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2. Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial

Author

Atreja, Ashish, Khan, Sameer, Rogers, Jason D, Otobo, Emamuzo, Patel, Nishant P, Ullman, Thomas, Colombel, Jean Fred, Moore, Shirley, and Sands, Bruce E

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundInflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE. ObjectiveThe objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients. MethodsParticipants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views). ResultsEnrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. ConclusionsHealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. Trial RegistrationClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr).

Published
2015
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3. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY)

Author

Hanauer, Stephen B., Sands, Bruce E., Schreiber, Stefan, Danese, Silvio, Kłopocka, Maria, Kierkuś, Jarosław, Kulynych, Roman, Gonciarz, Maciej, Sołtysiak, Artur, Smoliński, Patryk, Srećković, Slobodan, Valuyskikh, Ekaterina, Lahat, Adi, Horyński, Marek, Gasbarrini, Antonio, Osipenko, Marina, Borzan, Vladimir, Kowalski, Maciej, Saenko, Daria, Sardinov, Ruslan, Lee, Sang Joon, Kim, Sunghyun, Bae, Yunju, Lee, Sunhee, Lee, Seulgi, Lee, Joon Ho, Yang, Siyoung, Lee, Jimin, Lee, Juhyun, Kim, Jong Min, Park, Gahee, Sandborn, William J., and Colombel, Jean-Frederic

Published
2024
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4. Qualitative and Psychometric Evaluation of 29-Item Patient-Reported Outcomes Measurement Information System® to Assess General Health-Related Quality of Life in Patients With Moderately to Severely Active Inflammatory Bowel Disease

Author

Sands, Bruce E., Panés, Julian, Feagan, Brian G., Zhang, Hongyan, Vetter, Marion L., Mathias, Susan D., Huang, Kuan-Hsiang Gary, Johanns, Jewel, Germinaro, Matthew, Sahoo, Aparna, Terry, Natalie A., and Han, Chenglong

Published
2024
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10. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn’s Disease: The IM-UNITI Trial

Author

Sandborn, William J, Rebuck, Rory, Wang, Yuhua, Zou, Bin, Adedokun, Omoniyi J, Gasink, Christopher, Sands, Bruce E, Hanauer, Stephen B, Targan, Stephan, Ghosh, Subrata, de Villiers, Willem JS, Colombel, Jean-Frederic, Feagan, Brian G, and Lynch, John P

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Crohn Disease, Humans, Induction Chemotherapy, Maintenance Chemotherapy, Remission Induction, Treatment Outcome, Ustekinumab, Crohn's Disease, Long-Term Extension, Crohn’s Disease, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsThe IM-UNITI study and long-term extension (LTE) evaluated the long-term efficacy, safety, and immunogenicity of subcutaneous ustekinumab maintenance therapy in patients with Crohn's disease. Here, we report the final results of IM-UNITI LTE through 5 years.MethodsPatients completing safety and efficacy evaluations at week 44 of the maintenance study were eligible to participate in the LTE and continue the treatment they were receiving. Unblinding occurred after completion of maintenance study analyses (August 2015), and patients receiving placebo were discontinued from the study after unblinding. No dose adjustment occurred in the LTE. Efficacy assessments were conducted every 12 weeks until unblinding and at dosing visits thereafter through week 252. Serum ustekinumab concentrations and antidrug antibodies were evaluated through weeks 252 and 272, respectively.ResultsUsing an intent-to-treat analysis of all patients randomized to ustekinumab at maintenance baseline, 34.4% of patients in the every-8-weeks group and 28.7% in the every-12-weeks group were in clinical remission at week 252. Corresponding remission rates among patients who entered the LTE were 54.9% and 45.2%. Overall, adverse event rates (per 100 patient-years) from maintenance week 0 through the final visit generally were similar in the placebo and combined ustekinumab groups for all adverse events (440.3 vs 327.6), serious adverse events (19.3 vs 17.5), infections (99.8 vs 93.8), and serious infections (3.9 vs 3.4). Serum ustekinumab concentrations were maintained throughout the LTE. Antidrug antibodies occurred in 5.8% of patients who received ustekinumab during induction and maintenance and continued in the LTE.ConclusionsPatients receiving subcutaneous ustekinumab maintained clinical remission through 5 years. No new safety signals were observed. ClinicalTrials.gov number NCT01369355.

Published
2022

13. 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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14. Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

Author

Lukin, Dana, Faleck, David, Xu, Ronghui, Zhang, Yiran, Weiss, Aaron, Aniwan, Satimai, Kadire, Siri, Tran, Gloria, Rahal, Mahmoud, Winters, Adam, Chablaney, Shreya, Koliani-Pace, Jenna L, Meserve, Joseph, Campbell, James P, Kochhar, Gursimran, Bohm, Matthew, Varma, Sashidhar, Fischer, Monika, Boland, Brigid, Singh, Siddharth, Hirten, Robert, Ungaro, Ryan, Lasch, Karen, Shmidt, Eugenia, Jairath, Vipul, Hudesman, David, Chang, Shannon, Swaminath, Arun, Shen, Bo, Kane, Sunanda, Loftus, Edward V, Sands, Bruce E, Colombel, Jean-Frederic, Siegel, Corey A, Sandborn, William J, and Dulai, Parambir S

Subjects
Digestive Diseases, Clinical Research, Cancer, Inflammatory Bowel Disease, Patient Safety, Autoimmune Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Antibodies, Monoclonal, Humanized, Colitis, Ulcerative, Gastrointestinal Agents, Humans, Retrospective Studies, Treatment Outcome, Tumor Necrosis Factor Inhibitors, Tumor Necrosis Factor-alpha, Health Outcomes, Comparative Research, Biologics, Clinical Sciences, Gastroenterology & Hepatology
Abstract

Background & aimsWe aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice.MethodsA multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist-naïve and -exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately.ResultsA total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist-naïve and -exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist-treated patients. However, in TNF-antagonist-naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754).ConclusionsTreatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist-naïve patients.

