Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial
Primary result · DAS28 remission by trough level (serial samples weeks 12, 24 and 48)Result — go to the resultOR for DAS28 remission 3.88 95% CI 1.80–8.38Authors' conclusion
Adalimumab trough levels above 4.0 mg/L were associated with remission/low disease activity throughout the first year of adalimumab therapy
Study context
- Population
- TNFi-naïve RA with active disease starting adalimumab, all with concomitant MTX336, 330 and 302 at weeks 12, 24, 48
- Comparison
- Adalimumab trough levels above vs below threshold
- Primary endpoint
- Association of serum adalimumab trough levels with DAS28 remission and low disease activity
Methodological detailsexplorative analyses, longitudinal data, 48-week
- Explorative analyses
- Longitudinal data
- 48-week
Primary result
As reported in the abstract
DAS28 remission by trough level (serial samples weeks 12, 24 and 48)
OR for Disease Activity Score (DAS28) remission
3.88
95% CI 1.80–8.38
P < 0.001
Trough ≥3.9 mg/Lvs Trough <3.9 mg/L
OR for DAS28 remission 3.88 (95% CI 1.80–8.38); P < 0.001
Further findings
| Outcome | Estimate | P value | |
|---|---|---|---|
| DAS28 low disease activity at week 24 by week 12 troughWeek 12 trough ≥3.5 mg/Lvs Week 12 trough <3.5 mg/L | OR for DAS28 low disease activity 2.62 (CI 1.50–4.56) | P < 0.001 | |
| DAS28 remission at week 48 by week 12 troughWeek 12 trough ≥3.5 mg/Lvs Week 12 trough <3.5 mg/L | OR for DAS28 remission 1.99 (CI 1.02–3.88) | P = 0.04 | |
| 0.20.5125Ratio (log scale) |
C reactive protein (CRP) levels by trough level (serial samples weeks 12, 24 and 48)
- Trough levels ≥3.9 mg/L associated with lower CRP levels
- P < 0.001
CRP levels at weeks 24 and 48 by week 12 trough
- Week 12 trough ≥3.5 mg/L associated with lower CRP levels at both time points
- P < 0.001
Original publication
Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial. RMD Open. Published 13 November 2024. doi:10.
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