Kay L J, Griffiths I D
Musculoskeletal Unit, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, UK.
Rheumatology (Oxford). 2006 Nov;45(11):1376-9. doi: 10.1093/rheumatology/kel333. Epub 2006 Oct 10.
The British Society for Rheumatology Biologics Register (BSRBR) is a prospective cohort study to determine the efficacy and toxicity of biological agents in rheumatoid arthritis (RA) patients compared with RA controls. Entry of patients to the register is a condition of use of anti-tumour necrosis factor (anti-TNF) therapy in the UK, but little is known of clinicians' views of its usefulness. Data from the register suggest uneven provision of anti-TNF-alpha therapy.
A questionnaire was sent on behalf of the BSRBR to all UK consultant rheumatologists concerning provision and use of anti-TNF-alpha therapy and their experience of working with the BSRBR.
Response rate was 49.5% representing 252 consultants. Fourty-six per cent had some limitation of access to anti-TNF-alpha drugs, usually a financial cap (70%), even for RA patients meeting National Institute for Health and Clinical Excellence (NICE) criteria. Sixty-seven per cent could prescribe for ankylosing spondylitis (AS) or psoriatic arthritis (PsA) in some circumstances but only 25 and 35%, respectively, could prescribe according to BSR guidance. More than 50% found the workload involved in submitting data to the registry at least difficult, but most had favourable impressions of the BSRBR and thought similar registries desirable or essential for PsA, AS and rituximab.
Access to anti-TNF therapy for patients with inflammatory arthritis is variable in the UK, even for RA where it is NICE-approved. Access is more limited for conditions where NICE has not yet issued guidance. The BSRBR generates a significant workload for rheumatology staff but is generally well-regarded.
英国风湿病学会生物制剂注册研究(BSRBR)是一项前瞻性队列研究,旨在确定生物制剂在类风湿关节炎(RA)患者中的疗效和毒性,并与类风湿关节炎对照组进行比较。患者进入该注册研究是在英国使用抗肿瘤坏死因子(抗TNF)治疗的一项条件,但对于临床医生对其有用性的看法知之甚少。注册研究的数据表明抗TNF-α治疗的提供情况不均衡。
代表BSRBR向所有英国风湿病顾问医生发送了一份关于抗TNF-α治疗的提供和使用情况以及他们与BSRBR合作经验的问卷。
回复率为49.5%,代表252名顾问医生。46%的医生在获取抗TNF-α药物方面存在一些限制,通常是财务上限(70%),即使对于符合英国国家卫生与临床优化研究所(NICE)标准的类风湿关节炎患者也是如此。67%的医生在某些情况下可以为强直性脊柱炎(AS)或银屑病关节炎(PsA)开处方,但分别只有25%和35%的医生可以根据BSR指南开处方。超过50%的医生认为向注册研究提交数据所涉及的工作量至少很大,但大多数医生对BSRBR有良好印象,并认为类似的注册研究对于PsA、AS和利妥昔单抗是可取的或必不可少的。
在英国,炎性关节炎患者获得抗TNF治疗的情况各不相同,即使对于已获NICE批准的类风湿关节炎也是如此。对于NICE尚未发布指南的疾病,获得治疗的机会更为有限。BSRBR给风湿病学工作人员带来了大量工作量,但总体上受到好评。