Literature DB >> 33407817

Clinical outcomes of patients with giant cell arteritis treated with tocilizumab in real-world clinical practice: decreased incidence of new visual manifestations.

Sebastian Unizony1, Timothy J McCulley2, Robert Spiera3, Jinglan Pei4, Paris N Sidiropoulos4, Jennie H Best4, Christine Birchwood4, Andrey Pavlov5, John H Stone6.   

Abstract

BACKGROUND: Placebo-controlled clinical trials have demonstrated the efficacy of tocilizumab (TCZ) for remission maintenance and glucocorticoid sparing in patients with giant cell arteritis (GCA). However, limited data exist on the effectiveness and safety of TCZ for GCA in real-world clinical practice.
METHODS: This was a retrospective, single-center analysis of patients with GCA treated with intravenous or subcutaneous TCZ (2010-2018). Outcomes evaluated before and after TCZ initiation included occurrence of flare, time to flare, annualized flare rate, flare characteristics (i.e., polymyalgia rheumatica [PMR] symptoms, cranial manifestations), prednisone use, and safety. Flare was defined as the recurrence of unequivocal GCA manifestations requiring treatment intensification. Subgroup analyses of patients with PMR or visual manifestations at GCA diagnosis were performed.
RESULTS: Sixty patients with GCA were included. The median (IQR) disease duration before and after the start of TCZ was 0.6 (0.2-1.6) and 0.5 (0.3-1.4) years, respectively. At least 1 flare was observed in 43 patients (71.7%) before and in 18 (30.0%) after TCZ initiation. Median (IQR) time to flare was 0.5 (0.3-0.7) years before TCZ treatment and 2.1 (0.6-2.6) years after TCZ initiation (HR 0.22; 95% CI 0.10-0.50; p = 0.0003). The annualized flare rate significantly decreased following TCZ use (before TCZ 1.4 [95% CI 1.0-2.1]; after TCZ 0.6 [95% CI 0.3-1.0] events/year; p < 0.001). Similar improvements were observed in patients with visual manifestations or PMR symptoms at GCA diagnosis. TCZ reduced the incidence of new visual manifestations, and no flares associated with permanent vision loss occurred while patients were receiving TCZ. Mean (SD) prednisone dose at TCZ onset and at the end of follow-up was 30 (18.3) and 5 (6.9) mg/day, respectively (p < 0.0001). After TCZ initiation, 46.6% of patients successfully discontinued prednisone. The incidence of adverse events, primarily attributed to glucocorticoids, was similar before and after TCZ initiation.
CONCLUSIONS: In this real-world setting, TCZ improved GCA clinical outcomes significantly and demonstrated effectiveness in the subgroups of patients with PMR symptoms and GCA-related visual manifestations at GCA diagnosis. No new cases of blindness occurred after TCZ initiation. Adverse events, many attributable to glucocorticoids, were comparable before and after TCZ treatment.

Entities:  

Keywords:  Giant cell arteritis; Polymyalgia rheumatica; Real-world study; Tocilizumab; Visual manifestations

Mesh:

Substances:

Year:  2021        PMID: 33407817      PMCID: PMC7789742          DOI: 10.1186/s13075-020-02377-8

Source DB:  PubMed          Journal:  Arthritis Res Ther        ISSN: 1478-6354            Impact factor:   5.156


  24 in total

1.  Disease Relapses among Patients with Giant Cell Arteritis: A Prospective, Longitudinal Cohort Study.

Authors:  Tanaz A Kermani; Kenneth J Warrington; David Cuthbertson; Simon Carette; Gary S Hoffman; Nader A Khalidi; Curry L Koening; Carol A Langford; Kathleen Maksimowicz-McKinnon; Carol A McAlear; Paul A Monach; Philip Seo; Peter A Merkel; Steven R Ytterberg
Journal:  J Rheumatol       Date:  2015-04-15       Impact factor: 4.666

2.  Brief Report: A Prospective Open-Label Phase IIa Trial of Tocilizumab in the Treatment of Polymyalgia Rheumatica.

Authors:  Lindsay Lally; Lindsy Forbess; Christopher Hatzis; Robert Spiera
Journal:  Arthritis Rheumatol       Date:  2016-10       Impact factor: 10.995

3.  Successful use of tocilizumab in polymyalgic onset biopsy positive GCA with large vessel involvement.

Authors:  Dimitrios Christidis; Shaifali Jain; Bhaskar Das Gupta
Journal:  BMJ Case Rep       Date:  2011-06-30

4.  Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica.

