Department of Dermatology, Fukushima Medical University, Fukushima, Japan.
Drugs Today (Barc). 2021 Sep;57(9):535-542. doi: 10.1358/dot.2021.57.9.3293619.
Pyoderma gangrenosum is a refractory disease characterized by chronic ulcers, presenting with central deep ulceration and undermined borders predominantly involving the lower extremities. Oral prednisolone and/or cyclosporine has been considered to be a first line of therapy; however, there are still unmet needs for treatment. Recently, effects of adalimumab for pyoderma gangrenosum in 22 Japanese patients were examined in an open-label, multicenter study during a 26-week treatment period and a further 26-week extension period. Pyoderma gangrenosum area reduction 100 (PGAR 100, defined as complete skin re-epithelialization) response for the target ulcer was observed in 3 patients (13.6%) as early as week 6, and at week 26, 12 patients (54.5%) achieved the primary endpoint of PGAR 100. The mean percent change from baseline in target ulcer area was -63.8% at week 26. A physician's global assessment score of 0 (PGA 0) was achieved by 8 patients (36.4%), while PGA 0/1 (completely/almost clear) was achieved by 12 patients (54.5%) at week 26. Adverse events were reported by 18 patients, most commonly infections (n = 11) and serious adverse events (n = 4). These results suggest that adalimumab is effective and generally well tolerated in Japanese patients with pyoderma gangrenosum active ulcers.
坏疽性脓皮病是一种难治性疾病，以慢性溃疡为特征，表现为中央深部溃疡和边缘下挖，主要累及下肢。口服泼尼松龙和/或环孢素被认为是一线治疗方法;然而，治疗仍有未满足的需求。最近，在一项 26 周治疗期和 26 周扩展期的开放性、多中心研究中，检查了阿达木单抗治疗 22 例日本坏疽性脓皮病患者的疗效。目标溃疡的坏疽性脓皮病面积减少 100 （PGAR100，定义为完全皮肤再上皮化）反应在 6 周时就观察到了 3 例患者（13.6%），在 26 周时，12 例患者（54.5%）达到了 PGAR100 的主要终点。目标溃疡面积从基线的平均百分比变化在第 26 周时为-63.8%。8 例患者（36.4%）达到了医生整体评估评分 0（PGA0），而 12 例患者（54.5%）在第 26 周时达到了 PGA0/1（完全/几乎清除）。18 例患者报告了不良事件，最常见的是感染（n=11）和严重不良事件（n=4）。这些结果表明，阿达木单抗在日本活动性溃疡型坏疽性脓皮病患者中是有效且通常耐受良好的。
