Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis: First-Year Results of a Single-Blind Randomized Controlled Trial
Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis: First-Year Results of a Single-Blind Randomized Controlled Trial
复制标题
DOI：
10.1016/j.jid.2022.01.033
复制
发表时间：
2022-08-17
影响因子：
6.5
通讯作者：
Spuls, Phyllis
中科院分区：
文献类型：
--
作者：
van der Kraaij, Gayle;Busard, Celine;Spuls, Phyllis
简介：由于与阿达木单抗单药治疗（ADL）相比，阿达木单抗的治疗效果增强，抗药抗体形成减少，因此阿达木单抗通常与甲氨蝶呤（MTX）联合治疗类风湿性关节炎。在银屑病中，长期治疗效果和药代动力学特征尚未得到广泛研究。研究方法：我们进行了一项随机对照试验，以评估阿达木单抗联合MTX 10 mg/周（ADL-MTX组）与ADL（ADL组）治疗慢性斑块状银屑病的疗效、安全性、药代动力学和免疫原性。结果：共分析ADL-MTX组31例患者和ADL组30例患者。1年后，发现ADL-MTX组的药物存活率（无显著性）更好（74.2% vs. 58.6%，P = 0.15）。第49周的PASI 75应答率为58.1% vs 36.7%（P = 0.13），中位（四分位距）血清谷浓度为6.8（5.5.9.2）vs 5.9（3.5.9.2）。8.8)mg/l（P = 0.26）。ADL-MTX组抗药物抗体阳性率为22.6%，明显低于对照组的60.0%（P < 0.01）。未发生严重不良事件。结论：阿达木单抗和MTX联合治疗导致出现抗药抗体的患者较少，PASI 75应答、药物生存期和血清谷浓度高于ADL。两组患者报告的结局和不良事件相似。
Introduction: Adalimumab is normally prescribed with methotrexate (MTX) in rheumatoid arthritis given the enhanced treatment effect and reduced antidrug antibody formation compared with adalimumab monotherapy (ADL). In psoriasis, the long-term treatment effects and pharmacokinetic profile have not been investigated extensively. Methods: We conducted a randomized controlled trial to assess the efficacy, safety, pharmacokinetics, and immunogenicity of adalimumab combined with MTX 10 mg per week ( ADL-MTX group) compared with that of ADL (ADL group) in chronic plaque psoriasis. Results: A total of 31 patients in the ADL-MTX group and 30 in the ADL group were analyzed. After 1 year, a (nonsignificant) better drug survival was found in the ADL-MTX group ( 74.2 vs. 58.6%, P = 0.15). The PASI 75 response in week 49 was 58.1 versus 36.7% (P = 0.13), and the median (interquartile range) serum-trough concentrations were 6.8 (5.5.9.2) versus 5.9 (3.5. 8.8) mg/l (P = 0.26) in the ADL-MTX group and ADL group, respectively. Fewer patients showed antidrug antibodies in the ADL-MTX group (22.6 vs. 60.0%, P < 0.01). No serious adverse events occurred. Conclusion: Combination therapy of adalimumab and MTX results in fewer patients showing antidrug antibodies, with a trend toward a better PASI 75 response, drug survival, and higher serum-trough concentrations than ADL. Patient- reported outcomes and adverse events were comparable between the groups.