RESEARCH - Steroids and combination DMARDs in early RA

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Ann Rheum Dis. 2007 Sep 3; [Epub ahead of print]

Factorial randomised controlled trial of glucocorticoids and combination

disease modifying drugs in early rheumatoid arthritis.

Choy EH, CM, Farewell V, DJ, Hassell A, Chau L, DL.

Sir Alfred Baring Garrod Clinical Trials Unit, King's College London, United

Kingdom.

OBJECTIVE: Treating early active rheumatoid arthritis (RA) with disease

modifying anti-rheumatic drug (DMARD) monotherapy gives achieves incomplete

outcomes and intensive treatment seems preferable. As the relative benefits

of combining two DMARDs, one DMARD with glucocorticoids and two DMARDs with

glucocorticoids are uncertain we defined them in a factorial trial. METHODS:

A 2-year randomised double-blind factorial trial in RA patients within 2

years of diagnosis treated with methotrexate dissected the benefits of added

ciclosporin, 9-months intensive prednisolone or both (triple therapy). The

primary outcome was the number of patients with new erosions. Secondary

outcomes included Larsen's X-ray scores, disability, quality of life and

adverse events. Findings: 1391 patients were screened and 467 randomised.

Over 2 years 132 (28%) changed therapy and 88 (19%) were lost to follow up.

The number of patients with new erosions was reduced by nearly a half by

adding ciclosporin or prednisolone (p=0.01 and 0.03); both treatments

reduced increases in Larsen's x-ray scores by over two units (p=0.008 and

0.003). A further reduction in erosive damage was seen with combined use of

both treatments. Their effects on erosive damage appeared independent.

Triple therapy reduced disability and improved quality of life compared to

methotrexate; ciclosporin and prednisolone acted synergistically. More

patients withdrew because of adverse events with triple therapy, without an

increase in serious adverse effects.

CONCLUSIONS: This study confirms the existence of a " window of opportunity "

in early RA, when intensive combination therapy produces sustained benefits

on damage and disability. Although methotrexate-prednisolone combinations

reduce erosive damage, the synergistic effect of two disease modifying drugs

is needed to improve quality of life.

PMID: 17768173

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve & db=PubMed & list_uids=177681\

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