12262例初治生物制剂的银屑病关节炎患者接受肿瘤坏死因子抑制剂常规治疗的患者报告结局（PROs）及PRO缓解率
Patient-Reported Outcomes (PROs) and PRO Remission Rates in 12,262 Biologic-Naïve Patients With Psoriatic Arthritis Treated With Tumor Necrosis Factor Inhibitors in Routine Care.
作者信息
Ørnbjerg Lykke M, Rugbjerg Kathrine, Georgiadis Stylianos, Rasmussen Simon H, Jacobsson Lennart, Loft Anne G, Iannone Florenzo, Fagerli Karen M, Vencovsky Jiri, Santos Maria J, Möller Burkhard, Pombo-Suarez Manuel, Rotar Ziga, Gudbjornsson Bjorn, Cefle Ayse, Eklund Kari, Codreanu Catalin, Jones Gareth, van der Sande Marleen, Wallman Johan K, Sebastiani Marco, Michelsen Brigitte, Závada Jakub, Nissen Michael J, Sanchez-Piedra Carlos, Tomšič Matija, Love Thorvardur J, Relas Heikki, Mogosan Corina, Hetland Merete L, Østergaard Mikkel
机构信息
L.M. Ørnbjerg, MD, PhD, K. Rugbjerg, MSc, PhD, S. Georgiadis, MSc, PhD, S.H. Rasmussen, MSc, PhD, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark;
L.M. Ørnbjerg, MD, PhD, K. Rugbjerg, MSc, PhD, S. Georgiadis, MSc, PhD, S.H. Rasmussen, MSc, PhD, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.
出版信息
J Rheumatol. 2024 Apr 1;51(4):378-389. doi: 10.3899/jrheum.2023-0764.
OBJECTIVE
To evaluate patient-reported outcomes (PROs) after initiation of tumor necrosis factor inhibitor (TNFi) treatment in European real-world patients with psoriatic arthritis (PsA). Further, to investigate PRO remission rates across treatment courses, registries, disease duration, sex, and age at disease onset.
METHODS
Visual analog scale or numerical rating scale scores for pain, fatigue, patient global assessment (PtGA), and the Health Assessment Questionnaire-Disability Index (HAQ-DI) from 12,262 patients with PsA initiating a TNFi in 13 registries were pooled. PRO remission rates (pain ≤ 1, fatigue ≤ 2, PtGA ≤ 2, and HAQ-DI ≤ 0.5) were calculated for patients still on the treatment.
RESULTS
For the first TNFi, median pain score was reduced by approximately 50%, from 6 to 3, 3, and 2; as were fatigue scores, from 6 to 4, 4, and 3; PtGA scores, from 6 to 3, 3, and 2; and HAQ-DI scores, from 0.9 to 0.5, 0.5, and 0.4 at baseline, 6, 12, and 24 months, respectively. Six-month Lund Efficacy Index (LUNDEX)-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 24%, 31%, 36%, and 43% (first TNFi); 14%, 19%, 23%, and 29% (second TNFi); and 9%, 14%, 17%, and 20% (third TNFi), respectively. For biologic-naïve patients with disease duration < 5 years, 6-month LUNDEX-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 22%, 28%, 33%, and 42%, respectively. Corresponding rates for patients with disease duration > 10 years were 27%, 32%, 41%, and 43%, respectively. Remission rates were 33%, 40%, 45%, and 56% for men and 17%, 23%, 24%, and 32% for women, respectively. For patients aged < 45 years at diagnosis, 6-month LUNDEX-adjusted remission rate for pain was 29% vs 18% for patients ≥ 45 years.
CONCLUSION
In 12,262 biologic-naïve patients with PsA, 6 months of treatment with a TNFi reduced pain by approximately 50%. Marked differences in PRO remission rates across treatment courses, registries, disease duration, sex, and age at onset of disease were observed, emphasizing the potential influence of factors other than disease activity on PROs.
目的
评估欧洲银屑病关节炎（PsA）真实世界患者开始使用肿瘤坏死因子抑制剂（TNFi）治疗后的患者报告结局（PROs）。此外，研究不同治疗疗程、登记处、疾病持续时间、性别及发病年龄的PRO缓解率。
方法
汇总了13个登记处12262例开始使用TNFi的PsA患者的疼痛、疲劳、患者整体评估（PtGA）的视觉模拟量表或数字评定量表评分，以及健康评估问卷残疾指数（HAQ-DI）。计算仍在接受治疗患者的PRO缓解率（疼痛≤1、疲劳≤2、PtGA≤2、HAQ-DI≤0.5）。
结果
对于首次使用的TNFi，基线时、6个月、12个月和24个月时，疼痛中位数评分分别从6降至3、3和2，降低了约50%；疲劳评分从6降至4、4和3；PtGA评分从6降至3、3和2；HAQ-DI评分从0.9降至0.5、0.5和0.4。疼痛、疲劳、PtGA和HAQ-DI评分的6个月Lund疗效指数（LUNDEX）调整后缓解率分别为24%、31%、36%和43%（首次使用TNFi）；14%、19%、23%和29%（第二次使用TNFi）；9%、14%、17%和20%（第三次使用TNFi）。对于疾病持续时间<5年的初治生物制剂患者，疼痛、疲劳、PtGA和HAQ-DI评分的6个月LUNDEX调整后缓解率分别为22%、28%、33%和42%。疾病持续时间>10年患者的相应缓解率分别为27%、32%、41%和43%。男性缓解率分别为33%、40%、45%和56%，女性为17%、23%、24%和32%。对于诊断时年龄<45岁的患者，疼痛的6个月LUNDEX调整后缓解率为29%，而≥45岁患者为18%。
结论
在12262例初治生物制剂的PsA患者中，使用TNFi治疗6个月可使疼痛减轻约50%。观察到不同治疗疗程、登记处、疾病持续时间、性别及发病年龄的PRO缓解率存在显著差异，强调了疾病活动以外的因素对PROs的潜在影响。
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