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Infliximab-Methotrexate Combination Improves Function, Quality of Life and Inhibits Joint Damage in Rheumatoid Arthritis

A combination of infliximab and methotrexate provided significant and clinically relevant improvements in function, quality of life (QOL), and inhibition of joint damage in patients with rheumatoid arthritis (RA) when compared to methotrexate alone, according the results of 2-year long study.

The combination regimen also improved significantly the signs and symptoms of RA among patients who had an incomplete response to methotrexate alone.

Patients were enrolled in 34 study centres in North America and Europe by Avinder Maini, MD, and colleagues in the Anti-tumour Necrosis Factor Trial in RA with Concomitant Therapy Study Group (ATTRACT). Men and women between 18 and 75 were eligible for the study if they had active RA as defined by the protocol despite treatment with at least 12.5 mg/week of methotrexate.

Treatment involved infusions of infliximab at doses of 3 or 10 mg/kg or placebo plus methotrexate for 54 weeks, and those who completed the initial treatment were given the option of continuing treatment through 102 weeks.

Arthritis-related functional disability was measured every 4 weeks using the Health Assessment Questionnaire (HAQ) and QOL was assessed using the Medical Outcomes Study Short Form 36 (SF-36). Prevention of structural damage in the hands and feet was measured by changes from baseline in the Sharp radiographic damage score. An independent assessor evaluated the numbers of tender and swollen joints with a clinical response at week 102 being defined according to the American College of Rheumatology definition of 20% improvement (ACR20) and 50% improvement (ACR50).

The researchers found a significant improvement in both the HAQ and SF-36 scores in the infliximab plus methotrexate group when compared to the methotrexate-only group. There were no dose-response results evident in those getting different doses of infliximab.

Pairwise comparisons in the changes from baseline in total radiographic scores showed the change from baseline to week 102 in each treatment group was significantly lower than in the methotrexate-only group. Significant reductions from baseline for erosions and joint space narrowing were seen in the all combination groups except those being given infliximab 3 mg/kg every 8-weeks. There were also fewer newly eroded joints seen in the infliximab plus methotrexate groups. All methotrexate-infliximab treatment groups achieved an ACR20 treatment response as well as ACR 50% improvement.

"The combination of infliximab and [methotrexate] over a 2-year period provides significant and clinically relevant improvement in physical functions and QOL, and this improvement is accompanied by inhibition of progressive joint damage and sustained improvement in the signs and symptoms of inflammation in patients with RA who had an incomplete response to [methotrexate] alone," the authors conclude.
Arthritis Rheumat 2004 April;50:1051-1065. "Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate"

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