Brodmerkel Carrie, Wadman Eric, Langley Richard G, Papp Kim A A, Bourcier Marc, Poulin Yves, Ho Vincent, Guenther Lyn, Kunynetz Rod, Nigen Simon, Vender Ronald, Wasel Norman, Hsu Ming-Chun, Szapary Philippe
J Drugs Dermatol. 2013 Oct;12(10):1122-9.
Little is known about the impact of long-term use of immunosuppressive agents on immune response.
Assess the impact of continuous maintenance ustekinumab treatment on patients' ability to mount immune responses to pneumococcal (T-cell-independent) and tetanus toxoid (T-cell-dependent) vaccines.
Ustekinumab-treated patients with moderate-to-severe psoriasis treated in the long-term extension of the Phase 3 PHOENIX 2 trial (n=60) were compared with control psoriasis patients not receiving systemic therapy (n=56). Patients were vaccinated with both 23-valent pneumococcal and tetanus toxoid vaccines. Serum samples collected pre-vaccination and 4 weeks post-vaccination were assessed for antibody responses.
No differences in the ability of ustekinumab-treated patients to respond to pneumococcal or tetanus toxoid vaccinations were observed compared with controls. A ≥2-fold increase in antibody levels in ≥7 of 14 serotypes of the pneumococcal vaccine was observed in ustekinumab-treated (96.6%) and untreated control (92.6%) patients following vaccination. Ustekinumab-treated patients achieved a ≥4-fold increase (84.7%) in anti-tetanus antibody vs. 77.8% in the control group. No differences were detected in ex-vivo responses to anti-CD3/CD28 or tetanus toxoid between ustekinumab-treated and control groups.
Long-term treatment (≥3 years) with ustekinumab does not compromise the immune response to T-cell-dependent/-independent vaccines in patients with moderate-to-severe psoriasis.
关于长期使用免疫抑制剂对免疫反应的影响,人们了解甚少。
评估持续维持使用优特克单抗治疗对患者针对肺炎球菌(非T细胞依赖性)和破伤风类毒素(T细胞依赖性)疫苗产生免疫反应能力的影响。
将在3期PHOENIX 2试验长期扩展阶段接受优特克单抗治疗的中重度银屑病患者(n = 60)与未接受全身治疗的对照银屑病患者(n = 56)进行比较。患者接种了23价肺炎球菌疫苗和破伤风类毒素疫苗。在接种前和接种后4周采集血清样本,评估抗体反应。
与对照组相比,未观察到接受优特克单抗治疗的患者对肺炎球菌或破伤风类毒素疫苗的反应能力存在差异。接种疫苗后,接受优特克单抗治疗的患者(96.6%)和未治疗的对照患者(92.6%)中,肺炎球菌疫苗14种血清型中的≥7种血清型抗体水平升高≥2倍。接受优特克单抗治疗的患者抗破伤风抗体升高≥4倍(84.7%),而对照组为77.8%。在接受优特克单抗治疗的组和对照组之间,未检测到对抗CD3/CD28或破伤风类毒素的体外反应存在差异。
优特克单抗长期治疗(≥3年)不会损害中重度银屑病患者对T细胞依赖性/非依赖性疫苗的免疫反应。