Recommendations by the Spanish Society of Rheumatology on risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis

Alejandro Balsa , Petra Díaz del Campo Fontecha , Lucía Silva Fernández , José Valencia Martín , Virginia Nistal Martínez , Fernando León Vázquez , M. Vanesa Hernández Hernández , Héctor Corominas , Rafael Cáliz Cáliz , José María Aguado García , Gloria Candelas Rodríguez , Nora Ibargoyen Roteta , Arturo Martí Carvajal , M. Nieves Plana Farras , Janet Puñal Riobóo , Hye Sang Park , Yolanda Triñanes Pego , Virginia Villaverde García
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Abstract

Objective

To present recommendations based on the available evidence and the consensus of experts, for risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis.

Methods

Clinical research questions relevant to the purpose of the document were identified. These questions were reformulated in PICO format (patient, intervention, comparison, outcome or outcome) by a panel of experts, selected based on their experience in the area. A systematic review of the evidence was carried out, grading according to the GRADE criteria (Grading of Recommendations Assessment, Development, and Evaluation). Specific recommendations were then formulated.

Results

6 PICO questions were proposed by the panel of experts based on their clinical relevance and the existence of recent information regarding the risk of occurrence of serious infections, the risk of reactivation of the hepatitis B virus, the risk of reactivation of the virus varicella-zoster, the risk of appearance of skin (melanoma and non-melanoma) or haematological cancer, the risk of appearance of thromboembolic disease and the risk of progression of the human papilloma virus.

A total of 28 recommendations were formulated, structured by question, based on the evidence found and the consensus of the experts.

Conclusions

The SER recommendations on risk management of treatment with biologic therapies and JAK inhibitors in rheumatoid arthritis are presented.

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西班牙风湿病学会关于类风湿关节炎患者生物治疗和JAK抑制剂风险管理的建议
目的:根据现有证据和专家共识,对类风湿关节炎患者生物治疗和JAK抑制剂的风险管理提出建议。方法:确定与文献目的相关的临床研究问题。这些问题由专家小组根据他们在该领域的经验重新制定为PICO格式(患者、干预、比较、结果或结果)。对证据进行系统回顾,根据GRADE标准(建议评估、发展和评价分级)进行分级。然后拟订了具体建议。结果:6个PICO问题由专家小组根据其临床相关性和近期存在的信息提出,包括发生严重感染的风险、乙型肝炎病毒再激活的风险、水痘带状疱疹病毒再激活的风险、出现皮肤(黑色素瘤和非黑色素瘤)或血液系统癌症的风险、出现血栓栓塞性疾病的风险和人类乳头瘤病毒进展的风险。根据所发现的证据和专家的一致意见,按问题编制了总共28项建议。结论:本文提出了类风湿性关节炎生物疗法和JAK抑制剂治疗风险管理的SER建议。
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