Evaluation of the efficacy and safety of Iguratimod combined with traditional anti-rheumatic drugs in treating rheumatoid arthritis: a retrospective study.

BACKGROUND

Rheumatoid arthritis (RA) is a chronic autoimmune disease that may lead to progressive joint damage and disability. Although methotrexate is a first-line treatment, some patients have inadequate responses or adverse reactions. This study aimed to evaluate the efficacy and safety of methotrexate combined with iguratimod versus methotrexate monotherapy in patients with RA.

METHODS

Based on existing medical records, the clinical data of 80 patients with rheumatoid arthritis treated at our hospital between October 2021 and October 2023 were retrospectively analyzed. This was a single-center, retrospective, non-randomized controlled study, and the investigators were not involved in treatment allocation. According to the actual treatment regimens documented in the medical records, patients were divided into a conventional treatment group, which received methotrexate, and a combination treatment group, which received methotrexate plus iguratimod. Treatment efficacy, bone metabolism, CRP, RF, ESR, immune function, and adverse reactions were compared between the two groups. As the treatment regimens were not randomly assigned, the findings were mainly used to evaluate the associations between different treatment regimens and clinical outcomes.

RESULTS

The combination therapy group demonstrated significantly higher response rates for ACR20, ACR50, ACR70 and considerably higher levels of N-MID and T-PINP than the conventional treatment group following treatment. This group demonstrated significantly decreased levels of β-CTX, CRP, RF, and ESR compared to the conventional treatment group (p < 0.05). After treatment, except for the similar changes in CD4 + and CD8 + levels, the levels of IgG, IgA, and IgM in the combination treatment group were significantly lower than the conventional treatment group (p < 0.05). The combination therapy group showed a more significant drop in DAS28 values than conventional treatment group (p < 0.05). However, there was no significant difference in adverse effects (p > 0.05).

CONCLUSION

In this single-center retrospective study, compared with methotrexate monotherapy, methotrexate combined with iguratimod was associated with higher ACR20, ACR50, and ACR70 response rates, as well as greater improvements in inflammatory markers, bone metabolism indicators, and DAS28 scores, without a significant increase in the incidence of adverse reactions. However, because this study used a non-randomized design and did not include propensity score matching, the findings should be further validated in prospective randomized controlled trials.