Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study
Graeme Jones,Anthony Sebba,Jieruo Gu,Mitchell B. Lowenstein,Armando Calvo,Juan J. Gomez-Reino,Daniel Siri,Matija Tomšič,Emma Alecock,Thasia G. Woodworth,Mark C. Genovese +10 more
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TLDR
Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotRexate or biological agents has not previously failed.Abstract:
Background: The anti-interleukin (IL) 6 receptor antibody tocilizumab inhibits signalling of IL6, a key cytokine in rheumatoid arthritis (RA) pathogenesis. Objective: To evaluate through the AMBITION study the efficacy and safety of tocilizumab monotherapy versus methotrexate in patients with active RA for whom previous treatment with methotrexate/biological agents had not failed. Methods: This 24-week, double-blind, double-dummy, parallel-group study, randomised 673 patients to either tocilizumab 8 mg/kg every 4 weeks, or methotrexate, starting at 7.5 mg/week and titrated to 20 mg/week within 8 weeks, or placebo for 8 weeks followed by tocilizumab 8 mg/kg. The primary end point was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 24. Results: The intention-to-treat analysis demonstrated that tocilizumab was better than methotrexate treatment with a higher ACR20 response (69.9 vs 52.5%; p 3×– Conclusion: Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotrexate or biological agents has not previously failed. Trial registration number: NCT00109408read more
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Patterns of use and dosing of tocilizumab in the treatment of patients with rheumatoid arthritis in routine clinical practice: the ACT-LIFE study
Alejandro Balsa,Juan Víctor Tovar Beltrán,Rafael Cáliz,Isabel Mateo Bernardo,Rosario García-Vicuña,Manuel Rodríguez-Gómez,Miguel Angel Belmonte Serrano,Carlos Marras,Eduardo Loza Cortina,Eva Perez-Pampin,Vicente Vila +10 more
TL;DR: Tocilizumab seems to be more effective for biologics-naive patients than for biologicics-experienced patients, while it proves to be similarly effective when used in combination or monotherapy.
Journal ArticleDOI
Neutropenia During Tocilizumab Treatment Is Not Associated With Infection Risk in Systemic or Polyarticular-Course Juvenile Idiopathic Arthritis
Manuela Pardeo,Jianmei Wang,Nicolino Ruperto,Ekaterina Alexeeva,Vyacheslav Chasnyk,Rayfel Schneider,Gerd Horneff,Hans-Iko Huppertz,Kirsten Minden,Karen Onel,Lawrence S. Zemel,Alan Martin,Isabelle Koné-Paut,Antigoni Siamopoulou-Mavridou,Clovis Arthur Silva,Benjamin Porter-Brown,Kamal N. Bharucha,Hermine I. Brunner,Fabrizio De Benedetti +18 more
TL;DR: Patients with JIA treated with TCZ experienced transient neutropenia that was not associated with an increased number of infections and no increase in rates of serious or nonserious infections was observed during periods of neutropania in either trial.
Journal ArticleDOI
Adverse Events in Giant Cell Arteritis and Rheumatoid Arthritis Patient Populations: Analyses of Tocilizumab Clinical Trials and Claims Data.
Sara Gale,Huong Trinh,Katie Tuckwell,Neil Collinson,John H. Stone,Khaled Sarsour,Jinglan Pei,Jennie H. Best,Christine Birchwood,Shalini V. Mohan +9 more
TL;DR: Higher IRs of AESI were observed in patients with GCA versus those with RA in both TCZ-naïve and -treated cohorts, although the number of events was limited in the GCA trial cohort.
Journal ArticleDOI
Disentangling the effects of tocilizumab on neutrophil survival and function.
Timo Gaber,M. Hahne,C. Strehl,Paula Hoff,Yvonne Dörffel,Eugen Feist,Gerd-Rüdiger Burmester,Frank Buttgereit +7 more
TL;DR: The results suggest that both effects can at least in part be explained by a reduction in neutrophil survival, a dose-dependent inhibition of hypoxia-induced NADPH oxidase-mediated oxidative burst and phagocytosis of infiltrating hypoxic neutrophils and an alteration of mediator secretion.
Journal ArticleDOI
Safety of subcutaneous versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with rheumatoid arthritis
TL;DR: The safety profile of the newer, subcutaneous (SC) formulation of TCZ with the original intravenous (IV) formulation, in combination with traditional disease-modifying antirheumatic drugs (DMARDs) in patients with RA is compared.
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TL;DR: Subcutaneous [corrected] etanercept acted more rapidly to decrease symptoms and slow joint damage in patients with early active rheumatoid arthritis.
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