Subcutaneous (SC) methotrexate (MTX) is significantly more effective than oral MTX for patients with early, active rheumatoid arthritis (RA), and is even more effective for those who have had RA for =1 year, according to German researchers.
Jurgen Braun, MD, reported in Arthritis & Rheumatism that a 6-month prospective, randomized, controlled trial showed ACR20 rates of 78% with SC MTX and 70% with oral MTX (P <.05) at week 24.1 “Our findings from the present study showed that SC administration of MTX is significantly more effective than oral administration of MTX at the same dosage, with no increase in side effects. The results of our study support the use of MTX as monotherapy in patients with RA, being the best of the available monotherapies for this condition,” Dr. Braun said.
The patients in this study were MTX-naïve, had not previously taken biologic agent, and had active RA with DAS28 (Disease Activity Score in 28 joints) of =4. They were randomized to 15 mg/week of MTX either orally (MTX tablets plus a dummy syringe, n = 187) or SC (prefilled syringe with 10 ng/mL plus two dummy tablets, n = 188). Those who did not achieve ACR20 by 16 weeks were switched to the other study arm.
The researchers also found that ACR20 rates for patients with a disease duration =12 months were 89% for SC MTX and 63% for oral MTX (P <.05). ACR20 response differences became apparent at week 16 and increased over time. Time to ACR20 response was about 2 weeks shorter with SC MTX. At week 24, swollen joint counts were significantly lower in the SC group, and the number of tender joints was lower but not significantly so (3.5 versus 6, P = .08).
This improved efficacy did not come at the cost of increased adverse effects (AEs). “Overall, even the gastrointestinal AEs were similar between the two routes of MTX administration. This was rather unexpected since, in other studies, patients have been shown to benefit from parental administration of MTX, particularly with regard to the number of gastrointestinal AEs,” Dr. Braun said.
Reference
1. Braun J, Klastner P, Flaxenberg P, et al. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis. Results of a 6-month, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis Rheum. 2008;58:73-81.
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