Background

The optimal long-term dosing strategy for adalimumab (ADA) in hidradenitis suppurativa/acne inversa (HS) was evaluated by pooling the results of the PIONEER phase 3 trials and an open-label extension (OLE) study.

Objective

To assess the response to and tolerability of long-term administration of ADA in HS.

Methods

The durations of the PIONEER I/II periods A, B, and OLE were 12, 24, and 52 or more weeks, respectively. Patients who entered the OLE and received ADA (40 mg every week continuously) and responders plus partial responders (PRRs) were evaluated. Primary efficacy assessments included measurement of HS clinical response (HiSCR), lesion counts, skin pain, and Dermatology Life Quality Index (DLQI). Treatment-emergent adverse events were assessed.

Results

At week 12, 52.3% of those receiving ADA weekly and 73.0% of PRRs achieved HiSCR. Achievement of HiSCR was maintained through week 168 in 52.3% of patients who received ADA weekly and 57.1% of PRRs. Sustained improvement in lesion counts, skin pain, and DLQI score were also observed. The safety profile throughout the OLE was similar to the profiles observed in the PIONEER studies.

Limitations

The OLE was uncontrolled.

Conclusion

Continuous weekly dosing with ADA, 40 mg, is a reasonable treatment option for long-term control of moderate-to-severe HS.

中文翻译：

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阿达木单抗对中至重度化脓性尿道炎/痤疮的反面患者的长期疗效：3期开放标签扩展研究的3年结果

背景

通过汇总PIONEER 3期试验和开放标签扩展（OLE）研究的结果，评估了阿达木单抗（ADA）在化脓性汗腺炎/反痤疮（HS）中的最佳长期给药策略。

客观的

评估对HS长期服用ADA的反应和耐受性。

方法

PIONEER I / II期间A，B和OLE的持续时间分别为12、24和52周或更长时间。对进入OLE并接受ADA（每周连续40毫克）的患者以及缓解者和部分缓解者（PRR）进行评估。主要功效评估包括HS临床反应（HiSCR），病变计数，皮肤疼痛和皮肤病生活质量指数（DLQI）的测量。评估治疗中出现的不良事件。

结果

在第12周，每周接受ADA的人中有52.3％，在PRR中的73.0％达到了HiSCR。到第168周为止，每周接受ADA的患者中有52.3％和PRR的57.1％都保持了HiSCR的成就。还观察到病灶数，皮肤疼痛和DLQI评分的持续改善。整个OLE的安全性与PIONEER研究中观察到的安全性相似。

局限性

OLE是不受控制的。

结论

对于长期控制中至重度HS的患者，每周连续服用40 mg ADA是合理的治疗选择。