Objective: To investigate whether clinical and radiographic disease control can be achieved and maintained in patients with early, active rheumatoid arthritis (RA) during the 2nd year of aggressive treatment with conventional DMARD and intraarticular corticosteroid. This paper presents the results of the 2nd year of the randomized, controlled double-blind CIMESTRA study.
Methods: 160 patients with early RA (<6 months' duration) were randomized to receive intraarticular betamethasone in any swollen joint in combination with step-up treatment with either methotrexate and placebo-cyclosporine (monotherapy) or methotrexate plus cyclosporine (combination therapy) during the first 76 weeks. At week 68 hydroxychlorochine 200 mg daily was added. From week 76-104 cyclosporine/placebo-cyclosporine was tapered to zero.
Results: ACR20, ACR50 and ACR70 were achieved in 88%, 79% and 59% of patients in the combination vs. 72%, 62% and 54% in the monotherapy group (p= 0.03, 0.02 and 0.6 between groups). Patient’s global declined from 50 to 12 vs. 52 to 9, 51% and 50% were in DAS-remission, respectively. Mean±SD progressions in total Sharp/vdHeijde score were 1.42±3.52 and 2.03±5.86 in combination and monotherapy groups, respectively (NS). Serum creatinine levels increased by 7% in the combination group (4% in monotherapy), but hypertension was not more prevalent.
Conclusion: Continuous methotrexate and intraarticular corticosteroid treatment resulted in excellent clinical reponse and disease control at 2 years, and the radiographic erosive progression was minimal. Addition of cyclosporine during the first 76 weeks resulted in significantly better ACR20 and ACR50 responses, but did not have any additional effect on remission rate and radiographic outcome.
- placebo-controlled trial
- rheumatoid arthritis