin, Reyes, Adriana M, Truskinovsky, Yulya, Wiemers, Emily E, Wu, Huijing, Wolf, Douglas A, Wolff, Jennifer L, and Zarit, Steven H

Subjects
EXPERIMENTAL design, FRIENDSHIP, RESEARCH evaluation, PRIORITY (Philosophy), MEDICAL care for older people, SOCIAL change, FAMILIES, HEALTH insurance reimbursement, AGING, PSYCHOLOGY of caregivers, DEMOGRAPHY, FAMILY relations
Abstract

Repeated claims that a dwindling supply of potential caregivers is creating a crisis in care for the U.S. aging population have not been well-grounded in empirical research. Concerns about the supply of family care do not adequately recognize factors that may modify the availability and willingness of family and friends to provide care to older persons in need of assistance or the increasing heterogeneity of the older population. In this paper, we set forth a framework that places family caregiving in the context of older adults' care needs, the alternatives available to them, and the outcomes of that care. We focus on care networks, rather than individuals, and discuss the demographic and social changes that may alter the formation of care networks in the future. Last, we identify research areas to prioritize in order to better support planning efforts to care for the aging U.S. population. [ABSTRACT FROM AUTHOR]

Published
2024
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34. Efficacy and Safety of Approximately 3 Years of Continuous Ozanimod in Moderately to Severely Active Ulcerative Colitis: Interim Analysis of the True North Open-label Extension.

Author

Danese, Silvio, Panaccione, Remo, Abreu, Maria T, Rubin, David T, Ghosh, Subrata, Dignass, Axel, Afzali, Anita, Wolf, Douglas C, Chiorean, Michael V, Vermeire, Severine, Jain, Anjali, Charles, Lorna, Lawlor, Garrett, Osterman, Mark T, Wu, Hsiuanlin, Canavan, James B, Petersen, AnnKatrin, Colombel, Jean-Frederic, and Regueiro, Miguel

Published
2024
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36. S842 Pharmacokinetics, Exposure-Response Relationships, and Immunogenicity in Crohn’s Disease Patients With Ustekinumab Secondary Loss of Response Following Ustekinumab IV Re-Induction: Week 16 Results From the POWER Study

Author

Feagan, Brian G., primary, Lee, Scott D., additional, Janneke van der Woude, C., additional, Marín-Jiménez, Ignacio, additional, Wolf, Douglas C., additional, Schnoy, Elisabeth, additional, Salzberg, Bruce, additional, Busse, Christopher, additional, Nazar, Maciej, additional, Langholff, Wayne, additional, Gasink, Christopher, additional, Baker, Thomas, additional, Godwin, Bridget, additional, Adedokun, Omoniyi, additional, and Schreiber, Stefan, additional

Published
2023
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38. S906 Efficacy and Durability of Ozanimod by Baseline Endoscopic Disease Activity in Advanced Therapy–Naive Ulcerative Colitis Patients Suboptimally Controlled on Conventional Therapies

Author

Rubin, David T., primary, Siegmund, Britta, additional, D’Haens, Geert R., additional, Irving, Peter M., additional, Blumenstein, Irina, additional, Siegel, Corey A., additional, Loftus, Edward V., additional, Wolf, Douglas C., additional, Abraham, Bincy, additional, Caldera, Freddy, additional, Peyrin-Biroulet, Laurent, additional, Jain, Anjali, additional, Wu, Hsiuanlin, additional, Osterman, Mark T., additional, and Long, Millie D., additional

Published
2023
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39. S1067 Impact of Prior Biologic/Janus Kinase Inhibitor Therapy on the Efficacy of Etrasimod: Subgroup Analysis From the Phase 3 ELEVATE UC 52 and ELEVATE UC 12 Trials

Author

Vermeire, Séverine, primary, Sands, Bruce E., additional, Peyrin-Biroulet, Laurent, additional, D'Haens, Geert, additional, Panés, Julian, additional, Yarur, Andres J., additional, Wolf, Douglas C., additional, Ritter, Timothy E., additional, Schreiber, Stefan, additional, Shan, Kevin, additional, Rabbat, Christopher J., additional, Chiorean, Michael V., additional, Baert, Filip, additional, Dubinsky, Marla C., additional, Goetsch, Martina, additional, Danese, Silvio, additional, and Feagan, Brian G., additional

