By Roberta Friedman, PhD
SAN FRANCISCO, Calif -- October 27, 2008 -- Patients with rheumatoid arthritis (RA) lose fewer work days when infliximab is added to a combination of methotrexate, sulfasalazinesulphasalazine, hydroxychloroquine, and prednisolone, according to phase 4 trial results presented here at the American College of Rheumatology (ACR) - Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting.
The study results, from the NEO-RACo study, were reported here on October 27, by investigator Marjatta Leirisalo-Repo, MD, University Central Hospital, Helsinki, Finland.
The study followed 100 previously -untreated patients <65 years old and who had had RA symptoms for ≤1 year or less. These patients were randomised to receive treatment with infliximab 3 mg/kg or placebo at weeks 4, 6, 10, 18, and 26 after starting the combined combination drug regimen.
Doses of methotrexate up to ≤25 mg and sulfasalazine up to ≤2 g were used until the patient achieved disease remission was achieved.
Dr. Leirisalo-Repo noted that the study recruited newly -diagnosed patients who were given disease-modifying antirheumatic drugs (DMARD) therapy as well as local, intra-articular steroids injections. "We aim to [induce] remission," she said.
Patients had at least 6 swollen and at least 6 tender joints, morning stiffness for at least 45 minutes, and an erythrocyte sedimentation rate ESR of at least ≤30 mm/h or C-reactive proteinCRP of at least ≤20 mg/L.
Half of the patients received infliximab. Patients were followed up for 2 years, and days of RA-related absence from work were recorded at each visit.
Results at 2 years show a trend toward a higher percentage of patients having achieved RA remission according to American College of Rheumatology criteria in the infliximab arm (70%) compared with those receiving placebo (53%).
Dr. Leirisalo-Repo said that as the trial has continued, this difference has came to achieved statistical significance.
"Most important," she said, "work disability days are statistically significantly different between the 2 groups." Those on infliximab had 2.5 median missed days, compared with 31 days for those in the placebo arm.
Schering-Plough Corporation donated the study drug used for this trial.
[Presentation title: Adding Infliximab to Triple DMARD Plus Prednisolone Therapy Reduces Absence From Work in Patients With Early Active Rheumatoid Arthritis. Results From a Double-Blind Placebo-Controlled Study (NEO-RACo). Abstract number 1000]
E-Mail this DGDispatch to a colleague
