類風濕關節炎 RA 患者使用的注射藥物 HUMIRA 40MG SOLUTION FOR INJECTION
主成分: adalimumab
Adalimumab (Humira) 腫瘤患死因子阻斷劑 TNF blocker.
腫瘤壞死因子 (tumor necrosis factor; TNF) 是人體免疫系統製造的一種蛋白，當體內製造過多時會有關節受損及其他免疫疾病。〝艾伯維〞復邁針筒裝注射劑是一種阻斷腫瘤壞死因子的處方藥，藉由影響您的免疫系統，達到治療疾病的目的，但同時也會降低您抵抗感染的能力，非經醫師處方不得使用。
類風濕性關節炎, 乾癬性關節炎, 僵直性脊椎炎, 克隆氏症, 乾癬, 幼年型自發性多關節炎, 潰瘍性結腸炎, 腸道貝西氏症, 化膿性汗腺炎, 小兒克隆氏症
在553位類風濕關節炎患者, 使用一次以上的 adalimumab, 追蹤十年, 評估七支疫苗的效果
180位病患(32.5%)根據觀察者自由裁量接受疫苗注射, 施打第一次疫苗時的平均患病時間 14年, 其中 171位, 接受至少一次流感疫苗, 總共施打 351次疫苗, 流感相關的不良反應約 5% (8位/171位), 沒有打疫苗的病患不良反應為 14% (55位/382位)
In a post hoc analysis,7 vaccine use was evaluated in 553 patients with RA receiving ≥1 dose of adalimumab for up to 10 years (mean 5.6 years). One hundred and eighty patients (32.5%) received vaccinations at the discretion of the investigators (average disease duration, 14 years at first vaccination). Of these, 171 (30.9%) received at least one influenza vaccination, with a total of 351 influenza vaccinations administered. Influenza-related AEs occurred in 5% (8/171) of vaccinated patients compared with 14% (55/382) of patients not vaccinated during the study (see online supplementary figure S2).
adverse events (AEs)不良反應
Serious AE (SAE) was defined as fatal or immediately life-threatening; required hospitalisation or prolonged hospitalisation; resulted in persistent or significant disability/incapacity, congenital anomaly or required medical or surgical intervention to prevent a serious outcome.
美國疾病管制中心下屬的免疫接種實踐諮詢委員會建議, 類風濕關節炎患者即使在持續接受抗TNF治療期間, 也應該例行性接種非活菌疫苗, 接受疫苗注射的病患, 在追蹤的 5.6 年期間, 相較於未接受疫苗的患者, 明顯會降低流感相關的不良反應
Routine vaccination of patients with RA with non-live agents, even in the setting of ongoing anti-TNF treatment, is recommended by the Advisory Committee on Immunization Practices.1 However, awareness of this appears to be low, since a minority of patients with RA starting adalimumab in our studies received influenza vaccination. Patients that received this vaccine clearly presented with fewer influenza-related AEs over an average of 5.6 years of follow-up, compared with patients not receiving the vaccine.
下面是medscape
接受TNF-α阻斷劑治療的患者, 並不會降低流感疫苗的抗體生成反應, 在一項針對類風濕關節炎患者的研究, 111名患者接受流感疫苗注射後的保護力(血清抗體濃度), 接受 adalimumab 治療組為 94.5%, 安慰劑組為 98%, 其它針對使用TNF-α阻斷劑或其他非生物性製劑的病患, 施打流感疫苗反應研究也得到相似結果. 至於施打流感疫苗的時間間隔, Elkayam 等人研究發現, 同時施打 infliximab 與流感疫苗, 相較於使用infliximab 三周後再施打疫苗, 同時施打的免疫反應較高.
Patients Receiving TNF-α Blockers
An increasing amount of clinical studies have assessed the immunogenicity of the influenza vaccine in patients receiving biological agents. Overall, it appears that therapy with TNF-α blockers does not reduce the antibody response to the influenza vaccine when used in monotherapy. In a study assessing the immunogenicity of influenza vaccination in 111 patients with rheumatoid arthritis, seroprotection rates after influenza vaccination were similar irrespective if the patient had received adalimumab or not (94.5% in the adalimumab group and 98% in the placebo group).[60] Other studies have also reported similar antibody responses after influenza vaccination in patients receiving TNF-α blockers compared with other nonbiologic drugs.[61,62] The timing of vaccination in relation to administration of infliximab was assessed by Elkayam et al..[62] A trend toward a higher immune response was observed in patients that were vaccinated simultaneously to infliximab therapy than in patients who were vaccinated 3 weeks after infliximab therapy.
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