Adalimumab serum concentration to choose a subsequent biological DMARD in patients with rheumatoid arthritis (ADDORA-switch): results of a blinded randomised test-treatment trial
Authors' conclusion
Switching treatments based on adalimumab trough levels was not more effective than random switching in patients with RA who failed adalimumab treatment.
Study context
- Population
- Patients with rheumatoid arthritis (RA) who stopped adalimumab due to inefficacy (DAS28-CRP >2.9)78 initiated a new b/tsDMARD
- Participants
- 83 patients
- Comparison
- Therapeutic drug monitoring (TDM)-based switching vs random switching
- TDMn = 38
- Controln = 40reference
- Primary endpoint
- Difference in mean time-weighted DAS28-CRP between groups
- Follow-up
- 24 weeks
Methodological detailsmulticentre, triple-blinded, 1:1 randomisation, test-treatment, Enrolment July 2020 to November 2023
- Multicentre
- Triple-blinded
- 1:1 randomisation
- Test-treatment
- Enrolment July 2020 to November 2023
Primary result
As reported in the abstract
Mean time-weighted DAS28-CRP
TDM
3.15
mean · SD 0.99
Control
3.15
mean · SD 1.01
95% CI −0.46 to 0.47
Further findings
Flare rates, escape medication use, disease activity
- No significant differences between the groups
Predictive value of adalimumab levels for response to tumour necrosis factor inhibitor (TNFi) or non-TNFi (ROC analyses, control group)
- No predictive value found
Original publication
Adalimumab serum concentration to choose a subsequent biological DMARD in patients with rheumatoid arthritis (ADDORA-switch): results of a blinded randomised test-treatment trial. Ann Rheum Dis. Published 3 May 2025. doi:10.
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