van der Heijde Désirée, Braun Jürgen, Rudwaleit Martin, Purcaru Oana, Kavanaugh Arthur F
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Rheumazentrum Ruhrgebiet, Herne, Germany.
RMD Open. 2018 Apr 9;4(1):e000659. doi: 10.1136/rmdopen-2018-000659. eCollection 2018.
To evaluate the effect of certolizumab pegol (CZP) on work and household productivity, and on participation in family, social and leisure activities in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr-) axSpA.
RAPID-axSpA (NCT01087762) was a phase III, double-blind, placebo-controlled trial to week (Wk) 24, dose-blind to Wk48 and open-label to Wk204. A total of 325 patients were randomised 1:1:1 to placebo, CZP 200 mg Q2W or CZP 400 mg Q4W. The validated arthritis-specific Work Productivity Survey assessed the impact of axSpA on work and household productivity and participation in social activities during the preceding month. Data are shown to Wk96, with responses compared between treatment arms (placebo vs CZP 200 mg and 400 mg dose groups combined) and subpopulations using a non-parametric bootstrap-t method.
At baseline, 63.2% of placebo and 72.0% of CZP patients were employed. By Wk24, CZP patients reported on average 1.0 fewer days of absenteeism and 2.6 fewer days of presenteeism per month, compared with 0.4 and 0.9 fewer days for placebo. At home, by Wk24, CZP patients reported on average 3.0 household work days gained per month versus 1.3 for placebo. CZP patients reported fewer days with reduced household productivity or days lost for social participation. Similar improvements were observed in AS and nr-axSpA subpopulations and improvements with CZP were maintained to Wk96.
Compared with placebo, treatment with CZP significantly improved work and household productivity and resulted in greater social participation for patients with axSpA, which could lead to considerable indirect cost gains.
NCT01087762.
评估聚乙二醇化赛妥珠单抗（CZP）对中轴型脊柱关节炎（axSpA）患者的工作及家庭生产力，以及对其参与家庭、社交和休闲活动的影响，axSpA包括强直性脊柱炎（AS）和非放射学中轴型脊柱关节炎（nr-axSpA）。
RAPID-axSpA（NCT01087762）是一项III期双盲、安慰剂对照试验，至第24周，第48周为剂量盲法，第204周为开放标签。共325例患者按1:1:1随机分为安慰剂组、200mg CZP每2周一次组或400mg CZP每4周一次组。经过验证的关节炎特异性工作生产力调查评估了axSpA在前一个月对工作和家庭生产力以及参与社交活动的影响。数据显示至第96周，使用非参数自助t检验方法比较治疗组（安慰剂组与200mg和400mg CZP剂量组合并组）和亚组之间的反应。
在基线时，安慰剂组63.2%的患者和CZP组72.0%的患者受雇。到第24周时，CZP组患者报告每月平均旷工天数减少1.0天，出勤但工作效率低下天数减少2.6天，而安慰剂组分别减少0.4天和0.9天。在家中，到第24周时，CZP组患者报告每月平均家务劳动天数增加3.0天，而安慰剂组为1.3天。CZP组患者报告家庭生产力下降天数或社交参与天数损失减少。在AS和nr-axSpA亚组中观察到类似改善，且CZP的改善持续至第96周。
与安慰剂相比，CZP治疗显著提高了axSpA患者的工作和家庭生产力，并使其更多地参与社交活动，这可能带来可观的间接成本收益。
NCT01087762。
