Effect of iberdomide on cutaneous manifestations in systemic lupus erythematosus: a randomized phase 2 clinical trial.

IF 12.8 1区医学 Q1 DERMATOLOGY Journal of the American Academy of Dermatology Pub Date : 2024-10-24 DOI:10.1016/j.jaad.2024.09.074

Victoria P Werth, Joan T Merrill, Richard Furie, Thomas Dörner, Ronald van Vollenhoven, Peter Lipsky, Michael Weiswasser, Shimon Korish, Peter H Schafer, Mark Stern, Stan Li, Nikolay Delev

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Abstract

Background: Iberdomide, a cereblon modulator, promotes degradation of transcription factors Ikaros and Aiolos.

Objective: Evaluate iberdomide efficacy and safety in cutaneous lupus erythematosus (CLE) in a phase 2 study.

Methods: Patients were randomized (2:2:1:2) to iberdomide 0.45 (n=81), 0.30 (n=82), or 0.15 mg (n=42) or placebo (n=83) daily while continuing background lupus medications.

Results: The mean (SD) baseline Cutaneous Lupus Area and Severity Index Activity (CLASI-A) score was 6.9 (7.0); 28% of patients had a score ≥8; 56% had acute CLE, 29% chronic CLE, and 16% subacute CLE. Mean CLASI-A improvement in patients with baseline score ≥8 was 39.7% for iberdomide 0.45 mg versus 20.1% for placebo at week 4 (P=0.032), with continued improvement through week 24 (66.7% vs 54.2%; P=0.295). Proportions of patients achieving ≥50% CLASI-A reduction from baseline at week 24 were significantly greater for iberdomide 0.45 mg versus placebo for patients with subacute (91.7% vs 52.9%, P=0.035) and chronic (62.1% vs 27.8%; P=0.029) CLE but not for the overall population (55.6% vs 44.6%) or patients with baseline CLASI-A ≥8 (66.7% vs 50.0%).

Limitations: Small patient subgroups of CLE subtypes.

Conclusions: Iberdomide showed beneficial effects when added to background lupus medications in patients with subacute and chronic CLE.

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伊博多肽对系统性红斑狼疮皮肤表现的影响：随机二期临床试验。

背景：Iberdomide是一种脑龙调节剂，可促进转录因子Ikaros和Aiolos的降解：伊伯多米德是一种脑龙调节剂，可促进转录因子Ikaros和Aiolos的降解：在一项2期研究中评估伊伯多米德对皮肤红斑狼疮（CLE）的疗效和安全性：患者被随机分配（2:2:1:2），每天服用0.45毫克（81人）、0.30毫克（82人）或0.15毫克（42人）或安慰剂（83人），同时继续服用狼疮背景药物：基线皮肤狼疮面积和严重程度指数活动（CLASI-A）平均（标清）评分为6.9（7.0）；28%的患者评分≥8；56%的患者患有急性CLE，29%的患者患有慢性CLE，16%的患者患有亚急性CLE。基线评分≥8分患者的平均CLASI-A改善率为：第4周时，伊博多米德0.45毫克为39.7%，安慰剂为20.1%（P=0.032），持续改善至第24周（66.7% vs 54.2%；P=0.295）。对于亚急性（91.7% vs 52.9%，P=0.035）和慢性（62.1% vs 27.8%；P=0.029）CLE患者，第24周时CLASI-A较基线下降≥50%的患者比例，依维莫德0.45 mg显著高于安慰剂，但在总体人群（55.6% vs 44.6%）或基线CLASI-A≥8的患者（66.7% vs 50.0%）中则不明显：局限性：CLE亚型患者分组较小：在亚急性和慢性 CLE 患者中，伊伯多米加到狼疮背景药物中会产生有益的效果。

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来源期刊

Journal of the American Academy of Dermatology 医学-皮肤病学

CiteScore

8.60

自引率

5.80%

发文量

2023

审稿时长

49 days

期刊介绍： The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.