■维多珠单抗(VDZ)是一种具有良好安全性的肠道选择性药物。我们旨在评估炎症性肠病(IBD)患者在继续VDZ的同时,从其他高级疗法选择性转换为VDZ并随后进行减毒活疫苗接种的可行性。
■我们测量了麻疹特异性抗体滴度,风疹,腮腺炎,免疫抑制治疗下IBD患者的水痘病毒。滴度为阴性且无疫苗接种史的患者被判定为未免疫接种。患者在继续VDZ的同时给予疫苗,或者如果接受其他高级疗法则切换至VDZ,然后给予疫苗。共同的主要结果是疫苗接种后疾病严重程度的维持率和无疫苗诱导感染的发生率。
■在107名未免疫的患者中,37人同意接受减毒活疫苗,同时继续VDZ(17名患者)或转换为VDZ(20名患者)。在20名择期转为VDZ的患者中,除1例发生肠道感染的患者外,疾病严重程度维持不变.54周后,18名患者(90%)继续接受VDZ,不包括2名恢复原来使用生物制剂的患者。在VDZ治疗下给予减毒活疫苗的所有37例患者中,疫苗接种后疾病严重程度得以维持.34例患者(91.9%)的抗体滴度变为阳性或模棱两可。在121周的中位观察期内,没有疫苗诱导的感染病例。
■虽然减毒活疫苗在免疫抑制治疗中是禁忌的,在接受VDZ免疫疗法时,可以安全给药.在未免疫的患者中,从其他高级疗法切换到VDZ并随后接受减毒活疫苗可能是安全的选择。
UNASSIGNED: Vedolizumab (VDZ) is a gut-selective agent with a favorable safety profile. We aimed to assess the feasibility of elective switch from other advanced therapies to VDZ and subsequent live-attenuated vaccination while continuing VDZ in patients with inflammatory bowel diseases (IBD).
UNASSIGNED: We measured antibody titers specific for measles, rubella, mumps, and varicella viruses in IBD patients under immunosuppressive therapy. Those with negative titers and without vaccination history were judged unimmunized. Patients were administered vaccines while continuing VDZ or switched to VDZ if receiving other advanced therapies and then administered vaccines. Co-primary outcomes were the rate of maintaining disease severity after vaccination and the rate without vaccine-induced infection.
UNASSIGNED: Among 107 unimmunized patients, 37 agreed to receive live-attenuated vaccines while continuing VDZ (17 patients) or after switching to VDZ (20 patients). In the 20 patients who electively switched to VDZ, disease severity was maintained except for 1 patient who developed intestinal infection. After 54 weeks, 18 patients (90%) continued to receive VDZ, excluding 2 patients who reverted to their originally administered biologics. In all 37 patients administered live-attenuated vaccines under VDZ treatment, disease severity was maintained after vaccination. Antibody titers became positive or equivocal in 34 patients (91.9%). There were no cases of vaccine-induced infection during a median observation period of 121 weeks.
UNASSIGNED: While live-attenuated vaccines are contraindicated under immunosuppressive therapy, they may be safely administered while receiving VDZ immunotherapy. Switching from other advanced therapies to VDZ and subsequently receiving live-attenuated vaccines may be a safe alternative in unimmunized patients.