RESEARCH - Aggressive combination therapy with intra-articular steroid injections and DMARDs in early RA: CIMESTRA

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Ann Rheum Dis. 2008 Jun;67(6):815-22. Epub 2007 Sep 18.

Aggressive combination therapy with intra-articular glucocorticoid

injections and conventional disease-modifying anti-rheumatic drugs in

early rheumatoid arthritis: second-year clinical and radiographic

results from the CIMESTRA study.

Hetland ML, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I,

Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjødt H, Lauridsen UB,

Ellingsen T, Hansen GV, Lindegaard H, Vestergaard A, Jurik AG,

Østergaard M, Hørslev-sen K; CIMESTRA study group.

Collaborators (28)

Lorenzen T, Jensen SH, Pødenphant J, Bendtsen H, Faarvang KL, Hansen

MS, Hansen TM, Nielsen H, sen S, Majgaard O, Beier J, Ejstrup L,

Knudsen JB, Laustrup H, Krogh NS, Zitelab AS, Vallø J, Thomsen HS,

Ejbjerg B, Torfing T, Bukh G, Frederiksen J, Rasmussen P, Theilgård K,

Gerdes L, Holm H, Lorentzen KB, Pedersen-Zbinden B.

Department of Rheumatology, Copenhagen University Hospital, Hvidovre, Denmark.

OBJECTIVE: To investigate whether clinical and radiographic disease

control can be achieved and maintained in patients with early, active

rheumatoid arthritis (RA) during the second year of aggressive

treatment with conventional disease-modifying antirheumatic drugs

(DMARDs) and intra-articular corticosteroid. This paper presents the

results of the second year of the randomised, controlled double-blind

CIMESTRA (Ciclosporine, Methotrexate, Steroid in RA) study.

METHODS: 160 patients with early RA (duration <6 months) were

randomised to receive intra-articular betamethasone in any swollen

joint in combination with step-up treatment with either methotrexate

and placebo-ciclosporine (monotherapy) or methotrexate plus

ciclosporine (combination therapy) during the first 76 weeks. At week

68 hydroxychlorochine 200 mg daily was added. From week 76-104

ciclosporine/placebo-ciclosporine was tapered to zero.

RESULTS: American College of Rheumatology 20% improvement (ACR20),

ACR50 and ACR70 levels 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). The patients globally declined

from 50 to 12 vs 52 to 9, with 51% and 50% in Disease Activity Score

(DAS) remission, respectively. Mean (SD) progressions in total

Sharp-van der Heijde scores were 1.42 (3.52) and 2.03 (5.86) in

combination and monotherapy groups, respectively (not significant).

Serum creatinine levels increased by 7% in the combination group (4%

in monotherapy), but hypertension was not more prevalent.

CONCLUSION: 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.

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.

PMID: 17878209

http://www.ncbi.nlm.nih.gov/pubmed/17878209

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