Colombo Delia, Frassi Micol, Pagano Mariano Giusy, Fusaro Enrico, Lomater Claudia, Del Medico Patrizia, Iannone Florenzo, Foti Rosario, Limonta Massimiliano, Marchesoni Antonio, Raffeiner Bernd, Viapiana Ombretta, Grassi Walter, Grembiale Rosa Daniela, Guggino Giuliana, Mazzone Antonino, Tirri Enrico, Perricone Roberto, Sarzi Puttini Pier Carlo, De Vita Salvatore, Conti Fabrizio, Ori Alessandra, Simoni Lucia, Fiocchi Martina, Orsenigo Roberto, Zagni Emanuela
Novartis Farma S.p.A, Largo Umberto Boccioni, 1, 21040, Origgio, Varese, Italy.
ASST Spedali Civili, Brescia, Italy.
BMC Rheumatol. 2022 Sep 12;6(1):57. doi: 10.1186/s41927-022-00284-w.
Biologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical practice.
CHRONOS was a multicenter, non-interventional, cohort study conducted in 20 Italian hospital rheumatology clinics.
399 patients were eligible (56.9% females, mean (SD) age: 52.4 (11.6) years). The mean (SD) duration of PsA and psoriasis was 7.2 (6.9) and 15.3 (12.2) years, respectively. The mean (SD) duration of the biologic treatment under analysis was 18.6 (6.5) months. The most frequently prescribed biologic was secukinumab (40.4%), followed by adalimumab (17.8%) and etanercept (16.5%). The proportion of overall responders according to EULAR DAS28 criteria was 71.8% (95% CI: 66.7-76.8%) out of 308 patients at 6 months and 68.0% (95% CI: 62.7-73.3%) out of 297 patients at 1 year. Overall, ACR20/50/70 responses at 6 months were 41.2% (80/194), 29.4% (57/194), 17.1% (34/199) and at 1-year were 34.9% (66/189), 26.7% (51/191), 18.4% (36/196), respectively. Secondary outcome measures improved rapidly already at 6 months: mean (SD) PASI, available for 87 patients, decreased from 3.2 (5.1) to 0.6 (1.3), the proportion of patients with dactylitis from 23.6% (35/148) to 3.5% (5/142) and those with enthesitis from 33.3% (49/147) to 9.0% (12/133).
The CHRONOS study provides real-world evidence of the effectiveness of biologics in PsA in the Italian rheumatological practice, confirming the efficacy reported in RCTs across various outcome measures.
生物制剂在银屑病关节炎(PsA)的随机临床试验中已证明具有疗效。在实际临床实践条件下,还需要更多关于其有效性的证据。本研究的目的是提供生物制剂在日常临床实践中治疗PsA有效性的真实世界证据。
CHRONOS是一项在20家意大利医院风湿病诊所进行的多中心、非干预性队列研究。
399例患者符合条件(女性占56.9%,平均(标准差)年龄:52.4(11.6)岁)。PsA和银屑病的平均(标准差)病程分别为7.2(6.9)年和15.3(12.2)年。所分析的生物制剂治疗的平均(标准差)疗程为18.6(6.5)个月。最常处方的生物制剂是司库奇尤单抗(40.4%),其次是阿达木单抗(17.8%)和依那西普(16.5%)。根据欧洲抗风湿病联盟(EULAR)DAS28标准,308例患者在6个月时的总体缓解率为71.8%(95%置信区间:66.7 - 76.8%),297例患者在1年时的总体缓解率为68.0%(95%置信区间:62.7 - 73.3%)。总体而言,6个月时美国风湿病学会(ACR)20/50/70缓解率分别为41.2%(80/194)、29.4%(57/194)、17.1%(34/199),1年时分别为34.9%(66/189)、26.7%(51/191)、18.4%(36/196)。次要结局指标在6个月时就已迅速改善:87例患者的平均(标准差)银屑病面积和严重程度指数(PASI)从3.2(5.1)降至0.6(1.3),指(趾)炎患者比例从23.6%(35/148)降至3.5%(5/142),附着点炎患者比例从33.3%(49/147)降至9.0%(12/133)。
CHRONOS研究提供了生物制剂在意大利风湿病实践中治疗PsA有效性的真实世界证据,证实了随机对照试验(RCT)中报道的各种结局指标的疗效。