A recent study published in Annals of the Rheumatic Diseases has reported a better clinical remission rate for abatacept and certolizumab pegol than active conventional therapy, but not for tocilizumab in patients with rheumatoid arthritis (RA).
The study titled ‘NORD-STAR Trial’, conducted by Dr. Ostergaard and colleagues involved 812 patients with RA. Its objective was to evaluate the clinical and radiological outcomes of three biological therapies with various mechanisms of action compared to active conventional therapy. The results of this 48-week trial reported remission rates based on the Clinical Disease Activity Index (CDAI) for different treatments. Abatacept showed a remission rate of 59.3%, certolizumab had a rate of 52.3%, tocilizumab had a rate of 51.9%, and active conventional therapy had a rate of 39.2%. Both abatacept and certolizumab significantly increased CDAI remission rates compared to active conventional therapy, with adjusted differences of +20.1% (P < 0.001) and +13.1% (P = 0.021), respectively. However, tocilizumab did not show a significant increase in remission rates compared to active conventional therapy, with an adjusted difference of +12.7% (P = 0.030). Experts reported consistently higher key secondary clinical outcomes in the biological therapy groups, and a lack of group differences resulted in minimal radiographic advancement. The serious adverse event rate was 8.3% for abatacept, 12.4% for certolizumab, 9.2% for tocilizumab, and 10.7% for active conventional therapy.
In a 2020 randomized, open-label, blinded assessor, multiarm, phase IV study, the benefits of biological treatments were compared to active conventional treatments in patients with RA. The study included 812 patients from rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland, recruited between 2012 and 2018. The results, based on 24-week remission rates measured by the Clinical Disease Activity Index (CDAI), reported remission rates of 42.7% for active conventional treatment, 39.9% for certolizumab pegol, 52.0% for abatacept, and 42.1% for tocilizumab. There were no significant differences in secondary outcomes among the four treatments. All four therapies achieved high rates of remission. Abatacept showed a higher CDAI remission rate compared to active conventional treatment, while certolizumab pegol and tocilizumab did not. The frequencies of other remissions were comparable between the different treatment regimens.
In conclusion, based on the non-inferiority analysis, tocilizumab and certolizumab pegol did not show superiority compared to active conventional treatment, whereas abatacept demonstrated marginally better outcomes. These results highlight the effectiveness and safety of active conventional therapy, which typically involves a combination of methotrexate and corticosteroids, in managing early RA in treatment-naive patients. Abatacept and certolizumab pegol showed superior clinical remission rates compared to active conventional therapy. Additionally, the findings indicated that radiographic progression rates were lower and similar across the treatment groups.
References
- Ostergaard M, van Vollenhoven RF, Rudin A, Hetland ML, Heiberg MS, Nordstrom DC, et al. 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. Annals of the Rheumatic Diseases. 2023 Jul 7.
- Hetland ML, Haavardsholm EA, Rudin A, Nordstrom D, Nurmohamed M, Gudbjornsson B, et al. Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial. BMJ. 2020;371.