Adalimumab Plus Methotrexate Superior to Monotherapy for RA
NEW YORK (Reuters Health) Dec 30 - For patients with early, aggressive rheumatoid arthritis (RA), treatment with a combination of adalimumab (Humira, Abbott) and methotrexate leads to a better clinical response than treatment with either agent alone, according to results of the PREMIER study.
Dr. Ferdinand C. Breedveld, from Leiden University Medical Center in the Netherlands, and his colleagues enrolled 799 patients from centers in Australia, Europe and North America. The subjects all had active disease for more than 3 years and had never been treated with methotrexate.
The patients were randomly assigned to subcutaneous injections of adalimumab plus oral methotrexate (n = 268), adalimumab plus placebo (n = 274) or methotrexate plus placebo (n = 257). Adalimumab was initiated at 40 mg every other week, which could be increased to 40 mg every week. Methotrexate was started at 7.5 mg/week, which could be titrated up to 20 mg/week.
One primary co-endpoint was an American College of Rheumatology 50% improvement (ACR50) response. The other co-primary endpoint was radiographic progression according to changes in total Sharp scores. Dr. Breedveld's team reports the findings in the January issue of Arthritis and Rheumatism.
At the end of 1 year, 62% of those in the combination group achieved an ACR50 response, compared with 41% of those in the adalimumab group and 46% of patients in the methotrexate group (p < 0.001 for monotherapy versus combination therapy). This pattern was sustained at 2 years.
At 1 year, the mean increase in Sharp units was 1.3 in the combination group, 3.0 units in the adalimumab group and 5.7 units in the methotrexate group. At 2 years, scores were 1.9, 5.5, and 10.4 Sharp units, respectively.
At the end of 2 years, clinical remission, defined as 28-joint Disease Activity Score < 2.6, was achieved by 43% in the combination group, 23% in the adalimumab group, and 21% in the methotrexate group.
There were no significant differences among groups in the incidence of serious adverse events or in the number of subjects who withdrew because of adverse events. Withdrawal because of a lack of efficacy was less frequent in the combination therapy group (4.9% versus 19.0% and 17.9%).
Thus, the authors conclude," In this population of patients with early, aggressive RA, combination therapy with adalimumab plus methotrexate was significantly superior to either methotrexate alone or adalimumab alone in improving signs and symptoms of disease, inhibiting radiographic progression, and effecting clinical remission."
The PREMIER study was sponsored by Abbott Laboratories.
Arthritis Rheum 2006;54:26-37.
Dr. Ferdinand C. Breedveld, from Leiden University Medical Center in the Netherlands, and his colleagues enrolled 799 patients from centers in Australia, Europe and North America. The subjects all had active disease for more than 3 years and had never been treated with methotrexate.
The patients were randomly assigned to subcutaneous injections of adalimumab plus oral methotrexate (n = 268), adalimumab plus placebo (n = 274) or methotrexate plus placebo (n = 257). Adalimumab was initiated at 40 mg every other week, which could be increased to 40 mg every week. Methotrexate was started at 7.5 mg/week, which could be titrated up to 20 mg/week.
One primary co-endpoint was an American College of Rheumatology 50% improvement (ACR50) response. The other co-primary endpoint was radiographic progression according to changes in total Sharp scores. Dr. Breedveld's team reports the findings in the January issue of Arthritis and Rheumatism.
At the end of 1 year, 62% of those in the combination group achieved an ACR50 response, compared with 41% of those in the adalimumab group and 46% of patients in the methotrexate group (p < 0.001 for monotherapy versus combination therapy). This pattern was sustained at 2 years.
At 1 year, the mean increase in Sharp units was 1.3 in the combination group, 3.0 units in the adalimumab group and 5.7 units in the methotrexate group. At 2 years, scores were 1.9, 5.5, and 10.4 Sharp units, respectively.
At the end of 2 years, clinical remission, defined as 28-joint Disease Activity Score < 2.6, was achieved by 43% in the combination group, 23% in the adalimumab group, and 21% in the methotrexate group.
There were no significant differences among groups in the incidence of serious adverse events or in the number of subjects who withdrew because of adverse events. Withdrawal because of a lack of efficacy was less frequent in the combination therapy group (4.9% versus 19.0% and 17.9%).
Thus, the authors conclude," In this population of patients with early, aggressive RA, combination therapy with adalimumab plus methotrexate was significantly superior to either methotrexate alone or adalimumab alone in improving signs and symptoms of disease, inhibiting radiographic progression, and effecting clinical remission."
The PREMIER study was sponsored by Abbott Laboratories.
Arthritis Rheum 2006;54:26-37.
posted by Ricardo Pocurull at 7:29 AM
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