Low-Dose Prednisone Inclusion in a Methotrexate-Based, Tight Control Strategy for Early Rheumatoid Arthritis A Randomized Trial

Annals of Internal Medicine, 03/23/2012

Bakker MF et al. – Inclusion of low–dose prednisone in an methotrexate (MTX)–based treatment strategy for tight control in early rheumatoid arthritis (RA) improves patient outcomes.


  • A 2–year, prospective, randomized, placebo–controlled, double–blind, multicenter trial (CAMERA–II [Computer Assisted Management in Early Rheumatoid Arthritis trial–II]).
  • 7 hospitals in the Netherlands.
  • 236 patients with early RA (duration <1 year).
  • Patients were randomly assigned to an MTX–based, tight control strategy starting with either MTX and prednisone or MTX and placebo.
  • Methotrexate treatment was tailored to the individual patient at monthly visits on the basis of predefined response criteria aiming for remission.
  • The primary outcome was radiographic erosive joint damage after 2 years.
  • Secondary outcomes included response criteria, remission, and the need to add cyclosporine or a biologic agent to the treatment.


  • Erosive joint damage after 2 years was limited and less in the group receiving MTX and prednisone (n = 117) than in the group receiving MTX and placebo (n = 119).
  • The MTX and prednisone strategy was also more effective in reducing disease activity and physical disability, achieving sustained remission, and avoiding the addition of cyclosporine or biologic treatment.
  • Adverse events were similar in both groups, but some occurred less in the MTX and prednisone group.

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