Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study
Objectives In this large multicentre study, we compared the effectiveness and safety of tocilizumab intravenous versus subcutaneous (SC) in 109 Takayasu arteritis (TAK) patients.Methods We conducted a retrospective multicentre study in referral centres from France, Italy, Spain, Armenia, Israel, Jap...
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2023-06-01
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| author | Patrice Cacoub Arsène Mekinian David Saadoun Pavel I Novikov Savino Sciascia Corrado Campochiaro Olivier Fain Ilya Smitienko Nicolas Schleinitz Patrick Jégo Francesco Muratore Carlo Salvarani Elena Galli Sabine Berthier Marc Lambert François Maurier Isabelle Kone-Paut Sergey Moiseev Masataka Kuwana Alexandre Belot Martin Michaud Francis Gaches Achille Aouba Xavier Puechal Karim Sacre Tiphaine Goulenok Alessandro Tomelleri Thomas Sené Elena Marina Baldissera Luigi Boiardi Abid Awisat Ygal Benhamou Vahan Mukuchyan Mathieu Vautier Azeddine Dellal Lucie Biard Julie Seguier José Hernández-Rodríguez Olivier Espitia Sebastien Humbert Guillaume Denis Nolan Hassold Dagna Lorenzo Helene Munoz Pons Jean Baptiste Gaultier Le Mouel Edwige Antoinette Perlat Bertrand Lioger Jonathan Broner Virginie Dufrost Faten Frikha Alexandra Audemard-Verger Pascal Woaye-Hune Pierre Zeminsky Moya Alvarado Matheus Vieira Alberto Lo Gullo |
| author_facet | Patrice Cacoub Arsène Mekinian David Saadoun Pavel I Novikov Savino Sciascia Corrado Campochiaro Olivier Fain Ilya Smitienko Nicolas Schleinitz Patrick Jégo Francesco Muratore Carlo Salvarani Elena Galli Sabine Berthier Marc Lambert François Maurier Isabelle Kone-Paut Sergey Moiseev Masataka Kuwana Alexandre Belot Martin Michaud Francis Gaches Achille Aouba Xavier Puechal Karim Sacre Tiphaine Goulenok Alessandro Tomelleri Thomas Sené Elena Marina Baldissera Luigi Boiardi Abid Awisat Ygal Benhamou Vahan Mukuchyan Mathieu Vautier Azeddine Dellal Lucie Biard Julie Seguier José Hernández-Rodríguez Olivier Espitia Sebastien Humbert Guillaume Denis Nolan Hassold Dagna Lorenzo Helene Munoz Pons Jean Baptiste Gaultier Le Mouel Edwige Antoinette Perlat Bertrand Lioger Jonathan Broner Virginie Dufrost Faten Frikha Alexandra Audemard-Verger Pascal Woaye-Hune Pierre Zeminsky Moya Alvarado Matheus Vieira Alberto Lo Gullo |
| author_sort | Patrice Cacoub |
| collection | DOAJ |
| description | Objectives In this large multicentre study, we compared the effectiveness and safety of tocilizumab intravenous versus subcutaneous (SC) in 109 Takayasu arteritis (TAK) patients.Methods We conducted a retrospective multicentre study in referral centres from France, Italy, Spain, Armenia, Israel, Japan, Tunisia and Russia regarding biological-targeted therapies in TAK, since January 2017 to September 2019.Results A total of 109 TAK patients received at least 3 months tocilizumab therapy and were included in this study. Among them, 91 and 18 patients received intravenous and SC tocilizumab, respectively. A complete response (NIH <2 with less than 7.5 mg/day of prednisone) at 6 months was evidenced in 69% of TAK patients, of whom 57 (70%) and 11 (69%) patients were on intravenous and SC tocilizumab, respectively (p=0.95). The factors associated with complete response to tocilizumab at 6 months in multivariate analysis, only age <30 years (OR 2.85, 95% CI 1.14 to 7.12; p=0.027) and time between TAK diagnosis and tocilizumab initiation (OR 1.18, 95% CI 1.02 to 1.36; p=0.034). During the median follow-up of 30.1 months (0.4; 105.8) and 10.8 (0.1; 46.4) (p<0.0001) in patients who received tocilizumab in intravenous and SC forms, respectively, the risk of relapse was significantly higher in TAK patients on SC tocilizumab (HR=2.55, 95% CI 1.08 to 6.02; p=0.033). The overall cumulative incidence of relapse at 12 months in TAK patients was at 13.7% (95% CI 7.6% to 21.5%), with 10.3% (95% CI 4.8% to 18.4%) for those on intravenous tocilizumab vs 30.9% (95% CI 10.5% to 54.2%) for patients receiving SC tocilizumab. Adverse events occurred in 14 (15%) patients on intravenous route and in 2 (11%) on SC tocilizumab.Conclusion In this study, we confirm that tocilizumab is effective in TAK, with complete remission being achieving by 70% of disease-modifying antirheumatic drugs-refractory TAK patients at 6 months. |
