Armstrong April W, Feldman Steven R, Fitzgerald Timothy, Alkousakis Theodore, Sima Adam, Li Alvin, Kang Hyung-Joo, Main Sandra I, Khattri Saakshi, Stein Gold Linda
University of California Los Angeles, Los Angeles, CA, USA.
Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Dermatol Ther (Heidelb). 2025 Jun 11. doi: 10.1007/s13555-025-01456-5.
Psoriasis body surface area (BSA) of 10% or more has been a major criterion for determining systemic therapy eligibility. However, patients with BSA < 10% and even ≤ 3% may have high disease burden and difficulties accessing biologics. To assess psoriasis burden among patients with BSA ≤ 10%, this study characterized patient-reported outcomes (PROs) across BSA categories among systemic treatment-naïve patients initiating biologic therapy.
Patients from the CorEvitas Psoriasis Registry initiating biologics between April 2015 and September 2023 were categorized according to low (< 3%), medium (3-10%), or high (> 10%) BSA involvement. Measures assessed at initiation of biologic therapy included health-related quality of life, itch, pain, fatigue, psoriatic arthritis, psoriasis disease characteristics, and medical history. Overlap between BSA groups for each outcome was calculated via non-parametric Mann-Whitney statistic transformation (range 0.0-1.0; 0.5 indicates complete similarity [i.e., for a comparison between low and high BSA groups, overlap of 0.5 means there is 50% probability that a randomly selected patient with low BSA would have the same or greater PRO burden as one with high BSA]; 0 or 1 indicates complete dissimilarity) to determine whether each measure differed in randomly selected patients with low or medium versus high BSA.
Of 1640 patients who initiated biologics, 7.0% had low BSA, 46.9% had medium BSA, and 46.2% had high BSA involvement. PRO overlap statistics ranged from 0.52 to 0.59 and from 0.60 to 0.70 for randomly selected patients with high versus medium and low BSA, respectively, indicating patients with high and medium BSA are likely to have similar levels of disease burden, and patients with high BSA are slightly more likely to have higher disease burden than those with low BSA. Near complete overlap (range 0.44-0.58) was observed for psoriasis disease characteristics and medical history in the low versus high and medium BSA groups.
Observed overlap in PROs across BSA categories shows that patients with low BSA can experience similarly poor quality of life and high symptom burden to those with higher BSA. These findings support the appropriateness of considering biologic therapies for patients with low BSA and indicators of high disease burden.
ClinicalTrials.gov: NCT02707341.
银屑病体表面积（BSA）达到10%或更高一直是确定是否适合进行系统治疗的主要标准。然而，BSA < 10%甚至≤3%的患者可能疾病负担较重且难以获得生物制剂治疗。为评估BSA≤10%患者的银屑病负担，本研究对开始生物治疗的未接受过系统治疗的患者按BSA类别进行了患者报告结局（PRO）特征分析。
将2015年4月至2023年9月期间开始使用生物制剂的CorEvitas银屑病登记处患者，根据低（<3%）、中（3 - 10%）或高（> > 10%）BSA受累情况进行分类。在开始生物治疗时评估的指标包括健康相关生活质量、瘙痒、疼痛、疲劳、银屑病关节炎、银屑病疾病特征和病史。通过非参数曼 - 惠特尼统计转换计算每个结局在BSA组之间的重叠度（范围0.0 - 1.0；0.5表示完全相似[即，对于低和高BSA组之间的比较，重叠度为0.5意味着随机选择的低BSA患者与高BSA患者具有相同或更高PRO负担的概率为50%]；0或1表示完全不相似），以确定在随机选择的低或中BSA患者与高BSA患者中，每个指标是否存在差异。
在1640例开始使用生物制剂的患者中，7.0%的患者BSA低，46.9%的患者BSA中等，46.2%的患者BSA高。对于随机选择的高BSA与中BSA患者，PRO重叠统计范围为0.52至0.59，高BSA与低BSA患者之间为0.60至0.70，这表明高BSA和中BSA患者可能具有相似水平的疾病负担，且高BSA患者比低BSA患者更有可能具有更高的疾病负担。在低与高及中BSA组的银屑病疾病特征和病史方面观察到几乎完全重叠（范围0.44 - 0.58）。
观察到的不同BSA类别中PRO的重叠表明，低BSA患者可能与高BSA患者经历同样差的生活质量和高症状负担。这些发现支持考虑为低BSA且疾病负担高的指标患者使用生物治疗的合理性。
ClinicalTrials.gov：NCT02707341。