Published
2022

15. The Role of Resilience in Irritable Bowel Syndrome, Other Chronic Gastrointestinal Conditions, and the General Population

Author

Parker, Colleen H, Naliboff, Bruce D, Shih, Wendy, Presson, Angela P, Kilpatrick, Lisa, Gupta, Arpana, Liu, Cathy, Keefer, Laurie A, Sauk, Jenny S, Hirten, Robert, Sands, Bruce E, and Chang, Lin

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Chronic Pain, Clinical Research, Pain Research, Behavioral and Social Science, Digestive Diseases, Mental Health, 2.1 Biological and endogenous factors, Aetiology, Oral and gastrointestinal, Good Health and Well Being, Humans, Irritable Bowel Syndrome, Population Groups, Quality of Life, Severity of Illness Index, Surveys and Questionnaires, Resilience, Inflammatory Bowel Disease, Celiac Disease, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsResilience is the ability to adapt positively to stress and adversity. It is a potential therapeutic target as it is reduced in irritable bowel syndrome (IBS) compared to healthy controls and associated with worse symptom severity and poorer quality of life. The aim of this study was to examine if these findings are generalizable by comparing resilience between IBS versus the general population and other chronic gastrointestinal (GI) conditions.MethodsParticipants in the general population completed an online survey containing questionnaires measuring demographics, diagnosis of IBS and other GI conditions, symptom severity, psychological symptoms, resilience, and early adverse life events (EALs). IBS was defined as having a physician diagnosis of IBS and/or meeting Rome criteria without co-morbid GI disease. All others were included in the general population group. The chronic GI conditions group included those with inflammatory bowel disease, celiac disease and/or microscopic colitis.ResultsResilience was lower in IBS (n = 820) than the general population (n = 1026; p < 0.001) and associated with worse IBS symptom severity (p < 0.05). Global mental health affected resilience differently in IBS compared to the general population (all p's < 0.05). EALs were associated with decreased ability to bounce back from adversity in both IBS and the general population (p < 0.001). Resilience scores were similar in IBS and other chronic GI conditions that present with similar symptoms.ConclusionsResilience is lower compared to the general U.S. population but does not appear to be specific to IBS as it is comparable to other chronic GI conditions. Low resilience negatively affects symptom severity and mental health and thus, may serve as a novel therapeutic target.

Published
2021

20. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management

Author

Sands, Bruce E, Colombel, Jean-Frédéric, Ha, Christina, Farnier, Michel, Armuzzi, Alessandro, Quirk, Daniel, Friedman, Gary S, Kwok, Kenneth, Salese, Leonardo, Su, Chinyu, and Taub, Pam R

Subjects
Arthritis, Nutrition, Inflammatory Bowel Disease, Autoimmune Disease, Clinical Research, Atherosclerosis, Cardiovascular, Digestive Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Inflammatory and immune system, Good Health and Well Being, Arthritis, Rheumatoid, Cardiovascular Diseases, Cholesterol, Clinical Trials, Phase III as Topic, Colitis, Ulcerative, Heart Disease Risk Factors, Humans, Inflammation, Lipids, Lipoproteins, HDL, Lipoproteins, LDL, Piperidines, Protein Kinase Inhibitors, Psoriasis, Pyrimidines, Pyrroles, Risk Factors, Treatment Outcome, clinical trials, lipids, tofacitinib, clinical trials, Clinical Sciences, Gastroenterology & Hepatology
Abstract

BackgroundPatients with ulcerative colitis (UC) are at elevated risk of cardiovascular disease vs the general population, despite a lower prevalence of traditional risk factors, including hyperlipidemia. Mechanistic studies in patients with rheumatoid arthritis and psoriasis suggest that tofacitinib restores serum lipids to preinflammation levels by reversing inflammation-induced cholesterol metabolism changes. We reviewed data on lipid levels and cardiovascular events, alongside recommendations for managing lipid levels during tofacitinib treatment in patients with UC, based on up-to-date expert guidelines.MethodsData were identified from a phase 3/open-label, long-term extension (OLE) tofacitinib UC clinical program (cutoff May 27, 2019). Literature was identified from PubMed (search terms "lipid," "cholesterol," "lipoprotein," "cardiovascular," "inflammation," "atherosclerosis," "tofacitinib," "rheumatoid arthritis," "psoriasis," "inflammatory bowel disease," "ulcerative colitis," "hyperlipidemia," and "guidelines") and author knowledge. Data were available from 4 phase 3 clinical trials of 1124 patients with moderately to severely active UC who received ≥1 dose of tofacitinib 5 or 10 mg twice daily in induction (two identical trials), maintenance, and OLE studies (treatment duration ≤6.8 years; 2576.4 patient-years of drug exposure).ResultsIn the OLE study, tofacitinib treatment was not associated with major changes from baseline in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, total cholesterol/high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol/high-density lipoprotein cholesterol, with lipid levels and ratios generally remaining stable over time. The major adverse cardiovascular events incidence rate was 0.26/100 patient-years (95% confidence interval, 0.11-0.54).ConclusionsLipid levels and ratios remained generally unchanged from baseline in the OLE study after tofacitinib treatment, and major adverse cardiovascular events were infrequent. Long-term studies are ongoing.Clinicaltrials.gov identifiersNCT01465763, NCT01458951, NCT01458574, NCT01470612.

