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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

Permanent link
https://hdl.handle.net/10037/32840
DOI
https://doi.org/10.1136/ard-2023-224116
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Date
2023-07-09
Type
Journal article
Tidsskriftartikkel
Peer reviewed

Author
Østergaard, Mikkel; Van Vollenhoven, Ronald F; Rudin, Anna; Hetland, Merete Lund; Schrumpf, Marte; Nordström, Dan C; Nurmohamed, Michael T; Gudbjornsson, Bjorn; Ørnbjerg, Lykke Midtbøll; Bøyesen, Pernille; Lend, Kristina; Hørslev-Petersen, Kim; Uhlig, Till; Sokka, Tuulikki; Grondal, Gerdur; Krabbe, Simon; Lindqvist, Joakim; Gjertsson, Inger; Glinatsi, Daniel; Kapetanovic, Meliha Crnkic; Aga, Anna-Birgitte; Faustini, Francesca; Parmanne, Pinja; Lorenzen, Tove; Giovanni, Cagnotto; Back, Johan; Hendricks, Oliver; Vedder, Daisy; Rannio, Tuomas; Grenholm, Emma; Ljoså, Maud-Kristine Aga; Brodin, Eli; Lindegaard, Hanne; Söderbergh, Annika; Rizk, Milad; Kastbom, Alf; Larsson, Per; Uhrenholt, Line; Just, Søren Andreas; Stevens, David John; Bay Laurbjerg, Trine; Bakland, Gunnstein; Olsen, Inge Christoffer; Haavardsholm, Espen A.; Lampa, Jon
Abstract
Background - The optimal first-line treatment in early rheumatoid arthritis (RA) is debated. We compared clinical and radiographic outcomes of active conventional therapy with each of three biological treatments with different modes of action.

Methods - Investigator-initiated, randomised, blinded-assessor study. Patients with treatment-naïve early RA with moderate–severe disease activity were randomised 1:1:1:1 to methotrexate combined with (1) active conventional therapy: oral prednisolone (tapered quickly, discontinued at week 36) or sulfasalazine, hydroxychloroquine and intra-articular glucocorticoid injections in swollen joints; (2) certolizumab pegol; (3) abatacept or (4) tocilizumab. Coprimary endpoints were week 48 Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) and change in radiographic van der Heijde-modified Sharp Score, estimated using logistic regression and analysis of covariance, adjusted for sex, anticitrullinated protein antibody status and country. Bonferroni’s and Dunnet’s procedures adjusted for multiple testing (significance level: 0.025).

Results - Eight hundred and twelve patients were randomised. Adjusted CDAI remission rates at week 48 were: 59.3% (abatacept), 52.3% (certolizumab), 51.9% (tocilizumab) and 39.2% (active conventional therapy). Compared with active conventional therapy, CDAI remission rates were significantly higher for abatacept (adjusted difference +20.1%, p<0.001) and certolizumab (+13.1%, p=0.021), but not for tocilizumab (+12.7%, p=0.030). Key secondary clinical outcomes were consistently better in biological groups. Radiographic progression was low, without group differences.

The proportions of patients with serious adverse events were abatacept, 8.3%; certolizumab, 12.4%; tocilizumab, 9.2%; and active conventional therapy, 10.7%.

Conclusions - 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.

Publisher
BMJ Publishing Group
Citation
Østergaard, Van Vollenhoven, Rudin, Hetland, Schrumpf, Nordström, Nurmohamed, Gudbjornsson, Ørnbjerg, Bøyesen, Lend, Hørslev-Petersen, Uhlig, Sokka, Grondal, Krabbe, Lindqvist, Gjertsson, Glinatsi, Kapetanovic, Aga, Faustini, Parmanne, Lorenzen, Giovanni, Back, Hendricks, Vedder, Rannio, Grenholm, Ljoså, Brodin, Lindegaard, Söderbergh, Rizk, Kastbom, Larsson, Uhrenholt, Just, Stevens, Bay Laurbjerg, Bakland, Olsen, Haavardsholm, Lampa. 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
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