Supplement Article |
PP2. LONG-TERM FOLLOW-UP OF POLYMYALGIA RHEUMATICA PATIENTS TREATED WITH METHOTREXATE AND STEROIDS
1 Clinica Reumatologica, Università di Genova, Italy, 2 Divisione di Reumatologia, Reggio Emilia, Italy, 3 Dipartimento di Medicina Interna e Sperimentale, Università di Perugia, Italy, 4 Clinica Reumatologica, Università di Pavia, Italy
Introduction: We have recently demonstrated that combination therapy with prednisone and methotrexate (MTX) is effective as steroid-sparing treatment for patients with newly diagnosed polymyalgia rheumatica (PMR) [1]. This schedule reduces the incidence of flare-ups and the amount of prednisone required to maintain remission. However, no substantial reduction was found in the incidence of steroid-related side effects in the MTX-treated patients, despite the lower cumulative dose of prednisone they received. Possible explanations are the narrow difference in the cumulative dose of prednisone between groups, and the low incidence of side effects in this relatively "healthy" group of PMR patients, a common problem of controlled trials. Another possibility is the short follow-up. To test this last hypothesis, we decided to review the charts of the participating patients and to visit them again after a mean period of 5 years after completion of the original study.
Patients and methods: Four of the original five rheumatologic tertiary referral centres, covering 61 of the original 72 (84.7%) patients, agreed to participate in the study. Patients were contacted by phone and asked to visit the clinic. If the patient was dead, a close relative was interviewed and information was collected on his/her previous health conditions and cause of death through a standardized questionnaire.
Results: Data were obtained from 47/61 (77%) of the original patients. Five patients (10.6%) had died because of cerebrovascular accident, myocardial infarction, congestive heart failure (2 patients), or unknown cause. Two of the 23 MTX-treated patients (8.7%) had died in comparison with 3/24 (12.5%) controls. Exacerbations and relapses of PMR were seen in 4/23 (17.4%) MTX-treated patients in comparison with 10/24 (41.7%) controls (p = 0.11 by Fisher's exact test). Five out of 23 (21.7%) MTX-treated patients were still on steroids 5 years after completion of the study in comparison with 11/24 (45.8%) controls (p = 0.12). Girdle pain and stiffness, as well as results of the HAQ were not different in the two subgroups. Pain intensity, general health and physician's opinion on the patient's conditions by visual analogue scale tended to be better in MTX-treated patients than in controls, although not significantly so (20.2±21.1 mm vs. 17.2±22.7 mm, 17.3±19.7 mm vs. 13.7± 21.1 mm, and 13.2±18.8 mm vs. 6.9±8.6 mm, respectively). ESR (15.5 mm/h vs. 25.4 mm/h, p = 013) and CRP (2.7 mg/L vs. 11.3 mg/L, p = 0.009) were lower in MTX-treated patients.
Potential side effects of steroid treatment were relatively rare. No differences were observed in their incidence, with a mean of 1.9 side effects for MTX-treated patients and 2.6 for controls. The analysis of single steroid-related side effects gave similar results.
Conclusions: In this long-term evaluation of the effect of MTX supplementation for PMR patients, there was a tendency toward less residual disease activity over 5 years in MTX-treated patients. However, complications of steroid treatment were rare in both groups without a significant difference between them. To assess whether MTX-supplementation therapy could spare some side-effects of steroids, a prospective evaluation of unselected patients is probably more appropriate.