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Clinical and ultrasound remission after 6 months of treat-to-target therapy in early rheumatoid arthritis: associations to future good radiographic and physical outcomes
  1. Nina Paulshus Sundlisæter1,2,
  2. Anna-Birgitte Aga1,
  3. Inge Christoffer Olsen3,
  4. Hilde Berner Hammer1,
  5. Till Uhlig1,
  6. Désirée van der Heijde1,4,
  7. Tore K Kvien1,
  8. Siri Lillegraven1,
  9. Espen A Haavardsholm1,2
  10. the ARCTIC study group
    1. 1 Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
    2. 2 Faculty of Medicine, University of Oslo, Oslo, Norway
    3. 3 Research Support Services CTU, Oslo University Hospital, Oslo, Norway
    4. 4 Medical Department, Leiden University, Leiden, The Netherlands
    1. Correspondence to Dr Nina Paulshus Sundlisæter, Department of Rheumatology, Diakonhjemmet Hospital, Oslo N-0319, Norway; ninasundlisater{at}gmail.com

    Abstract

    Objective To explore associations between remission, based on clinical and ultrasound definitions, and future good radiographic and physical outcome in early rheumatoid arthritis (RA).

    Methods Newly diagnosed patients with RA followed a treat-to-target strategy incorporating ultrasound information in the Aiming for Remission in rheumatoid arthritis: a randomised trial examining the benefit of ultrasound in a Clinical TIght Control regimen (ARCTIC) trial. We defined 6-month remission according to Disease Activity Score, Disease Activity Score in 28 joints-erythrocyte sedimentation rate, American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean criteria, Simplified Disease Activity Index, Clinical Disease Activity Index and two ultrasound definitions (no power Doppler signal, grey scale score ≤2). Two outcomes were defined: no radiographic progression and good outcome (no radiographic progression+physical function≥general population median), both sustained 12–24 months. We calculated the ORs of these outcomes for the remission definitions.

    Results Of 103 patients, 42%–82% reached remission at 6 months, dependent on definition. Seventy-one per cent of patients had no radiographic progression and 37% had good outcome. An association between 6-month remission and no radiographic progression was observed for ACR/EULAR Boolean remission (44 joints, OR 3.2, 95% CI 1.2 to 8.4), ultrasound power Doppler (OR 3.6, 95% CI 1.3 to 10.0) and grey scale remission (OR 3.2, 95% CI 1.2 to 8.0). All clinical, but not ultrasound remission criteria were associated with achievement of a good outcome.

    Conclusions Our data support ACR/EULAR Boolean remission based on 44 joints as the preferred treatment target in early RA. Absence of ultrasound inflammation was associated with no radiographic progression.

    Trial registration number NCT01205854; Post-results.

    • early rheumatoid arthritis
    • disease activity
    • outcome research
    • ultrasonography

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    Footnotes

    • SL and EAH share last authorship.

    • Handling editor Josef S Smolen

    • Contributors Conception and design of the study: ABA, ICO, HBH, TU, DvdH, TKK, SL and EAH. Acquisition of data: ABA, HBH, TU and EAH. Analysis and interpretation of data: NPS, ABA, ICO, HBH, TU, DvdH, TKK, SL and EAH.

    • Funding The study has received grants from the Norwegian Research Council, the South-East Health Region in Norway, the Norwegian Rheumatism Association, the Norwegian Women’s Public Health Association and unrestricted grant support from AbbVie, Pfizer, MSD, Roche and UCB.

    • Competing interests ICO has received consultancy honorarium from Pfizer. ABA has sat on advisory boards for UCB, AbbVie and Pfizer and received honorariums for development of educational material for UCB. HBH has received honorariums as a speaker from AbbVie, Bristol-Myers Squibb, Roche, UCB Pharma, Novartis and Pfizer. TU has received honorariums as a speaker from AbbVie, Bristol-Myers Squibb, Lilly, Roche, Novartis, UCB Pharma and Pfizer. DvdH has received consultancy honorariums from AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi, Eli Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi Aventis, Janssen and UCB and is the owner of Imaging Rheumatology. TKK has received fees for speaking and/or consulting from AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Epirus, Hospira, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB. EAH has received research funding from Pfizer, UCB, Roche, MSD and AbbVie for the submitted work, honorariums as a speaker from Pfizer, UCB, Roche and AbbVie, and honorariums for development of educational material from Pfizer and has sat on advisory boards for Pfizer, Eli Lilly and Celgene.

    • Patient consent Not required.

    • Ethics approval The study was approved by an independent ethics committee (the Regional Committee for Medical and Health Research Ethics South-East; reference number 2010/744).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators The ARCTIC study group: Hallvard Fremstad, Tor Magne Madland, Åse Stavland Lexberg, Hilde Haukeland, Erik Rødevand, Christian Høili, Hilde Stray, Anne Noraas Bendvold, Dag Magnar Soldal and Gunnstein Bakland.

    • Correction notice This article has been corrected since it published Online First. The shared authorship statement has been added.