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Rheumatoid arthritis
Original article
Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials
  1. Vibeke Strand1,
  2. Margaret Michalska2,
  3. Christine Birchwood2,
  4. Jinglan Pei2,
  5. Katie Tuckwell3,
  6. Rebecca Finch9,
  7. Cem Gabay10,
  8. Arthur Kavanaugh11 and
  9. Graeme Jones12
  1. 1 Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA
  2. 2 US Medical Affairs, Immunology, Genentech, Inc., South San Francisco, California, USA
  3. 3 gRED Early Clinical Development, OMNI, Genentech, Inc., South San Francisco, California, USA
  4. 9 PDBB-Biostatistics, Roche, Welwyn Garden City, UK
  5. 10 Division of Rheumatology, Geneva University Hospitals, Geneva, Switzerland
  6. 11 Division of Rheumatology, Allergy and Immunology, University of California San Diego, La Jolla, California, USA
  7. 12 Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia
  1. Correspondence to Professor Graeme Jones; graeme.jones{at}utas.edu.au

Abstract

Objective Two randomised controlled trials, AMBITION (NCT00109408) and ADACTA (NCT01119859), showed tocilizumab (TCZ) monotherapy superior to methotrexate (MTX) and adalimumab (ADA) monotherapy, respectively, for improving rheumatoid arthritis (RA) disease activity. This study compared the benefit of TCZ versus MTX or ADA monotherapy for improving patient-reported outcomes (PROs) in patients with RA.

Methods PROs included patient global assessment (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue and Short Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) and eight domain scores. Outcomes included proportions of patients reporting changes from baseline in PRO scores ≥minimum clinically important differences (MCID) and ≥age-matched and gender-matched normative values at 24 weeks.

Results In AMBITION, TCZ-treated patients reported significantly greater mean improvements in HAQ (−0.7 vs −0.5), FACIT-Fatigue (8.7 vs 5.7), SF-36 PCS (9.8 vs 7.8) and five SF-36 domains at week 24 than with MTX; 45.0%–84.0% of TCZ-treated patients reported improvements ≥MCID, and 24.3%–52.1% reported scores ≥normative values across all PROs versus 39.4%–81.8% and 14.5%–45.0%, respectively, with MTX. In ADACTA, TCZ-treated patients reported significantly greater improvements in PtGA (−42.3 vs −31.8), pain (−40.1 vs −28.7), SF-36 MCS (7.9 vs 5.0) and three SF-36 domains than with ADA; 57.7%–83.3% of TCZ-treated patients reported improvements ≥MCID, and 22.1%–49.3% reported scores ≥normative values across all PROs versus 13.6%–37.8%, respectively, with ADA.

Conclusions TCZ monotherapy resulted in more patients reporting clinically meaningful PRO improvements and PRO scores ≥normative values compared with MTX or ADA monotherapy.

Trial registration numbers NCT00109408 and NCT01119859; Post-results.

  • monotherapy
  • patient-reported outcomes
  • rheumatoid arthritis
  • tocilizumab

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/

https://doi.org/10.1136/rmdopen-2017-000496

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    Footnotes

    • Contributors All authors were involved in the study design and/or collection, analysis and interpretation of the data, provided critical revision of the manuscript and approved the final version to be submitted for publication.

    • Funding This study was funded by F. Hoffmann-La Roche Ltd/Genentech, Inc.

    • Competing interests VS has received consulting fees from AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Ltd/Genentech, Inc., GSK, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sanofi and UCB. MM, CB, JP and KT are employees of Genentech, Inc. RF is an employee and shareholder of F. Hoffmann-La Roche Ltd. CG has received research grants and consulting fees from AB2 Bio, AbbVie, Actelion, BMS, Debiopharm, MSD, Novartis, Pfizer, Regeneron, F. Hoffmann-La Roche Ltd, Sanofi and UCB. AK is a consultant for F. Hoffmann-La Roche Ltd/Genentech, Inc. GJ serves as a speaker, consultant or clinical trialist for Sanofi, AbbVie, Janssen, Pfizer, F. Hoffmann-La Roche Ltd, Eli Lilly, Amgen, BMS and UCB.

    • Ethics approval The AMBITION and ADACTA study protocols were approved by an ethics committee or institutional review board at each participating center before the start of the study.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.