Teng Gim Gee, Cheung Peter P, Lahiri Manjari, Clayton Jane A, Chew Li Ching, Koh Ee Tzun, Koh Wei Howe, Lau Tang Ching, Ng Swee Cheng, Thong Bernard Y, Vasudevan Archana R, Yoong Jon K C, Leong Keng Hong
Division of Rheumatology, University Medicine Cluster, National University Health System, Singapore.
Ann Acad Med Singap. 2014 Aug;43(8):400-11.
Up to 30% of patients with rheumatoid arthritis (RA) respond inadequately to conventional non-biologic disease modifying antirheumatic drugs (nbDMARDs), and may benefit from therapy with biologic DMARDs (bDMARDs). However, the high cost of bDMARDs limits their widespread use. The Chapter of Rheumatologists, College of Physicians, Academy of Medicine, Singapore aims to define clinical eligibility for government-assisted funding of bDMARDs for local RA patients.
Evidence synthesis was performed by reviewing 7 published guidelines on use of biologics for RA. Using the modified RAND/UCLA Appropriateness Method (RAM), rheumatologists rated indications for therapies for different clinical scenarios. Points reflecting the output from the formal group consensus were used to formulate the practice recommendations.
Ten recommendations including diagnosis of RA, choice of disease activity measure, initiation and continuation of bDMARD and option of first and second-line therapies were formulated. The panellists agreed that a bDMARD is indicated if a patient has (1) active RA with a Disease Activity Score in 28 joints (DAS28) score of ≥3.2, (2) a minimum of 6 swollen and tender joints, and (3) has failed a minimum of 2 nbDMARD combinations of adequate dose regimen for at least 3 months each. To qualify for continued biologic therapy, a patient must have (1) documentation of DAS28 every 3 months and (2) at least a European League Against Rheumatism (EULAR) moderate response by 6 months after commencement of therapy.
The recommendations developed by a formal group consensus method may be useful for clinical practice and guiding funding decisions by relevant authorities in making bDMARDs usage accessible and equitable to eligible patients in Singapore.
高达30%的类风湿关节炎(RA)患者对传统非生物改善病情抗风湿药物(nbDMARDs)反应不佳,可能从生物改善病情抗风湿药物(bDMARDs)治疗中获益。然而,bDMARDs的高昂成本限制了它们的广泛使用。新加坡医学科学院内科医生学院风湿病学家分会旨在确定当地RA患者使用bDMARDs获得政府资助的临床资格标准。
通过回顾7篇已发表的关于使用生物制剂治疗RA的指南进行证据综合分析。风湿病学家使用改良的兰德/加州大学洛杉矶分校适当性方法(RAM)对不同临床场景下治疗的适应证进行评分。反映正式小组共识结果的分数用于制定实践建议。
制定了10条建议,包括RA的诊断、疾病活动度测量方法的选择、bDMARDs的起始和持续使用以及一线和二线治疗方案的选择。小组成员一致认为,如果患者符合以下条件,则表明需要使用bDMARDs:(1)患有活动性RA,28个关节疾病活动度评分(DAS28)≥3.2;(2)至少有6个关节肿胀和压痛;(3)至少两种nbDMARDs足量方案治疗至少3个月均失败。为了符合继续生物治疗的条件,患者必须(1)每3个月记录一次DAS28;(2)治疗开始后6个月至少有欧洲抗风湿病联盟(EULAR)中度反应。
通过正式小组共识方法制定的建议可能有助于临床实践,并指导相关当局做出资助决策,使符合条件的新加坡患者能够公平地使用bDMARDs。