Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Double-Blind Randomized CAMERA-II Trial: Better Control of Disease and Erosive Joint Damage with Inclusion of Low-Dose Prednisone Into a MTX-Based Tight Control Strategy for Early Rheumatoid Arthritis.
Bakker1, Marije F., Jacobs1, Johannes W.G., Welsing1, Paco M.J., Verstappen1, Suzanne M.M., Tekstra1, Janneke, Ton1, Evelien, Geurts2, Monique A.W.
UMC Utrecht, Utrecht, Netherlands
St. Antonius hospital, Nieuwegein, Netherlands
Diakonessenhuis, Utrecht, Netherlands
Meander Medical Center, Amersfoort, Netherlands
Tergooi hospital, Hilversum, Netherlands
St. Jansdal hospital, Harderwijk, Netherlands
Flevohospital, Almere, Netherlands
Tight control treatment strategies for early rheumatoid arthritis (RA) are highly effective, but leave room for improvement. This study investigated whether including 10 mg/day prednisone from the start of treatment to a methotrexate (MTX) based tight control strategy for early RA is more effective than this strategy without prednisone, regarding disease activity and radiographic outcome, i.e. erosive joint damage.
Patients with early RA (<1 year) were enrolled in the two-year prospective randomized, placebo-controlled, double-blind, multi-centre MTX-based tight control step-up trial CAMERA-II (Computer Assisted Management in Early RA-II). Patients were randomized to a MTX-based tight control strategy with either prednisone (MTX-pred) or placebo (MTX-plac). MTX treatment was tailored to the individual patient at monthly visits, based on predefined response criteria, aiming for remission. If remission was not achieved at the maximum (tolerable) dose of MTX, a biological was added to the regimen. Primary endpoint was radiographic erosive joint damage after two years. Secondary endpoints included response criteria, remission, and the need of a biological during the trial.
Respectively 117 and 119 patients were randomized to MTX-pred and MTX-plac. Erosive joint damage at the end of the trial was less in the MTX-pred than in the MTX-plac group (median (IQR); 0 (00) vs. 0 (02), p=0.04). The strategy with MTX-pred was also more effective in reducing disease activity and disability (p<=0.03). A higher proportion of patients in the MTX-pred group achieved sustained remission (72% vs. 61%, p=0.09) and a lower proportion needed biological treatment (14% vs. 36%, p<0.001), compared to the proportions in the MTX-plac group. In the MTX-pred group 29% of patients experienced adverse events compared to 35% in the MTX-plac group.
Inclusion of low-dose prednisone from the start into a two-year MTX-based tight control treatment strategy for early RA increases both effectiveness (i.e. disease activity variables) and outcome (i.e. erosive joint damage) without increasing toxicity. It also reduces the need for (early) treatment with biologicals.
To cite this abstract, please use the following information:
Bakker, Marije F., Jacobs, Johannes W.G., Welsing, Paco M.J., Verstappen, Suzanne M.M., Tekstra, Janneke, Ton, Evelien, et al; Double-Blind Randomized CAMERA-II Trial: Better Control of Disease and Erosive Joint Damage with Inclusion of Low-Dose Prednisone Into a MTX-Based Tight Control Strategy for Early Rheumatoid Arthritis. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1695