Clinical Trial

. 2020 Dec 2:371:m4328.

doi: 10.1136/bmj.m4328.

Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial

Merete Lund Hetland^{1

2}, Espen A Haavardsholm³, Anna Rudin^{4

5}, Dan Nordström^{6

7}, Michael Nurmohamed^{8

9}, Bjorn Gudbjornsson^{10

11}, Jon Lampa¹², Kim Hørslev-Petersen^{13

14}, Till Uhlig^{3

15}, Gerdur Grondal^{10

11}, Mikkel Østergaard^{16

2}, Marte S Heiberg³, Jos Twisk¹⁷, Kristina Lend¹², Simon Krabbe^{16

2}, Lise Hejl Hyldstrup^{16

2}, Joakim Lindqvist¹², Anna-Karin Hultgård Ekwall^{4

5}, Kathrine Lederballe Grøn¹⁶, Meliha Kapetanovic¹⁸, Francesca Faustini¹², Riitta Tuompo^{6

7}, Tove Lorenzen¹⁹, Giovanni Cagnotto^{20

21}, Eva Baecklund²², Oliver Hendricks¹³, Daisy Vedder⁸, Tuulikki Sokka-Isler²³, Tomas Husmark²⁴, Maud-Kristine Aga Ljoså²⁵, Eli Brodin²⁶, Torkell Ellingsen²⁷, Annika Söderbergh²⁸, Milad Rizk²⁹, Åsa Reckner Olsson³⁰, Per Larsson³¹, Line Uhrenholt³², Søren Andreas Just³³, David John Stevens³⁴, Trine Bay Laurberg³⁵, Gunnstein Bakland³⁶, Inge C Olsen³⁷, Ronald van Vollenhoven^{9

12}; NORD-STAR study group

Collaborators, Affiliations

Collaborators

NORD-STAR study group:
Anders Bengtsson, Anders Gülfe, Anna-Birgitte Aga, Annelies Blanken, Annette Schlemmer, Aulikki Kononoff, Carl Turesson, Christina Dackhammar, Cidem Gentline, Daniel Glinatsi, Elisabet Lindqvist, Ellen-Margrethe Hauge, Elsa Hermansson, Emma Grenholm, Erik Af Klint, Erik Rødevand, Fredrik Markros, Hamed Rezaei, Hanne Merete Lindegaard, Heikki Relas, Heikki Valleala, Ilia Qirjazo, Inger Marie Jensen Hansen, Jarno Rutanen, Jens Kristian Pedersen, Jens Rathmann, Johan Back, Johan Wallman, Johanna Carlestam, Jon Einarsson, Jörgen Lysholm, Kajsa Öberg, Katarina Almehed, Kati Mykkänen, Lena Karlberg, Malin Hemberg, Maria K Stilling-Vinther, Marjatta Leirisalo-Repo, Mohaned Hameed, Nancy Vivar, Oili Kaipiainen-Seppänen, Peter Olsson, Petrus Linge, Pia Lindell, Pia Neuer Jensen, Pinja Parmanne, René Østgård, Sabine Dieperink, Sara Nysom Christiansen, Sofia Exarchou, Thiab Saleh, Tor Olofsson, Trude Bruun, Vappu Rantalaiho, Ylva Borgas

Affiliations

¹ Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark merete.hetland@dadlnet.dk.
² Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
³ Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
⁴ Rheumatology Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden.
⁵ Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy of University of Gothenburg, Gothenburg, Sweden.
⁶ Division of Rheumatology, Helsinki University Hospital, Helsinki, Finland.
⁷ University of Helsinki, Helsinki, Finland.
⁸ Amsterdam Rheumatology and Immunology Center, Reade, Netherlands.
⁹ Department of Rheumatology and Amsterdam Rheumatology Center, Amsterdam University Medical Centers, Amsterdam, Netherlands.
¹⁰ Landspitali University Hospital, Reykjavik, Iceland.
¹¹ Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
¹² Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.
¹³ Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Sønderborg, Denmark.
¹⁴ Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
¹⁵ University of Oslo, Oslo, Norway.
¹⁶ Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
¹⁷ Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, Amsterdam, Netherlands.
¹⁸ Section of Rheumatology, Department of Clinical Sciences Lund, Skåne University Hospital, Lund and Malmö, Sweden.
¹⁹ Department of Rheumatology, Silkeborg University Clinic, Silkeborg, Denmark.
²⁰ Department of Rheumatology, Skåne University Hospital, Malmö, Sweden.
²¹ Rheumatology, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
²² Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
²³ Department of Medicine and University of Eastern Finland, Jyväskylä Central Hospital, Jyväskylä, Finland.
²⁴ Department of Rheumatology, Falu Hospital, Falun, Sweden.
²⁵ Department of Rheumatology, Ålesund Hospital, Ålesund, Norway.
²⁶ Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.
²⁷ Rheumatology Research Unit, Odense University Hospital, Southern University of Denmark, Denmark.
²⁸ Department of Rheumatology, Örebro University Hospital, Örebro, Sweden.
²⁹ Rheumatology Clinic, Västmanlands Hospital Västerås, Sweden.
³⁰ Department of Rheumatology, Linköping University Hospital, Sweden.
³¹ Academic Specialist Center, Stockholm, Sweden.
³² Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark.
³³ Section of Rheumatology, Department of Medicine, Svendborg Hospital OUH, Denmark.
³⁴ Department of Rheumatology, St Olav's Hospital, University Hospital of Trondheim, Trondheim, Norway.
³⁵ Department of Rheumatology, Aarhus University Hospital, Denmark.
³⁶ Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway.
³⁷ Department of Research Support for Clinical Trials, Oslo University Hospital, Norway.

