Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial

Herrath, Matthias von; Bain, Stephen C.; Bode, Bruce W.; Clausen, Jesper O.; Coppieters, Ken; Gaysina, Leylya; Gumprecht, Janusz; Hansen, Troels Krarup; Mathieu, Chantal; Morales, Cristóbal; Mosenzon, Ofri; Segel, Stine; Tsoukas, George; Pieber, Thomas R.; Ludvik, Bernhard; Prager, Rudolf; Paulweber, Bernhard; Ebenbichler, Christoph; Keymeulen, Bart; Block, Christophe De; Grossman, Loren; Houlden, Robyn L.; Perron, Patrice; Ransom, Thomas; Senior, Peter; Weisnagel, S. John; Woo, Vincent; Dumas, R; Thompson, David M.; Vilsbøll, Tina; Gram, Jeppe; Juhl, Claus Bogh; Hukkanen, Janne; Lahtela, Jorma; Niskanen, Leo; O’Shea, Donal; O’Brien, Timothy; Sreenan, Séamus; Wainstein, Julio; Phillip, Moshe; Knobler, Hilla; Dotta, Francesco; Piatti, Pier Marco; Trevisan, Roberto; Gnasso, Agostino; Gulseth, Hanne Løvdal; Cooper, John G.; Pańkowska, Ewa; Łukaszewicz, Monika; Wolnik, Bogumił; Manita, Isabel; Marques, Olinda; Roque, Cristina; Príncipe, Rosa Maria; Neves, Celestino; Heitor, Susana; Ruyatkina, Lyudmila A.; Dvoryashina, I. V.; Vagapova, Gulnar; Belousova, Lidiya; Sergeeva-Kondrachenko, M.; Peskov, A.B.; Frolova, Elena; Головач, А В; Куницына, М. А.; Krasnopeeva, Natalia; Ипатко, И. А.; Cuesta, C.; Tinahones, Francisco J.; Rigla, Mercedes; Merino, Juan Francisco Roldán; Gómez, Luis Alberto; Fernández, Mercè; Simó, Rafael; Rydén, Mikael; Jendle, Johan; Filipsson, Karin; Eliasson, Björn; Mankovsky, B.; Lymar, Iurii; Sokolova, L A; Myshanych, Galyna; Zlova, Tetiana; Vlasenkо, М.V.; Kuskalo, Petro; Courtney, Hamish; Dayan, Colin; English, Patrick; Heller, Simon; Johnson, Andrew B.; Nair, Sunil; Leslie, R. David; Narendran, Parth; Oliver, Nick; Ramtoola, Shenaz; Shaw, J. H. F.; Viljoen, Adie; Al-Karadsheh, Amer; Dostou, Jean M.; Gangi, Sumana; Gottlieb, Peter A.; Jerkins, Terri; Magnotti, Michael; Marks, Jennifer B.; Nakhle, Samer; Bonabi, Gholamreza; Myers, L.; Pratley, Richard E.; Hagopian, William; Pettus, Jeremy; Scholten, Bernt Johan von; Wesley, Johnna D.; Kreiner, Frederik Flindt

doi:10.1016/s2213-8587(21)00019-x

Cited by 114 publications

(53 citation statements)

References 36 publications

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“…Glucagon like peptide-1 receptor agonists (GLP-1 RA) have been explored in people with type 1 diabetes for two indications; the first aimed to ameliorate beta cell decline at the time of diagnosis and there are ongoing trials of this approach. In one study of 308 people with recently diagnosed type 1 diabetes, liraglutide, when used in combination with anti-IL-21, preserved beta cell function [ 255 ]. The second indication is as an adjunctive therapy in established type 1 diabetes by blunting glucagon secretion, decreasing gastric emptying, and promoting satiety and weight loss [ 256 ].…”

Section: Section 13: Adjunctive Therapiesmentioning

confidence: 99%

The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2021

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The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycaemia, behavioural considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that healthcare professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors.

