Lunardon Luisa, Tsai Kathleen J, Propert Kathleen J, Fett Nicole, Stanley John R, Werth Victoria P, Tsai Donald E, Payne Aimee S
Department of Dermatology, University of Pennsylvania, Philadelphia, PA 19104, USA.
Arch Dermatol. 2012 Sep;148(9):1031-6. doi: 10.1001/archdermatol.2012.1522.
We conducted a retrospective study of patients with pemphigus vulgaris (n = 24) and foliaceus (n = 7) treated with adjuvant rituximab to determine efficacy and adverse events. The end point for efficacy was complete remission of disease taking no or minimal therapy.
Eighteen patients (58%) achieved the study end point. Of these, 13 patients achieved complete remission off systemic therapy. Patients achieving the study end point had a median disease duration before rituximab therapy of 19 months vs 86 months in those not achieving the end point (P = .01). For the 18 patients achieving the end point, the median (SD) duration of remission was 19 (2) months. Eight of these 18 patients (44%) relapsed from 6 to 17 months after treatment. Serious adverse events attributed to rituximab treatment (osteomyelitis or phlegmon) occurred in 2 patients (6%). In paired serum samples from 10 patients before and after rituximab treatment, the percent change in serum desmoglein index value (median, -80%) was unrelated to the percent change in pneumococcal antibodies (median, +8%) (Spearman rank correlation coefficient r = -0.2).
Patients treated with rituximab earlier in the course of disease may have better outcomes. A discussion of rituximab's mechanism of action supports the rationale for early therapy. Prospective clinical studies are necessary to substantiate this observation.
我们对24例寻常型天疱疮患者和7例落叶型天疱疮患者进行了一项回顾性研究,这些患者接受了利妥昔单抗辅助治疗,以确定其疗效和不良事件。疗效的终点是疾病完全缓解且无需或仅需极少治疗。
18例患者(58%)达到了研究终点。其中,13例患者在停用全身治疗后实现了完全缓解。达到研究终点的患者在接受利妥昔单抗治疗前的疾病持续时间中位数为19个月,而未达到终点的患者为86个月(P = 0.01)。对于达到终点的18例患者,缓解期的中位数(标准差)为19(2)个月。这18例患者中有8例(44%)在治疗后6至17个月复发。2例患者(6%)发生了归因于利妥昔单抗治疗的严重不良事件(骨髓炎或蜂窝织炎)。在10例患者利妥昔单抗治疗前后的配对血清样本中,血清桥粒芯糖蛋白指数值的变化百分比(中位数,-80%)与肺炎球菌抗体的变化百分比(中位数,+8%)无关(斯皮尔曼等级相关系数r = -0.2)。
在疾病病程早期接受利妥昔单抗治疗的患者可能有更好的结局。对利妥昔单抗作用机制的讨论支持了早期治疗的理论依据。需要进行前瞻性临床研究来证实这一观察结果。