PMID: 33268527
PMCID: PMC7708829
DOI: 10.1136/bmj.m4328

Clinical Trial

Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial

Merete Lund Hetland et al. BMJ. 2020.

. 2020 Dec 2:371:m4328.

doi: 10.1136/bmj.m4328.

Authors

Collaborators

NORD-STAR study group:
Anders Bengtsson, Anders Gülfe, Anna-Birgitte Aga, Annelies Blanken, Annette Schlemmer, Aulikki Kononoff, Carl Turesson, Christina Dackhammar, Cidem Gentline, Daniel Glinatsi, Elisabet Lindqvist, Ellen-Margrethe Hauge, Elsa Hermansson, Emma Grenholm, Erik Af Klint, Erik Rødevand, Fredrik Markros, Hamed Rezaei, Hanne Merete Lindegaard, Heikki Relas, Heikki Valleala, Ilia Qirjazo, Inger Marie Jensen Hansen, Jarno Rutanen, Jens Kristian Pedersen, Jens Rathmann, Johan Back, Johan Wallman, Johanna Carlestam, Jon Einarsson, Jörgen Lysholm, Kajsa Öberg, Katarina Almehed, Kati Mykkänen, Lena Karlberg, Malin Hemberg, Maria K Stilling-Vinther, Marjatta Leirisalo-Repo, Mohaned Hameed, Nancy Vivar, Oili Kaipiainen-Seppänen, Peter Olsson, Petrus Linge, Pia Lindell, Pia Neuer Jensen, Pinja Parmanne, René Østgård, Sabine Dieperink, Sara Nysom Christiansen, Sofia Exarchou, Thiab Saleh, Tor Olofsson, Trude Bruun, Vappu Rantalaiho, Ylva Borgas

Affiliations

¹ Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark merete.hetland@dadlnet.dk.
² Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
³ Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
⁴ Rheumatology Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden.
⁵ Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy of University of Gothenburg, Gothenburg, Sweden.
⁶ Division of Rheumatology, Helsinki University Hospital, Helsinki, Finland.
⁷ University of Helsinki, Helsinki, Finland.
⁸ Amsterdam Rheumatology and Immunology Center, Reade, Netherlands.
⁹ Department of Rheumatology and Amsterdam Rheumatology Center, Amsterdam University Medical Centers, Amsterdam, Netherlands.
¹⁰ Landspitali University Hospital, Reykjavik, Iceland.
¹¹ Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
¹² Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.
¹³ Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Sønderborg, Denmark.
¹⁴ Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
¹⁵ University of Oslo, Oslo, Norway.
¹⁶ Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
¹⁷ Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, Amsterdam, Netherlands.
¹⁸ Section of Rheumatology, Department of Clinical Sciences Lund, Skåne University Hospital, Lund and Malmö, Sweden.
¹⁹ Department of Rheumatology, Silkeborg University Clinic, Silkeborg, Denmark.
²⁰ Department of Rheumatology, Skåne University Hospital, Malmö, Sweden.
²¹ Rheumatology, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
²² Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
²³ Department of Medicine and University of Eastern Finland, Jyväskylä Central Hospital, Jyväskylä, Finland.
²⁴ Department of Rheumatology, Falu Hospital, Falun, Sweden.
²⁵ Department of Rheumatology, Ålesund Hospital, Ålesund, Norway.
²⁶ Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.
²⁷ Rheumatology Research Unit, Odense University Hospital, Southern University of Denmark, Denmark.
²⁸ Department of Rheumatology, Örebro University Hospital, Örebro, Sweden.
²⁹ Rheumatology Clinic, Västmanlands Hospital Västerås, Sweden.
³⁰ Department of Rheumatology, Linköping University Hospital, Sweden.
³¹ Academic Specialist Center, Stockholm, Sweden.
³² Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark.
³³ Section of Rheumatology, Department of Medicine, Svendborg Hospital OUH, Denmark.
³⁴ Department of Rheumatology, St Olav's Hospital, University Hospital of Trondheim, Trondheim, Norway.
³⁵ Department of Rheumatology, Aarhus University Hospital, Denmark.
³⁶ Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway.
³⁷ Department of Research Support for Clinical Trials, Oslo University Hospital, Norway.

