Rheumatology, Hospital for Special Surgery, New York City, New York, USA.
Rheumatology, Cedars-Sinai Medical Center, West Hollywood, California, USA.
Lupus Sci Med. 2024 Jul 14;11(2):e001201. doi: 10.1136/lupus-2024-001201.
Omega-3 polyunsaturated fatty acids (PUFAs) play a critical role in regulating inflammation and lipid metabolism. This study sought to ascertain the frequency of omega-3 deficiency in patients with SLE and investigate whether supplementation with krill oil concentrate (KOC) could replenish omega-3 levels and decrease SLE disease activity.
A multicentre, randomised, double-blind, placebo-controlled trial was conducted in adult patients with active SLE. Eligible patients were randomised to receive 4 g/day KOC or placebo (vegetable oil mixture) for the first 24 weeks, and thereafter patients could opt to enter an open-label extension. The primary end point was improvement of the red blood cell Omega-3 Index from baseline to week 24. Changes in clinical features, including SLE Disease Activity Index 2000 (SLEDAI-2K) disease activity scores, were also monitored.
Seventy-eight patients met eligibility criteria and were randomised to a treatment group (n=39 per group). The baseline Omega-3 Index in the total SLE cohort was a mean 4.43% (±SD 1.04%). After 4 weeks of KOC treatment, the Omega-3 Index rapidly increased to 7.17%±1.48% (n=38) and after 24 weeks to 8.05%±1.79% (n=25) (each p<0.001 vs baseline), whereas no significant change from baseline was noted in patients receiving placebo. Increases in the Omega-3 Index in KOC-treated patients persisted through week 48. After patients switched from placebo to KOC at 24 weeks, the mean Omega-3 Index showed a rapid and significant increase (from 4.63%±1.39% at week 24 (n=26) to 7.50%±1.75% at week 48 (n=12); p<0.001). Although there were no changes in disease activity in the study population overall, SLEDAI-2K scores decreased significantly in the KOC group during the 24-week randomised period among those who had high disease activity at baseline (SLEDAI-2K ≥9) (p=0.04, p=0.02 and p=0.01 vs placebo at 4, 8 and 16 weeks, respectively; n=9 per group). KOC was well-tolerated, with no significant safety concerns.
KOC corrected omega-3 deficiency in patients with SLE. Supplementation with KOC was safe and decreased disease activity in those with more active disease. These findings warrant further evaluation of omega-3 fatty acid supplementation with KOC in the management of SLE.
NCT03626311.
ω-3 多不饱和脂肪酸（PUFAs）在调节炎症和脂质代谢方面起着关键作用。本研究旨在确定 SLE 患者ω-3 缺乏的频率，并探讨补充磷虾油浓缩物（KOC）是否可以补充 ω-3 水平并降低 SLE 疾病活动度。
对活动性 SLE 成年患者进行了一项多中心、随机、双盲、安慰剂对照试验。符合条件的患者被随机分配接受 4 g/天的 KOC 或安慰剂（植物油混合物）治疗 24 周，此后患者可以选择进入开放标签扩展期。主要终点是从基线到第 24 周红细胞ω-3 指数的改善。还监测了临床特征的变化，包括 SLE 疾病活动指数 2000（SLEDAI-2K）疾病活动评分。
78 名患者符合入选标准并被随机分配到治疗组（每组 39 名患者）。总 SLE 队列的基线ω-3 指数为 4.43%（±SD 1.04%）。接受 KOC 治疗 4 周后，ω-3 指数迅速增加至 7.17%±1.48%（n=38），24 周后增加至 8.05%±1.79%（n=25）（均 p<0.001 与基线相比），而接受安慰剂的患者则没有明显变化。KOC 治疗患者的ω-3 指数增加持续到第 48 周。患者在 24 周时从安慰剂转换为 KOC 后，平均ω-3 指数迅速显著增加（从第 24 周的 4.63%±1.39%（n=26）到第 48 周的 7.50%±1.75%（n=12）；p<0.001）。尽管总体研究人群的疾病活动没有变化，但在基线疾病活动较高（SLEDAI-2K≥9）的患者中，KOC 组在 24 周随机期间的 SLEDAI-2K 评分显著降低（p=0.04、p=0.02 和 p=0.01 分别与安慰剂相比，在 4、8 和 16 周时；每组 n=9）。KOC 耐受性良好，无明显安全性问题。
KOC 纠正了 SLE 患者的 ω-3 缺乏。补充 KOC 安全，并降低了疾病活动度较高的患者的疾病活动度。这些发现证明了在 SLE 管理中进一步评估 KOC 补充 ω-3 脂肪酸的必要性。
NCT03626311。