Published
2021

21. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study

Author

Abrahamovych, Orest, Afanasieva, Halyna, Aitova, Lilia, Altintas, Engin, Altwegg, Romain, Andreev, Pavel, Aomatsu, Kazuki, Augustyn, Monika, Balestrieri, Paola, Begun, Jakob, Brunatto, Luciana, Bulgheroni, Diego, Bunkova, Elena, Cabello, Mercedes, Cao, Qian, Caprioli, Flavio, Cerqueira, Rute, Chen, Baili, Chen, Chou-Chen, Chen, Chou-Pin, Chiu, Cheng-Tang, Choi, Chang Hwan, Cicala, Michele, Datsenko, Olena, Dewint, Pieter, Domenech, Eugeni, Dutré, Joris, Duvall, George, Fernandez, Juan, Filip, Rafal, Fogel, Ronald, Fowler, Sharyle, Fujii, Toshimitsu, Fukata, Masayuki, Furumoto, Yohei, Gasbarrini, Antonio, Gawdis-Wojnarska, Beata, Gilletta, Cyrielle, Gionchetti, Paolo, Goldin, Eran, Golovchenko, Oleksandr, Gonciarz, Maciej, Gonen, Can, Segura, Gaston Gonzalez, Gridnyev, Oleksii, Gyokeres, Tibor, Hébuterne, Xavier, Hedin, Charlotte, Hellström, Per, Hilmi, Ida Normiha, Horný, Ivo, Horvat, Gyula, Hoshi, Namiko, Hrdlicka, Ludek, Ishihara, Shunji, Ivanishyn, Olha, Jang, Byung Ik, Junior, Odery, Kagaya, Takashi, Kanmura, Shuji, Karakina, Marina, Katsuhiko, Nakai, Kierkus, Jaroslaw, Kim, Hyo Jong, Kim, Tae-Oh, Kim, Young-Ho, Kiss, Gyula G., Klaus, Jochen, Kleczkowski, Dariusz, Klopocka, Maria, Kobayashi, Taku, Kobielusz-Gembala, Iwona, Koo, Ja Seol, Kopon, Adam, Kravchenko, Tetiana, Kudo, Masatoshi, Kwon, Kwang An, Lago, Paula, Laharie, David, Lawrance, Ian, Leszczyszyn, Jaroslaw, Li, Yan, Lukas, Milan, Maaser, Christian, Maemoto, Atsuo, Marusawa, Hiroyuki, McBride, Matthew, Mendu, Shoba, Miheller, Pal, Miyabayashi, Hideharu, Mohl, Wolfgang, Moore, Gregory, Motoya, Satoshi, Murali, Narayanachar, Naem, Mohammed, Nakajima, Koichi, Nakamoto, Yasunari, Nancey, Stéphane, Neto, Joaquim, Onizawa, Michio, Ono, Yohei, Osada, Taro, Osipenko, Marina, Owczarek, Danuta, Patel, Bhaktasharan, Patel, Kamal, Petrova, Elina, Poroshina, Elena, Portela, Francisco, Prystupa, Lyudmyla, Rivero, Monserrat, Roblin, Xavier, Romatowski, Jacek, Rydzewska, Grazyna, Saibeni, Simone, Sakuraba, Hirotake, Samaan, Mark, Schultz, Michael, Schulze, Joerg, Sedghi, Shahriar, Seidler, Ursula, Shin, Sung Jae, Stanislavchuk, Mykola, Stokesberry, David, Suzuki, Takayoshi, Taguchi, Hiroki, Tankova, Lyudmila, Thin, Lena, Tkachev, Alexander, Torrealba, Leyanira, Tsarynna, Nataliia, Tulassay, Zsolt, Ueo, Tetsuya, Valuyskikh, Ekaterina, Vasilevskaya, Olga, Viamonte, Manuel, Wei, Shu-Chen, Weisshof, Roni, Wojcik, Katarzyna, Ye, Byong Duk, Yen, Hsu-Heng, Yoon, Hyuk, Yoshida, Kosuke, Yurkiv, Andriy, Zaha, Osamu, Zhan, Qiang, Peyrin-Biroulet, Laurent, Allegretti, Jessica R., Rubin, David T., Bressler, Brian, Germinaro, Matthew, Huang, Kuan-Hsiang (Gary), Shipitofsky, Nicole, Zhang, Hongyan, Wilson, Rebbecca, Han, Chenglong, Feagan, Brian G., Sandborn, William J., Panés, Julian, Hisamatsu, Tadakazu, Lichtenstein, Gary R., Sands, Bruce E., and Dignass, Axel

Published
2023
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22. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease

Author

Mahadevan, Uma, Long, Millie D, Kane, Sunanda V, Roy, Abhik, Dubinsky, Marla C, Sands, Bruce E, Cohen, Russell D, Chambers, Christina D, Sandborn, William J, and Alliance, Crohn’s Colitis Foundation Clinical Research

Subjects
Preterm, Low Birth Weight and Health of the Newborn, Clinical Research, Infant Mortality, Contraception/Reproduction, Digestive Diseases, Pediatric, Inflammatory Bowel Disease, Prevention, Perinatal Period - Conditions Originating in Perinatal Period, Conditions Affecting the Embryonic and Fetal Periods, Reproductive health and childbirth, Good Health and Well Being, Adult, Anti-Inflammatory Agents, Azathioprine, Biological Products, Colitis, Ulcerative, Crohn Disease, Drug Therapy, Combination, Female, Humans, Infant, Newborn, Intestinal Mucosa, Mercaptopurine, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Prenatal Exposure Delayed Effects, Prospective Studies, United States, Crohn's Disease, Ulcerative Colitis, Crohn’s Colitis Foundation Clinical Research Alliance, Crohn’s Disease, Clinical Sciences, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology
Abstract

