Favourable effect of a ‘second hit’ after 13 weeks in early RA non-responders: the Amsterdam COBRA treat-to-target randomized trial
Primary result · Target (DAS44 < 1.6 or EULAR good response) in high-risk 13-week non-respondersResult — go to the resultDifference 36% 95% CI 2%–71%Authors' conclusion
Initial combination therapy was very successful in high-risk RA, and early intensification was beneficial in patients not reaching the strict target.
Study context
- Population
- Early RA patients classified as high or low risk of worsening RA by disease activity and prognostic factorshigh-risk n = 150
- Participants
- 15 / 16 / 8 / 7
- Comparison
- Intensification vs continuation of initial therapy in non-responders at 13 weeks
- Intensification (high-risk)n = 15
- Continuation (high-risk)n = 16reference
- Intensification (low-risk)n = 8
- Continuation (low-risk)n = 7reference
- Primary endpoint
- DAS44 < 1.6 or EULAR good response (target)
- Follow-up
- 26 weeks
Methodological detailsopen-label, treat-to-target, randomisation of 13-week non-responders, Protocol violations were frequent and mostly led to mitigation of actual treatment intensification
- Open-label
- Treat-to-target
- Randomisation of 13-week non-responders
- Protocol violations were frequent and mostly led to mitigation of actual treatment intensification
Primary result
As reported in the abstract
Target (DAS44 < 1.6 or EULAR good response) in high-risk 13-week non-responders
Difference
36%
95% CI 2%–71%
P = 0.04
Events by treatment group
Intensificationvs Continuation
difference 36% (95% CI 2%–71%); P = 0.04
Further findings
Events
| Outcome | Intensification | Continuation |
|---|---|---|
| Target (DAS44 < 1.6 or EULAR good response) in low-risk 13-week non-responders · 26 weeks | 4 | 3 |
- Target (DAS44 < 1.6 or EULAR good response) in low-risk 13-week non-responders: low-risk group (n = 40), randomised n = 8 vs n = 7
Safety
- Adverse event rates higher in the high-risk group, and higher in its intensification subgroup
- Serious adverse events were rare
Original publication
Favourable effect of a ‘second hit’ after 13 weeks in early RA non-responders: the Amsterdam COBRA treat-to-target randomized trial. Rheumatology (Oxford). Published 7 October 2022. doi:10.
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