Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial
Abstract Objective To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis. Design Investigator initiated, randomised, open label, blinded assessor, multiarm, phase IV st...
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Online Access: | http://dx.doi.org/10.1136/bmj.m4328 http://data.bmj.org/tdm/10.1136/bmj.m4328 https://syndication.highwire.org/content/doi/10.1136/bmj.m4328 |
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crjcrbmj:10.1136/bmj.m4328 2024-09-09T19:47:38+00:00 Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial Hetland, Merete Lund Haavardsholm, Espen A Rudin, Anna Nordström, Dan Nurmohamed, Michael Gudbjornsson, Bjorn Lampa, Jon Hørslev-Petersen, Kim Uhlig, Till Grondal, Gerdur Østergaard, Mikkel Heiberg, Marte S Twisk, Jos Lend, Kristina Krabbe, Simon Hyldstrup, Lise Hejl Lindqvist, Joakim Hultgård Ekwall, Anna-Karin Grøn, Kathrine Lederballe Kapetanovic, Meliha Faustini, Francesca Tuompo, Riitta Lorenzen, Tove Cagnotto, Giovanni Baecklund, Eva Hendricks, Oliver Vedder, Daisy Sokka-Isler, Tuulikki Husmark, Tomas Ljoså, Maud-Kristine Aga Brodin, Eli Ellingsen, Torkell Söderbergh, Annika Rizk, Milad Olsson, Åsa Reckner Larsson, Per Uhrenholt, Line Just, Søren Andreas Stevens, David John Laurberg, Trine Bay Bakland, Gunnstein Olsen, Inge C van Vollenhoven, Ronald 2020 http://dx.doi.org/10.1136/bmj.m4328 http://data.bmj.org/tdm/10.1136/bmj.m4328 https://syndication.highwire.org/content/doi/10.1136/bmj.m4328 en eng BMJ http://creativecommons.org/licenses/by-nc/4.0/ BMJ page m4328 ISSN 1756-1833 journal-article 2020 crjcrbmj https://doi.org/10.1136/bmj.m4328 2024-08-22T04:11:38Z Abstract Objective To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis. Design Investigator initiated, randomised, open label, blinded assessor, multiarm, phase IV study. Setting Twenty nine rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland between 2012 and 2018. Participants Patients aged 18 years and older with treatment naive rheumatoid arthritis, symptom duration less than 24 months, moderate to severe disease activity, and rheumatoid factor or anti-citrullinated protein antibody positivity, or increased C reactive protein. Interventions Randomised 1:1:1:1, stratified by country, sex, and anti-citrullinated protein antibody status. All participants started methotrexate combined with (a) active conventional treatment (either prednisolone tapered to 5 mg/day, or sulfasalazine combined with hydroxychloroquine and intra-articular corticosteroids), (b) certolizumab pegol, (c) abatacept, or (d) tocilizumab. Main outcome measures The primary outcome was adjusted clinical disease activity index remission (CDAI≤2.8) at 24 weeks with active conventional treatment as the reference. Key secondary outcomes and analyses included CDAI remission at 12 weeks and over time, other remission criteria, a non-inferiority analysis, and harms. Results 812 patients underwent randomisation. The mean age was 54.3 years (standard deviation 14.7) and 68.8% were women. Baseline disease activity score of 28 joints was 5.0 (standard deviation 1.1). Adjusted 24 week CDAI remission rates were 42.7% (95% confidence interval 36.1% to 49.3%) for active conventional treatment, 46.5% (39.9% to 53.1%) for certolizumab pegol, 52.0% (45.5% to 58.6%) for abatacept, and 42.1% (35.3% to 48.8%) for tocilizumab. Corresponding absolute differences were 3.9% (95% confidence interval −5.5% to 13.2%) for certolizumab pegol, 9.4% (0.1% to 18.7%) for abatacept, and −0.6% (−10.1% to 8.9%) ... Article in Journal/Newspaper Iceland The BMJ Norway BMJ m4328 |
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The BMJ |
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crjcrbmj |
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English |
description |
Abstract Objective To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis. Design Investigator initiated, randomised, open label, blinded assessor, multiarm, phase IV study. Setting Twenty nine rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland between 2012 and 2018. Participants Patients aged 18 years and older with treatment naive rheumatoid arthritis, symptom duration less than 24 months, moderate to severe disease activity, and rheumatoid factor or anti-citrullinated protein antibody positivity, or increased C reactive protein. Interventions Randomised 1:1:1:1, stratified by country, sex, and anti-citrullinated protein antibody status. All participants started methotrexate combined with (a) active conventional treatment (either prednisolone tapered to 5 mg/day, or sulfasalazine combined with hydroxychloroquine and