PMID: 33268527
PMCID: PMC7708829
DOI: 10.1136/bmj.m4328

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%) for tocilizumab. Key secondary outcomes showed no major differences among the four treatments. Differences in CDAI remission rates for active conventional treatment versus certolizumab pegol and tocilizumab, but not abatacept, remained within the prespecified non-inferiority margin of 15% (per protocol population). The total number of serious adverse events was 13 (percentage of patients who experienced at least one event 5.6%) for active conventional treatment, 20 (8.4%) for certolizumab pegol, 10 (4.9%) for abatacept, and 10 (4.9%) for tocilizumab. Eleven patients treated with abatacept stopped treatment early compared with 20-23 patients in the other arms.

Conclusions: All four treatments achieved high remission rates. Higher CDAI remission rate was observed for abatacept versus active conventional treatment, but not for certolizumab pegol or tocilizumab versus active conventional treatment. Other remission rates were similar across treatments. Non-inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept. The results highlight the efficacy and safety of active conventional treatment based on methotrexate combined with corticosteroids, with nominally better results for abatacept, in treatment naive early rheumatoid arthritis.

Trial registration: EudraCT2011-004720-35, NCT01491815.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from Academy of Finland, Finska Läkaresällskapet, South-Eastern Health Region (Norway), HUCH (Finland), Icelandic Society for Rheumatology, all health regions in Norway, NordForsk, Regionernes Medicinpulje (Denmark), Stockholm County Council (Sweden), Swedish Medical Research Council, Swedish Rheumatism Association, The Research Fund of University Hospital (Reykjavik, Iceland) for the submitted work; MLH reports grants from Nordforsk, from Danske Regioner during the conduct of the study; grants from Bristol-Myers Squibb, grants from AbbVie, grants from Roche, grants from Novartis, grants and personal fees from Merck, grants and personal fees from Biogen, grants and personal fees from Pfizer, personal fees from Eli Lilly, personal fees from Orion Pharma, personal fees from CellTrion, personal fees from Samsung Bioepsi, personal fees from Janssen Biologics BV, personal fees from MSD, outside the submitted work; she chairs the steering committee of the Danish Rheumatology Quality Registry (DANBIO), which receives public funding from the hospital owners and funding from pharamaceutical companies; EAH reports grants from NORDFORSK, grants from the Norwegian Regional Health Authorities, grants from the South-Eastern Norway Regional Health Authority, during the conduct of the study; personal fees from Pfizer, personal fees from AbbVie, personal fees from Celgene, personal fees from Novartis, personal fees from Janssen, personal fees from Gilead, personal fees from Eli-Lilly, personal fees from UCB, outside the submitted work; AR reports grants from the Swedish Research Council, financial support from AstraZeneca, outside the submitted work; DN reports grants from UCB, grants from BMS, during the conduct of the study; grants from AbbVie, grants from Celgene, grants from MSD, grants from Novartis, grants from Pfizer outside the submitted work; MN reports grants from BMS, during the conduct of the study; grants from Abbvie, grants from BMS, personal fees from Celltrion, grants from MSD, grants from Pfizer, personal fees from Eli Lilly, grants from Amgen, outside the submitted work; BG reports personal fees from Novartis, outside the submitted work; TU reports a grant from NORDFORSK during the conduct of the study; personal fees from Grünenthal, personal fees from Lilly, personal fees from Novartis, personal fees from Pfizer, outside the submitted work; MØ reports grants, personal fees and non-financial support from AbbVie, grants, personal fees and non-financial support from BMS, personal fees from Boehringer-Ingelheim, personal fees from Eli Lilly, personal fees and non-financial support from Janssen, grants, personal fees and non-financial support from Merck, personal fees and non-financial support from Pfizer, personal fees and non-financial support from Roche, grants, personal fees and non-financial support from UCB, grants and personal fees from Celgene, personal fees from Sanofi, personal fees from Regeneron, grants, personal fees and non-financial support from Novartis, personal fees from Orion, personal fees from Hospira, outside the submitted work; MSH reports grants from the South-Eastern Norway Regional Health Authority, during the conduct of the study; personal fees from Lilly, outside the submitted work; SK reports receiving grants from AbbVie, MSD and Novartis outside the submitted work; AKHE reports receiving personal fees from AbbVie, personal fees from Pfizer, outside the submitted work; KLG reports grants from BMS, outside the submitted work; RT reports grants from Finnish Rheumatology