Background & aimsPregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy, with health repercussions to mother and child.MethodsBetween 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, multicenter study across the United States. The primary analysis was a comparison of 5 outcomes (congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infant infections) among pregnancies exposed vs unexposed in utero to biologics, thiopurines, or a combination. Bivariate analyses followed by logistic regression models adjusted for relevant confounders were used to determine the independent effects of specific drug classes on outcomes of interest.ResultsAmong 1490 completed pregnancies, there were 1431 live births. One-year infant outcomes were available in 1010. Exposure was to thiopurines (n = 242), biologics (n = 642), or both (n = 227) vs unexposed (n = 379). Drug exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infections during the first year of life. Higher disease activity was associated with risk of spontaneous abortion (hazard ratio, 3.41; 95% confidence interval, 1.51-7.69) and preterm birth with increased infant infection (odds ratio, 1.73; 95% confidence interval, 1.19-2.51).ConclusionsBiologic, thiopurine, or combination therapy exposure during pregnancy was not associated with increased adverse maternal or fetal outcomes at birth or in the first year of life. Therapy with these agents can be continued throughout pregnancy in women with IBD to maintain disease control and reduce pregnancy-related adverse events. ClinicalTrials.gov, Number: NCT00904878.

Published
2021

23. Standardizing Scoring Conventions for Crohn’s Disease Endoscopy: An International RAND/UCLA Appropriateness Study

Author

Khanna, Reena, Ma, Christopher, Hogan, Malcolm, Zou, Guangyong, Bessissow, Talat, Bressler, Brian, Colombel, Jean-Frédéric, Danese, Silvio, Daperno, Marco, East, James E., Hookey, Lawrence, Loftus, Edward V., Jr., McDonald, John W.D., Panaccione, Remo, Peyrin-Biroulet, Laurent, Rutter, Matt, Sands, Bruce E., Vermeire, Séverine, Rémillard, Julie, McFarlane, Stefanie C., Sandborn, William J., D’Haens, Geert R., Feagan, Brian G., and Jairath, Vipul

Published
2023
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24. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis

Author

Dulai, Parambir S, Singh, Siddharth, Casteele, Niels Vande, Meserve, Joseph, Winters, Adam, Chablaney, Shreya, Aniwan, Satimai, Shashi, Preeti, Kochhar, Gursimran, Weiss, Aaron, Koliani-Pace, Jenna L, Gao, Youran, Boland, Brigid S, Chang, John T, Faleck, David, Hirten, Robert, Ungaro, Ryan, Lukin, Dana, Sultan, Keith, Hudesman, David, Chang, Shannon, Bohm, Matthew, Varma, Sashidhar, Fischer, Monika, Shmidt, Eugenia, Swaminath, Arun, Gupta, Nitin, Rosario, Maria, Jairath, Vipul, Guizzetti, Leonardo, Feagan, Brian G, Siegel, Corey A, Shen, Bo, Kane, Sunanda, Loftus, Edward V, Sandborn, William J, Sands, Bruce E, Colombel, Jean-Frederic, Lasch, Karen, and Cao, Charlie

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Genetics, Inflammatory Bowel Disease, Digestive Diseases, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Management of diseases and conditions, 7.3 Management and decision making, Good Health and Well Being, Antibodies, Monoclonal, Humanized, Colitis, Ulcerative, Gastrointestinal Agents, Humans, Remission Induction, Treatment Outcome, Prognostic Factor, Response to Treatment, Personalized Medicine, Biologic, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsWe created and validated a clinical decision support tool (CDST) to predict outcomes of vedolizumab therapy for ulcerative colitis (UC).MethodsWe performed logistic regression analyses of data from the GEMINI 1 trial, from 620 patients with UC who received vedolizumab induction and maintenance therapy (derivation cohort), to identify factors associated with corticosteroid-free remission (full Mayo score of 2 or less, no subscore above 1). We used these factors to develop a model to predict outcomes of treatment, which we called the vedolizumab CDST. We evaluated the correlation between exposure and efficacy. We validated the CDST in using data from 199 patients treated with vedolizumab in routine practice in the United States from May 2014 through December 2017.ResultsAbsence of exposure to a tumor necrosis factor (TNF) antagonist (+3 points), disease duration of 2 y or more (+3 points), baseline endoscopic activity (moderate vs severe) (+2 points), and baseline albumin concentration (+0.65 points per 1 g/L) were independently associated with corticosteroid-free remission during vedolizumab therapy. Patients in the derivation and validation cohorts were assigned to groups of low (CDST score, 26 points or less), intermediate (CDST score, 27-32 points), or high (CDST score, 33 points or more) probability of vedolizumab response. We observed a statistically significant linear relationship between probability group and efficacy (area under the receiver operating characteristic curve, 0.65), as well as drug exposure (P < .001) in the derivation cohort. In the validation cohort, a cutoff value of 26 points identified patients who did not respond to vedolizumab with high sensitivity (93%); only the low and intermediate probability groups benefited from reducing intervals of vedolizumab administration due to lack of response (P = .02). The vedolizumab CDST did not identify patients with corticosteroid-free remission during TNF antagonist therapy.ConclusionsWe used data from a trial of patients with UC to develop a scoring system, called the CDST, which identified patients most likely to enter corticosteroid-free remission during vedolizumab therapy, but not anti-TNF therapy. We validated the vedolizumab CDST in a separate cohort of patients in clinical practice. The CDST identified patients most likely to benefited from reducing intervals of vedolizumab administration due to lack of initial response. ClinicalTrials.gov no: NCT00783718.

