Background

Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling.

Objectives

The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD).

Methods

In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo.

Results

Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [P = .027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%).

Limitations

A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD.

Conclusions

Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.

中文翻译：

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成人中度至重度特应性皮炎患者的Baricitinib：2期平行，双盲，随机安慰剂对照多剂量研究

背景

Baricitinib是Janus激酶1和Janus激酶2的口服选择性抑制剂，可调节促炎性细胞因子信号传导。

目标

在中重度特应性皮炎（AD）患者中评估了Baricitinib的疗效和安全性。

方法

在该阶段2的随机，双盲，安慰剂对照研究中，对124位中度至重度AD患者应用局部皮质类固醇（TCS）进行了4周的治疗，然后随机分配至每日一次的安慰剂，2 mg的Baricitinib或4 mg接受baricitinib治疗16周。在研究期间允许使用TCS。主要结局是与安慰剂相比，湿疹面积和严重程度指数（EASI-50）至少降低50％的患者比例。

结果

 在16周时，接受安慰剂4 mg的患者比接受安慰剂的患者达到EASI-50的比例更高（分别为61％和37％[ P = .027]）。早在第4周，达到EASI-50的接受Baricitinib的2或4 mg患者的比例与接受安慰剂并达到EASI-50的患者比例之间的差异就很明显。Baricitinib还改善了瘙痒和睡眠丧失。据报道，接受安慰剂的患者中有24名出现治疗突发事件（49％），接受2mg巴西替尼的患者中有17名（46％），接受4mg巴西替尼的患者中有27名（71％）。

局限性

随机分组前的TCS标准化期可降低疾病的严重程度，从而限制了将结果与Baricitinib单一疗法进行比较的能力。需要更长时间的研究以确认baricitinib在AD患者中的疗效和安全性。

结论

Baricitinib与TCS一起使用可减轻中度至重度AD患者的炎症和瘙痒。