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

Mikkel Østergaard*, Ronald F. Van Vollenhoven, Anna Rudin, Merete Lund Hetland, Marte Schrumpf Heiberg, Dan C Nordström, Michael T. Nurmohamed, Bjorn Gudbjornsson, Lykke Midtbøll Ørnbjerg, Pernille Bøyesen, Kristina Lend, Kim Hørslev-Petersen, Till Uhlig, Tuulikki Sokka, Gerdur Grondal, Simon Krabbe, Joakim Lindqvist, Inger Gjertsson, Daniel Glinatsi, Meliha Crnkic KapetanovicAnna Birgitte Aga, Francesca Faustini, Pinja Parmanne, Tove Lorenzen, Cagnotto Giovanni, Johan Back, Oliver Hendricks, Daisy Vedder, Tuomas Rannio, Emma Grenholm, Maud Kristine Ljoså, Eli Brodin, Hanne Lindegaard, Annika Söderbergh, Milad Rizk, Alf Kastbom, Per Larsson, Line Uhrenholt, Søren Andreas Just, David J Stevens, Trine Bay Laurbjerg, Gunnstein Bakland, Inge Christoffer Olsen, Espen A Haavardsholm, Jon Lampa, NORD-STAR Study Group

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

4 Citations (Scopus)

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.
Original languageEnglish
JournalAnnals of the Rheumatic Diseases
Volume82
Issue number10
ISSN0003-4967
DOIs
Publication statusPublished - Oct 2023

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

  • Abatacept
  • Biological Therapy
  • Certolizumab pegol
  • Methotrexate
  • Rheumatoid Arthritis

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this