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

Kimberly Velthuis*, Naomi T. Jessurun, Thi D.M. Nguyen, Joep Scholl, Jurriaan R.G. Jansen, Jette A. van Lint, Leanne J. Kosse, Peter M. ten Klooster, Harald E. Vonkeman

*Corresponding author for this work

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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.

Original languageEnglish
Pages (from-to)485-492
Number of pages8
JournalExpert opinion on drug safety
Issue number6
Early online date27 Jan 2023
Publication statusPublished - 3 Jun 2023


  • adverse drug reactions
  • bDMARDs
  • biologicals
  • drug survival
  • real-world data
  • Rheumatoid arthritis
  • 2023 OA procedure

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