Research Fund, during the conduct of the study; OH reports non-financial support from Pfizer, personal fees from Abbvie, personal fees from Novartis, during the conduct of the study; TSI reports non-financial support from DiaGraphIT, personal fees from Abbvie, personal fees from BMS, personal fees from Celgene, personal fees from Medac, personal fees from Merck, personal fees from Novartis, personal fees from Orion Pharma, personal fees from Pfizer, personal fees from Roche, personal fees from Sandoz, personal fees from UCB, personal fees from Bohringer Ingelheim, outside the submitted work; LU reports personal fees from Abbvie, Eli Lilly and Novartis (speaker fees), outside the submitted work; DJS reports grants from KLINBEFORSK, during the conduct of the study; TBL reports personal fees from UCB, outside the submitted work; GB reports personal fees from BMS, outside the submitted work; ABA reports personal fees from Abbvie, personal fees from Eli Lilly, personal fees from Novartis, personal fees from Pfizer, outside the submitted work; AB reports grants from BMS, during the conduct of the study; CT reports grants and personal fees from Bristol Myers-Squibb, personal fees from Roche, personal fees from Abbvie, personal fees from Pfizer, outside the submitted work; HR reports personal fees from MSD, personal fees from Roche, personal fees from Abbvie, personal fees from Celgene, outside the submitted work; JR reports grants from BMS, during the conduct of the study; JW reports fees from Celgene, fees from Eli Lilly, fees from Novartis, outside the submitted work; KM reports personal fees from Abbvie, personal fees from Celgene, personal fees from Medac, personal fees from BMS, outside the submitted work; OKS reports grants from the Research Committee of the Kuopio University Hospital Catchment Area for the State Research Funding, during the conduct of the study; non-financial support from Pfizer, non-financial support from Novartis, non-financial support from MSD, personal fees from Boeringer Ingelheim, outside the submitted work; PP reports personal fees from Novartis Finland Oy, outside the submitted work; RØ reports personal fees from Bristol-Meyer Squibb, personal fees and non-financial support from AbbVie, personal fees from Gilead, personal fees from Janssen, personal fees from Eli-Lilly, personal fees from Novartis, outside the submitted work; SNC reports personal fees from Bristol Myers Squibb, personal fees from General Electric, outside the submitted work; SE reports personal fees from Novartis, outside the submitted work; TO reports personal fees from Eli Lilly, consultancy fee from Merck Sharp and Dohme, outside the submitted work; reports grants from BMS, during the conduct of the study; grants from Roche, grants from Mylan, other from Abbvie, outside the submitted work; VR reports grants from BMS, during the conduct of the study; grants from Roche, grants from Mylan, other from Abbvie, outside the submitted work; RvV reports grants from BMS, during the conduct of the study; grants from BMS, GSK, Lilly, UCB, grants from Pfizer, Roche, personal fees from AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Galapagos, Gilead, Janssen, Pfizer, Servier, UCB, outside the submitted work; no other relationships or activities that could appear to have influenced the submitted work.

Figures

**Fig 1**
Probability of clinical disease activity index (CDAI) remission over time for each treatment group. Longitudinal analysis on the intention-to-treat population using adjusted generalised estimating equations and accounting for within patient correlation. Average marginal estimates are shown, averaged over the covariates as observed in the sample. Bars indicate 95% confidence intervals

**Fig 2**
Forest plot of risk differences. Estimated differences (95% confidence intervals) in clinical disease activity index (CDAI) remission rates at 24 weeks between active conventional treatment and methotrexate in combination with certolizumab pegol, abatacept, or tocilizumab. Logistic regression analysis, adjusted for sex, anti-citrullinated protein antibody positivity status, country, age, body mass index and baseline disease activity score of 28 joints (C reactive protein based, four variables; marginal estimates averaged over covariates as observed in sample). Dashed line shows non-inferiority margin. Figure based on per protocol dataset

See this image and copyright information in PMC

References

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1. Emery P, Salmon M. Early rheumatoid arthritis: time to aim for remission? Ann Rheum Dis 1995;54:944-7 10.1136/ard.54.12.944. - DOI - PMC - PubMed
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1. Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016. http://onlinelibrary.wiley.com/doi/ - PubMed

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Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial

Collaborators

Affiliations

Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials