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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

Østergaard, Mikkel ; Van Vollenhoven, Ronald F. ; Rudin, Anna ; Hetland, Merete Lund ; Heiberg, Marte Schrumpf ; Nordström, Dan C. ; Nurmohamed, Michael T. ; Gudbjornsson, Bjorn ; Ørnbjerg, Lykke Midtbøll and Bøyesen, Pernille , et al. (2023) In Annals of the Rheumatic Diseases 82(10). p.1286-1295
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... (More)

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. Trial registration number: NCT01491815.

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type
Contribution to journal
publication status
published
subject
keywords
Abatacept, Biological Therapy, Certolizumab pegol, Methotrexate, Rheumatoid Arthritis
in
Annals of the Rheumatic Diseases
volume
82
issue
10
pages
1286 - 1295
publisher
BMJ Publishing Group
external identifiers
  • pmid:37423647
  • scopus:85165210988
ISSN
0003-4967
DOI
10.1136/ard-2023-224116
language
English
LU publication?
yes
id
e0e1127f-df8b-441d-8741-63f6d30b07cc
date added to LUP
2023-10-03 13:49:01
date last changed
2024-04-19 01:52:30
@article{e0e1127f-df8b-441d-8741-63f6d30b07cc,
  abstract     = {{<p>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&lt;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. Trial registration number: NCT01491815.</p>}},
  author       = {{Østergaard, Mikkel and Van Vollenhoven, Ronald F. and Rudin, Anna and Hetland, Merete Lund and Heiberg, Marte Schrumpf and Nordström, Dan C. and Nurmohamed, Michael T. and Gudbjornsson, Bjorn and Ørnbjerg, Lykke Midtbøll and Bøyesen, Pernille and Lend, Kristina and Hørslev-Petersen, Kim and Uhlig, Till and Sokka, Tuulikki and Grondal, Gerdur and Krabbe, Simon and Lindqvist, Joakim and Gjertsson, Inger and Glinatsi, Daniel and Kapetanovic, Meliha Crnkic and Aga, Anna Birgitte and Faustini, Francesca and Parmanne, Pinja and Lorenzen, Tove and Giovanni, Cagnotto and Back, Johan and Hendricks, Oliver and Vedder, Daisy and Rannio, Tuomas and Grenholm, Emma and Ljoså, Maud Kristine and Brodin, Eli and Lindegaard, Hanne and Söderbergh, Annika and Rizk, Milad and Kastbom, Alf and Larsson, Per and Uhrenholt, Line and Just, Søren Andreas and Stevens, David J. and Bay Laurbjerg, Trine and Bakland, Gunnstein and Olsen, Inge Christoffer and Haavardsholm, Espen A. and Lampa, Jon}},
  issn         = {{0003-4967}},
  keywords     = {{Abatacept; Biological Therapy; Certolizumab pegol; Methotrexate; Rheumatoid Arthritis}},
  language     = {{eng}},
  number       = {{10}},
  pages        = {{1286--1295}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{Annals of the Rheumatic Diseases}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1136/ard-2023-224116}},
  doi          = {{10.1136/ard-2023-224116}},
  volume       = {{82}},
  year         = {{2023}},
}