medwireNews: Study findings pitting methotrexate plus glucocorticoid treatment against methotrexate plus one of three biologics in early rheumatoid arthritis (RA) provide support for the active conventional treatment.
The results of the NORD-STAR randomized trial, presented as a poster at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, showed that CDAI remission rates were high among 795 patients with early rheumatoid arthritis after 24 weeks of treatment with methotrexate plus glucocorticoids, certolizumab, tocilizumab, or abatacept.
A significant 9% difference in remission was seen between active conventional therapy and abatacept after taking into account age, BMI, and baseline DAS28, but the differences between conventional therapy and certolizumab (4%) and conventional therapy and tocilizumab (–1%) were not significant.
The 95% confidence intervals for the differences between methotrexate plus glucocorticoids versus methotrexate plus certolizumab or tocilizumab did not cross the predefined noninferiority margin of 15%, making it statistically noninferior to these options. But the confidence interval for the difference versus abatacept did not exclude the latter being superior.
All the patients received methotrexate 25 mg/week. In addition to this, 200 patients were randomly assigned to receive the active conventional treatment regimen, which comprised either oral prednisone (20 mg tapered to 5 mg in 9 weeks) or sulfasalazine (2 g/day), hydroxychloroquine (35 mg/kg per week), and mandatory intra-articular triamcinolone hexacetonide in up to four swollen joints (≤80 mg/visit up to week 20).
The remaining 595 patents received one of three biologics: certolizumab 400 mg every other week for the first 4 weeks followed by 200 mg every other week thereafter (n=203); tocilizumab 8 mg/week every 4 weeks or 162 mg/week subcutaneously (n=188); or subcutaneous abatacept 125 mg/week.
The primary outcome of a CDAI score of 2.8 points or below at 24 weeks was achieved by 42.0% of patients receiving active conventional treatment, and by 47.8%, 41.0%, and 52.5% of those receiving certolizumab, tocilizumab, and abatacept, respectively.
The numbers of serious adverse events were comparable across the four treatment arms, at 13, 20, 10, and 10 for the conventional, certolizumab, tocilizumab, and abatacept groups, respectively.
The researchers, led by Merete Hetland, from the University of Copenhagen in Denmark, conclude: “These results underscore the efficacy and safety of active conventional therapy based on methotrexate combined with glucocorticoids and may guide future treatment strategies for early RA.”
By Lucy Piper
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Arthritis Rheumatol 2019; 71 (suppl 10)
ACR/ARP 2019; Atlanta, Georgia, USA: 8–13 November