First-time adverse drug reactions, survival analysis, and the share of adverse drug reactions in treatment discontinuation in real-world rheumatoid arthritis patients: a comparison of first-time treatment with adalimumab and etanercept

Expert Opin Drug Saf. 2023 Jan-Jun;22(6):485-492. doi: 10.1080/14740338.2023.2172157. Epub 2023 Jan 27.

Abstract

Background: This study aims to compare nature and frequency of adverse drug reactions (ADRs), time to first ADR, drug survival, and the share of ADRs in treatment discontinuation of first-time treatment with adalimumab (ADA) and etanercept (ETN) in real-world RA patients.

Research design and methods: Retrospective, single-center cohort study including naïve patients treated between January 2003-April 2020. Time to first ADR and drug survival of first-time treatment were studied using Kaplan-Meier and Cox-regression models up to 10 years, with 2- and 5-year post-hoc sensitivity analysis. Nature and frequencies of first-time ADRs and causes of treatment discontinuation were assessed.

Results: In total, 416 patients (ADA: 255, ETN: 161, 4865 patient years) were included, of which 92 (22.1%) experienced ADR(s) (ADA: 59, 23.1%; ETN: 33, 20.4%). Adjusted for age, gender and concomitant conventional DMARD use, ADA was more likely to be discontinued than ETN up to 2-, 5- and 10-year follow-up (adjusted HRs 1.63; 1.62; 1.59 (all p<0.001)). ADRs were the second reason of treatment discontinuation (ADA 20.7%, ETN 21.4%).

Conclusions: Despite seemingly different nature and frequencies, ADRs are the second reason of treatment discontinuation for both bDMARDs. Furthermore, 2-, 5-, and 10-year drug survival is longer for ETN compared to ADA.

Keywords: Rheumatoid arthritis; adverse drug reactions; bDMARDs; biologicals; drug survival; real-world data.

MeSH terms

  • Adalimumab / adverse effects
  • Antirheumatic Agents* / adverse effects
  • Arthritis, Rheumatoid* / drug therapy
  • Cohort Studies
  • Drug-Related Side Effects and Adverse Reactions*
  • Etanercept / adverse effects
  • Humans
  • Retrospective Studies
  • Survival Analysis
  • Treatment Outcome

Substances

  • Etanercept
  • Adalimumab
  • Antirheumatic Agents