Recombinant human tumor necrosis factor receptor-Fc fusion protein combined with sulfasalzine in the induction and maintenance treatment of active ankylosing spondylitis / 中华风湿病学杂志

ABSTRACT

Objective To evaluate the dosage regimen of sulfasalzine combined with recombinant human tumor necrosis factor receptor-Fc fusion protein (rhTNFR) in the induction and maintenance of remission in active ankylosing spondylitis.Methods This study enrolled 100 ankylosing spondylitis patients with disease duration for less than five years who were treated with sulfasalzine and rhTNFR combination therapy.Patients were randomly assigned to three groups six weeks later:patients in the G1 group received sulfasalzine combined with rhTNFR at a 25 mg dosage twice each week.Patients shifted to monotherapy with sulfasalzine six weeks later:patients in G2 group received sulfasalzine combined with rhTNFR at 25 mg dosage per week.Patients were switched to monotherapy of sulfasalzine twelve weeks later:patients in G3 group received sulfasalzine combined with rhTNFR at 25 mg dosage once every ten days.Patients were changed to monotherapy of sulfasalzine seventeen weeks later.The whole treatment lasted for 24 weeks.All participants were followed up at week 0,6,12,18,24 respectively and were evaluated by BASDAI 50.The primary end-point of this study was the percentage of patients achieved BASDAI 50 remission.Data were analyzed with SPSS version 17.0.Independent t-test and x2 test were adopted to analyze data.Results 90％ of patients treated with combination therapy reached BASDAI50 at the 6th week.All patients in the G1 group achieved BASDAI 50 remission at 12th week,but the percentage dropped to 68.7％ at 18th week,which gradually decreased to 37.5％ at the 24th week.In G2 group,93.9％ patients reached BASDAI50,which declined to 81.8％ at the 18th week.The whole number accounted for 60％ at the end point of 24th week.In G3 group,85.7％ patients achieved BASDAI50 at the 12th week,accounted for 74.3％ at 18th week,and declined to 68.6％ at the 24th week.G3 group of patients presented a significantly higher rate than other groups(P＜0.05).Conclusion Sulfasalzine and rhTNFR combination therapy can gain remission in active AS patients after treated for six weeks.Doctors may extend TNF antagonist treatment in order to achieve long-term remission.