AMSTERDAM — In the first direct comparison of oral versus subcutaneous methotrexate for patients with active rheumatoid arthritis, the injectable formulation was significantly more effective, Dr. Jürgen Braun said at the annual European Congress of Rheumatology.
The multicenter study involved 384 patients, none of whom had previously taken methotrexate (MTX) or biologics. They were predominantly female. Mean age was 59 and mean time since diagnosis was 2 months, said Dr. Braun of Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.
They were randomized to 15 mg oral MTX plus placebo injections or injectable MTX in the same dose plus dummy pills, once weekly, for 24 weeks. At week 16, patients receiving oral MTX could be switched to subcutaneous, and those receiving the injectable drug could have a dosage increase to 20 mg, he said.
A total of 78% of patients on subcutaneous MTX met the primary efficacy outcome of ACR20 response at 24 weeks, compared with 67% of those on oral MTX, Dr. Braun reported at the meeting, sponsored by the European League Against Rheumatism. This difference was statistically significant, as was the difference in percentages achieving ACR70 responses (43% vs. 31%, respectively).
Remission, defined as a Disease Activity Score 28 less than 2.6, was reached by 34% of patients on the subcutaneous formulation, compared with only 24% of those on the oral drug, a statistically significant difference.