Rheumatology, Allergology and Clinical Immunology, Department of Medicina Dei Sistemi, University of Rome Tor Vergata, Via Montpellier 1, Rome, Italy.
Rheumatology Unit, Department of Clinical Medicine and Surgery, University Federico II, Naples, Italy.
Clin Rheumatol. 2022 Jan;41(1):75-84. doi: 10.1007/s10067-021-05874-6. Epub 2021 Aug 19.
To determine the effectiveness of golimumab (GLM) in improving joint, periarticular structures and cutaneous manifestations in patients with moderate to severe psoriatic arthritis (PsA) with cutaneous psoriasis in different real-life clinical settings and 48-month drug survival.
Clinical and laboratory records were collected from PsA patients treated with GLM at baseline (T0) and after 6, 12, 24, 36, and 48 months of treatment. Comparisons were performed using a paired t-test or Wilcoxon test. Drug survival rates were analyzed using Kaplan-Meier estimates. p value < 0.05 was considered statistically significant.
Data from 105 patients were collected. PsO occurred in 80% of patients and enthesitis in 78%, peripheral and axial arthritis in 63.8% and 35.3%, respectively, while erosions in 36.2%. The main comorbidities were cardiovascular diseases (31.4%) and metabolic syndrome (MetS) (19%). A statistically significant improvement in articular and cutaneous psoriasis was registered at T48 of GLM-therapy in clinical (DAPSA p < 0.0001; PASI p < 0.01; BASDAI p < 0.0001) and laboratory (CRP < 0.05) indexes. Gender (p = 0.652), BMI (p = 0.655), smoking habit (p = 0.466), and line of treatment (p = 0.208) did not affect treatment efficacy nor persistence. At T48, 42% of patients discontinued GLM: the most frequent reason was an insufficient response or loss of efficacy (28.6%).
A 48-month GLM high drug persistence of PsA patients was observed in real-life, in patients presenting high disease activity, elevated prevalence of comorbidities, and more than one line of treatment at baseline. Patients' characteristics as gender, smoke, BMI, different lines of treatment, and concomitant methotrexate treatment affected treatment persistence, making GLM effective and safe in moderate-severe PsA in a long-term real-life setting. Key Points • Golimumab was effective in psoriatic arthritis, including both musculoskeletal and cutaneous manifestations. • Golimumab effectiveness and drug survival were not affected by comorbidities and patient-related characteristics. • The 4-year drug survival curves confirm the efficacy and safety of golimumab in psoriatic arthritis patients in a real-life setting.
在不同的真实临床环境下和 48 个月的药物存活期内,确定戈利木单抗(GLM)在改善中重度银屑病关节炎(PsA)合并皮肤银屑病患者的关节、关节周围结构和皮肤表现方面的疗效。
收集基线(T0)时和治疗后 6、12、24、36 和 48 个月接受 GLM 治疗的 PsA 患者的临床和实验室记录。使用配对 t 检验或 Wilcoxon 检验进行比较。使用 Kaplan-Meier 估计分析药物生存率。p 值<0.05 被认为具有统计学意义。
共收集了 105 名患者的数据。80%的患者出现银屑病,78%的患者出现肌腱炎,63.8%的患者出现外周关节炎,35.3%的患者出现中轴关节炎,36.2%的患者出现侵蚀。主要合并症为心血管疾病(31.4%)和代谢综合征(MetS)(19%)。在 GLM 治疗的 T48 时,临床(DAPSA p<0.0001;PASI p<0.01;BASDAI p<0.0001)和实验室(CRP<0.05)指标均显示出关节和皮肤银屑病有显著改善。性别(p=0.652)、BMI(p=0.655)、吸烟习惯(p=0.466)和治疗线(p=0.208)均不影响治疗效果或持续性。在 T48 时,42%的患者停止使用 GLM:最常见的原因是疗效不足或丧失(28.6%)。
在真实环境中,观察到接受 GLM 治疗的中重度银屑病关节炎患者具有 48 个月的高药物持久性,这些患者在基线时具有较高的疾病活动度、较高的合并症发生率和超过一条治疗线。患者特征如性别、吸烟、BMI、不同的治疗线以及同时使用甲氨蝶呤治疗,影响了治疗的持久性,使 GLM 在中重度银屑病关节炎的长期真实环境中具有有效性和安全性。关键点:
戈利木单抗对银屑病关节炎有效,包括肌肉骨骼和皮肤表现。
戈利木单抗的疗效和药物生存时间不受合并症和患者相关特征的影响。
4 年的药物生存曲线证实了戈利木单抗在真实环境中治疗银屑病关节炎患者的疗效和安全性。