Dermatology Centre, Salford Royal NHS Foundation Trust, the University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, U.K.
Centre for Pharmacoepidemiology and Drug Safety, School of Health Sciences, the University of Manchester, Manchester, U.K.
Br J Dermatol. 2019 Aug;181(2):256-264. doi: 10.1111/bjd.17625. Epub 2019 Mar 27.
The persistence and effectiveness of systemic therapies for moderate-to-severe psoriasis in current clinical practice are poorly characterized.
To systematically review observational studies investigating the persistence and effectiveness of acitretin, ciclosporin, fumaric acid esters (FAE) and methotrexate, involving at least 100 adult patients with moderate-to-severe psoriasis, exposed to therapy for ≥ 3 months.
MEDLINE, Embase, the Cochrane Library and PubMed were searched from 1 January 2007 to 1 November 2017 for observational studies reporting on persistence (therapy duration or the proportion of patients discontinuing therapy during follow-up) or effectiveness [improvements in Psoriasis Area and Severity Index (PASI) or Physician's Global Assessment (PGA)]. This review was registered with PROSPERO, number CRD42018099771.
Of 411 identified studies, eight involving 4624 patients with psoriasis were included. Variations in the definitions and analyses of persistence and effectiveness outcomes prevented a meta-analysis from being conducted. One prospective multicentre study reported drug survival probabilities of 23% (ciclosporin), 42% (acitretin) and 50% (methotrexate) at 1 year. Effectiveness outcomes were not reported for either acitretin or ciclosporin. The persistence and effectiveness of FAE and methotrexate were better characterized, but mean discontinuation times ranged from 28 to 50 months for FAE and 7·7 to 22·3 months for methotrexate. At 12 months of follow-up, three studies reported that 76% (FAE), 53% (methotrexate) and 59% (methotrexate) of patients achieved ≥ 75% reduction in PASI, and one reported that 76% of FAE-exposed patients achieved a markedly improved or clear PGA.
The comparative persistence and effectiveness of acitretin, ciclosporin, FAE and methotrexate in real-world clinical practice in the past decade cannot be well described due to the inconsistency of the methods used.
目前临床实践中，中重度银屑病的系统治疗的持久性和有效性尚未得到充分描述。
系统评价至少 100 例接受中重度银屑病治疗且治疗时间≥3 个月的成人患者的阿维 A、环孢素、富马酸酯（FAE）和甲氨蝶呤的观察性研究，以评估其治疗的持久性（治疗持续时间或治疗期间停止治疗的患者比例）和有效性（改善银屑病面积和严重程度指数（PASI）或医生整体评估（PGA））。
从 2007 年 1 月 1 日至 2017 年 11 月 1 日，通过 MEDLINE、Embase、Cochrane 图书馆和 PubMed 检索关于持久性（治疗持续时间或治疗期间停止治疗的患者比例）或有效性[改善 PASI 或 PGA]的观察性研究。本研究已在 PROSPERO 注册，编号为 CRD42018099771。
在 411 项研究中，有 8 项涉及 4624 例银屑病患者的研究被纳入。由于持久性和有效性结果的定义和分析存在差异，无法进行荟萃分析。一项前瞻性多中心研究报告了环孢素、阿维 A 和甲氨蝶呤的药物生存率分别为 23%（环孢素）、42%（阿维 A）和 50%（甲氨蝶呤），1 年时。阿维 A 或环孢素的有效性结果未报告。FAE 和甲氨蝶呤的持久性和有效性得到了更好的描述，但 FAE 的平均停药时间为 28-50 个月，甲氨蝶呤为 7.7-22.3 个月。12 个月随访时，3 项研究报告称，76%（FAE）、53%（甲氨蝶呤）和 59%（甲氨蝶呤）的患者 PASI 改善≥75%，1 项研究报告称，76%的 FAE 暴露患者 PGA 明显改善或完全清除。
由于所使用方法的不一致，过去十年中阿维 A、环孢素、FAE 和甲氨蝶呤在真实世界临床实践中的比较持久性和有效性尚无法很好地描述。
