School of Medicine and Pharmacology, The University of Western Australia, Perth, Western Australia, Australia
Department of Rheumatology, St John of God Murdoch, Perth, Western Australia, Australia.
RMD Open. 2022 May;8(1). doi: 10.1136/rmdopen-2022-002301.
To assess the antibody response to disease-modifying antirheumatic drug (DMARD) therapy after the first and second dose of the ChAdOx1nCov-19 (AstraZeneca (AZ)) and BNT162b (Pfizer) vaccines in patients with immune-mediated inflammatory disease (IMID) compared with controls and if withholding therapy following the first vaccination dose has any effect on seroconversion and SARS-CoV-2 antibody (Ab) levels.
A multicentre three-arm randomised controlled trial compared the immunogenicity of the Pfizer and AZ vaccines in adult patients on conventional synthetic (csDMARD), biologic (bDMARD) or targeted synthetic (tsDMARD) therapy for IMID (n=181) with a control group (n=59). Patients were randomised to continue or withhold DMARD therapy for 1-2 weeks post first dose vaccination only. Serum SARS-CoV-2 IgG detection (IgG ≥1.0 U/mL) and titres against the S1/S2 proteins were measured at baseline, 3-4 weeks post first vaccination and 4 weeks post second vaccination.
AZ vaccination was given to 47.5%, 41.5% and 52.5% in the continue, withhold and control groups, respectively while Pfizer vaccination was given to 52.5%, 58.5% and 47.5% among the continue, withhold and control groups, respectively. Seroconversion rates following the first dose in the AZ and Pfizer groups were only 27.3% vs 79.2% (p=0.000) and 64.58% vs 100% (p=0.000), respectively in the IMID groups who continued therapy compared with the AZ and Pfizer controls, respectively. Withholding DMARD therapy following the first vaccination dose resulted in higher seroconversion to 67.7% and 84.1% in the AZ and Pfizer groups, respectively. Following the second AZ and Pfizer vaccinations when all DMARDs were continued, despite a slightly lower seroconversion rate (83.7% vs 100%, p=0.000 and 95.9% vs 100%, p=0.413), respectively, the mean SARS-CoV2 IgG Ab titres were not significantly different in the csDMARD and bDMARD groups compared with the controls regardless of hold while it was significantly lower in patients taking tsDMARD (12.88 vs 79.49 U/mL, p=0.000).
Following the first vaccination dose, antibody responses were lower in IMID on DMARD therapy, however the final responses were excellent regardless of hold with the exception of the tsDMARD group where withholding therapy is recommended. At least 2 vaccinations are therefore recommended preferably with an messenger RNA vaccine.
ANZCTR: 12621000661875.
评估在接受第一剂和第二剂 ChAdOx1nCov-19（阿斯利康（AZ））和 BNT162b（辉瑞）疫苗后，免疫介导的炎症性疾病（IMID）患者对疾病修饰抗风湿药物（DMARD）治疗的抗体反应，并探讨第一剂疫苗后是否停药对血清转化和 SARS-CoV-2 抗体（Ab）水平的影响。
一项多中心三臂随机对照试验比较了 Pfizer 和 AZ 疫苗在接受常规合成（csDMARD）、生物（bDMARD）或靶向合成（tsDMARD）治疗的 IMID 成年患者（n=181）中的免疫原性与对照组（n=59）。患者在第一剂疫苗接种后仅继续或停药 1-2 周。在基线、第一剂接种后 3-4 周和第二剂接种后 4 周测量血清 SARS-CoV-2 IgG 检测（IgG≥1.0 U/mL）和针对 S1/S2 蛋白的滴度。
AZ 疫苗分别在继续治疗、停药和对照组中给予 47.5%、41.5%和 52.5%，而 Pfizer 疫苗分别在继续治疗、停药和对照组中给予 52.5%、58.5%和 47.5%。与 AZ 和 Pfizer 对照组相比，继续治疗的 IMID 组中 AZ 和 Pfizer 组的第一剂疫苗后的血清转化率分别为 27.3%对 79.2%（p=0.000）和 64.58%对 100%（p=0.000）。第一剂疫苗后停药导致 AZ 和 Pfizer 组的血清转化率分别升高至 67.7%和 84.1%。在第二剂 AZ 和 Pfizer 疫苗接种后，尽管继续治疗的 csDMARD 和 bDMARD 组的血清转化率略低（分别为 83.7%对 100%，p=0.000 和 95.9%对 100%，p=0.413），但无论停药如何，SARS-CoV2 IgG Ab 滴度在对照组中均无显著差异，而在接受 tsDMARD 治疗的患者中则显著降低（12.88 对 79.49 U/mL，p=0.000）。
在接受第一剂疫苗后，DMARD 治疗的 IMID 患者的抗体反应较低，但最终反应无论停药如何均非常出色，除了 tsDMARD 组，该组建议停药。因此，建议至少接种两剂疫苗，最好是使用信使 RNA 疫苗。
澳大利亚新西兰临床试验注册中心：12621000661875。
