The effect of two golimumab doses on radiographic progression in ankylosing spondylitis: results through 4 years of the GO-RAISE trial.
The effect of two golimumab doses on radiographic progression in ankylosing spondylitis: results through 4 years of the GO-RAISE trial.
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DOI：
10.1136/annrheumdis-2012-203075
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发表时间：
2014-06
影响因子：
27.4
通讯作者：
Hsu B
中科院分区：
文献类型：
--
作者：
Braun J;Baraliakos X;Hermann KG;Deodhar A;van der Heijde D;Inman R;Beutler A;Zhou Y;Xu S;Hsu B
评价接受两种不同剂量肿瘤坏死因子拮抗剂戈利木单抗治疗的强直性脊柱炎（AS）患者的放射学进展。356例AS患者随机分配至安慰剂组、戈利木单抗50 mg组或戈利木单抗100 mg组，每4周1次。 在第16周，早期应答不充分的患者通过设盲剂量调整（安慰剂→戈利木单抗50 mg，50 mg→100 mg）逃避治疗。 第24周时，仍接受安慰剂的患者交叉至戈利木单抗50 mg。 在第0周、第104周和第208周获得颈椎/腰椎的侧位X线片，并进行评分（两名设盲阅片人，改良斯托克AS脊柱评分（mSASSS））。观察到的数据用于第104周分析;缺失的第208周评分进行线性外推。安慰剂交叉组第104周mSASSS较基线的平均变化为1.6±4.6，50 mg组为0.9±2.7，100 mg组为0.9±3.9。 到第208周，戈利木单抗治疗3.5-4年后，安慰剂交叉组mSASSS的平均变化为2.1±5.2，50 mg组为1.3±4.1，100 mg组为2.0±5.6。 不到三分之一的患者（安慰剂交叉，19/66（28.8%）; 50 mg，29/111（26.1%）; 100 mg，35/122（28.7%））相对于基线mSASSS有明确变化（>2）。 在基线无韧带联合赘生物（0.2 vs 2.8，≥1个韧带联合赘生物; p<0.0001）和基线C反应蛋白（CRP）水平≤1.5 mg/dl（0.9 vs 2.9，CRP >1.5 mg/dl; p=0.0004）的患者中，观察到208周的放射学进展较少。 戈利木单抗50 mg和100 mg之间未观察到mSASSS变化的差异。 放射学进展率在第2年和第4年保持稳定，表明新骨形成没有随着时间的推移而加速。基线时无韧带赘生物和全身炎症较少的Golimumab治疗的AS患者的放射学进展显著较少。
To evaluate radiographic progression in patients with ankylosing spondylitis (AS) receiving two different doses of the tumour necrosis factor antagonist golimumab. 356 patients with AS were randomly assigned to placebo, or golimumab 50 mg or 100 mg every 4 weeks (wks). At wk16, patients with inadequate response early escaped with blinded dose adjustments (placebo→golimumab 50 mg, 50 mg→100 mg). At wk24, patients still receiving placebo crossed over to golimumab 50 mg. Lateral view radiographs of the cervical/lumbar spine were obtained at wk0, wk104 and wk208, and scored (two blinded readers, modified Stoke AS Spine Score (mSASSS)). Observed data were used for wk104 analyses; missing wk208 scores were linearly extrapolated. Wk104 changes from baseline in mSASSS averaged 1.6±4.6 for placebo crossover, 0.9±2.7 for 50 mg and 0.9±3.9 for 100 mg. By wk208, following golimumab therapy for 3.5–4 years, mean changes in mSASSS were 2.1±5.2 for placebo crossover, 1.3±4.1 for 50 mg and 2.0±5.6 for 100 mg. Less than a third of patients (placebo crossover, 19/66 (28.8%); 50 mg, 29/111 (26.1%); 100 mg, 35/122 (28.7%)) had a definitive change from baseline mSASSS (>2). Less radiographic progression was observed through wk208 in patients without baseline syndesmophytes (0.2 vs 2.8 in patients with ≥1 syndesmophyte; p<0.0001) and with baseline C-reactive protein (CRP) levels ≤1.5 mg/dl (0.9 vs 2.9 with CRP >1.5 mg/dl; p=0.0004). No difference in mSASSS change was observed between golimumab 50 mg and 100 mg. The radiographic progression rate remained stable at years 2 and 4, suggesting no acceleration of new bone formation over time. Golimumab-treated AS patients with no syndesmophytes and less systemic inflammation at baseline had considerably less radiographic progression.
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影响因子：
--
作者：
Inman, Robert D.;Davis, John C., Jr.;Braun, Juergen
通讯作者：
Braun, Juergen
影响因子：
27.4
作者：
Braun, Juergen;Deodhar, Atul;Hsu, Benjamin
通讯作者：
Hsu, Benjamin
影响因子：
27.4
作者：
Visvanathan S;Wagner C;Marini JC;Baker D;Gathany T;Han J;van der Heijde D;Braun J
通讯作者：
Braun J
影响因子：
4.9
作者：
van der Heijde D;Salonen D;Weissman BN;Landewé R;Maksymowych WP;Kupper H;Ballal S;Gibson E;Wong R;Canadian (M03-606) study group;ATLAS study group
通讯作者：
ATLAS study group
影响因子：
--
作者：
van der Heijde, D.;Landewe, R.;Davis, J. C., Jr.
通讯作者：
Davis, J. C., Jr.