| format | Article |
| id | doaj-art-516d057fd503452483e4b0dac563dcdb |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2023-06-01 |
| publisher | BMJ Publishing Group |
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| series | RMD Open |
| spelling | doaj-art-516d057fd503452483e4b0dac563dcdb2025-02-06T21:15:09ZengBMJ Publishing GroupRMD Open2056-59332023-06-019210.1136/rmdopen-2022-002830Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective studyPatrice Cacoub0Arsène Mekinian1David Saadoun2Pavel I Novikov3Savino Sciascia4Corrado Campochiaro5Olivier Fain6Ilya Smitienko7Nicolas Schleinitz8Patrick Jégo9Francesco Muratore10Carlo Salvarani11Elena Galli12Sabine Berthier13Marc Lambert14François Maurier15Isabelle Kone-Paut16Sergey Moiseev17Masataka Kuwana18Alexandre Belot19Martin Michaud20Francis Gaches21Achille Aouba22Xavier Puechal23Karim Sacre24Tiphaine Goulenok25Alessandro Tomelleri26Thomas Sené27Elena Marina Baldissera28Luigi Boiardi29Abid Awisat30Ygal Benhamou31Vahan Mukuchyan32Mathieu Vautier33Azeddine Dellal34Lucie Biard35Julie Seguier36José Hernández-Rodríguez37Olivier Espitia38Sebastien Humbert39Guillaume Denis40Nolan Hassold41Dagna Lorenzo42Helene Munoz Pons43Jean Baptiste Gaultier44Le Mouel Edwige45Antoinette Perlat46Bertrand Lioger47Jonathan Broner48Virginie Dufrost49Faten Frikha50Alexandra Audemard-Verger51Pascal Woaye-Hune52Pierre Zeminsky53Moya Alvarado54Matheus Vieira55Alberto Lo Gullo56Department of Internal Medicine and Clinical Immunology, Centre National de Références Maladies Autoimmunes et Systémiques Rares, Centre National de Références Maladies Autoinflammatoires Rares et Amylose Inflammatoire and INSERM, UMR S 959, Immunology- Immunopathology-Immunotherapy, Sorbonne Universités, AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Paris, FranceSorbonne Université, service de médecine interne, Hôpital Saint-Antoine, AP-HP, Paris, FranceDepartment of Internal Medicine and Clinical Immunology, Centre National de Références Maladies Autoimmunes et Systémiques Rares, Centre National de Références Maladies Autoinflammatoires Rares et Amylose Inflammatoire and INSERM, UMR S 959, Immunology- Immunopathology-Immunotherapy, Sorbonne Universités, AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Paris, FranceTareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russian FederationUniversity Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases (ERK-Net, ERN-Reconnect and RITA-ERN Member), Nephrology and Dialysis Unit and Center of Immuno-Rheumatology and Rare Diseases (CMID), Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, ASL Città di Torino and Department of Clinical and Biological Sciences, Turin, Italy, University of Turin, Torino, Piemonte, ItalyUnit of Immunology, Rheumatology, Allergy ad Rre Disesaes. IRCCS San Raffaele Hospital. Vita-Salute Vita-Salute San Raffaele University, Milan, ItalySorbonne Université, service de médecine interne, Hôpital Saint-Antoine, AP-HP, Paris, FranceRheumatology Department, Medical Center K-31, Moscow, Russian Federation8 Médecine interne, Aix-Marseille Universite, Hôpital de la Timone, Marseille, FranceInternal Medicine and Clinical Immunology Department, CHU Rennes, Universitaire de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, Rennes, FranceUnit of Rheumatology, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy13 Rheumatology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, ItalyUniv Rennes, CHU Rennes, Inserm, LTSI – UMR 1099, Rennes, FranceService de médecine interne et immunologie clinique, Université Dijon, Hôpital Dijon, Dijon, France20 Internal Medicine, CHU Lille, Lille, France11 Department of Internal Medicine, Hôpitaux Privés de Metz, Metz, France3 French National Reference Center for Autoinflammatory Diseases (CEREMAIA), Le