intra-articular corticosteroids), (b) certolizumab pegol, (c) abatacept, or (d) tocilizumab. Main outcome measures The primary outcome was adjusted clinical disease activity index remission (CDAI≤2.8) at 24 weeks with active conventional treatment as the reference. Key secondary outcomes and analyses included CDAI remission at 12 weeks and over time, other remission criteria, a non-inferiority analysis, and harms. Results 812 patients underwent randomisation. The mean age was 54.3 years (standard deviation 14.7) and 68.8% were women. Baseline disease activity score of 28 joints was 5.0 (standard deviation 1.1). Adjusted 24 week CDAI remission rates were 42.7% (95% confidence interval 36.1% to 49.3%) for active conventional treatment, 46.5% (39.9% to 53.1%) for certolizumab pegol, 52.0% (45.5% to 58.6%) for abatacept, and 42.1% (35.3% to 48.8%) for tocilizumab. Corresponding absolute differences were 3.9% (95% confidence interval −5.5% to 13.2%) for certolizumab pegol, 9.4% (0.1% to 18.7%) for abatacept, and −0.6% (−10.1% to 8.9%) ... |
format |
Article in Journal/Newspaper |
author |
Hetland, Merete Lund Haavardsholm, Espen A Rudin, Anna Nordström, Dan Nurmohamed, Michael Gudbjornsson, Bjorn Lampa, Jon Hørslev-Petersen, Kim Uhlig, Till Grondal, Gerdur Østergaard, Mikkel Heiberg, Marte S Twisk, Jos Lend, Kristina Krabbe, Simon Hyldstrup, Lise Hejl Lindqvist, Joakim Hultgård Ekwall, Anna-Karin Grøn, Kathrine Lederballe Kapetanovic, Meliha Faustini, Francesca Tuompo, Riitta Lorenzen, Tove Cagnotto, Giovanni Baecklund, Eva Hendricks, Oliver Vedder, Daisy Sokka-Isler, Tuulikki Husmark, Tomas Ljoså, Maud-Kristine Aga Brodin, Eli Ellingsen, Torkell Söderbergh, Annika Rizk, Milad Olsson, Åsa Reckner Larsson, Per Uhrenholt, Line Just, Søren Andreas Stevens, David John Laurberg, Trine Bay Bakland, Gunnstein Olsen, Inge C van Vollenhoven, Ronald |
spellingShingle |
Hetland, Merete Lund Haavardsholm, Espen A Rudin, Anna Nordström, Dan Nurmohamed, Michael Gudbjornsson, Bjorn Lampa, Jon Hørslev-Petersen, Kim Uhlig, Till Grondal, Gerdur Østergaard, Mikkel Heiberg, Marte S Twisk, Jos Lend, Kristina Krabbe, Simon Hyldstrup, Lise Hejl Lindqvist, Joakim Hultgård Ekwall, Anna-Karin Grøn, Kathrine Lederballe Kapetanovic, Meliha Faustini, Francesca Tuompo, Riitta Lorenzen, Tove Cagnotto, Giovanni Baecklund, Eva Hendricks, Oliver Vedder, Daisy Sokka-Isler, Tuulikki Husmark, Tomas Ljoså, Maud-Kristine Aga Brodin, Eli Ellingsen, Torkell Söderbergh, Annika Rizk, Milad Olsson, Åsa Reckner Larsson, Per Uhrenholt, Line Just, Søren Andreas Stevens, David John Laurberg, Trine Bay Bakland, Gunnstein Olsen, Inge C van Vollenhoven, Ronald Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial |
author_facet |
Hetland, Merete Lund Haavardsholm, Espen A Rudin, Anna Nordström, Dan Nurmohamed, Michael Gudbjornsson, Bjorn Lampa, Jon Hørslev-Petersen, Kim Uhlig, Till Grondal, Gerdur Østergaard, Mikkel Heiberg, Marte S Twisk, Jos Lend, Kristina Krabbe, Simon Hyldstrup, Lise Hejl Lindqvist, Joakim Hultgård Ekwall, Anna-Karin Grøn, Kathrine Lederballe Kapetanovic, Meliha Faustini, Francesca Tuompo, Riitta Lorenzen, Tove Cagnotto, Giovanni Baecklund, Eva Hendricks, Oliver Vedder, Daisy Sokka-Isler, Tuulikki Husmark, Tomas Ljoså, Maud-Kristine Aga Brodin, Eli Ellingsen, Torkell Söderbergh, Annika Rizk, Milad Olsson, Åsa Reckner Larsson, Per Uhrenholt, Line Just, Søren Andreas Stevens, David John Laurberg, Trine Bay Bakland, Gunnstein Olsen, Inge C van Vollenhoven, Ronald |
author_sort |
Hetland, Merete Lund |
title |
Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial |
title_short |
Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial |
title_full |
Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial |
title_fullStr |
Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial |
title_full_unstemmed |
Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial |
title_sort |
active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase iv investigator initiated, randomised, observer blinded clinical trial |
publisher |
BMJ |
publishDate |
2020 |
url |
http://dx.doi.org/10.1136/bmj.m4328 http://data.bmj.org/tdm/10.1136/bmj.m4328 https://syndication.highwire.org/content/doi/10.1136/bmj.m4328 |
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Norway |
geographic_facet |
Norway |
genre |
Iceland |
genre_facet |
Iceland |
op_source |
BMJ page m4328 ISSN 1756-1833 |
op_rights |
http://creativecommons.org/licenses/by-nc/4.0/ |
op_doi |
https://doi.org/10.1136/bmj.m4328 |
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BMJ |
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m4328 |
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