Published
2023
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40. S1035 Analysis of Baseline Characteristics Associated With Clinical Response to Ustekinumab IV Re-Induction Strategy in Patients With Crohn’s Disease in the POWER Trial

Author

Wolf, Douglas C., primary, Lee, Scott D., additional, Schreiber, Stefan, additional, Janneke van der Woude, C., additional, Marín-Jiménez, Ignacio, additional, Schnoy, Elisabeth, additional, Salzberg, Bruce, additional, Busse, Christopher, additional, Nazar, Maciej, additional, Langholff, Wayne, additional, Gasink, Christopher, additional, Baker, Thomas, additional, Godwin, Bridget, additional, and Feagan, Brian G., additional

Published
2023
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41. S1134 Association of Nonswitched Memory B-Cell (MBC) Levels With Ozanimod (OZA) Efficacy in Patients (Pts) With Moderately to Severely Active Crohn’s Disease (CD): Results From the Phase 2 STEPSTONE Study

Author

Harris, Sarah, primary, Feagan, Brian G., additional, Hanauer, Stephen B., additional, Vermeire, Séverine, additional, Ghosh, Subrata, additional, Yan, Jim, additional, Wu, Chun, additional, Hu, Yanhua, additional, Maddux, Rachel, additional, Wolf, Douglas C., additional, and D’Haens, Geert R., additional

Published
2023
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42. S911 Long-Term Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis and Relapsing Multiple Sclerosis

Author

Rubin, David T., primary, Cree, Bruce A.C., additional, Wolf, Douglas C., additional, Alekseeva, Olga, additional, Charles, Lorna, additional, Petersen, AnnKatrin, additional, Sheffield, James K., additional, Cheng, Chun-Yen, additional, Riolo, Jon V., additional, Silva, Diego, additional, Lublin, Fred D., additional, Cohen, Jeffrey A., additional, and Danese, Silvio, additional

Published
2023
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43. Vedolizumab, Adalimumab, and Methotrexate Combination Therapy in Crohn’s Disease (EXPLORER)

Author

Colombel, Jean-Frederic, primary, Ungaro, Ryan C., additional, Sands, Bruce E., additional, Siegel, Corey A., additional, Wolf, Douglas C., additional, Valentine, John F., additional, Feagan, Brian G., additional, Neustifter, Blue, additional, Kadali, Harisha, additional, Nazarey, Pradeep, additional, James, Alexandra, additional, Jairath, Vipul, additional, and Qasim Khan, Rana M., additional

Published
2023
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44. Efficacy and Safety of Approximately 3 Years of Continuous Ozanimod in Moderately to Severely Active Ulcerative Colitis: Interim Analysis of the True North Open-label Extension

Author

Danese, Silvio, primary, Panaccione, Remo, additional, Abreu, Maria T, additional, Rubin, David T, additional, Ghosh, Subrata, additional, Dignass, Axel, additional, Afzali, Anita, additional, Wolf, Douglas C, additional, Chiorean, Michael V, additional, Vermeire, Severine, additional, Jain, Anjali, additional, Charles, Lorna, additional, Lawlor, Garrett, additional, Osterman, Mark T, additional, Wu, Hsiuanlin, additional, Canavan, James B, additional, Petersen, AnnKatrin, additional, Colombel, Jean-Frederic, additional, and Regueiro, Miguel, additional

Published
2023
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45. Practical Primer Addressing Real-World Use Scenarios of Subcutaneous Vedolizumab in Ulcerative Colitis and Crohn’s Disease: Post Hoc Analyses of VISIBLE Studies

Author

Sandborn, William J, primary, Chen, Jingjing, additional, Kisfalvi, Krisztina, additional, Loftus, Edward V, additional, D’Haens, Geert, additional, Candela, Ninfa, additional, Lasch, Karen, additional, Wolf, Douglas C, additional, Uddin, Sharif M, additional, and Danese, Silvio, additional

Published
2023
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48. Effects of Paid Caregiving Leave on Government Costs

Author

Wolf, Douglas A.

Subjects
United States. Social Security Administration -- Officials and employees, United States. Medicare Payment Advisory Commission -- Officials and employees, United States. Bureau of Labor Statistics -- Officials and employees, Employers -- Laws, regulations and rules -- Analysis, Government regulation, Social sciences
Abstract

Paid time off from employment to address a family member's illness and its associated care needs is an issue attracting much attention. At the national level, the Family and Medical [...]

Published
2020

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