Comparison of the efficacy and safety of methotrexate injection and methotrexate tablets in active active rheumatoid arthritis.

Objectives: This study aimed to compare the efficacy and safety of subcutaneous methotrexate (SC MTX) and oral MTX (OR MTX) in treating Chinese patients with active rheumatoid arthritis (RA).

Methods: This study included patients with active RA in China. All patients were randomly assigned to receive SC MTX or OR MTX. The primary end point was Disease Activity Score-28 for erythrocyte sedimentation rate (DAS28-ESR) after 12 weeks of treatment.

Results: DAS28-ESR scores of the SC MTX and OR MTX groups significantly decreased compared with baseline at week 12. The least squares mean (± standard error) of the change in DAS28-ESR scores were -1.972 ± 0.1448 and -1.800 ± 0.1438 in the SC MTX and OR MTX groups. The intergroup difference was -0.173 ± 0.2041, indicating that the SC MTX group was not inferior to the OR MTX group. With respect to the secondary endpoints of ACR20/50/70, DAS28-CRP, and the proportion of patients in disease remission by DAS28(CRP) but not with DAS28(ESR), SC MTX was numerically better than OR MTX during the first 8 weeks but not all by week 12. The safety profile of SC MTX is similar to that of OR MTX in general, and the incidence, occurrences and Preferred Term types of drug-related TEAE of gastrointestinal system disorders were lower.

Conclusions: SC MTX had similar overall therapeutic effects compared with OR MTX and was generally well tolerated. Some efficacy results showed greater improvement during the first 8 weeks of SC MTX vs OR MTX but not by week 12.

Clinical Trial Registration: https://www.chictr.org.cn, identifier ChiCTR2200066425.