Background In the second Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA–II) trial, patients initiated treatment with methotrexate (MTX) with randomized 10 mg/d prednisone (pred) or placebo (plac), given for 2 years . Significantly more patients in the MTX+pred strategy arm than in the MTX+plac arm were erosion free at 2 years, and disease activity improved faster. The frequency of adverse events (AE) during the 2 year trial was comparable between the groups. There is paucity of data on long-term AEs after treatment with medium dose of glucocorticoids, however.
Objectives To investigate the incidence of long-term AEs/comorbidities in early rheumatoid arthritis patients, who had been treated additionally with pred10 mg/day or plac in CAMERA-II.
Methods After the 2 year trial, patients were followed according to a protocol in clinical care. The occurrence of AEs/comorbidities and the use of pred (it was the strategy to taper and stop it) was collected retrospectively from the medical charts. The incidence of long-term AEs/comorbidities in the former MTX+pred group was tested versus that in the former MTX+plac group using Fisher's Exact tests.
Results Of the 236 patients included in the CAMERA-II trial, follow-up data was available of 218 patients: MTX+pred N=107, MTX+plac N=111; no longer followed according to protocol N=18. The median follow-up time after the end of the 2-year trial period was 6 (range 0–9) and 6 (0–11) years, respectively. 86 (80%) patients treated with pred could discontinue it after a median of 9 months after the end of the trial end. The percentage of patients with AEs/comorbidities is shown in Table 1. No statistically significant differences between the two groups were found.
Conclusions Of patients in the MTX+pred group during CAMERA-II, 80% could discontinue pred after the trial. There was no increased incidence of long-term AEs/comorbidities in the former MTX+pred group.
Bakker MF, Jacobs JWG, Welsing PMJ, et al. Low-dose prednisone inclusion in a methotrexate-based, tight control strategy for early rheumatoid arthritis: a randomized trial. Ann Intern Med 2012;156:329–39.
Disclosure of Interest None declared