Temporal Outcomes after Rituximab Therapy for Pemphigus Vulgaris.

Temporal Outcomes after Rituximab Therapy for Pemphigus Vulgaris.
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利妥昔单抗治疗寻常型天疱疮后的时间结果。

DOI:
10.1016/j.jid.2021.09.013
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发表时间:
2022-04
期刊:
The Journal of investigative dermatology
影响因子:
--
通讯作者:
Payne AS
Payne AS
中科院分区:
其他
文献类型:
--
作者:
Tovanabutra N;Bax CE;Feng R;Kushner CJ;Payne AS

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寻常型天疱疮是一种自身免疫性水疱疾病,其特征是针对黏着蛋白的自身抗体。利妥昔单抗和皮质类固醇是fda批准的治疗寻常性天疱疮的药物。随着天疱疮的新疗法进入临床试验,分析利妥昔单抗治疗后的临床和血清学结果作为时间的函数对于指导临床试验设计至关重要。在这里,我们报告了利妥昔单抗治疗寻常型天疱疮的详细时间和血清学结果。单周期利妥昔单抗口服全身治疗后完全缓解的最大患病率为12个月时的32.4%,或36个月时的43.1%,包括额外的利妥昔单抗周期。利用受者工作特征曲线建立单周期美罗华治疗后完全缓解的预测模型,从基线到3 - 9个月平均粘蛋白3 (desmoglein 3) ELISA滴度下降90.7%为94%敏感性,3 - 9个月平均绝对滴度≤130 RU/mL为96%特异性,实现口服全身治疗后完全缓解。所有在6-9个月时滴度呈阴性的患者最终在口服全身治疗后完全缓解。这个关于寻常型天疱疮患者接受利妥昔单抗治疗后的临床和血清学结果的数据集将有助于临床试验计划,并指导临床医生和患者对利妥昔单抗治疗后的期望。
Pemphigus vulgaris is an autoimmune blistering disease characterized by autoantibodies that target desmoglein adhesion proteins. Rituximab and corticosteroids are FDA-approved therapies for pemphigus vulgaris. As newer treatments for pemphigus enter clinical trials, analysis of clinical and serologic outcomes after rituximab therapy as a function of time is essential to guide clinical trial design. Here, we report detailed temporal and serological outcomes of rituximab treatment of pemphigus vulgaris. The maximal prevalence of complete remission off oral systemic therapy after a single cycle of rituximab was 32.4% at 12 months, or 43.1% by 36 months including additional rituximab cycles. Using receiver operating characteristic curves to develop prediction models for complete remission after a single cycle of rituximab, >90.7% reduction in average desmoglein 3 ELISA titers from baseline to months 3–9 was 94% sensitive, and an average absolute titer ≤130 RU/mL between months 3–9 was 96% specific, for achievement of complete remission off oral systemic therapy. All patients with negative titers at 6–9 months ultimately achieved complete remission off oral systemic therapy. This dataset of clinical and serological outcomes for pemphigus vulgaris patients after rituximab therapy will facilitate clinical trial planning and also guide clinician and patient expectations after rituximab therapy.
DOI: 10.1001/jamadermatol.2019.3236
发表时间: 2019-12-01
期刊: JAMA DERMATOLOGY
影响因子: 10.9
作者:
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