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225 results on '"Cohen, Stanley"'

5. Safety and efficacy of elsubrutinib or upadacitinib alone or in combination (ABBV-599) in patients with rheumatoid arthritis and inadequate response or intolerance to biological therapies: a multicentre, double-blind, randomised, controlled, phase 2 trial

Author

Fleischmann, Roy, Friedman, Alan, Drescher, Edit, Singhal, Atul, Cortes-Maisonet, Gregorio, Doan, Thao, Lu, Wenjing, Wang, Zailong, Nader, Ahmed, Housley, William, Cohen, Stanley, Taylor, Peter C, and Blanco, Ricardo

Published
2022
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8. Outcomes in Adult Inflammatory Bowel Disease Clinical Trials: Assessment of Similarity Among Participants with Adolescent-onset and Adult-onset Disease.

Author

Rosh, Joel R, Turner, Dan, Hyams, Jeffrey S, Dubinsky, Marla, Griffiths, Anne M, Cohen, Stanley A, Lo, Kim Hung, Kim, Lilianne, Volger, Sheri, Zhang, Renping, Strauss, Richard, and Conklin, Laurie S

Abstract

Background and Aims Most paediatric inflammatory bowel disease [IBD] studies are performed after medications are approved in adults, and the majority of participants in these studies are adolescents. We hypothesised that adolescent-onset IBD is not fundamentally different from adult-onset IBD. If this is correct, the value of delaying access to novel drugs in adolescents becomes questioned. Methods Data from 11 randomised, double-blind, placebo-controlled, adult Phases 2 and 3 trials of four biologics were analysed. Participants were categorised as having adolescent- or adult-onset disease [diagnosed 12 to <18, or ≥18 years]. Multivariable modelling explored the association between age at diagnosis and response to treatment, after adjustment for disease duration, extent, and severity at baseline. Data from dose arms were pooled to evaluate similarity of therapeutic response between adolescent- and adult-onset IBD within the same trial [not between doses or across trials]. Ratios of odds ratios [ORs] between the two groups were evaluated. Results Data from 6283 study participants (2575 with Crohn's disease [CD], 3708 with ulcerative colitis [UC]) were evaluated. Of 2575 study participants with CD, 325 were 12–<18 years old at diagnosis; 836 participants [32.4%] received placebo. Of 3708 participants with UC, 221 were 12–<18 years old at diagnosis; 1212 [33%] were receiving placebo. The majority of the ratios of ORs were within 2-fold, suggesting that responses in adolescent- and adult-onset participants are generally similar. Conclusion Data presented lend support for extrapolating efficacy of biologics from adults to adolescents with IBD, which would facilitate earlier labelling and patient access. [ABSTRACT FROM AUTHOR]

Published
2024
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13. A Molecular Signature Response Classifier to Predict Inadequate Response to Tumor Necrosis Factor-α Inhibitors: The NETWORK-004 Prospective Observational Study

Author

Cohen, Stanley, Wells, Alvin F., Curtis, Jeffrey R., Dhar, Rajat, Mellors, Theodore, Zhang, Lixia, Withers, Johanna B., Jones, Alex, Ghiassian, Susan D., Wang, Mengran, Connolly-Strong, Erin, Rapisardo, Sarah, Gatalica, Zoran, Pappas, Dimitrios A., Kremer, Joel M., Saleh, Alif, and Akmaev, Viatcheslav R.

Published
2021
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16. A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis

Author

Cohen, Stanley, Beebe, Jean S., Chindalore, Vishala, Guan, Shunjie, Hassan-Zahraee, Mina, Saxena, Madhurima, Xi, Li, Hyde, Craig, Koride, Sarita, Levin, Robert, Lubaczewski, Shannon, Salganik, Mikhail, Sloan, Abigail, Stevens, Erin, Peeva, Elena, Vincent, Michael S., Martin, David A., and Chu, Myron

Published
2024
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17. Eight Weeks of Treatment With Glecaprevir/Pibrentasvir Is Safe and Efficacious in an Integrated Analysis of Treatment-Naïve Patients With Hepatitis C Virus Infection

Author

Zuckerman, Eli, Gutierrez, Julio A., Dylla, Douglas E., de Ledinghen, Victor, Muir, Andrew J., Gschwantler, Michael, Puoti, Massimo, Caruntu, Florin, Slim, Jihad, Nevens, Frederik, Sigal, Samuel, Cohen, Stanley, Fredrick, Linda M., Pires dos Santos, Ana Gabriela, Rodrigues, Lino, Jr., and Dillon, John F.

