Codullo Veronica, Iannone Florenzo, Sinigaglia Luigi, Favalli Ennio Giulio, Sarzi-Puttini Piercarlo, Atzeni Fabiola, Ferraccioli Gianfranco, Gremese Elisa, Carletto Antonio, Giollo Alessandro, Govoni Marcello, Bergossi Francesca, Galeazzi Mauro, Cantarini Luca, Salaffi Fausto, Di Carlo Marco, Bazzani Chiara, Pellerito Raffaele, Sebastiani Marco, Ramonda Roberta, Lapadula Giovanni, Caporali Roberto
Rheumatology Unit, University of Pavia, IRCCS Policlinico San Matteo, Pavia, Italy.
Interdisciplinary Department of Medicine-Rheumatology Unit, Policlinico, University of Bari, Italy.
Clin Exp Rheumatol. 2017 Jul-Aug;35(4):660-665. Epub 2017 May 8.
Targeted drugs against key pathogenetic molecules such as TNF-alpha have significantly improved outcomes in rheumatoid arthritis (RA). They are widely used in clinical practice and drug registries give us information to support their use. Adalimumab (ADA) is able to induce a comprehensive disease control in RA by achieving clinical, functional and radiographic control.
By interrogating 2 Italian registries, LORHEN and GISEA, we analysed the efficacy of ADA in first- or second-line in a total of 2262 RA patients.
Patients in 1st line were significantly older, with lower disease activity and HAQ scores compared to 2nd line. In 1st line, rates of DAS28-remission (DAS28rem) at 2 years were 34.4% while 26.5% in 2nd line (p=0.038). A normal HAQ score (HAQ≤0.5) was achieved in 53.5% after 2 years in 1st line versus 30.1% in 2nd (p<0.0001). DAS28rem+HAQ≤0.5, a combined parameter that we defined global clinical disease control, was reached in 20.7% in 1st line versus 13.3% in 2nd (p<0.01). Five-year-survival on therapy was higher for patients in 1st line (45.6% vs. 33.2%, p<0.0001). Discontinuation due to lack of efficacy was lower in 1st line (37.4 vs. 54.4%, p<0.0001). Rates of adverse events were similar.
Responses in 1st line are generally significantly better than after a first anti-TNF-alpha failure but patients in 2nd line have a worse clinical and functional profile. A global disease control with clinical and functional remission is an achievable target in both lines.
针对关键致病分子(如肿瘤坏死因子-α)的靶向药物显著改善了类风湿关节炎(RA)的治疗效果。它们在临床实践中广泛应用,药物登记处为我们提供了支持其使用的信息。阿达木单抗(ADA)能够通过实现临床、功能和影像学控制,在类风湿关节炎中诱导全面的疾病控制。
通过查询两个意大利登记处LORHEN和GIS EA,我们分析了ADA在2262例类风湿关节炎患者一线或二线治疗中的疗效。
与二线治疗患者相比,一线治疗患者年龄显著更大,疾病活动度和健康评估问卷(HAQ)评分更低。在一线治疗中,2年时疾病活动度评分28(DAS28)缓解率为34.4%,而二线治疗为26.5%(p = 0.038)。一线治疗2年后53.5%的患者达到正常HAQ评分(HAQ≤0.5),而二线治疗为30.1%(p < 0.0001)。一线治疗中20.7%的患者达到DAS28缓解+HAQ≤0.5,这是我们定义的综合临床疾病控制参数,而二线治疗为13.3%(p < 0.01)。一线治疗患者的5年治疗生存率更高(45.6%对33.2%,p < 0.0001)。因疗效不佳而停药的比例在一线治疗中更低(37.4%对54.4%,p < 0.0001)。不良事件发生率相似。
一线治疗的反应通常明显优于首次抗肿瘤坏死因子-α治疗失败后,但二线治疗患者的临床和功能状况较差。在两条治疗线中,实现临床和功能缓解的全面疾病控制都是可以达到的目标。