Maul Julia-Tatjana, Djamei Vahid, Kolios Antonios G A, Meier Barbara, Czernielewski Justine, Jungo Pascal, Yawalkar Nikhil, Mainetti Carlo, Laffitte Emmanuel, Spehr Christina, Anliker Mark, Streit Markus, Augustin Matthias, Rustenbach Stephan, Conrad Curdin, Hafner Jürg, Boehncke Wolf-Henning, Borradori Luca, Gilliet Michel, Itin Peter, French Lars E, Häusermann Peter, Navarini Alexander A
Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.
Dermatology. 2016;232(6):640-647. doi: 10.1159/000452740. Epub 2017 Jan 12.
The Swiss psoriasis registry SDNTT (Swiss Dermatology Network for Targeted Therapies) records the long-term safety and effectiveness of systemic treatment regimens for psoriasis.
Patients with moderate to severe psoriasis are included in the SDNTT when treatment with a conventional systemic agent or biologic is initiated that was not previously used by the respective patient. Patients are followed over a 5-year period. Clinical data are obtained every 3-6 months using standardized case report forms. Here, baseline data and follow-up data for 1 year of patients included from October 2011 until December 2014 were analyzed.
Within 39 months, 323 patients from 7 tertiary dermatology centers in Switzerland were recruited in the SDNTT; 165 patients received biologics and 158 conventional systemic therapies. Patients treated with biologics had a significantly higher severity (PASI 11.3 vs. 9.2, BSA 15.6 vs.11.9, psoriatic arthritis 36.4 vs. 10.8%; p ≤ 0.005, p ≤ 0.013, p ≤ 0.001) and a longer duration of illness (19.2 vs. 14.4 years, p ≤ 0.003) compared to patients starting a conventional systemic treatment. PASI reduction was satisfying in both treatment groups, with 60.6% of patients treated with biologics achieving PASI75 after 1 year compared to 54.2% of patients receiving conventional systemic drugs (nonsignificant). On average, the drug survival in patients receiving a biologic therapy was significantly longer than those receiving conventional systemic treatments (30.5 vs. 19.2 months, p ≤ 0.001).
In the real-world setting of a prospective national therapy registry, the application of current therapeutic guidelines for patients with moderate to severe psoriasis resulted in a PASI reduction of approximately 70% within the first year of treatment, but current therapeutic targets of PASI75 and PASI90 were reached in only 58 and 36% of patients, respectively, at 1 year, highlighting a gap in efficacy between selective clinical trials and the real-world setting.
瑞士银屑病登记处SDNTT(瑞士靶向治疗皮肤病学网络)记录了银屑病全身治疗方案的长期安全性和有效性。
当中度至重度银屑病患者开始使用其之前未用过的传统全身用药或生物制剂进行治疗时,被纳入SDNTT。对患者进行为期5年的随访。每隔3至6个月使用标准化病例报告表获取临床数据。在此,对2011年10月至2014年12月纳入的患者的基线数据和1年随访数据进行分析。
在39个月内,瑞士7个三级皮肤科中心的323例患者被纳入SDNTT;165例患者接受生物制剂治疗,158例接受传统全身治疗。与开始接受传统全身治疗的患者相比,接受生物制剂治疗的患者病情严重程度显著更高(银屑病面积和严重程度指数[PASI]分别为11.3对9.2,体表面积[BSA]分别为15.6对11.9,银屑病关节炎分别为36.4%对10.8%;p≤0.005,p≤0.013,p≤0.001),病程更长(19.2对14.4年,p≤0.003)。两个治疗组的PASI降低情况均令人满意,1年后接受生物制剂治疗的患者中有60.6%达到PASI75,而接受传统全身药物治疗的患者为54.2%(无显著差异)。平均而言,接受生物制剂治疗的患者的药物生存期显著长于接受传统全身治疗的患者(30.5对19.2个月,p≤0.001)。
在一项前瞻性全国治疗登记处的实际应用中,对中度至重度银屑病患者应用当前治疗指南,在治疗的第一年PASI降低了约70%,但在1年时,仅分别有58%和36%的患者达到当前PASI75和PASI90的治疗目标,凸显了选择性临床试验与实际应用之间的疗效差距。