Published
2020

25. Shorter Disease Duration Is Associated With Higher Rates of Response to Vedolizumab in Patients With Crohn’s Disease But Not Ulcerative Colitis

Author

Faleck, David M, Winters, Adam, Chablaney, Shreya, Shashi, Preeti, Meserve, Joseph, Weiss, Aaron, Aniwan, Satimai, Koliani-Pace, Jenna L, Kochhar, Gursimran, Boland, Brigid S, Singh, Siddharth, Hirten, Robert, Shmidt, Eugenia, Kesar, Varun, Lasch, Karen, Luo, Michelle, Bohm, Matthew, Varma, Sashidhar, Fischer, Monika, Hudesman, David, Chang, Shannon, Lukin, Dana, Sultan, Keith, Swaminath, Arun, Gupta, Nitin, Siegel, Corey A, Shen, Bo, Sandborn, William J, Kane, Sunanda, Loftus, Edward V, Sands, Bruce E, Colombel, Jean-Frederic, Dulai, Parambir S, and Ungaro, Ryan

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Crohn's Disease, Clinical Research, Autoimmune Disease, Digestive Diseases, Inflammatory Bowel Disease, Oral and gastrointestinal, Adult, Antibodies, Monoclonal, Humanized, Colitis, Ulcerative, Crohn Disease, Endoscopy, Digestive System, Female, Gastrointestinal Agents, Humans, Male, Middle Aged, Registries, Remission Induction, Retrospective Studies, Time Factors, Young Adult, Integrin, Monoclonal Antibody Therapy, Time, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsPatients with Crohn's disease (CD), but not ulcerative colitis (UC), of shorter duration have higher rates of response to tumor necrosis factor (TNF) antagonists than patients with longer disease duration. Little is known about the association between disease duration and response to other biologic agents. We aimed to evaluate response of patients with CD or UC to vedolizumab, stratified by disease duration.MethodsWe analyzed data from a retrospective, multicenter, consortium of patients with CD (n = 650) or UC (n = 437) treated with vedolizumab from May 2014 through December 2016. Using time to event analyses, we compared rates of clinical remission, corticosteroid-free remission (CSFR), and endoscopic remission between patients with early-stage (≤2 years duration) and later-stage (>2 years) CD or UC. We used Cox proportional hazards models to identify factors associated with outcomes.ResultsWithin 6 months initiation of treatment with vedolizumab, significantly higher proportions of patients with early-stage CD, vs later-stage CD, achieved clinical remission (38% vs 23%), CSFR (43% vs 14%), and endoscopic remission (29% vs 13%) (P < .05 for all comparisons). After adjusting for disease-related factors including previous exposure to TNF antagonists, patients with early-stage CD were significantly more likely than patients with later-stage CD to achieve clinical remission (adjusted hazard ratio [aHR], 1.59; 95% CI, 1.02-2.49), CSFR (aHR, 3.39; 95% CI, 1.66-6.92), and endoscopic remission (aHR, 1.90; 95% CI, 1.06-3.39). In contrast, disease duration was not a significant predictor of response among patients with UC.ConclusionsPatients with CD for 2 years or less are significantly more likely to achieve a complete response, CSFR, or endoscopic response to vedolizumab than patients with longer disease duration. Disease duration does not associate with response vedolizumab in patients with UC.

Published
2019

26. 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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27. Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial

Author

Tkachev, Alexander, Kalimullina, Dilara, Petryka, Robert, Osipenko, Marina, Tsarynna, Nataliia, Bilianskyi, Leonid, Kleczkowski, Dariusz, Yurkiv, Andrii, Woynarowski, Marek, Abrahamovych, Orest, Ivanishyn, Olha, Rydzewska, Grazyna, Kierkus, Jaroslaw, Petrova, Elina, Vasilevskaya, Olga, Afanasieva, Halyna, Francesconi, Carlos, Leszczyszyn, Jaroslaw, Bunkova, Elena, Platonov, Dmitry, Datsenko, Olena, Gridnyev, Oleksii, Hospodarsky, Ihor, Prystupa, Liudmyla, Stanislavchuk, Mykola, Pershko, Anatoly, Shchukina, Oksana, Simanenkov, Vladimir, Golovchenko, Oleksandr, Holderman, William, Lasa, Juan, Begun, Jakob, de Lourdes de Abreu Ferrari, Maria, Lopez, Pedro, Obrezan, Andrey, Farooq, Shiraz, Tiongco, Felix, Novillo, Abel, Tron, Emiliano, Macrae, Finlay, Leong, Rupert, Yukie Sassaki, Ligia, Zaltman, Cyrla, Kaiser Junior, Roberto, Stallmach, Andreas, Klaus, Jochen, Martinez, Manuel, Ruiz, Azalia, Abdulkhakov, Rustem, Sharma, Vishvinder, Korman, Louis, Lord, James, Patel, Bhaktasharan, Ritter, Timothy, Feagan, Brian G, Sands, Bruce E, Sandborn, William J, Germinaro, Matthew, Vetter, Marion, Shao, Jie, Sheng, Shihong, Johanns, Jewel, and Panés, Julián

Published
2023
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28. Anti-Integrin αvβ6 Autoantibodies Are a Novel Biomarker That Antedate Ulcerative Colitis

Author

Abreu, Maria, Beck, Paul, Bernstein, Charles, Croitoru, Kenneth, Dieleman, Leo, Feagan, Brian, Griffiths, Anne, Guttman, David, Jacobson, Kevan, Kaplan, Gilaad, Krause, Denis O., Madsen, Karen, Marshall, John, Moayyedi, Paul, Ropeleski, Mark, Seidman, Ernest, Silverberg, Mark, Snapper, Scott, Stadnyk, Andy, Steinhart, Hillary, Surette, Michael, Turner, Dan, Walters, Thomas, Vallance, Bruce, Aumais, Guy, Bitton, Alain, Cino, Maria, Critch, Jeff, Denson, Lee, Deslandres, Colette, El-Matary, Wael, Herfarth, Hans, Higgins, Peter, Huynh, Hien, Hyams, Jeff, Mack, David, McGrath, Jerry, Otley, Anthony, Panancionne, Remo, Shapiro, Jason, Shah, Samir, Leleiko, Neal S., Livanos, Alexandra E., Dunn, Alexandra, Fischer, Jeremy, Ungaro, Ryan C., Turpin, Williams, Lee, Sun-Ho, Rui, Shumin, Del Valle, Diane Marie, Jougon, Julia J., Martinez-Delgado, Gustavo, Riddle, Mark S., Murray, Joseph A., Laird, Renee M., Torres, Joana, Agrawal, Manasi, Magee, Jared S., Dervieux, Thierry, Gnjatic, Sacha, Sheppard, Dean, Sands, Bruce E., Porter, Chad K., Petralia, Francesca, Colombel, Jean-Frederic, and Mehandru, Saurabh

