Braun Jürgen, van der Heijde Désirée, Doyle Mittie K, Han Chenglong, Deodhar Atul, Inman Robert, de Vlam Kurt, Burmester Gerd R, Van den Bosch Filip, Xu Stephen, Visvanathan Sudha, Rahman Mahboob U
Rheumazentrum Ruhrgebiet, Herne, Germany.
Arthritis Rheum. 2009 Aug 15;61(8):1032-6. doi: 10.1002/art.24865.
Anemia is a common complication in patients with inflammatory diseases such as ankylosing spondylitis (AS). This post hoc analysis of a large, randomized, placebo-controlled trial examined the effect of infliximab on hemoglobin levels, physical function, and fatigue in patients with AS.
Patients received infliximab 5 mg/kg (n = 188) or placebo (n = 68) at weeks 0, 2, 6, 12, and 18. Hemoglobin, interleukin-6 (IL-6), and C-reactive protein (CRP) levels, fatigue (visual analog scale [VAS]), physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and disease activity were evaluated at baseline and week 24. Anemia was defined as a hemoglobin level <12 gm/dl for women and <13 gm/dl for men.
At baseline, 11 placebo group patients (16.2%) and 37 infliximab group patients (19.7%) had anemia. Of these, more infliximab-treated patients achieved normal hemoglobin levels at week 24 compared with patients receiving placebo (70.3% versus 27.3%; P = 0.0155). Infliximab-treated patients had significant improvements in mean hemoglobin concentration (0.7 gm/dl versus -0.3 gm/dl), BASFI score (-2.1 versus -0.2), and fatigue VAS score (-2.4 versus -0.4) compared with placebo patients (P < 0.001). Multiple regression analyses showed that improvements in hemoglobin level were significantly and independently associated with improvements in physical function and fatigue. Infliximab-treated patients with elevated CRP or IL-6 levels at baseline were more likely than those with low levels to have improvement in hemoglobin levels.
Infliximab treatment significantly decreased the proportion of AS patients with anemia and improved hemoglobin levels compared with placebo. Improvement in hemoglobin level was independently associated with improvements in physical function and fatigue.
贫血是强直性脊柱炎(AS)等炎症性疾病患者常见的并发症。这项对一项大型随机安慰剂对照试验的事后分析,研究了英夫利昔单抗对AS患者血红蛋白水平、身体功能和疲劳的影响。
患者在第0、2、6、12和18周接受5mg/kg英夫利昔单抗(n = 188)或安慰剂(n = 68)治疗。在基线和第24周评估血红蛋白、白细胞介素-6(IL-6)和C反应蛋白(CRP)水平、疲劳(视觉模拟量表[VAS])、身体功能(巴斯强直性脊柱炎功能指数[BASFI])和疾病活动度。贫血定义为女性血红蛋白水平<12g/dl,男性血红蛋白水平<13g/dl。
在基线时,安慰剂组有11名患者(16.2%)和英夫利昔单抗组有37名患者(19.7%)患有贫血。其中,与接受安慰剂的患者相比,接受英夫利昔单抗治疗的患者在第24周时达到正常血红蛋白水平的更多(70.3%对27.3%;P = 0.0155)。与安慰剂组患者相比,接受英夫利昔单抗治疗的患者平均血红蛋白浓度(0.7g/dl对 -0.3g/dl)、BASFI评分(-2.1对 -0.2)和疲劳VAS评分(-2.4对 -0.4)有显著改善(P < 0.001)。多元回归分析表明,血红蛋白水平的改善与身体功能和疲劳的改善显著且独立相关。基线时CRP或IL-6水平升高的接受英夫利昔单抗治疗的患者比水平低的患者更有可能血红蛋白水平得到改善。
与安慰剂相比,英夫利昔单抗治疗显著降低了AS贫血患者的比例,并改善了血红蛋白水平。血红蛋白水平的改善与身体功能和疲劳的改善独立相关。