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001-es BibID:	BIBFORM091877
Első szerző:	Fisher, Benjamin
Cím:	Assessment of the anti-CD40 antibody iscalimab in patients with primary Sjögren's syndrome : a multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study / Benjamin A. Fisher, Antonia Szanto, Wan-Fai Ng, Michele Bombardieri, Maximilian G. Posch, Athena S. Papas, Arwa M. Farag, Thomas Daikeler, Bettina Bannert, Diego Kyburz, Alan J. Kivitz, Steven E. Carsons, David A. Isenberg, Francesca Barone, Simon J. Bowman, Pascal Espié, David Floch, Cyrielle Dupuy, Xiaohui Ren, Petra M. Faerber, Andrew M. Wright, Hans-Ulrich Hockey, Michael Rotte, Julie Milojevic, Alexandre Avrameas, Marie-Anne Valentin, James S. Rush, Peter Gergely
Dátum:	2020
ISSN:	2665-9913
Megjegyzések:	Background Primary Sjogren's syndrome is an autoimmune disease that presents as dryness of the mouth and eyes due to impairment of the exocrine glands. To our knowledge, no systemic therapies for primary Sjogren's syndrome have shown efficacy. CD40-CD154-mediated T cell-B cell interactions in primary Sjogren's syndrome contribute to aberrant lymphocyte activation in inflamed tissue, leading to sialadenitis and other tissue injury. Therefore, we investigated the safety and preliminary efficacy of iscalimab (CFZ533), a novel anti-CD40 monoclonal antibody, in patients with primary Sjogren's syndrome. Methods This multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study took place at ten investigational sites across Europe (UK, n=4; Germany, Switzerland, and Hungary, n=1 each) and the USA (n=3). Eligible patients were aged 18-75 years and fulfilled the 2002 American European consensus group diagnostic dassification criteria for primary Sjogren's syndrome. In the double-blind phase of the trial, patients were randomly assigned (2:1) via computer-generated unique randomisation numbers to receive subcutaneous iscalimab (3 mg/kg) or placebo at weeks 0, 2, 4, and 8 (cohort 1) or intravenous iscalimab (10 mg/kg) or placebo at weeks 0, 2, 4, and 8 (cohort 2). Randomisation was stratified according to baseline intake of oral corticosteroids. At week 12, patients in both cohorts received open-label iscalimab (same dose and route) for 12 weeks. The primary objectives of the study were to assess the safety, tolerability, and efficacy of multiple doses of iscalimab in the two sequential dose cohorts. Safety and tolerability were assessed by adverse events and efficacy of iscalimab versus placebo was assessed by dinical disease activity, as measured by the change in European League Against Rheumatism Sjogren's syndrome disease activity index (ESSDAI) score after 12 weeks of treatment. Analyses were done on a per-protocol basis. The trial was registered with ClinicalTrials.gov, NCT02291029. Findings Between Oct 22, 2014, and June 28, 2016, we assessed 82 patients for eligibility (25 for cohort 1 and 57 for cohort 2). 38 patients were excluded because of ineligibility. In cohort 1, 12 patients were randomly assigned to receive either 3 mg/kg doses of iscalimab (n=8) or placebo (n=4), and in cohort 2, 32 patients were randomly assigned to receive either intravenous 10 mg/kg doses of iscalimab (n=21) or placebo (n=11). Adverse events were similar between iscalimab treatment groups and placebo groups, with adverse events occurring in all patients in cohort 1, and in 52% and 64% of the iscalimab and placebo groups, respectively, in cohort 2. Two serious adverse events were reported (one case of bacterial conjunctivitis in cohort 1 and one case of atrial fibrillation in cohort 2), which were unrelated to treatment with iscalimab. Intravenous treatment with iscalimab resulted in a mean reduction of 5.21 points (95% CI 0.96-9.46; one-sided p=0.0090) in ESSDAI score compared with placebo. There was no signficiant difference in ESSDAI score between subcutaneous iscalimab and placebo. Interpretation To our knowledge, this is the first randomised, placebo-controlled proof-of-concept study of a new investigational drug for primary Sjogren's syndrome that indicates preliminary efficacy. Our data suggest a role of CD40-CD154 interactions in primary Sjogren's syndrome pathology and the therapeutic potential for CD40 blockade in this disease should be investigated further. Copyright (C) 2020 Elsevier Ltd. All rights reserved
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk GERMINAL CENTER FORMATION EPITHELIAL-CELLS DISEASE-ACTIVITY EXPRESSION CD40 APOPTOSIS CXCL13
