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To compare the efficacy and safety of iguratimod or methotrexate combined with leflunomide in patients with active elderly-onset rheumatoid arthritis.
A single-center, randomized, double-blinded, controlled clinical trial was conducted in elderly-onset patients. The patients were randomly assigned to two groups of iguratimod combined with leflunomide (Group Iguratimod) or methotrexate combined with leflunomide (Group Methotrexate) treatments at a ratio of 1∶1. The efficacy and safety of both groups were evaluated at weeks 4, 12, 24 and 52, respectively. The primary endpoint was the American Colleague of Rheumatology 20 (ACR20) response rates at week 52 and disease activity score (DAS28) (CRP) at 52 weeks after treatment.
A total of 104 patients with elderly-onset rheumatoid arthritis were enrolled in the study. The comparison of the two groups on the baseline demographic data and RA activity showed that the iguratimod group was older (67.0 and 64.0, Z=-2.874, P=0.004), and the methotrexate group had a higher DAS28 (CRP) score (4.7 and 6.0, Z=-3.163, P=0.002). There was no statistically significant difference between the remaining results of the two groups. After 52 weeks of treatment, the ACR20 compliance rates in the iguratimod group and the methotrexate group were 90.0% and 93.9%, respectively (χ2=0.115, P=0.735). There was no statistically significant difference in compliance rates of ACR20, ACR50 and ACR70 between the groups at other time points compared to the baseline. There was no statistically significant difference in the DAS28 (CRP) score between the two groups at the end point of 52 weeks. Fewer adverse events were observed in the iguratimod group compared to the methotrexate group (26.0% and 46.9%, χ2=4.689, P=0.030). No serious adverse events were found in Group Iguratimod, but 3 cases of pneumonia were hospitalized in Group Methotrexate.
Iguratimod combined with leflunomide is an effective regimen with good safety for the treatment of active elderly-onset rheumatoid arthritis, with comparable efficacy and better safety compared to methotrexate combined with leflunomide.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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