Skroza Nevena, Bernardini Nicoletta, Tolino Ersilia, Proietti Ilaria, Mambrin Alessandra, Marchesiello Anna, Marraffa Federica, Rossi Giovanni, Volpe Salvatore, Potenza Concetta
Dermatology Unit "D. Innocenzi", Sapienza University of Rome, Polo Pontino, 04100 Terracina, Italy.
J Clin Med. 2021 Jul 29;10(15):3355. doi: 10.3390/jcm10153355.
Since all clinical trials conducted during the development of anti-COVID-19 vaccines have adopted among the exclusion criteria the presence of immunodepression or immunomodulating therapy, to date, the effects of vaccination against the new coronavirus 2 in people under such conditions have yet to be clearly defined. The primary objective of the study is to assess the safety of treatment with biotechnological drugs in patients suffering from moderate-severe psoriasis and subjected to the prophylactic vaccination against SARS-Cov-2. Additionally, the secondary objective of the research is to investigate the existence of a possible impact of anti-COVID-19 vaccination on the natural chronic-relapsing course and the severity of the psoriatic disease. The study included 436 patients with moderate-severe psoriasis, both male and female, in treatment with biologics. The data were collected using the direct interview method. A reduction of 74.13% of average Psoriasis Area Severity Index (PASI )compared to baseline (T0) was found in all subjects; this does not differ significantly from the group that underwent vaccination (73.4%). Moreover; at the end of the study, neither mild nor severe adverse events (ADR) were observed among them. In conclusion, biotechnological drugs used in the management of patients with moderate-severe psoriasis demonstrate a high safety profile also in subjects immunized against SARS-Cov-2.
由于在抗新冠病毒疫苗研发过程中开展的所有临床试验都将存在免疫抑制或免疫调节治疗纳入了排除标准,因此迄今为止,在这类情况下接种针对新型冠状病毒2的疫苗的效果尚未明确界定。本研究的主要目的是评估生物技术药物治疗对中度至重度银屑病患者并接受针对SARS-CoV-2的预防性疫苗接种的安全性。此外,该研究的次要目的是调查抗新冠病毒疫苗接种对银屑病自然慢性复发性病程及严重程度是否可能产生影响。该研究纳入了436例正在接受生物制剂治疗的中度至重度银屑病患者,男女均有。数据通过直接访谈法收集。所有受试者的银屑病面积和严重程度指数(PASI)平均值较基线(T0)降低了74.13%;这与接种疫苗的组(73.4%)相比无显著差异。此外,在研究结束时,未观察到他们中有轻度或重度不良事件(ADR)。总之,用于治疗中度至重度银屑病患者的生物技术药物在接种SARS-CoV-2疫苗的受试者中也显示出高度的安全性。