Authors:  S Unizony; L Arias-Urdaneta; E Miloslavsky; S Arvikar; A Khosroshahi; B Keroack; J R Stone; J H Stone
Journal:  Arthritis Care Res (Hoboken)       Date:  2012-11       Impact factor: 4.794

5.  Predictors of relapse and treatment outcomes in biopsy-proven giant cell arteritis: a retrospective cohort study.

Authors:  Cristian Labarca; Matthew J Koster; Cynthia S Crowson; Ashima Makol; Steven R Ytterberg; Eric L Matteson; Kenneth J Warrington
Journal:  Rheumatology (Oxford)       Date:  2015-09-18       Impact factor: 7.580

6.  Tocilizumab for induction and maintenance of remission in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial.

Authors:  Peter M Villiger; Sabine Adler; Stefan Kuchen; Felix Wermelinger; Diana Dan; Veronika Fiege; Lukas Bütikofer; Michael Seitz; Stephan Reichenbach
Journal:  Lancet       Date:  2016-03-04       Impact factor: 79.321

7.  The association of vascular risk factors with visual loss in giant cell arteritis.

Authors:  Max Yates; Alex J MacGregor; Joanna Robson; Anthea Craven; Peter A Merkel; Raashid A Luqmani; Richard A Watts
Journal:  Rheumatology (Oxford)       Date:  2017-04-01       Impact factor: 7.580

Review 8.  Polymyalgia rheumatica and giant-cell arteritis.

Authors:  Carlo Salvarani; Fabrizio Cantini; Gene G Hunder
Journal:  Lancet       Date:  2008-07-19       Impact factor: 79.321

9.  Flares in Biopsy-Proven Giant Cell Arteritis in Northern Italy: Characteristics and Predictors in a Long-Term Follow-Up Study.

Authors:  Giovanna Restuccia; Luigi Boiardi; Alberto Cavazza; Mariagrazia Catanoso; Pierluigi Macchioni; Francesco Muratore; Luca Cimino; Raffaella Aldigeri; Filippo Crescentini; Nicolò Pipitone; Carlo Salvarani
Journal:  Medicine (Baltimore)       Date:  2016-05       Impact factor: 1.889

10.  Relapses in patients with giant cell arteritis: prevalence, characteristics, and associated clinical findings in a longitudinally followed cohort of 106 patients.

Authors:  Marco A Alba; Ana García-Martínez; Sergio Prieto-González; Itziar Tavera-Bahillo; Marc Corbera-Bellalta; Ester Planas-Rigol; Georgina Espígol-Frigolé; Montserrat Butjosa; José Hernández-Rodríguez; Maria C Cid
Journal:  Medicine (Baltimore)       Date:  2014-07       Impact factor: 1.889

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  10 in total

Review 1.  Large-vessel vasculitis.

Authors:  Dan Pugh; Maira Karabayas; Neil Basu; Maria C Cid; Ruchika Goel; Carl S Goodyear; Peter C Grayson; Stephen P McAdoo; Justin C Mason; Catherine Owen; Cornelia M Weyand; Taryn Youngstein; Neeraj Dhaun
Journal:  Nat Rev Dis Primers       Date:  2022-01-06       Impact factor: 65.038

2.  Patients' Baseline Characteristics, but Not Tocilizumab Exposure, Affect Severe Outcomes Onset in Giant Cell Arteritis: A Real-World Study.

