Effectiveness of biologics in Australian patients with rheumatoid arthritis: a large observational study: REAL

Intern Med J. 2018 Oct;48(10):1185-1192. doi: 10.1111/imj.14028.

Abstract

Background: The comparative effectiveness of biologic treatment regimens in a real world Australian population is unknown.

Aim: To assess the effectiveness of biological disease-modifying anti-rheumatic drugs (bDMARD) as monotherapy or in combination with methotrexate and/or other conventional DMARD (cDMARD) for the treatment of rheumatoid arthritis (RA).

Methods: A retrospective, non-interventional study was conducted that investigated the use of bDMARD in adult patients with RA in routine clinical practice. Data were extracted from the Optimising Patient Outcomes in Australian Rheumatology - Quality Use of Medicines Initiative database. Real-world effectiveness was measured using the 28-joint disease activity score (DAS28) and clinical disease activity index (CDAI) by treatment group at baseline, weeks 12 and 24.

Results: A total of 2970 patients was included with a median (min-max) age of 60.0 (19.0-94.0) years and median (min-max) duration of RA before first bDMARD treatment of 6.0 (0.2-58.3) years. A total of 1177 patients received more than one bDMARD during the analysis period of 1 January 1997 to 15 August 2015. Patients had 4922 treatment 'episodes' (defined as a cycle of continuous individual bDMARD prescribing in a single patient). Patients received a mean (SD) of 1.7 (1.0) episodes of treatment with median (min-max) treatment duration of 0.7 (0-11.8) years; median treatment duration was higher with the first treatment episode. bDMARD were most commonly initiated in combination with methotrexate (73.9% of episodes) and least commonly as monotherapy (9.9% of episodes). Median (min-max) baseline DAS28 decreased from 5.3 (0-8.7) with the first bDMARD to 3.7 (0-8.8) with the second. Median baseline CDAI similarly decreased.

Conclusions: Patients tended to persist longer on their first bDMARD treatment. bDMARD as monotherapy or in combination appear to be accepted treatment strategies in the real world.

Keywords: OPAL-QUMI; biologic DMARD; monotherapy; persistence; rheumatoid arthritis.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / epidemiology
  • Australia / epidemiology
  • Biological Products / therapeutic use*
  • Databases, Factual
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Antirheumatic Agents
  • Biological Products
  • Methotrexate

Grants and funding