Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada
Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.
RMD Open. 2023 Nov 29;9(4):e003400. doi: 10.1136/rmdopen-2023-003400.
To assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease.
We conducted a 12-month, prospective, non-randomised, open-label, comparative trial of adults with either rheumatoid arthritis (RA, n=131) on stable treatment; systemic lupus erythematosus (SLE, n=23) on mycophenolate mofetil (MMF); other rheumatic diseases on prednisone ≥10 mg/day (n=8) or age-matched/sex-matched controls (healthy control, HC, n=58). Adverse events (AEs), humoral immune responses (immunogenicity: IgG positivity for anti-SARS-CoV-2 spike protein and its receptor binding domain, neutralising antibodies (NAbs)), cellular responses (ELISpot) and COVID-19 infection rates were assessed.
Frequency of solicited self-reported AEs following vaccination was similar across groups (HC 90%, RA 86%, SLE 90%); among them, musculoskeletal AEs were more frequent in RA (HC 48% vs RA 66% (Δ95% CI CI 3 to 32.6)). Disease activity scores did not increase postvaccination. No vaccine-related serious AEs were reported. Postvaccination immunogenicity was reduced in RA and SLE (RA 90.2%, SLE 86.4%; for both, ΔCIs compared with HC excluded the null). Similarly, NAbs were reduced among patients (RA 82.6%, SLE 81.8%). In RA, age >65 (OR 0.3, 95% CI 0.1 to 0.8) and rituximab treatment (OR 0.003, 95% CI 0.001 to 0.02) were negative predictors of immunogenicity. ELISpot was positive in 16/52 tested RA and 17/26 HC (ΔCI 11.2-53.3). During the study, 11 HC, 19 RA and 3 SLE patients self-reported COVID-infection.
In COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases, the Moderna Spikevax primary series was safe. MMF, RA age >65 and rituximab were associated with reduced vaccine-induced protection.
评估 Moderna Spikevax 初级系列在风湿性疾病中的安全性、免疫原性和细胞反应。
我们进行了一项为期 12 个月的前瞻性、非随机、开放标签、对照试验，纳入了接受稳定治疗的类风湿关节炎（RA，n=131）、接受吗替麦考酚酯（MMF）的系统性红斑狼疮（SLE，n=23）、接受泼尼松≥10mg/天（n=8）的其他风湿性疾病或年龄和性别匹配的对照组（健康对照，HC，n=58）的成年人。评估不良事件（AE）、体液免疫反应（免疫原性：抗 SARS-CoV-2 刺突蛋白及其受体结合域 IgG 阳性、中和抗体（NAb））、细胞反应（ELISpot）和 COVID-19 感染率。
接种疫苗后，各组的自报告不良事件发生率相似（HC 90%，RA 86%，SLE 90%）；其中，RA 中肌肉骨骼 AE 更为常见（HC 48% vs RA 66%（Δ95%CI CI 3 至 32.6））。接种疫苗后疾病活动评分未增加。未报告与疫苗相关的严重不良事件。RA 和 SLE 的疫苗接种后免疫原性降低（RA 90.2%，SLE 86.4%；两者均排除 HC 的零假设）。同样，患者的 NAb 也降低（RA 82.6%，SLE 81.8%）。在 RA 中，年龄>65 岁（OR 0.3，95%CI 0.1 至 0.8）和利妥昔单抗治疗（OR 0.003，95%CI 0.001 至 0.02）是免疫原性的负预测因子。在 52 例 RA 中进行的 ELISpot 检测中有 16 例阳性，在 26 例 HC 中进行的 ELISpot 检测中有 17 例阳性（ΔCI 11.2-53.3）。在研究期间，11 例 HC、19 例 RA 和 3 例 SLE 患者自我报告 COVID 感染。
在《免疫抑制性自身免疫性疾病成人中的 COVID-19 疫苗》中，Moderna Spikevax 初级系列是安全的。MMF、RA 年龄>65 岁和利妥昔单抗与降低疫苗诱导的保护有关。