Published
2023
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31. Qualitative and Psychometric Evaluation of PROMIS®-29 to Assess General Health-Related Quality of Life in Patients With Moderately to Severely Active Inflammatory Bowel Disease

Author

Sands, Bruce E., primary, Panés, Julian, additional, Feagan, Brian G., additional, Zhang, Hongyan, additional, Vetter, Marion L., additional, Mathias, Susan D., additional, Gary Huang, Kuan-Hsiang, additional, Johanns, Jewel, additional, Germinaro, Matthew, additional, Sahoo, Aparna, additional, Terry, Natalie A., additional, and Han, Chenglong, additional

Published
2024
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32. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure

Author

Panés, Julian, primary, D’Haens, Geert R., additional, Sands, Bruce E., additional, Ng, Siew C., additional, Lawendy, Nervin, additional, Kulisek, Nicole, additional, Guo, Xiang, additional, Wu, Joseph, additional, Vranic, Ivana, additional, Panaccione, Remo, additional, and Vermeire, Séverine, additional

Published
2024
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33. EFFICACY AND SAFETY OF GUSELKUMAB THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: RESULTS OF THE GALAXI 2 G 3 PHASE 3 STUDIES

Author

Panaccione, Remo, primary, Danese, Silvio, additional, Feagan, Brian G., additional, D’Haens, Geert, additional, Afzali, Anita, additional, Reinisch, Walter, additional, Panés, Julián, additional, Rubin, David T., additional, Andrews, Jane M., additional, Hisamatsu, Tadakazu, additional, Terry, Natalie A., additional, Salese, Leonardo, additional, Van Rampelbergh, Rian, additional, Frustaci, Mary Ellen S., additional, Yang, Zijiang, additional, Johanns, Jewel, additional, Wan, Kitty Y., additional, Yee, Jacqueline, additional, and Sands, Bruce E., additional

Published
2024
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37. ABX464 (obefazimod) for moderate-to-severe, active ulcerative colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension

Author

Vermeire, Severine, Sands, Bruce E, Tilg, Herbert, Tulassay, Zsolt, Kempinski, Radoslaw, Danese, Silvio, Bunganič, Ivan, Nitcheu, Josianne, Santo, Julien, Scherrer, Didier, Biguenet, Sophie, Ehrlich, Hartmut J, Steens, Jean-Marc, Gineste, Paul, and Sandborn, William J

Published
2022
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38. IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis: The PROCTRIAL Consensus

Author

Caron, Bénédicte, Abreu, Maria T., Siegel, Corey A., Panaccione, Remo, Sands, Bruce E., Dignass, Axel, Turner, Dan, Dotan, Iris, Hart, Ailsa L., Ahuja, Vineet, Allez, Matthieu, Ananthakrishnan, Ashwin N., Ghosh, Subrata, Griffiths, Anne M., Halfvarson, Jonas, Kaser, Arthur, Kotze, Paulo G., Koutroubakis, Ioannis E., Lakatos, Peter L., Levine, Arie, Lewis, James D., Magro, Fernando, Mantzaris, Gerassimos J., O’Morain, Colm, Ran, Zhihua, Reinisch, Walter, Rogler, Gerhard, Sachar, David B., Siegmund, Britta, Silverberg, Mark S., Sood, Ajit, Spinelli, Antonino, Steinwurz, Flavio, Tysk, Curt, Yamamoto-Furusho, Jesus K., Schreiber, Stefan, Rubin, David T., Sandborn, William J., Danese, Silvio, and Peyrin-Biroulet, Laurent

Published
2022
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39. Microbiotas from Humans with Inflammatory Bowel Disease Alter the Balance of Gut Th17 and RORγt+ Regulatory T Cells and Exacerbate Colitis in Mice

Author

Britton, Graham J, Contijoch, Eduardo J, Mogno, Ilaria, Vennaro, Olivia H, Llewellyn, Sean R, Ng, Ruby, Li, Zhihua, Mortha, Arthur, Merad, Miriam, Das, Anuk, Gevers, Dirk, McGovern, Dermot PB, Singh, Namita, Braun, Jonathan, Jacobs, Jonathan P, Clemente, Jose C, Grinspan, Ari, Sands, Bruce E, Colombel, Jean-Frederic, Dubinsky, Marla C, and Faith, Jeremiah J

Subjects
Autoimmune Disease, Inflammatory Bowel Disease, Digestive Diseases, Crohn's Disease, 1.1 Normal biological development and functioning, 2.1 Biological and endogenous factors, Aetiology, Underpinning research, Oral and gastrointestinal, Animals, Cell Differentiation, Colitis, Disease Models, Animal, Disease Progression, Gastrointestinal Microbiome, Homeostasis, Humans, Inflammatory Bowel Diseases, Mice, Mice, Inbred C57BL, Nuclear Receptor Subfamily 1, Group F, Member 3, RNA, Ribosomal, 16S, T-Lymphocytes, Regulatory, Th17 Cells, Immunology
Abstract

Microbiota are thought to influence the development and progression of inflammatory bowel disease (IBD), but determining generalizable effects of microbiota on IBD etiology requires larger-scale functional analyses. We colonized germ-free mice with intestinal microbiotas from 30 healthy and IBD donors and determined the homeostatic intestinal T cell response to each microbiota. Compared to microbiotas from healthy donors, transfer of IBD microbiotas into germ-free mice increased numbers of intestinal Th17 cells and Th2 cells and decreased numbers of RORγt+ Treg cells. Colonization with IBD microbiotas exacerbated disease in a model where colitis is induced upon transfer of naive T cells into Rag1-/- mice. The proportions of Th17 and RORγt+ Treg cells induced by each microbiota were predictive of human disease status and accounted for disease severity in the Rag1-/- colitis model. Thus, an impact on intestinal Th17 and RORγt+ Treg cell compartments emerges as a unifying feature of IBD microbiotas, suggesting a general mechanism for microbial contribution to IBD pathogenesis.

