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

↓ Direkt till sidans innehåll
↓ Direkt till sidans sekundära innehåll (sidomenyn)

Tyck till om SwePub Sök här!

Sökning: WFRF:(Nordstrom T) > Active conventional...

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

Hetland, M. L. (författare): Copenhagen University Hospital,University of Copenhagen,Rigshosp, Copenhagen Ctr Arthrit Res COPECARE, Ctr Rheumatol & Spine Dis, Glostrup, Denmark.;Rigshosp, DANBIO, Ctr Rheumatol & Spine Dis, Glostrup, Denmark.;Univ Copenhagen, Dept Clin Med, Fac Hlth Sci, Copenhagen, Denmark.

Ekwall, Anna-Karin H (författare): Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för reumatologi och inflammationsforskning,Institute of Medicine, Department of Rheumatology and Inflammation Research

Rudin, Anna, 1961 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för reumatologi och inflammationsforskning,Institute of Medicine, Department of Rheumatology and Inflammation Research,Sahlgrenska University Hospital,Sahlgrens Univ Hosp, Rheumatol Clin, Gothenburg, Sweden.;Univ Gothenburg, Inst Med, Dept Rheumatol & Inflammat Res, Sahlgrenska Acad, Gothenburg, Sweden.

visa fler...

Nordstrom, D. (författare): Helsinki University Central Hospital,University of Helsinki,Helsinki Univ Hosp, Div Rheumatol, Helsinki, Finland.;Univ Helsinki, Helsinki, Finland.;Univ Southern Denmark, Dept Reg Hlth Res, Odense, Denmark.

Nurmohamed, M. (författare): Amsterdam Rheumatology and Immunology Center,Academic Medical Center of University of Amsterdam (AMC),Amsterdam Rheumatol & Immunol Ctr, Reade, Netherlands.;Univ Amsterdam, Dept Rheumatol, Med Ctr, Amsterdam, Netherlands.;Univ Amsterdam, Amsterdam Rheumatol Ctr, Med Ctr, Amsterdam, Netherlands.

Gudbjornsson, B. (författare): National University Hospital of Iceland,University of Iceland,Landspitali Univ Hosp, Reykjavik, Iceland.;Univ Iceland, Fac Med, Reykjavik, Iceland.

Lampa, J. (författare): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital,Karolinska Univ Hosp, Karolinska Inst, Dept Med, Rheumatol Unit, Stockholm, Sweden.

Horslev-Petersen, K. (författare): University of Southern Denmark,Danish Hospital for Rheumatic Diseases (IRS),Univ Hosp Southern Denmark, Danish Hosp Rheumat Dis, Sonderborg, Denmark.;Univ Southern Denmark, Dept Reg Hlth Res, Odense, Denmark.

Uhlig, T. (författare): University of Oslo,Diakonhjemmet Hospital,Univ Oslo, Oslo, Norway.

Grondal, G. (författare): National University Hospital of Iceland,University of Iceland,Landspitali Univ Hosp, Reykjavik, Iceland.;Univ Iceland, Fac Med, Reykjavik, Iceland.

Ostergaard, M. (författare): Copenhagen University Hospital,University of Copenhagen,Rigshosp, Denmark; Univ Copenhagen, Denmark

Heiberg, M. S. (författare): Diakonhjemmet Hospital, Oslo, Norway

Twisk, J. (författare): Academic Medical Center of University of Amsterdam (AMC),Univ Amsterdam, Dept Epidemiol & Biostat, Med Ctr, Amsterdam, Netherlands.

Lend, K. (författare): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital,Karolinska Univ Hosp, Karolinska Inst, Dept Med, Rheumatol Unit, Stockholm, Sweden.

Krabbe, S. (författare): Copenhagen University Hospital,University of Copenhagen,Karolinska Univ Hosp, Karolinska Inst, Dept Med, Rheumatol Unit, Stockholm, Sweden.

Hyldstrup, L. H. (författare): Copenhagen University Hospital,University of Copenhagen,Rigshosp, Copenhagen Ctr Arthrit Res COPECARE, Ctr Rheumatol & Spine Dis, Glostrup, Denmark.

Lindqvist, J. (författare): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital,Karolinska Univ Hosp, Karolinska Inst, Dept Med, Rheumatol Unit, Stockholm, Sweden.

Ekwall, Anna-Karin H (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för reumatologi och inflammationsforskning,Institute of Medicine, Department of Rheumatology and Inflammation Research,Sahlgrenska University Hospital,Karolinska Univ Hosp, Karolinska Inst, Dept Med, Rheumatol Unit, Stockholm, Sweden.

Gron, K. L. (författare): Copenhagen University Hospital,Rigshospitalet, Glostrup, Denmark

Kapetanovic, Meliha (författare): Skåne University Hospital,Skane Univ Hosp, Dept Clin Sci Lund, Rheumatol Sect, Lund, Sweden.;Lund Univ, Dept Clin Sci Malmö, Rheumatol, Malmö, Sweden.

Faustini, F. (författare): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital,Svendborg Hospital OUH, Denmark

Tuompo, R. (författare): University of Helsinki,Helsinki University Central Hospital,Univ Helsinki, Helsinki, Finland.

Lorenzen, T. (författare): Silkeborg Regional Hospital,Silkeborg Univ Clin, Dept Rheumatol, Silkeborg, Denmark.