Megjelenés:	The Lancet Rheumatology. - 2 : 3 (2020), p. 142-152. -
További szerzők:	Szántó Antónia (1977-) (belgyógyász, allergológus és klinikai immunológus) Ng, Wan Fai Bombardieri, Michele Posch, Maximilian G. Papas, Athena S. Farag, Arwa M. Daikeler, Thomas Bannert, Bettina Kyburz, Diego Kivitz, Alan J. Carsons, Steven E. Isenberg, David A. Barone, Francesca Bowman, Simon J. Espié, Pascal Floch, David Dupuy, Cyrielle Ren, Xiaohui Faerber, Petra M. Wright, Andrew M. Hockey, Hans-Ulrich Rotte, Michael Milojevic, Julie Avrameas, Alexandre Valentin, Marie-Anne Rush, James S. Gergely Péter (Budapest)
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001-es BibID:	BIBFORM135729
035-os BibID:	(scopus)105009928363 (wos)001505219700001
Első szerző:	Ramos-Casals, Manuel
Cím:	2023 International Rome consensus for the nomenclature of Sjögren disease / Ramos-Casals Manuel, Baer Alan N., Brito-Zerón María del Pilar, Hammitt Katherine M., Bouillot Coralie, Retamozo Soledad, Mackey Alison, Yarowsky David, Turner Breck, Blanck Jaime, Fisher Benjamin A., Akpek Esen K., Baldini Chiara, Bootsma Hendrika, Bowman Simon J., Dörner Thomas, Laing Leslie, Lieberman Scott M., Mariette Xavier, Pflugfelder Stephen C., Sankar Vidya, Sisó-Almirall Antoni, Tzioufas Athanasios G., Anaya Juan-Manuel, Armagan Berkan, Bombardieri Michele, Carsons Steven, de Vita Salvatore, Fox Robert I., Gerli Roberto, Giacomelli Roberto, Gottenberg Jacques-Eric, Hernández-Molina Gabriela, Jonsson Roland, Kruize Aike A., Kwok Seung-Ki, Li Xiaomei, McCoy Sara S., Ng Wan-Fai, Olsson Peter, Rischmueller Maureen, Saraux Alain, Scofield R. Hal, Valim Valéria, Vitali Claudio, Vivino Frederick, Wahren-Herlenius Marie, Moutsopoulos Haralampos M., International Task Force on Nomenclature of Sjögren Disease
Dátum:	2025
ISSN:	1759-4790 1759-4804
Megjegyzések:	Nomenclature for the disease widely known as Sjögren syndrome has proven unsatisfactory. Patients have perceived ♭syndrome' as indicative of a vague collection of symptoms, prompting the Sjögren's Foundation to abandon the term. Furthermore, the traditional distinction between ♭primary' and ♭secondary' forms fails to account for the complex interplay between overlapping autoimmune diseases. Following a bibliometric analysis, systematic literature review and a Delphi consensus process with equal involvement of professional and patient representatives, five recommendations are now issued. First, the term ♭Sjögren disease' should replace ♭Sjögren syndrome'. Second, the acronym ♭SjD' should be used as an abbreviation for ♭Sjögren disease'. Third, the descriptor ♭associated' should be used in lieu of ♭secondary' for Sjögren disease occurring in association with a second systemic autoimmune disease for which classification criteria are fulfilled. Fourth, Sjögren disease is the preferred terminology in common parlance and in clinical diagnosis, without differentiation as to primary and associated forms. Fifth, the differentiation between primary and associated Sjögren is recommended for scientific studies to define a homogeneous population. In conclusion, the consensus endorses ♭Sjögren disease' as the official nomenclature to acknowledge the distinct pathogenesis of this disorder and to improve clarity in both clinical practice and research.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Consensus Delphi Technique Humans Sjogren's Syndrome Terminology as Topic
Megjelenés:	Nature Reviews Rheumatology. - 21 : 7 (2025), p. 426-437. -
További szerzők:	Baer, Alan N. Brito-Zerón, Pilar Hammitt, Katherine M. Bouillot, Coralie Retamozo, Soledad Mackey, Alison Yarowsky, David Turner, Breck Blanck, Jaime Fisher, Benjamin Akpek, Esen K. Baldini, Chiara Bootsma, Hendrika Bowman, Simon J. Dörner, Thomas Laing, Leslie Lieberman, Scott M. Mariette, Xavier Pflugfelder, Stephen C. Sankar, Vidya Sisó-Almirall, Antoni Tzioufas, Athanasios G. Anaya, Juan-Manuel Armagan, Berkan Bombardieri, Michele Carsons, Steven E. Vita, Salvatore de Fox, Robert I. Gerli, Roberto Giacomelli, Roberto Gottenberg, Jacques-Eric Hernandez-Molina, Gabriela Jonsson, Roland Kruize, Aike A. Kwok, Seung-Ki Li, Xiaomei McCoy, Sara S. Ng, Wan Fai Olsson, Peter Rischmueller, Maureen Saraux, Alain Scofield, R. Hal Valim, Valeria Vitali, Claudio Vivino, Frederick Wahren-Herlenius, Marie Moutsopoulos, Haralampos M. Szántó Antónia (1977-) (belgyógyász, allergológus és klinikai immunológus) International Task Force on Nomenclature of Sjögren Disease
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