Continuous methotrexate and intra-articular corticosteroids can achieve "excellent clinical response and disease control after 2 years" in patients with early rheumatoid arthritis (RA), Danish investigators report in the June issue of the Annals of Rheumatic Diseases.
The findings come from the second year of follow-up of the randomized, placebo-controlled, multicenter Ciclosporine, Methotrexate, Steroid in RA (CIMESTRA) study.
Dr. Kim Horslev-Petersen of Arhus University Hospital and colleagues randomized 160 patients with RA diagnosed within the past 6 months to receive intra-articular betamethasone in all swollen joints plus step-up treatment with either methotrexate plus placebo, ciclosporine plus placebo or combination therapy with methotrexate and ciclosporine for 76 weeks.
Hydroxychloroquine, 200 mg daily, was added at week 68. Patients randomized to ciclosporine were tapered off the drug beginning at week 76 with the drug completely discontinued by week 104.
American College of Rheumatology 20%, 50% or 70% improvement (ACR20, ACR50 and ACR70) was achieved in 88%, 79% and 59% of patients, respectively, on combination therapy. Rates were 72%, 62% and 54%, respectively, for patients in either monotherapy group.
There was an approximate 50% reduction in Disease Activity Score (DAS) in all patients overall, whether they were on monotherapy or combination therapy.
Serum creatinine levels increased 7% in the combination group and 4% in those on monotherapy. Hypertension was not more prevalent in one group over another.
"Continuous methotrexate and intra-articular corticosteroid treatment resulted in excellent clinical response and disease control at 2 years, and the radiographic erosive progression was minimal," Dr. Horslev-Petersen and colleagues write.
"Addition of ciclosporine 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," they acknowledge.
"We are probably even more aggressive now, focusing on remission with our treatment today," Dr. Horslev-Petersen said in an interview with Reuters Health. "Methotrexate, or in special cases sulphasalazine, is our first DMARD drug of choice."
"A strategy including intra-articular steroid injections in addition to DMARDs is now used for early RA in 19 out of 21 rheumatologic departments in Denmark," the investigator noted. "Most departments in Denmark now use a faster increase in methotrexate dosage, starting with 10 mg/week increasing up to 20-25 mg/week within 8 weeks."
Ann Rheum Dis 2008;7:815-822.