Cagnotto, Giovanni (författare): Lund University,Lunds universitet,Reumatologi och molekylär skelettbiologi,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Rheumatology,Section III,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Skane Univ Hosp, Dept Rheumatol, Malmö, Sweden.;Lund Univ, Dept Clin Sci Malmö, Rheumatol, Malmö, Sweden.;Jyvaskyla Cent Hosp, Dept Med, Jyvaskyla, Finland.;Univ Eastern Finland, Jyvaskyla Cent Hosp, Jyvaskyla, Finland.

Baecklund, Eva, 1956- (författare): Uppsala universitet,Uppsala University,Reumatologi,Uppsala Univ, Sweden

Hendricks, O. (författare): Danish Hospital for Rheumatic Diseases (IRS),University Hospital of Southern Denmark, Sønderborg, Denmark

Vedder, D. (författare): Amsterdam Rheumatology and Immunology Center, Reade, Netherlands

Sokka-Isler, T. (författare): University of Eastern Finland,Jyväskylä Central Hospital,Jyvaskyla Cent Hosp, Dept Med, Jyvaskyla, Finland.

Husmark, T. (författare): Falun Central Hospital,Univ Eastern Finland, Jyvaskyla Cent Hosp, Jyvaskyla, Finland.

Ljosa, M. K. A. (författare): Ålesund Hospital,Falun Cent Hosp, Dept Rheumatol, Falun, Sweden.

Brodin, E. (författare): Haukeland University Hospital,Iesund Hosp, Dept Rheumatol, Iesund, Norway.

Ellingsen, T. (författare): Odense University Hospital,Haukeland Hosp, Dept Rheumatol, Bergen, Norway.;Univ Southern Denmark, Odense Univ Hosp, Rheumatol Res Unit, Odense, Denmark.

Soderbergh, A. (författare): Örebro University Hospital,Örebro Univ Hosp, Dept Rheumatol, Örebro, Sweden.

Rizk, M. (författare): Västmanland Hospital,Vastmanlands Hosp Västerås, Rheumatol Clin, Västerås, Sweden.

Reckner-Olsson, Åsa (författare): Linköping University Hospital,Linköping Univ Hosp, Dept Rheumatol, Linköping, Sweden.,Region Östergötland, Reumatologiska kliniken i Östergötland

Larsson, P. (författare): Akademiskt specialistcentrum, Stockholm,Acad Specialist Ctr, Stockholm, Sweden.

Uhrenholt, L. (författare): Aalborg University Hospital,Aalborg Univ Hosp, Dept Rheumatol, Aalborg, Denmark.

Just, S. A. (författare): Svendborg Hospital,Amsterdam Rheumatol & Immunol Ctr, Reade, Netherlands.;Univ Iceland, Fac Med, Reykjavik, Iceland.;Svendborg Hosp OUH, Rheumatol Sect, Dept Med, Svendborg, Denmark.

Stevens, D. J. (författare): St. Olav’s University Hospital,Univ Trondheim Hosp, St Olavs Hosp, Dept Rheumatol, Trondheim, Norway.

Laurberg, T. B. (författare): Aarhus University Hospital,Aarhus Univ Hosp, Dept Rheumatol, Aarhus, Denmark.

Bakland, G. (författare): University Hospital of North Norway,Univ Hosp North Norway, Dept Rheumatol, Tromso, Norway.

Olsen, I. C. (författare): Oslo university hospital,Oslo Univ Hosp, Dept Res Support Clin Trials, Oslo, Norway.

van Vollenhoven, R. (författare): Karolinska University Hospital,Academic Medical Center of University of Amsterdam (AMC),Univ Amsterdam, Dept Rheumatol, Med Ctr, Amsterdam, Netherlands.;Univ Iceland, Fac Med, Reykjavik, Iceland.

Nord Star Study Grp, Nord Star Study Grp (författare)

visa färre...

(creator_code:org_t)

2020-12-02
2020
Engelska.
Ingår i: Bmj-British Medical Journal. - : BMJ. - 1756-1833. ; 371

Relaterad länk:: https://www.bmj.com/...; visa fler...; http://dx.doi.org/10... (free); https://doi.org/10.1...; https://uu.diva-port... (primary) (Raw object); https://liu.diva-por... (primary) (Raw object); https://gup.ub.gu.se...; https://doi.org/10.1...; https://lup.lub.lu.s...; https://urn.kb.se/re...; http://kipublication...; https://urn.kb.se/re...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

Stäng

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 intraarticular 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Geriatrik (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Geriatrics (hsv//eng)

Nyckelord

parallel-group
rheumatology/european league
methotrexate monotherapy
plus methotrexate
american-college
2-year efficacy
non-inferiority
combination
multicenter
remission
General & Internal Medicine

Publikations- och innehållstyp

ref (ämneskategori)
art (ämneskategori)

Hitta via bibliotek

Bmj-British Medical Journal (Sök värdpublikationen i LIBRIS)

Till lärosätets databas

Hitta mer i SwePub

Om ämnet

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Reumatologi och ...

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Medicinska och f ...; och Immunologi inom ...

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Geriatrik

Artiklar i publikationen: Bmj-British Medi ...; The BMJ

Av lärosätet: Göteborgs universitet; Lunds universitet; Uppsala universitet; Karolinska Institutet; Linköpings universitet

Sök utanför SwePub

Sök vidare i:: Google; Google Book Search; Google Scholar

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

LIBRIS.kb.se