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SAT0126 Comorbidities after Daily Concomitant Treatment with 10mg Prednisone or Placebo in The 2-Year Computer Assisted Management in Early Rheumatoid Arthritis Trial-Ii
  1. M.J. De Hair,
  2. M. Safy,
  3. N. Ijff,
  4. J.W. Jacobs,
  5. J.M. van Laar,
  6. on behalf of the whole Society for Rheumatology Research Utrecht (SRU)
  1. Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands

Abstract

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 [1]. 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.

Table 1.

Percentage of new onset AEs/comorbidities after the trial in the former pred vs former plac group

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.

  1. 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

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