Published
2019

42. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial

Author

Afzali, Anita, Aitova, Lilia, Aldeguer i Mante, Xavier, Allez, Matthieu, Altorjay, István, Argüelles Arias, Federico, Armuzzi, Alessandro, Augustyn, Monika, Bafutto, Mauro, Barrio, Jesus, Begun, Jakob, Behrend, Clint, Bezemer, Geert, Bonnaud, Guillaume, Brankovic, Marija, Byung, Ik Jang, Calvet Calvo, Xavier, Chachu, Karen, Chebli, Julio Maria Fonseca, Cheon, Jae Hee, Cichoz-Lach, Halina, Clark, Larry, Cummings, Fraser, Dalal, Kunal, Danese, Silvio, De Boer, Nanne, De Lourdes Ferrari, Maria, Désilets, Etienne, Dugalic, Predrag, Duvall, George, Fedorishina, Olga, Filip, Rafal, Flores, Cristina, Fogel, Ronald, Fon, James, Frankel, Michael, Friedenberg, Keith, Fries, Walter, Galina, Vassileva, Gietka, Piotr, Goel, Rishi, Hasselblatt, Peter, Herfarth, Hans, Herszényi, László, Hindryckx, Pieter, Hoentjen, Frank, Horjus Talabur Horje, Carmen, Iduru, Satish, Irving, Peter, Isfort, Robert, Jairath, Vipul, Jones, Michael, Kalimullina, Dilara, Katz, Jeffry, Kaur, Manreet, Khurana, Sunil K, Kim, Joo Sung, Kim, Youngho, Kleczkowski, Dariusz, Knezevic, Slavko, Knoll, Aaron, Korman, Louis Y, Kotzev, Iskren, Kulyapin, Andrey, Lee, Kang Moon, Leemreis, Desiree, Leszczyszyn, Jaroslaw, Limdi, Jimmy, Lissauer, Jack, Loftus, Edward, Malecka-Panas, Ewa, Marshall, John, Mihály, Emese, Milan, Lukas, Monteleone, Giovanni, Nagorni, Aleksandar, Owczarek, Danuta, Palekar, Nichole, Panaccione, Remo, Park, Young Soo, Park, Sang Hyoung, Parra, Rogério, Patai, Árpád, Patel, Kamal, Patel, Bhaktasharan, Pershko, Anatoly, Petrova, Elina, Pineton de Chambrun, Guillaume, Randall, Charles, Riestra Menendez, Sabino, Ritter, Timothy, Rivero, Montserrat, Roblin, Xavier, Rocca, Rodolfo, Romatowski, Jacek, Rydzewska, Grazyna, Saibeni, Simone, Salzberg, Bruce, Sarles, Harry, Saunders, John, Savarino, Edoardo Vincenzo, Serclova, Zuzana, Shchukina, Oksana, Siegel, Jonathan, Soofi, Najm, Sparrow, Miles, Stokesberry, David, Suiter, Daniel, Svorcan, Petar, Tkachev, Alexander, Tsonev, Nikolay, Tünde, Kristóf, Ulbrych, Jan, Vanasek, Tomas, Varga, Márta, Vermeire, Severine, Vicente Lidon, Raquel, Weiss, Michael L, Wesley, Emma, Winstead, Nathaniel, Wojcik, Katarzyna, Wypych, Joanna, Zaltman, Cyrla, Zdena, Zadorova, Sands, Bruce E, Irving, Peter M, Hoops, Timothy, Izanec, James L, Gao, Long-Long, Gasink, Christopher, Greenspan, Andrew, Hanauer, Stephen B, Kuehbacher, Tanja, Lewis, James D, Loftus, Edward V, Jr, Mihaly, Emese, Scherl, Ellen, Shchukina, Oksana B, and Sandborn, William J

Published
2022
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43. Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study

Author

Sandborn, William J., D’Haens, Geert R., Reinisch, Walter, Panés, Julián, Chan, Daphne, Gonzalez, Susana, Weisel, Kathleen, Germinaro, Matthew, Frustaci, Mary Ellen, Yang, Zijiang, Adedokun, Omoniyi J., Han, Chenglong, Panaccione, Remo, Hisamatsu, Tadakazu, Danese, Silvio, Rubin, David T., Sands, Bruce E., Afzali, Anita, Andrews, Jane M., and Feagan, Brian G.

