Literature DB >> 27747515

Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry.

Dimitrios A Pappas1, Ani John2, Jeffrey R Curtis3, George W Reed4,5, Chitra Karki4, Robert Magner5, Joel M Kremer6, Ashwini Shewade2, Jeffrey D Greenberg4,7.   

Abstract

INTRODUCTION: In the United States, the recommended starting dose of intravenous tocilizumab (TCZ) is 4 mg/kg every 4 weeks, with an increase to 8 mg/kg based on clinical response for patients with moderate to severe rheumatoid arthritis; however, data on how TCZ dose is escalated in real life are missing. The objective of this analysis was to describe patterns of early intravenous TCZ dose escalation in a real-world setting using data from the Corrona registry.
METHODS: All patients enrolled in the comparative effectiveness substudy (CERTAIN) nested within Corrona who initiated TCZ and completed 3- and 6-month study visits were eligible for inclusion. Patients who initiated TCZ 4 mg/kg were categorized into 1 of 2 groups: those who remained on TCZ 4 mg/kg at 3 months (Group 1) and those who escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Changes in clinical disease activity measures were provided.
RESULTS: Of the 213 patients who were eligible for analysis, 86 (40.4%) remained on their initial dose of TCZ 4 mg/kg (Group 1) and 110 (51.6%) were escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Baseline demographic and clinical characteristics were similar between the 2 groups; except in Group 2, patients were older (58.3 vs. 54.0 years) and a lower proportion was female (75.5% vs. 89.4%) than in Group 1. Significant improvements in disease activity measures were observed at 3 and 6 months in both groups, with the majority of patients in both groups achieving moderate or good European League Against Rheumatism response.
CONCLUSION: Real-world data demonstrated that physicians escalate TCZ dose at varying frequencies. The ability to administer TCZ in varying doses allows physicians to tailor TCZ therapy to disease activity. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01625650.

Entities:  

Keywords:  Biologic agents; Disease-modifying antirheumatic drugs; Prescribing patterns; Registry; Rheumatoid arthritis; Tocilizumab

Year:  2016        PMID: 27747515      PMCID: PMC4999578          DOI: 10.1007/s40744-016-0028-0

Source DB:  PubMed          Journal:  Rheumatol Ther        ISSN: 2198-6576


  16 in total

Review 1.  2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis.

Authors:  Jasvinder A Singh; Daniel E Furst; Aseem Bharat; Jeffrey R Curtis; Arthur F Kavanaugh; Joel M Kremer; Larry W Moreland; James O'Dell; Kevin L Winthrop; Timothy Beukelman; S Louis Bridges; W Winn Chatham; Harold E Paulus; Maria Suarez-Almazor; Claire Bombardier; Maxime Dougados; Dinesh Khanna; Charles M King; Amye L Leong; Eric L Matteson; John T Schousboe; Eileen Moynihan; Karen S Kolba; Archana Jain; Elizabeth R Volkmann; Harsh Agrawal; Sangmee Bae; Amy S Mudano; Nivedita M Patkar; Kenneth G Saag
Journal:  Arthritis Care Res (Hoboken)       Date:  2012-05       Impact factor: 4.794

Review 2.  The CORRONA database.

Authors:  Joel M Kremer
Journal:  Autoimmun Rev       Date:  2005-08-30       Impact factor: 9.754

3.  Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study.

Authors:  Mark C Genovese; James D McKay; Evgeny L Nasonov; Eduardo F Mysler; Nilzio A da Silva; Emma Alecock; Thasia Woodworth; Juan J Gomez-Reino
Journal:  Arthritis Rheum       Date:  2008-10

4.  Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial.

Authors:  Josef S Smolen; Andre Beaulieu; Andrea Rubbert-Roth; Cesar Ramos-Remus; Josef Rovensky; Emma Alecock; Thasia Woodworth; Rieke Alten
Journal:  Lancet       Date:  2008-03-22       Impact factor: 79.321

5.  Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial.

Authors:  Norihiro Nishimoto; Kazuyuki Yoshizaki; Nobuyuki Miyasaka; Kazuhiko Yamamoto; Shinichi Kawai; Tsutomu Takeuchi; Jun Hashimoto; Junichi Azuma; Tadamitsu Kishimoto
Journal:  Arthritis Rheum       Date:  2004-06

6.  Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY).

Authors:  Maxime Dougados; Karsten Kissel; Tom Sheeran; Paul P Tak; Philip G Conaghan; Emilio Martín Mola; Georg Schett; Howard Amital; Federico Navarro-Sarabia; Antony Hou; Corrado Bernasconi; T W J Huizinga
Journal:  Ann Rheum Dis       Date:  2012-05-05       Impact factor: 19.103

7.  Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study.

Authors:  G Jones; A Sebba; J Gu; M B Lowenstein; A Calvo; J J Gomez-Reino; D A Siri; M Tomsic; E Alecock; T Woodworth; M C Genovese
Journal:  Ann Rheum Dis       Date:  2010-01       Impact factor: 19.103

8.  EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update.

Authors:  Josef S Smolen; Robert Landewé; Ferdinand C Breedveld; Maya Buch; Gerd Burmester; Maxime Dougados; Paul Emery; Cécile Gaujoux-Viala; Laure Gossec; Jackie Nam; Sofia Ramiro; Kevin Winthrop; Maarten de Wit; Daniel Aletaha; Neil Betteridge; Johannes W J Bijlsma; Maarten Boers; Frank Buttgereit; Bernard Combe; Maurizio Cutolo; Nemanja Damjanov; Johanna M W Hazes; Marios Kouloumas; Tore K Kvien; Xavier Mariette; Karel Pavelka; Piet L C M van Riel; Andrea Rubbert-Roth; Marieke Scholte-Voshaar; David L Scott; Tuulikki Sokka-Isler; John B Wong; Désirée van der Heijde
Journal:  Ann Rheum Dis       Date:  2013-10-25       Impact factor: 19.103

9.  "Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients".

Authors:  Dimitrios A Pappas; Joel M Kremer; George Reed; Jeffrey D Greenberg; Jeffrey R Curtis
Journal:  BMC Musculoskelet Disord       Date:  2014-04-01       Impact factor: 2.362

10.  IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial.

Authors:  P Emery; E Keystone; H P Tony; A Cantagrel; R van Vollenhoven; A Sanchez; E Alecock; J Lee; J Kremer
Journal:  Ann Rheum Dis       Date:  2008-07-14       Impact factor: 19.103

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  3 in total

Review 1.  A Review of Recent Advances Using Tocilizumab in the Treatment of Rheumatic Diseases.

Authors:  Andrea Rubbert-Roth; Daniel E Furst; Jan Michael Nebesky; Angela Jin; Erhan Berber
Journal:  Rheumatol Ther       Date:  2018-03-03

2.  Real-World Dose Modification Patterns of Subcutaneous Tocilizumab Among Patients with Rheumatoid Arthritis.

Authors:  Rajeshwari Punekar; Jeannie Choi; Susan Boklage; Melitza Iglesias-Rodriguez; Kamala Nola
Journal:  Am Health Drug Benefits       Date:  2019-12

3.  Budget impact analysis of sarilumab for the treatment of rheumatoid arthritis in patients with an inadequate response to conventional synthetic DMARD or TNF inhibitor therapies.

Authors:  Cheryl P Ferrufino; Julie Munakata; Wenhui Wei; Clare Proudfoot; Andreas Kuznik; Susan H Boklage; Chieh-I Chen
Journal:  Clinicoecon Outcomes Res       Date:  2018-11-16
  3 in total

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