Department of Clinical Epidemiology, Kochi Medical School, Kochi University, Kochi, Japan
Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University Hospital, Fukushima, Japan.
Lupus Sci Med. 2022 Sep;9(1). doi: 10.1136/lupus-2022-000746.
Lupus nephritis (LN) is more prevalent in patients with SLE of Asian ethnicity than in Caucasian patients. Belimumab became available in Japan in 2017 to treat patients with SLE, including those with LN. In the BLISS-LN trial (NCT01639339), belimumab showed a favourable effect on renal outcomes when combined with standard therapy (ST) starting at the induction treatment phase for active LN, but real-world effectiveness of belimumab in LN has not been extensively studied. Here we describe the protocol for the MOONLIGHT (post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide ReGistry (LUNA) coHorT) study, which will use data from a Japan postmarketing surveillance study and the Lupus Registry of Nationwide Institutions (LUNA) to evaluate the real-world effectiveness of belimumab plus ST versus ST alone in patients with a history of active LN who are not in the induction phase.
This multicentre, retrospective, observational study (GSK Study 214710) will enrol adults with SLE and a history of active LN, holding ≥3 years of complete follow-up data from the initiation of belimumab (no continuous treatment required). Data for patients with belimumab plus ST treatment (postmarketing registry data, belimumab cohort) will be compared with those for patients with ST only treatment (LUNA data, comparison cohort). Patients who discontinue/initiate belimumab after the start of the follow-up may be included in the comparison/belimumab cohort, respectively. The primary endpoint will be the occurrence of renal flares, for which belimumab's effectiveness will be estimated using a marginal structural model to consider time-dependent treatment and confounding factors. Secondary endpoints will include change in corticosteroid dose, renal disease activity, extrarenal disease activity, disease severity/activity biomarkers, LN class changes, end-stage kidney disease events and hospitalisations.
This study will be conducted according to the Declaration of Helsinki and the local ethical guidelines. Findings will be submitted to peer-reviewed journals and presented at scientific meetings.
狼疮肾炎（LN）在亚洲人群的系统性红斑狼疮（SLE）患者中比在高加索人群更为常见。贝利尤单抗于 2017 年在日本上市，用于治疗 SLE 患者，包括 LN 患者。在 BLISS-LN 试验（NCT01639339）中，贝利尤单抗联合标准治疗（ST）在 LN 活动诱导治疗阶段开始时对肾脏结局显示出有利影响，但在 LN 中贝尤单抗的实际有效性尚未得到广泛研究。在这里，我们描述了 MOONLIGHT（贝利尤单抗上市后疗效的观察性研究）的研究方案，该研究将利用日本上市后监测研究和全国机构狼疮登记处（LUNA）的数据，评估在诱导期之外有 LN 活动史的患者中，贝利尤单抗联合 ST 与单独 ST 的真实世界疗效。
这项多中心、回顾性、观察性研究（GSK 研究 214710）将招募有 SLE 病史和 LN 活动史的成年人，他们在开始使用贝利尤单抗时具有≥3 年的完整随访数据（不需要连续治疗）。将比较贝利尤单抗加 ST 治疗患者（上市后登记数据，贝利尤单抗队列）的数据与仅接受 ST 治疗患者（LUNA 数据，对照队列）的数据。在开始随访后停止/开始使用贝利尤单抗的患者可能分别被纳入对照/贝利尤单抗队列。主要终点是肾脏发作的发生，将使用边缘结构模型估计贝利尤单抗的有效性，以考虑时间依赖性治疗和混杂因素。次要终点将包括皮质类固醇剂量的变化、肾脏疾病活动度、肾脏外疾病活动度、疾病严重程度/活动生物标志物、LN 分类变化、终末期肾病事件和住院治疗。
本研究将根据《赫尔辛基宣言》和当地伦理准则进行。研究结果将提交给同行评议的期刊，并在科学会议上发表。
