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Clinical Trial
. 2020 Jul 23;10(1):12339.
doi: 10.1038/s41598-020-69309-z.

Leflunomide monotherapy versus combination therapy with conventional synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis: a retrospective study

Daihua Deng #  1 , Jun Zhou #  2 , Min Li  1 , Siyin Li  1 , Lan Tian  1 , Jinmei Zou  1 , Tingting Wang  3 , Jianhong Wu  3 , Fanxin Zeng  4 , Jing Yang  5
Affiliations
Clinical Trial

Leflunomide monotherapy versus combination therapy with conventional synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis: a retrospective study

Daihua Deng et al. Sci Rep. .

Abstract

Leflunomide (LEF) is a conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of rheumatoid arthritis. However, there are few reports on the comparison of efficacy between LEF alone and combined with other csDMARDs. Here, the efficacy and safety of LEF monotherapy (88) and combination (361) therapy groups were evaluated. After 3 months, there were no significant differences in 28-joint disease activity score (DAS28), health assessment questionnaire (HAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) between the monotherapy and combination groups (all P > 0.05). According to the European League Against Rheumatism (EULAR) response criteria, it was found that the DAS28 response rates were similar in the two groups (P > 0.05). Besides, the two groups presented similar safety profiles. Subgroup analysis found that there was no difference in efficacy among the three combined therapies (LEF + methotrexate (MTX), LEF + hydroxychloroquine (HCQ), and LEF + MTX + HCQ) and LEF monotherapy. Furthermore, when the dose of LEF was less than 40 mg/day, no significant difference in efficacy was observed between low and high doses. Overall, these results indicated that low dose LEF monotherapy was not inferior to the combination therapy.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Primary and secondary endpoint results for the monotherapy and combination groups. (A) DAS28, (B) HAQ, (C) ESR, (D) CRP, (E) TJC28, (F) SJC28, (G) MSD, (H) PtGA. DAS28 28-joint disease activity score calculated with C-reactive protein, HAQ health assessment questionnaire, CRP C-reactive protein, ESR erythrocyte sedimentation rate, TJC28 tender joint count of 28 joints, SJC28 swollen joint count of 28 joints, MSD morning stiffness duration, PtGA patient global assessment. Data are shown as means ± SEM. *Indicate significant differences between different groups at the same time point (P < 0.05). #Significance as compared with baseline in the monotherapy group (P < 0.05). $Significance as compared with baseline in the combination group ($P < 0.05; $$P < 0.01; $$$P < 0.001).
Figure 2
Figure 2
DAS28 response rates in the monotherapy and combination groups.
Figure 3
Figure 3
Selection of the study population. RA rheumatoid arthritis, DAS28 28-joint disease activity score calculated with C-reactive protein, LEF leflunomide, MTX methotrexate, HCQ hydroxychloroquine, GCs glucocorticoids.
See this image and copyright information in PMC

References

    1. Ferucci ED, Templin DW, Lanier AP. Rheumatoid arthritis in American Indians and Alaska natives: A review of the literature. Semin. Arthrit. Rheum. 2005;34:662–667. doi: 10.1016/j.semarthrit.2004.08.003. - DOI - PubMed
    1. Strand V. Recent advances in the treatment of rheumatoid arthritis. Clin. Cornerstone. 1999;2:38–50. doi: 10.1016/S1098-3597(99)90013-3. - DOI - PubMed
    1. Humphreys JH, et al. The incidence of rheumatoid arthritis in the UK: Comparisons using the 2010 ACR/EULAR classification criteria and the 1987 ACR classification criteria. Results from the Norfolk Arthritis register. Ann. Rheum. Dis. 2013;72:1315–1320. doi: 10.1136/annrheumdis-2012-201960. - DOI - PMC - PubMed
    1. Myasoedova E, Crowson CS, Kremers HM, Therneau TM, Gabriel SE. Is the incidence of rheumatoid arthritis rising? Results from Olmsted County, Minnesota, 1955–2007. Arthrit. Rheum. 2010;62:1576–1582. doi: 10.1002/art.27425. - DOI - PMC - PubMed
    1. MacGregor AJ, et al. Characterizing the quantitative genetic contribution to rheumatoid arthritis using data from twins. Arthrit. Rheum. 2000;43:30–37. doi: 10.1002/1529-0131(200001)43:1<30::AID-ANR5>3.0.CO;2-B. - DOI - PubMed

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