Short research on the efficacy and safety of Methotrexate combined with the TNF-α receptor fusion protein etanercept in patients with severe undifferentiated spondyloarthropathy

【Objectives】To explore the efficacy and safety of combination therapy with Methotrexate(MTX) and the TNF-α receptor fusion protein etanercept in patients with severe undifferentiated spondyloarthropathy(uSpA).【Methods】Sixty active and severe uSpA patients were randomly divided into two groups,with 30 patients receiving the combination(MTX 10 mg/week+SSZ 1.0 bid) as control group,while 30 patients receiving MTX(10 mg/week) and etanercept(25 mg ihyp two times a week) for 12 weeks.The changes of disease activity variables and the occurrence of side effects were recorded at the end of 12 week.【Results】Etanercept group has more significant improvement in pain,swollen joint scores,BASDAI,BASFI,CRP and ESR than control group(P 0.05).More Patients receiving MTX and etanercept achieved 50% and 70% BASDAI improvement than those receiving MTX and SSZ(P 0.05),while no significant difference in 20% BASDAI improvement between two groups(P 0.05).After cessation of anti-TNF therapy,10 out of 30 patients relapsed after an average of 4.2 weeks.There is no significant differences in side effects between two groups(P 0.05).【Conclusion】The combination of MTX and etanercept had short term efficacy and was well-tolerated in patients with active and severe uSpA.