UMMS Affiliation

Department of Medicine, Division of Rheumatology

Date

10-28-2015

Document Type

Article

Disciplines

Musculoskeletal Diseases | Rheumatology

Abstract

OBJECTIVES: The efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early rheumatoid arthritis (RA).

METHODS: In a double-blind randomised controlled trial (FUNCTION), 1162 methotrexate (MTX)-naive patients with early progressive RA were randomly assigned (1:1:1:1) to one of four treatment groups: 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo and placebo+MTX (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28-erythrocyte sedimentation rate (ESR) < 2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week 52.

RESULTS: The intent-to-treat population included 1157 patients. Significantly more patients receiving 8 mg/kg TCZ+MTX and 8 mg/kg TCZ+placebo than receiving placebo+MTX achieved DAS28-ESR remission at week 24 (45% and 39% vs 15%; p < 0.0001). The 8 mg/kg TCZ+MTX group also achieved significantly greater improvement in radiographic disease progression and physical function at week 52 than did patients treated with placebo+MTX (mean change from baseline in van der Heijde-modified total Sharp score, 0.08 vs 1.14 (p=0.0001); mean reduction in Health Assessment Disability Index, -0.81 vs -0.64 (p=0.0024)). In addition, the 8 mg/kg TCZ+placebo and 4 mg/kg TCZ+MTX groups demonstrated clinical efficacy that was at least as effective as MTX for these key secondary endpoints. Serious adverse events were similar among treatment groups. Adverse events resulting in premature withdrawal occurred in 20% of patients in the 8 mg/kg TCZ+MTX group.

CONCLUSIONS: TCZ is effective in combination with MTX and as monotherapy for the treatment of patients with early RA.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT01007435.

Rights and Permissions

Citation: Ann Rheum Dis. 2015 Oct 28. pii: annrheumdis-2015-207628. doi: 10.1136/annrheumdis-2015-207628. [Epub ahead of print] Link to article on publisher's site

DOI of Published Version

10.1136/annrheumdis-2015-207628

Comments

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Related Resources

Link to Article in PubMed

Keywords

DMARDs (biologic), Early Rheumatoid Arthritis, Methotrexate

Journal Title

Annals of the rheumatic diseases

PubMed ID

26511996

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

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