Published
2020
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19. Real-World Evidence to Contextualize Clinical Trial Results and Inform Regulatory Decisions: Tofacitinib Modified-Release Once-Daily vs Immediate-Release Twice-Daily for Rheumatoid Arthritis

Author

Cohen, Stanley B., Greenberg, Jeffrey D., Harnett, James, Madsen, Ann, Smith, Timothy W., Gruben, David, Zhang, Richard, Lukic, Tatjana, Woolcott, John, Dandreo, Kimberly J., Litman, Heather J., Blachley, Taylor, Lenihan, Anne, Chen, Connie, Rivas, Jose L., and Dougados, Maxime

Published
2021
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21. Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial

Author

Cohen, Stanley B., Radominski, Sebastiao C., Kameda, Hideto, Kivitz, Alan J., Tee, Michael, Cronenberger, Carol, Zhang, Min, Hackley, Sarah, Rehman, Muhammad I., von Richter, Oliver, and Alten, Rieke

Published
2020
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26. Age-of-diagnosis dependent ileal immune intensification and reduced alpha-defensin in older versus younger pediatric Crohn Disease patients despite already established dysbiosis

Author

Haberman, Yael, Schirmer, Melanie, Dexheimer, Phillip J., Karns, Rebekah, Braun, Tzipi, Kim, Mi-Ok, Walters, Thomas D., Baldassano, Robert N., Noe, Joshua D., Rosh, Joel, Markowitz, James, Crandall, Wallace V., Mack, David R., Griffiths, Anne M., Heyman, Melvin B., Baker, Susan S., Kellermayer, Richard, Moulton, Dedrick, Patel, Ashish S., Gulati, Ajay S., Steiner, Steven J., LeLeiko, Neal, Otley, Anthony, Oliva-Hemker, Maria, Ziring, David, Kirschner, Barbara S, Keljo, David J., Guthery, Stephen L., Cohen, Stanley A., Snapper, Scott, Evans, Jonathan, Dubinsky, Marla, Aronow, Bruce, Hyams, Jeffrey S., Kugathasan, Subra, Huttenhower, Curtis, Xavier, Ramnik J., and Denson, Lee A.

Published
2019
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27. Prediction of complicated disease course for children newly diagnosed with Crohn's disease: a multicentre inception cohort study

Author

Kugathasan, Subra, Denson, Lee A, Walters, Thomas D, Kim, Mi-Ok, Marigorta, Urko M, Schirmer, Melanie, Mondal, Kajari, Liu, Chunyan, Griffiths, Anne, Noe, Joshua D, Crandall, Wallace V, Snapper, Scott, Rabizadeh, Shervin, Rosh, Joel R, Shapiro, Jason M, Guthery, Stephen, Mack, David R, Kellermayer, Richard, Kappelman, Michael D, Steiner, Steven, Moulton, Dedrick E, Keljo, David, Cohen, Stanley, Oliva-Hemker, Maria, Heyman, Melvin B, Otley, Anthony R, Baker, Susan S, Evans, Jonathan S, Kirschner, Barbara S, Patel, Ashish S, Ziring, David, Trapnell, Bruce C, Sylvester, Francisco A, Stephens, Michael C, Baldassano, Robert N, Markowitz, James F, Cho, Judy, Xavier, Ramnik J, Huttenhower, Curtis, Aronow, Bruce J, Gibson, Greg, Hyams, Jeffrey S, and Dubinsky, Marla C

Published
2017
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28. A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis.

Author

Baker, Matthew C., Kavanagh, Sarah, Cohen, Stanley, Matsumoto, Alan K., Dikranian, Ara, Tesser, John, Kivitz, Alan, Alataris, Konstantinos, and Genovese, Mark C.

Subjects
RHEUMATOID arthritis treatment, BIOTHERAPY, RHEUMATOID arthritis diagnosis, C-reactive protein, VAGUS nerve, ANTIRHEUMATIC agents, TREATMENT effectiveness, RANDOMIZED controlled trials, BLIND experiment, QUESTIONNAIRES, DESCRIPTIVE statistics, STATISTICAL sampling, DATA analysis software, NEURAL stimulation, TRANSCUTANEOUS electrical nerve stimulation
Abstract

