RESEARCH - Very early treatment with Remicade and MTX in early, poor-prognosis RA reduces MRI, with sustained benefit after Remicade withdrawal

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Arthritis Rheum. 2005 Jan;52(1):27-35.

Very early treatment with infliximab in addition to methotrexate in

early, poor-prognosis rheumatoid arthritis reduces magnetic resonance

imaging evidence of synovitis and damage, with sustained benefit after

infliximab withdrawal: results from a twelve-month randomized,

double-blind, placebo-controlled trial.

Quinn MA, Conaghan PG, O'Connor PJ, Karim Z, Greenstein A, Brown A,

Brown C, Fraser A, Jarret S, Emery P.

Academic Unit of Musculoskeletal Disease, First Floor, Leeds General

Infirmary, Great Street, Leeds LS1 3EX, UK.

OBJECTIVE: Anti-tumor necrosis factor alpha agents are among the most

effective therapies for rheumatoid arthritis (RA). However, their

optimal use is yet to be determined. This 12-month double-blind study

attempted remission induction using standard therapy with or without

infliximab in patients with early, poor-prognosis RA. The primary end

point was synovitis (measured by magnetic resonance imaging [MRI]).

Clinical observations continued to 24 months. METHODS: All patients

had fewer than 12 months of symptoms. Assessments included full

metrologic evaluation, laboratory tests, radiographs, functional

evaluation using the Health Assessment Questionnaire (HAQ), and

quality of life measurement using the RA Quality of Life (RAQoL)

questionnaire. MRI was performed at 0, 4, 14, and 54 weeks; MR images

were scored blindly. Patients received methotrexate (MTX) and were

randomized to receive either infliximab or placebo for 12 months.

RESULTS: Twenty patients were recruited (mean age 52 years, mean

symptom duration 6 months, mean C-reactive protein level 42 mg/liter,

and 65% rheumatoid factor positive). At 1 year, all MRI scores were

significantly better, with no new erosions in the infliximab plus MTX

group; a greater percentage of infliximab plus MTX-treated patients

fulfilled the American College of Rheumatology (ACR) 50% and 70%

improvement criteria (78% versus 40% in the placebo plus MTX group and

67% versus 30%, respectively) and had a greater functional benefit (P

< 0.05 for all comparisons). Importantly, at 1 year after stopping

induction therapy, response was sustained in 70% of the patients in

the infliximab plus MTX group, with a median Disease Activity Score in

28 joints (DAS28) of 2.05 (remission range). At 2 years, there were no

significant between-group differences in the DAS28, ACR response, or

radiographic scores, but differences in the HAQ and RAQoL scores were

maintained (P < 0.05).

CONCLUSION: Remission induction with infliximab plus MTX provided a

significant reduction in MRI evidence of synovitis and erosions at 1

year. At 2 years, functional and quality of life benefits were

sustained, despite withdrawal of infliximab therapy. These data may

have significant implications for the optimal use of expensive

biologic therapies.

PMID: 15641102

http://www.ncbi.nlm.nih.gov/pubmed/15641102

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