Authors:  Cyril Dumain; Jonathan Broner; Erik Arnaud; Emmanuel Dewavrin; Jan Holubar; Myriam Fantone; Benoit de Wazières; Simon Parreau; Pierre Fesler; Philippe Guilpain; Camille Roubille; Radjiv Goulabchand
Journal:  J Clin Med       Date:  2022-05-31       Impact factor: 4.964

3.  Efficacy and safety of mavrilimumab in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial.

Authors:  Maria C Cid; Sebastian H Unizony; Daniel Blockmans; Elisabeth Brouwer; Lorenzo Dagna; Bhaskar Dasgupta; Bernhard Hellmich; Eamonn Molloy; Carlo Salvarani; Bruce C Trapnell; Kenneth J Warrington; Ian Wicks; Manoj Samant; Teresa Zhou; Lara Pupim; John F Paolini
Journal:  Ann Rheum Dis       Date:  2022-03-09       Impact factor: 19.103

Review 4.  Need and value of targeted immunosuppressive therapy in giant cell arteritis.

Authors:  Maria Sandovici; Niels van der Geest; Yannick van Sleen; Elisabeth Brouwer
Journal:  RMD Open       Date:  2022-02

5.  Tocilizumab for the treatment of giant cell arteritis in Scotland: a report on behalf of the Scottish Society for Rheumatology standards subgroup.

Authors:  Owen Cronin; Hannah Preston; Heba Fahmy; Barbara Kuske; Malinder Singh; Naomi Scott; Sean Kerrigan; Lucy Moran; John Harvie; Helen Harris; Barbara Hauser; Neil D McKay
Journal:  Rheumatol Adv Pract       Date:  2022-03-09

Review 6.  Is Tocilizumab Effective and Safe in Polymyalgia Rheumatica and Giant-Cell Arteritis With Polymyalgia Rheumatica?

Authors:  Michelle Farinango; Akhil Ansary; Amulya Dakka; Zahra Nazir; Humaira Shamim; Marie Jean; Muaaz Umair; Pratyusha Muddaloor; Yeny Chavarria; Safeera Khan
Journal:  Cureus       Date:  2022-08-02

7.  Tocilizumab in visual involvement of giant cell arteritis: a multicenter study of 471 patients.

Authors:  Javier Loricera; Santos Castañeda; Clara Moriano; Javier Narváez; Vicente Aldasoro; Olga Maiz; Rafael Melero; Ignacio Villa; Paloma Vela; Susana Romero-Yuste; José L Callejas; Eugenio de Miguel; Eva Galíndez-Agirregoikoa; Francisca Sivera; Jesús C Fernández-López; Carles Galisteo; Iván Ferraz-Amaro; Julio Sánchez-Martín; Lara Sánchez-Bilbao; Mónica Calderón-Goercke; Alfonso Casado; José L Hernández; Miguel A González-Gay; Ricardo Blanco
Journal:  Ther Adv Musculoskelet Dis       Date:  2022-07-22       Impact factor: 3.625

8.  An Insight into Giant Cell Arteritis Pathogenesis: Evidence for Oxidative Stress and SIRT1 Downregulation.

Authors:  Alessandro Ianni; Poonam Kumari; Shahriar Tarighi; Flavia Rita Argento; Eleonora Fini; Giacomo Emmi; Alessandra Bettiol; Thomas Braun; Domenico Prisco; Claudia Fiorillo; Matteo Becatti
Journal:  Antioxidants (Basel)       Date:  2021-05-31

Review 9.  Advances in the Treatment of Giant Cell Arteritis.

Authors:  Santos Castañeda; Diana Prieto-Peña; Esther F Vicente-Rabaneda; Ana Triguero-Martínez; Emilia Roy-Vallejo; Belén Atienza-Mateo; Ricardo Blanco; Miguel A González-Gay
Journal:  J Clin Med       Date:  2022-03-13       Impact factor: 4.241

10.  Treatment failure in giant cell arteritis.

Authors:  Sebastian H Unizony; Min Bao; Jian Han; Yves Luder; Andrey Pavlov; John H Stone
Journal:  Ann Rheum Dis       Date:  2021-05-28       Impact factor: 19.103

  10 in total

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