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Infliximab Dose Reduction Sustains the Clinical Treatment Effect in Active HLAB27 Positive Ankylosing Spondylitis: A Two-Year Pilot Study

机译:英夫利昔单抗减量维持主动HLAB27阳性强直性脊柱炎的临床治疗效果:一项为期两年的试验研究

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摘要

The rationale of the study was to evaluate the efficacy of infliximab (IFX) treatment in patients with ankylosing spondylitis (AS) and to determine whether IFX dose reduction and interval extension sustains the treatment effect. Nineteen patients were included and treated with IFX 5 mg/kg every 6 weeks for 56 weeks. All patients concomitantly received MTX with median dose 7.5 mg/weekly. During the second year, the IFX dose was reduced to 3 mg/kg every 8 weeks. Eighteen patients completed the 1-year and 15 patients the 2-year trial. The ≥50% improvement at week 16 from baseline of BASDAI was achieved in 16/19 (84%) patients. Significant reductions in BASDAI, BASFI, and BASMI scores, decrease in ESR and CRP, and improvement in SF-36 were observed at weeks 16 and 56. The MRI-defined inflammatory changes in the sacroiliac joints disappeared in 10/15 patients (67%) already at 16 weeks. IFX treatment effect was sustained throughout the second year after IFX dose reduction and interval extension. We conclude that IFX treatment is effective in well-established active AS and a dose reduction sustains the treatment effect. These observations are of clinical importance and open the opportunity to reduce the drug costs. This trial is registered with ClinicalTrials.gov .
机译:该研究的基本原理是评估英夫利昔单抗(IFX)在强直性脊柱炎(AS)患者中的疗效,并确定IFX剂量的减少和间隔时间的延长能否维持治疗效果。入组19例患者,每6周用IFX 5mg / kg治疗56周。所有患者同时接受MTX,中位剂量为每周7.5μmg。在第二年,IFX剂量每8周降低到3μmg/ kg。 18名患者完成了1年期试验,15名患者完成了2年期试验。 16/19(84%)患者在第16周时比BASDAI基线改善了≥50%。在第16周和第56周观察到BASDAI,BASFI和BASMI评分显着降低,ESR和CRP降低以及SF-36改善。MRI定义的sa关节炎症变化在10/15患者中消失了(67% )已经16周了。在降低IFX剂量和延长间隔后的第二年,IFX的治疗效果一直持续。我们得出的结论是,IFX治疗对有效的主动性AS有效,并且降低剂量可维持治疗效果。这些观察结果具有临床重要性,并为降低药物成本提供了机会。该试验已在ClinicalTrials.gov上注册。

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