Kremlin-Bicêtre, FranceTareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russian Federation1 Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, JapanService de pédiatrie et immunologie clinique, Université Lyon, Hôpital Lyon, Lyon, FranceMédecine Interne, Hôpital Joseph Ducuing, Toulouse, FranceMédecine Interne, Hôpital Joseph Ducuing, Toulouse, FranceDepartment of Internal Medicine, University Hospital Centre Caen, Caen, Basse-Normandie, FranceNational Referral Center for Rare Systemic Autoimmune Diseases, Hospital Cochin, Paris, Île-de-France, France1 Médecine Interne, Hôpital Bichat, AP-HP, Paris, FranceService de Médecine Interne, Hôpital Bichat-Claude Bernard, Assistance Publique Hôpitaux de Paris, Université de Paris, Paris, France56 Unit of Immunology, Rheumatology, Allergy and Rare Diseases, San Raffaele Scientific Institute, Milan, Italy6Rothschild Ophtalmologic Fondation, Internal medicine, Paris, FranceUnit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, ItalyUnit of Rheumatology, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, ItalyBnai-zion medical center, Haifa, IsraelService de médecine interne, Université Rouen, CHU de Rouen, Rouen, FranceDepartment of Internal Medicine and Rheumatology, Nairi hospital, Erevan, ArmeniaDepartment of Internal Medicine and Clinical Immunology, Centre National de Références Maladies Autoimmunes et Systémiques Rares, Centre National de Références Maladies Autoinflammatoires Rares et Amylose Inflammatoire and INSERM, UMR S 959, Immunology- Immunopathology-Immunotherapy, Sorbonne Universités, AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Paris, FranceService de rhumatologie, Hôpital Montfermeil, GHI Le Raincy Montfermeil, Montfermeil, FranceDepartment of Biostatistics and Medical Information, CRESS UMR 1153, INSERM, ECSTRRA Team, Saint-Louis University Hospital, AP-HP, University of Paris, Paris, France5 Département de Médecine Interne, Hôpital de la Timone, Marseille, FranceDepartment of Autoimmune Diseases, Reference Centre for Systemic Autoimmune Diseases, Vasculitis and Autoinflammatory Diseases (UEC/CSUR) of the Catalan and Spanish Health Systems. Member of ERN-ReCONNET/RITA. Hospital Clínic de Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Catalonia, SpainDepartement of internal and vascular medicine, CHU Nantes, Nantes, Pays de la Loire, FranceDepartment of Internal Medicine, Centre Hospitalier Universitaire de Besancon, Besancon, Bourgogne-Franche-Comté, France22 Médecine interne et hématologie, Centre Hospitalier de Rochefort, Rochefort, FranceService de Rhumatologie pédiatrique et centre de référence des maladies autoinflammatoires et de l`amylose inflammatoire, CEREMAIA, hôpital de Bicêtre, APHP, France, université de Paris Sud-Saclay, Paris, FranceUnit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, ItalyDépartement de médecine interne, CHU Saint Etienne, Saint-Etienne, FranceService de Médecine Interne, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, Auvergne-Rhône-Alpes, FranceInternal Medicine and Clinical Immunology Department, CHU Rennes, Universitaire de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, Rennes, FranceInternal Medicine and Clinical Immunology Department, CHU Rennes, Universitaire de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, Rennes, FranceService de médecine interne, CHU de Blois, Blois, FranceInternal Medicine Department, University Hospital Centre Nimes, Nimes, FranceVascular Medicine Division and Regional Competence Center for Rare Vascular and Systemic Autoimmune Diseases, University of Lorraine, Inserm UMR_S 1116, CHRU de Nancy, Nancy, FranceService de Médecine interne CHU Hédi Chaker, Route El Ain 3029 Sfax -Faculté de Médecine de Sfax, Sfax, TunisiaDepartment of Internal Medicine and Clinical Immunology, CHRU Tours, University of Tours, Tours, FranceService de Médecine interne, CHD Vendée, La Roche-sur-Yon, FranceVascular Medicine Division and Regional Competence Center for Rare Vascular and Systemic Autoimmune Diseases, University of Lorraine, Inserm