Objective：To establish recommendations based on an expert consensus on the early and appropriate use of high-efcacy disease-modifying therapies (HE-DMTs) in the management of multiple sclerosis (MS) patients, based on current clinical evidence and real-world practice in Italy. 

Material and methods：A Delphi panel comprising 65 neurologists from 54 Italian MS centers engaged in a two-round consensus process. Experts rated 43 statements across fve domains: therapeutic goals, defnitions of HE-DMT, MS patient profling, and use of HE-DMT at diagnosis and later in MS course, using a 5-point Likert scale. A statement reached strong consensus if ≥80% of panelists agreed; whereas between 70% and 80% it was considered as moderate. 

Results：In Round 2, 53 experts completed the survey on 43 statements. Strong consensus was achieved for 33 (76.7%), and moderate consensus for 6 (14.0%) statements. Experts strongly supported early HE-DMT initiation to prevent irreversible disability, endorsed a multidimensional defnitions of treatment efcacy, and recommended personalized approaches based on clinical, radiological, and biomarker indicators. Consensus supported initiating HE-DMTs in patients with poor prognostic features and identifed magnetic resonance imaging (MRI) activity, neurodegeneration markers, and suboptimal clinical response as specifc factors requiring escalation to HE-DMTs. 

Conclusion：This Italian Delphi underscores the importance of early, personalized HE-DMT use to optimize long-term outcomes in MS. The strong expert alignment refects a paradigm shift toward proactive treatment and highlights actionable clinical, radiological, and biological indicators that should guide therapeutic decisions. These fndings may support national policy changes and promote more equitable and evidence-based access to HE-DMTs across healthcare systems.

目的：基于意大利当前的临床证据和真实世界实践，就多发性硬化症（MS）患者中高效疾病修正疗法（HE-DMTs）的早期及合理使用达成专家共识，并制定相关建议。

材料与方法：由来自意大利54个MS中心的65名神经科医生组成德尔菲专家小组，开展两轮共识流程。专家采用5分制李克特量表，对5个领域的43项陈述进行评分，包括治疗目标、HE-DMT的定义、MS患者分型，以及确诊时和MS病程后期HE-DMT的使用。若≥80%的专家同意某项陈述，则达成强共识；若70%-80%的专家同意，则视为中等共识。

结果：在第二轮中，53名专家完成了对43项陈述的调查。其中33项（76.7%）达成强共识，6项（14.0%）达成中等共识。专家强烈支持早期启动HE-DMT以预防不可逆残疾，认可治疗 efficacy的多维度定义，并建议基于临床、影像学和生物标志物指标采取个性化方案。共识支持对具有不良预后特征的患者启动HE-DMT，并明确磁共振成像（MRI）活动度、神经退行性变标志物及临床应答不佳是需要升级为HE-DMTs治疗的特定因素。

结论：本次意大利德尔菲共识强调，早期、个性化使用HE-DMT对优化MS患者的长期结局至关重要。专家们的高度一致反映了向积极治疗模式的转变，并突出了可指导治疗决策的临床、影像学和生物学可操作指标。这些发现可能为国家政策调整提供支持，促进医疗体系中HE-DMTs更公平、更循证地可及。