Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial
Authors' conclusion
Compared with active conventional therapy, clinical remission rates were superior for abatacept and certolizumab pegol, but not for tocilizumab. Radiographic progression was low and similar between treatments.
Study context
- Population
- Patients with treatment-naïve early rheumatoid arthritis (RA) with moderate-severe disease activity
- Participants
- 812 patients
- Comparison
- MTX plus certolizumab pegol, abatacept or tocilizumab vs MTX plus active conventional therapy
- Primary endpoint
- Coprimary: Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) and change in radiographic van der Heijde-modified Sharp Score
- Follow-up
- Week 48
Methodological detailsinvestigator-initiated, blinded-assessor, 1:1:1:1 randomisation, Bonferroni's and Dunnet's procedures for multiple testing (significance level: 0.025)
- Investigator-initiated
- Blinded-assessor
- 1:1:1:1 randomisation
- Bonferroni's and Dunnet's procedures for multiple testing (significance level: 0.025)
Primary result
As reported in the abstract
CDAI remission (adjusted rates)
Adjusted difference
+20.1%
P < 0.001
Abatacept
Adjusted difference
+13.1%
P = 0.021
Certolizumab
Adjusted difference
+12.7%
P = 0.030
Tocilizumab · not significant (significance level: 0.025)
Further findings
Coprimary: radiographic progression (van der Heijde-modified Sharp Score) · week 48
- Radiographic progression was low, without group differences
Key secondary clinical outcomes
- Consistently better in biological groups
Safety
Serious adverse events
Original publication
Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial. Ann Rheum Dis. Published 9 July 2023. doi:10.
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