Objective: Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap. Methods: This randomized, double‐blind, sham‐controlled trial enrolled patients aged 18 to 75 years with active RA who had failed conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C‐reactive protein (DAS28‐CRP) and Health Assessment Questionnaire‐Disability Index (HAQ‐DI). Results: A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation versus 26.9% for sham (difference vs. sham, −1.9; 95% CI, −18.8, 14.9, P = 0.823). The least square mean ± SE change in DAS28‐CRP was −0.95 ± 0.16 for active stimulation and −0.66 ± 0.16 for sham (P = 0.201); in HAQ‐DI it was −0.19 ± 0.06 for active stimulation and −0.02 ± 0.06 for sham (P = 0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate. Conclusion: Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility. [ABSTRACT FROM AUTHOR]

Published
2023
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31. The Effect of Early-Life Environmental Exposures on Disease Phenotype and Clinical Course of Crohn’s Disease in Children

Author

Lindoso, Livia, Mondal, Kajari, Venkateswaran, Suresh, Somineni, Hari K., Ballengee, Cortney, Walters, Thomas D., Griffiths, Anne, Noe, Joshua D., Crandall, Wallace, Snapper, Scott, Rabizadeh, Shervin, Rosh, Joel R., LeLeiko, Neal, Guthery, Stephen, Mack, David, Kellermayer, Richard, Gulati, Ajay S., Pfefferkorn, Marian D., Moulton, Dedrick E., Keljo, David, Cohen, Stanley, Oliva-Hemker, Maria, Heyman, Melvin B., Otley, Anthony, Baker, Susan S., Evans, Jonathan S., Kirschner, Barbara S., Patel, Ashish S., Ziring, David, Stephens, Michael C., Baldassano, Robert, Dubinsky, Marla C., Markowitz, James, Denson, Lee A., Hyams, Jeffrey, Kugathasan, Subra, and Ananthakrishnan, Ashwin N.

Published
2018
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34. Spt4 selectively regulates the expression of C9orf72 sense and antisense mutant transcripts

Author

Kramer, Nicholas J., Carlomagno, Yari, Zhang, Yong-Jie, Almeida, Sandra, Cook, Casey N., Gendron, Tania F., Prudencio, Mercedes, Van Blitterswijk, Marka, Belzil, Veronique, Couthouis, Julien, Paul, Joseph West, Goodman, Lindsey D., Daughrity, Lillian, Chew, Jeannie, Garrett, Aliesha, Pregent, Luc, Jansen-West, Karen, Tabassian, Lilia J., Rademakers, Rosa, Boylan, Kevin, Graff-Radford, Neill R., Josephs, Keith A., Parisi, Joseph E., Knopman, David S., Petersen, Ronald C., Boeve, Bradley F., Deng, Ning, Feng, Yanan, Cheng, Tzu-Hao, Dickson, Dennis W., Cohen, Stanley N., Bonini, Nancy M., Link, Christopher D., Gao, Fen-Biao, Petrucelli, Leonard, and Gitler, Aaron D.

Published
2016

36. Variation in Care in the Management of Children With Crohn’s Disease: Data From a Multicenter Inception Cohort Study

Author

Krishnakumar, Chenthan, Ballengee, Cortney R, Liu, Chunyan, Kim, Mi-Ok, Baker, Susan S, Baldassano, Robert N, Cohen, Stanley A, Crandall, Wallace V, Denson, Lee A, Dubinsky, Marla C, Evans, Jonathan, Gokhale, Ranjana, Griffiths, Anne, Guthery, Stephen L, Oliva-Hemker, Maria, Heyman, Melvin B, Keljo, David, Kellermayer, Richard, Leleiko, Neal S, Mack, David R, Markowitz, James F, Moulton, Dedrick E, Noe, Joshua D, Otley, Anthony R, Patel, Ashish S, Pfefferkorn, Marian, Rabizadeh, Shervin, Rosh, Joel R, Snapper, Scott, Walters, Thomas D, Ziring, David, Mondal, Kajari, Kappelman, Michael D, Hyams, Jeffrey S, and Kugathasan, Subra

Published
2019
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39. Biosimilars for Rheumatoid Arthritis: Riding the 2023 Wave [Podcast].

