Article Text

other Versions

PDF
Concise report
Biologic discontinuation studies: a systematic review of methods
  1. Kazuki Yoshida1,2,
  2. Yoon-Kyoung Sung1,3,
  3. Arthur Kavanaugh4,
  4. Sang-Cheol Bae3,
  5. Michael E Weinblatt1,
  6. Mitsumasa Kishimoto5,
  7. Kazuo Matsui2,
  8. Shigeto Tohma6,
  9. Daniel H Solomon1
  1. 1Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, Massachusetts, USA
  2. 2Department of Rheumatology, Kameda Medical Center, Kamogawa, Chiba Prefecture, Japan
  3. 3Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea
  4. 4Division of Rheumatology, Allergy and Immunology, University of California, San Diego, La Jolla, California, USA
  5. 5Division of Allergy and Rheumatology, St. Luke's International Hospital, Chuo-ku, Tokyo, Japan
  6. 6Department of Rheumatology, Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan
  1. Correspondence to Dr Kazuki Yoshida, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA; kazukiyoshida{at}mail.harvard.edu

Abstract

Objectives We conducted a systematic review to assess the design and ‘failure definition’ in studies of biologic discontinuation in rheumatoid arthritis (RA).

Methods We found 403 studies on PubMed, and included nine published papers and five abstracts from scientific meetings. We used a structured extraction form to collect information regarding study design and outcome (failure) definition.

Results Three types of studies were found: randomised controlled trials, long-term extension studies of clinical trials and prospective discontinuation studies. The largest study had 196 subjects in the discontinuation arm. Most studies allowed concomitant use of non-biologic drugs at biologic discontinuation. Heterogeneity was also found in the failure definition. Although all studies used measures of disease activity, the threshold for failure and the time point of assessment differed among studies. Few studies incorporated changing use of non-biologic drugs or glucocorticoids into the failure definition.

Conclusions Although many studies have examined the outcome of biologic discontinuation, they have all been relatively small. Typical practice studies from registries may add important information but will likely need to rely on a broader failure definition.

  • biologic DMARDs
  • remission
  • discontinuation
  • rheumatoid arthritis

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.