UMR_S 1116, CHRU de Nancy, Nancy, FranceAzienda USL-IRCCS; Division of Rheumatology, Azienda USL-IRCCS di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, ItalyDépartement de Médecine Interne et Immunologie Clinique, Centre National de Référence Maladies Auto-immunes Systémiques Rares, Centre National de Référence Maladies Auto-inflammatoires et Amylose Inflammatoire, Hôpital Universitaire Pitié-Salpêtrière, Paris, FranceUOSD Reumatologia ARNAS Garibaldi, Catania, ItalyObjectives In this large multicentre study, we compared the effectiveness and safety of tocilizumab intravenous versus subcutaneous (SC) in 109 Takayasu arteritis (TAK) patients.Methods We conducted a retrospective multicentre study in referral centres from France, Italy, Spain, Armenia, Israel, Japan, Tunisia and Russia regarding biological-targeted therapies in TAK, since January 2017 to September 2019.Results A total of 109 TAK patients received at least 3 months tocilizumab therapy and were included in this study. Among them, 91 and 18 patients received intravenous and SC tocilizumab, respectively. A complete response (NIH <2 with less than 7.5 mg/day of prednisone) at 6 months was evidenced in 69% of TAK patients, of whom 57 (70%) and 11 (69%) patients were on intravenous and SC tocilizumab, respectively (p=0.95). The factors associated with complete response to tocilizumab at 6 months in multivariate analysis, only age <30 years (OR 2.85, 95% CI 1.14 to 7.12; p=0.027) and time between TAK diagnosis and tocilizumab initiation (OR 1.18, 95% CI 1.02 to 1.36; p=0.034). During the median follow-up of 30.1 months (0.4; 105.8) and 10.8 (0.1; 46.4) (p<0.0001) in patients who received tocilizumab in intravenous and SC forms, respectively, the risk of relapse was significantly higher in TAK patients on SC tocilizumab (HR=2.55, 95% CI 1.08 to 6.02; p=0.033). The overall cumulative incidence of relapse at 12 months in TAK patients was at 13.7% (95% CI 7.6% to 21.5%), with 10.3% (95% CI 4.8% to 18.4%) for those on intravenous tocilizumab vs 30.9% (95% CI 10.5% to 54.2%) for patients receiving SC tocilizumab. Adverse events occurred in 14 (15%) patients on intravenous route and in 2 (11%) on SC tocilizumab.Conclusion In this study, we confirm that tocilizumab is effective in TAK, with complete remission being achieving by 70% of disease-modifying antirheumatic drugs-refractory TAK patients at 6 months.https://rmdopen.bmj.com/content/9/2/e002830.full |
| spellingShingle | Patrice Cacoub Arsène Mekinian David Saadoun Pavel I Novikov Savino Sciascia Corrado Campochiaro Olivier Fain Ilya Smitienko Nicolas Schleinitz Patrick Jégo Francesco Muratore Carlo Salvarani Elena Galli Sabine Berthier Marc Lambert François Maurier Isabelle Kone-Paut Sergey Moiseev Masataka Kuwana Alexandre Belot Martin Michaud Francis Gaches Achille Aouba Xavier Puechal Karim Sacre Tiphaine Goulenok Alessandro Tomelleri Thomas Sené Elena Marina Baldissera Luigi Boiardi Abid Awisat Ygal Benhamou Vahan Mukuchyan Mathieu Vautier Azeddine Dellal Lucie Biard Julie Seguier José Hernández-Rodríguez Olivier Espitia Sebastien Humbert Guillaume Denis Nolan Hassold Dagna Lorenzo Helene Munoz Pons Jean Baptiste Gaultier Le Mouel Edwige Antoinette Perlat Bertrand Lioger Jonathan Broner Virginie Dufrost Faten Frikha Alexandra Audemard-Verger Pascal Woaye-Hune Pierre Zeminsky Moya Alvarado Matheus Vieira Alberto Lo Gullo Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study RMD Open |
| title | Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study |
| title_full | Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study |
| title_fullStr | Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study |
| title_full_unstemmed | Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study |
| title_short | Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study |
| title_sort | intravenous versus subcutaneous tocilizumab in takayasu arteritis multicentre retrospective study |
| url | https://rmdopen.bmj.com/content/9/2/e002830.full |
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