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Extended report
In early rheumatoid arthritis, patients with a good initial response to methotrexate have excellent 2-year clinical outcomes, but radiological progression is not fully prevented: data from the methotrexate responders population in the SWEFOT trial
  1. Hamed Rezaei1,2,
  2. Saedis Saevarsdottir1,2,
  3. Kristina Forslind3,4,
  4. Kristina Albertsson2,
  5. Helena Wallin1,
  6. Johan Bratt2,
  7. Sofia Ernestam2,
  8. Pierre Geborek3,
  9. Ingemar F Pettersson3,5,
  10. Ronald F van Vollenhoven1,2
  1. 1Unit of Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden
  2. 2Department of Rheumatology, The Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden
  3. 3Department of Rheumatology, Lund University Hospital, Lund, Sweden
  4. 4Department of Medicine, Section of Rheumatology, Helsingborg Hospital, Sweden
  5. 5Department of Orthopedics, South Sweden Musculoskeletal Research Centre, Lund University Hospital, Lund, Sweden
  1. Correspondence to Dr Hamed Rezaei, Rheumatology Unit, Department of Medicine, Karolinska Institute/Karolinska University Hospital, SE-17176 Stockholm, Sweden; hamed.rezaei{at}


Objective To investigate the 2-year clinical and radiological outcomes of patients with early rheumatoid arthritis (RA; symptom duration <1 year) who had initially responded well to methotrexate monotherapy.

Methods In the SWEFOT trial, all 487 patients started methotrexate (target dose 20 mg/week). After 3–4 months, 147 had low disease activity, 28-joint based disease activity score (DAS28) ≤3.2. These patients were not randomly selected but were followed in regular care for 2 years. Clinical outcomes and radiographic progression according to the van der Heijde modified Sharp (SvdH) score were analysed.

Results The majority of the 147 patients continued on methotrexate monotherapy. After 1 and 2 years, DAS28 remission was achieved in 59.6% and 71.8% and mean observed DAS28 values were 2.53 and 2.25, respectively. Despite the favourable clinical course, a proportion of the patients progressed radiographically with a mean (SD) increase in the SvdH score after 2 years of 3.90 (6.84). There was no significant difference in progression between patients in DAS28 remission versus not in remission (p=0.73). At baseline, approximately half the patients had no radiographic damage, while after 2 years the proportion was approximately 20%.

Conclusion Most early RA patients who achieve low disease activity after 3–4 months of methotrexate monotherapy continue to have low disease activity during 2 years follow-up, and additional treatment is needed infrequently. Some radiological progression occurs in most patients, and may be marked or severe in some, even despite sustained DAS28 remission. Close monitoring for radiological progression is thus warranted.

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  • The SWEFOT trial investigators group Lars Cöster, Linköping; Eva Waltbrand, Borås; Agneta Zickert, Stockholm; Jan Theander, Kristianstad; Åke Thörner, Eskilstuna; Helena Hellström, Falun; Annika Teleman, Halmstad; Christina Dackhammar, Mölndal; Finn Akre, Örebro; Lotta Ljung, Umeå; Rolf Oding, Västerås; Katerina Chatzidionysiou, Stockholm; Margareta Wörnert, Stockholm.

  • Funding The study was supported in part by a grant from the Swedish Rheumatism Association. The authors were supported by clinical research funds from Stockholm County (ALF funds). An annual unrestricted grant was provided by Schering-Plough Sweden that was used to support a study coordinator and a medical monitor. RFvV has received research funding and/or honoraria from Abbott, Bristol-Myers Squibb, Merck, Pfizer, Roche and UCB Pharma.

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval The study was approved by the regional ethics committees of all participating units and was registered at http// (NCT00764725).

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