Author

Cohen, Stanley B and Leach, Mariah Z

Subjects
RHEUMATOID arthritis, BIOSIMILARS, ADALIMUMAB
Abstract

This article discusses some of the queries and concerns that patients may have about initiating or switching to treatment with a biosimilar for rheumatoid arthritis following the US 2023 release of several biosimilars of the adalimumab reference product, also known by the brand name, Humira. The article also covers the difference between a generic medicine and a biosimilar, and the clinical evidence to support the safety and efficacy of adalimumab biosimilars in patients with rheumatoid arthritis. [ABSTRACT FROM AUTHOR]

Published
2023
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45. Long ncRNA Landscape in the Ileum of Treatment-Naive Early-Onset Crohn Disease

Author

Haberman, Yael, BenShoshan, Marina, Di Segni, Ayelet, Dexheimer, Phillip J, Braun, Tzipi, Weiss, Batia, Walters, Thomas D, Baldassano, Robert N, Noe, Joshua D, Markowitz, James, Rosh, Joel, Heyman, Melvin B, Griffiths, Anne M, Crandall, Wallace V, Mack, David R, Baker, Susan S, Kellermayer, Richard, Patel, Ashish, Otley, Anthony, Steiner, Steven J, Gulati, Ajay S, Guthery, Stephen L, LeLeiko, Neal, Moulton, Dedrick, Kirschner, Barbara S, Snapper, Scott, Avivi, Camila, Barshack, Iris, Oliva-Hemker, Maria, Cohen, Stanley A, Keljo, David J, Ziring, David, Anikster, Yair, Aronow, Bruce, Hyams, Jeffrey S, Kugathasan, Subra, and Denson, Lee A

Published
2018
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48. Commentary on Cohen et al.: Role of Clinical Factors in Precision Medicine Test to Predict Nonresponse to TNFi Therapies in Rheumatoid Arthritis.

Author

Cohen, Stanley, Curtis, Jeffrey R., Mellors, Theodore, Zhang, Lixia, Withers, Johanna B., Jones, Alex, Ghiassian, Susan D., and Akmaev, Viatcheslav R.

Subjects
*INDIVIDUALIZED medicine, *BODY mass index, *GENE expression
Abstract

A 2021 study described the development and validation of a blood-based precision medicine test called the molecular signature response classifier (MSRC) that uses 23 features to identify rheumatoid arthritis (RA) patients who are likely nonresponders to tumor necrosis factor-α inhibitor (TNFi) therapy. Both the gene expression features and clinical components (sex, body mass index, patient global assessment, and anti-cyclic citrullinated protein) included in the MSRC were statistically significant contributors to MSRC results. In response to continued inquiries on this topic, we write this letter to provide additional insights into the contribution of clinical components to the MSRC on the Network-004 validation cohort. [ABSTRACT FROM AUTHOR]

Published
2023
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49. Increasing liver stiffness is associated with higher incidence of hepatocellular carcinoma in hepatitis C infection and non-alcoholic fatty liver disease–A population-based study.

Author

Davitkov, Perica, Hoffman, Kyle, Falck-Ytter, Yngve, Wilson, Brigid, Stojadinovikj, Gjorgje, Anthony, Donald D., Cohen, Stanley Martin, and Cooper, Gregory

Subjects
FATTY liver, HEPATITIS C, NON-alcoholic fatty liver disease, HEPATOCELLULAR carcinoma, HEPATIC fibrosis
Abstract

Background & aims: Both non-alcoholic fatty liver disease (NAFLD) and hepatitis C virus (HCV) infection commonly result in hepatic fibrosis and may lead to cirrhosis. This study aims to determine the incidence of HCC in patients with HCV or NAFLD complicated by advanced fibrosis, inferred from measurements of liver stiffness. Methods: Using Veterans Affairs (VA) Informatics and Computing Infrastructure (VINCI), we identified a nationwide cohort of patients with an existing diagnosis of HCV or NAFLD with liver transient elastography (TE) testing from 2015 to 2019. HCC cases, along with a random sample of non-HCC patients, were identified and validated, leading to calculation of incidence rates for HCC after adjustment for confounders. Results: 26,161 patients carried a diagnosis of HCV and 13,629 were diagnosed with NAFLD at the time of testing. In those with HCV, rates of HCC increased with liver stiffness with incidences of 0.28 (95% CI 0.24, 0.34), 0.93 (95% CI 0.72, 1.17), 1.28 (95% CI 0.89, 1.79), and 2.79 (95% CI 2.47, 3.14)/100,000 person years for TE score ranges <9.5 kPa, 9.5–12.5 kPa, 12.5–14.5 kPa and >14.5 kPa, respectively, after a median follow-up of 2.3 years. HCC incidence also increased with higher TE liver stiffness measures in NAFLD after a median follow-up of 1.1 years. Conclusion: In this retrospective cohort, the incidence of HCC in HCV and NAFLD increases with higher TE liver stiffness measures, confirming that advanced fibrosis portends risk in viral and non-viral fibrotic liver diseases. Additional comparative studies are needed to determine the optimal cut point of TE liver stiffness to inform HCC screening guidelines and approaches. [ABSTRACT FROM AUTHOR]

Published
2023
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