Objective

SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED.

Methods

Eligible participants who completed 1–2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION.

Results

Ninety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0–24 was 0.21 (0.16–0.29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17.4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.

Conclusions

The effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED.

Trial registration

Clinicaltrials.gov NCT01051349; first registered on January 15, 2010.

中文翻译：

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达珠单抗β在复发缓解型多发性硬化症中的长期安全性和有效性：SELECTED开放标签扩展研究的6年结果。

目的

SELECTED是一项开放标签扩展研究，在完成了随机SELECT / SELECTION研究的复发性多发性硬化症参与者中，评估了达克里珠单抗beta治疗长达6年。我们报告SELECTED的最终结果。

方法

在SELECT / SELECTION中完成daclizumab beta治疗1-2年的合格参与者，每4周皮下接受daclizumab beta 150 mg治疗，在SELECTED中长达6年。在选定的治疗期间评估安全性评估；从SELECT / SELECTION中第一剂daclizumab beta评估疗效数据。

结果

在SELECTION中完成治疗的参与者中有90％（410/455）参与了SELECTED。在SELECTED中，有69％的参与者接受daclizumab beta≥3年，39％接受> 4年，9％接受> 5年；87％的参与者经历了不良事件，而26％的是严重不良事件（不包括多发性硬化症复发）。没有死亡发生。总体而言，有25％的参与者报告了肝脏事件；严重肝事件占2％。没有确诊的免疫介导性脑炎病例。根据SELECT / SELECTION中首次使用daclizumab beta剂量的几周，调整后的0-24周年化复发率（95％置信区间）为0.21（0.16-0.29），在继续治疗时仍然较低。24周确认的残疾进展的总发生率为17.4％。新发/新发T2高强度病变的平均数量仍然很少；整个大脑体积的百分比变化随时间减少。

结论

达珠单抗β对临床和放射学结果的影响持续了约8年的治疗。在SELECTED中未发现新的安全隐患。

试用注册

Clinicaltrials.gov NCT01051349; 于2010年1月15日首次注册。