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Section: Section 13: Adjunctive Therapiesmentioning

confidence: 99%

The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2021

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“…Emerging evidence supports this perspective of protection after previous SARS-CoV-2 infection. Several large cohort studies have reported that reinfection is rare, and that the risk of reinfection with SARS-CoV-2 is reduced by 80–95% for at least 5–7 months with no signs of waning immunity [ 17 – 19 ], though protection may be less robust in the elderly [ 20 ]. There are implications to giving broad instruction to everyone and discounting natural immunity, despite a recognized difference in disease risk.…”

Section: Discussionmentioning

confidence: 99%

Knowledge and Attitudes Toward Covid-19 and Vaccines Among a New York Haredi-Orthodox Jewish Community

et al. 2021

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The Covid-19 pandemic has exposed the difficulty of the US public health system to respond effectively to vulnerable subpopulations, causing disproportionate rates of morbidity and mortality. New York Haredi-Orthodox Jewish communities represent a group that have been heavily impacted by Covid-19. Little research has examined their experience or perceptions toward Covid-19 and vaccines. We conducted a cross-sectional, observational study to explore the experience of Covid-19 among Haredim. Paper surveys were self-administered between December 2020 and January 2021 in Haredi neighborhood pediatricians' offices in Brooklyn, New York. Of 102 respondents, 43% reported either a positive SARS-CoV-2 viral or antibody test. Participants trusted their physicians, Orthodox medical organizations, and rabbinic leaders for medical information. Knowledge of Covid-19 transmission and risk was good (69% answered ≥ 4/6 questions correctly). Only 12% of respondents would accept a Covid-19 vaccine, 41% were undecided and 47% were strongly hesitant. Independent predictors of strong vaccine hesitancy included believing natural infection to be better than vaccination for developing immunity (adjusted odds ratio [aOR] 4.28; 95% confidence interval [CI] 1.23-14.86), agreement that prior infection provides a path toward resuming communal life (aOR 4.10; 95% CI 1.22-13.77), and pandemic-related loss of trust in physicians (aOR 5.01; 95% CI 1.05-23.96). The primary disseminators of health information for self-protective religious communities should be stakeholders who understand these groups' unique health needs. In communities with significant Covid-19 experience, vaccination messaging may need to be tailored toward protecting infection-naïve individuals and boosting natural immunity against emerging variants.

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“…When given every 2 weeks as a subcutaneous injection to 84 individuals aged 6-21 years with newly diagnosed T1D, it showed impressive preservation of betacell function and was well tolerated [31]. Anti-IL-21 to inhibit trafficking of CD8+ T cells to pancreatic islets in combination with a glucagon like peptide (GLP-1) agonist to promote beta cell survival (NCT02443155) has also shown potential for benefit [32].…”

Section: Recent Advances In Secondary Prevention Of Type 1 Diabetesmentioning

confidence: 99%

Preventing type 1 diabetes in childhood

Dayan

Besser

Oram

et al. 2021

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Type 1 diabetes (T1D) is an autoimmune disease in which the insulin-producing β cells of the pancreas are destroyed by T lymphocytes. Recent studies have demonstrated that monitoring for pancreatic islet autoantibodies, combined with genetic risk assessment, can identify most children who will develop T1D when they still have sufficient β cell function to control glucose concentrations without the need for insulin. In addition, there has been recent success in secondary prevention using immunotherapy to delay the progression of preclinical disease, and primary prevention approaches to inhibiting the initiating autoimmune process have entered large-scale clinical trials. By changing the focus of T1D management from late diagnosis and insulin replacement to early diagnosis and β cell preservation, we can anticipate a future without the need for daily insulin injections for children with T1D.

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Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial

Cited by 114 publications

References 36 publications

The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

Knowledge and Attitudes Toward Covid-19 and Vaccines Among a New York Haredi-Orthodox Jewish Community

Preventing type 1 diabetes in childhood

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