RESEARCH - Early Treatment With Remicade May Be Helpful in RA

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Early Treatment With Infliximab May Be Helpful in Rheumatoid Arthritis

Laurie Barclay, MD

Jan. 11, 2005 - Early treatment of rheumatoid arthritis (RA) with infliximab

added to methotrexate (MTX) reduces detectable progression on magnetic

resonance imaging (MRI) and has sustained effects, according to the results

of a pilot randomized study published in the January issue of Arthritis &

Rheumatism.

" Anti-tumor necrosis factor-alpha agents are among the most effective

therapies for RA, " write Mark A. Quinn, from Leeds General Infirmary in the

U.K., and colleagues. " However, their optimal use is yet to be determined. "

In this double-blind study, 20 patients with early, poor RA prognosis were

randomized to attempted remission induction using standard MTX therapy with

or without infliximab for 12 months. At baseline, mean age was 52 years,

mean symptom duration was six months, and mean C-reactive protein level was

42 mg/L. All patients had symptoms for fewer than 12 months, and rheumatoid

factor was positive in 65% of patients.

The primary outcome was synovitis as determined by MRI images scored blindly

at week 0, 4, 14, and 54. Other outcomes 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. Clinical observations

continued to 24 months.

At one year, the infliximab plus MTX group had significant improvement in

all MRI scores, with no new erosions. The percentage of patients fulfilling

the American College of Rheumatology (ACR) 50% improvement criteria was 78%

for the infliximab plus MTX group and 40% for the placebo group (P < .05).

For 70% improvement, the corresponding percentages were 67% vs 30% (P <

05). Functional benefit was also greater in the infliximab plus MTX group.

One year after stopping induction therapy, response was sustained in 70% of

patients in the infliximab plus MTX group. Median Disease Activity Score in

28 joints (DAS28) was 2.05, which was in remission range. Differences

between groups in the DAS28, ACR response, and radiographic scores were not

significantly different at two years, but differences in the HAQ and RAQoL

scores were maintained (P < .05).

" Remission induction with infliximab plus MTX provided a significant

reduction in MRI evidence of synovitis and erosions at one year, " the

authors write. " At two 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. "

Study limitations included a lack of power to show differences in

conventional radiographs over the study period, observational collection of

second-year data, and small sample size.

" Despite the design limitations of the study, however, for patients with RA,

these results are comparable to the best reported (and were achieved in

patients selected for poor prognosis), " the authors conclude. " If larger

studies confirm these data, this protocol may provide a possible solution to

the economic issues of early therapy with biologics. "

The Arthritis Research Campaign supported this study.

Arthritis Rheum. 2005;52:27-35

Reviewed by D. Vogin, MD

http://www.medscape.com/viewarticle/497226

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