Published
2022
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44. Ulcerative colitis is characterized by a plasmablast-skewed humoral response associated with disease activity

Author

Uzzan, Mathieu, Martin, Jerome C., Mesin, Luka, Livanos, Alexandra E., Castro-Dopico, Tomas, Huang, Ruiqi, Petralia, Francesca, Magri, Giuliana, Kumar, Shashi, Zhao, Qing, Rosenstein, Adam K., Tokuyama, Minami, Sharma, Keshav, Ungaro, Ryan, Kosoy, Roman, Jha, Divya, Fischer, Jeremy, Singh, Harpriya, Keir, Mary E., Ramamoorthi, Nandhini, Gorman, William E. O’, Cohen, Benjamin L., Rahman, Adeeb, Cossarini, Francesca, Seki, Akihiro, Leyre, Louise, Vaquero, Sonia Tejedor, Gurunathan, Sakteesh, Grasset, Emilie K., Losic, Bojan, Dubinsky, Marla, Greenstein, Alexander J., Gottlieb, Zoe, Legnani, Peter, George, James, Irizar, Haritz, Stojmirovic, Aleksandar, Brodmerkel, Carrie, Kasarkis, Andrew, Sands, Bruce E., Furtado, Glaucia, Lira, Sergio A., Tuong, Zewen K., Ko, Huaibin M., Cerutti, Andrea, Elson, Charles O., Clatworthy, Menna R., Merad, Miriam, Suárez-Fariñas, Mayte, Argmann, Carmen, Hackney, Jason A., Victora, Gabriel D., Randolph, Gwendalyn J., Kenigsberg, Ephraim, Colombel, Jean Frederic, and Mehandru, Saurabh

Published
2022
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46. Integrative Analysis of the Inflammatory Bowel Disease Serum Metabolome Improves Our Understanding of Genetic Etiology and Points to Novel Putative Therapeutic Targets

Author

Di'Narzo, Antonio F., Houten, Sander M., Kosoy, Roman, Huang, Ruiqi, Vaz, Frédéric M., Hou, Ruixue, Wei, Gabrielle, Wang, Wenhui, Comella, Phillip H., Dodatko, Tetyana, Rogatsky, Eduard, Stojmirovic, Aleksandar, Brodmerkel, Carrie, Perrigoue, Jacqueline, Hart, Amy, Curran, Mark, Friedman, Joshua R., Zhu, Jun, Agrawal, Manasi, Cho, Judy, Ungaro, Ryan, Dubinsky, Marla C., Sands, Bruce E., Suárez-Fariñas, Mayte, Schadt, Eric E., Colombel, Jean-Frédéric, Kasarskis, Andrew, Hao, Ke, and Argmann, Carmen

Published
2022
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47. Endpoints for extraintestinal manifestations in inflammatory bowel disease trials: the EXTRA consensus from the International Organization for the Study of Inflammatory Bowel Diseases

Author

Guillo, Lucas, Abreu, Maria, Panaccione, Remo, Sandborn, William J, Azevedo, Valderilio F, Gensler, Lianne, Moghaddam, Bahar, Ahuja, Vineet, Ali, Sabrina A, Allez, Matthieu, Ananthakrishnan, Ashwin N, Bhattacharya, Abhik, Dubinsky, Marla, Griffiths, Anne, Hart, Ailsa, Korelitz, Burton, Kotze, Paulo G, Koutroubakis, Ioannis E, Lakatos, Peter L, Lindsay, James O, Magro, Fernando, Mantzaris, Gerassimos J, Ng, Siew C, O'Morain, Colm, Panés, Julian, Parigi, Tommaso, Ran, Zhihua, Rogler, Gerhard, Rubin, David T, Sachar, David B, Siegmund, Britta, Steinwurz, Flavio, Tysk, Curt, Vavricka, Stephan, Verstraete, Sofia G, Brezin, Antoine P, Haemel, Anna K, Dignass, Axel, Sands, Bruce E, Danese, Silvio, and Peyrin-Biroulet, Laurent

Published
2022
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50. Phase 2 Trial of Anti-TLlA Monoclonal Antibody Tulisokibart for Ulcerative Colitis.

Author

Sands, Bruce E., Feagan, Brian G., Peyrin-Biroulet, Laurent, Danese, Silvio, Rubin, David T., Laurent, Olivier, Luo, Allison, Nguyen, Deanna D., Jiandong Lu, Yen, Mark, Leszczyszyn, Jaroslaw, Kempiński, Radosław, McGovern, Dermot P. B., Ma, Christopher, Ritter, Timothy E., and Targan, Stephan

Subjects
*ULCERATIVE colitis, *DISEASE remission, *CONFIDENCE intervals, *MONOCLONAL antibodies, *DIAGNOSIS methods
Abstract

BACKGROUND: Tulisokibart is a tumor necrosis factor-like cytokine lA (TLlA) monoclonal antibody in development for the treatment of moderately to severely active ulcerative colitis. A genetic-based diagnostic test was designed to identify patients with ati increased likelihood of response. METHODS: We randomly assigned patients with glucocorticoid dependence or failure of conventional or advanced therapies for ulcerative colitis to receive intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo. Cohort 1 included Gastroenterpatients regardless of status with respect to the test for likelihood of response. Cohort 2 included only patients with a positive test for likelihood of response. The primary analysis was performed in cohort 1; the primary end point was clinical remission at week 12. Patients with a positive test for likelihood of response from cohorts 1 and 2 were combined in prespecified analyses. RESULTS: In cohort 1, a total of 135 patients underwent randomization. A significantly higher percentage of patients who received tulisokibart had clinical remission than Gastroenterthose who received placebo (26% vs. 1%; difference, 25 percentage points; 95°/0 confidence interval [CI], 14 to 37; P<0.001). In cohort 2, a total of 43 patients underwent randomization. A total of 75 patients with a positive test for likelihood Wiof response underwent randomization across both cohorts. Among patients with Instia positive test for likelihood of response (cohorts 1 and 2 combined), clinical remission occurred in a higher percentage of patients who received tulisokibart than in those who received placebo (32% vs. 1196; difference, 21 percentage points; 95% CI, 2 to 38; P= 0.02). Among all the enrolled patients, the incidence of adverse events Anwas similar in the tulisokibart and placebo groups; most adverse events were mild to moderate in severity. CONCLUSIONS: In this short-term trial, tulisokibart was more effective than placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis. [ABSTRACT FROM AUTHOR]

Published
2024
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