在真实世界中观察目标治疗策略实施1年对初诊RA患者的影响

在真实世界中观察目标治疗策略实施1年对初诊RA患者的影响

Tan AL, et al. Rheumatology 2016.Present ID: 083.

              

背景:制订目标治疗(T2T)建议是要将获得RA优化结局的治疗策略告知风湿病医师和患者,这些策略构建于偱证和专家意见。本文报道的真实世界前瞻性观察对RA患者进行了12个月以上的随访,以评估T2T治疗策略对初诊RA患者的影响。

方法:自2012年4月,英国国家健康服务体系(NHS)提供风湿病诊疗服务的48家机构登记了初诊RA患者,以前瞻性观察的形式对T2T治疗策略进行审计。患者在门诊随诊时采集有关疾病管理、治疗和结局评估的数据。这里我们介绍随访≥12个月的分析结果。

结果:截至2015年8月,共有1470例患者录入审计系统,从初诊至分析截止日随访≥12个月的共有460例(31%)。

在这个队列,发病时年龄(中位数, IQR)为61岁, 32%为男性。74%(342/460)患者在疾病诊断时就将临床缓解目标(DAS28 < 2.6)设定为治疗目标, 7%(33/460)的患者将低度活动度(LDA, DAS28: 2.6 - 3.2)设定为治疗目标。分析可用数据显示,45%(135/301)的患者在每次访问时都评估和记录DAS28。在设定治疗目标的患者中,缓解组210/342例、LDA组21/33例同时拥有基线和第12个月的DAS28评估数据。一年里平均随访次数为4次(SD: 3.1)。

12个月后,接受DMARD单药、两药联合、三药联合治疗的患者例数分别为56%(182/325)、35%(114/325)和5%(15/325)。临床缓解和LDA达标率分别为56%(182/325)和29%(6/21)。12个月时,缓解目标组和LDA目标组的DAS28均值(中位数)分别为2.38和3.89。

持续缓解率为21%患者(51/248),持续缓解的定义为连续3次随访均为临床缓解。其中, 59%(30/51)接受单药治疗, 39%(20/51)接受两药联合治疗,无患者接受三药联合治疗。满足使用生物制剂条件(连续2次随访的DAS> 5.1,且2种DMARDs治疗失败)的患者比例为9%(42/460),其中处方了一种生物制剂的患者比例为45%(19/42)。

在年龄小于60岁的患者群中,受雇佣工作率在基线时为57%(125/221),随访12个月时为46%(77/169)。在年龄≥60岁的患者中,基线和随访12个月时的受雇佣率分别为8%(19/239)和4%(7/156)。报告“工作时有难度”的患者比例由基线时的40%(34/84)下降至12月时的16%(8/49)。

结论:在RA初诊时设立临床缓解为治疗目标的患者中,经12个月治疗达到临床缓解的患者比例超过50%。然而,尽管应用了T2T策略,在实现持续缓解方面还有待进一步完善。其中值得注意的是, DAS28评估次数相对较低, DMARDs三联疗法很少在初诊后12个月给予,适合使用生物制剂的患者却未处方生物制剂。未来应该通过与传统治疗策略比较对雇佣的影响,以明确目标治疗策略(T2T)对于RA患者而言的社会价值。

---

原文链接或参见以下信息。

THE IMPACT OF TREAT TO TARGET ON 1 YEAR REAL WORLD OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS

 

Ai Lyn Tan¹, Maya Buch¹, David O'Reilly², Tom Sheeran³, Sarah Keidel⁴, Sarang Chitale⁵, Paul Emery¹

¹Leeds Musculoskeletal Biomedical Research Unit, The Leeds Teaching Hospitals Trust, Leeds, UNITED KINGDOM, ²Rheumatology Department, West Suffolk Hospital, Bury St Edmunds, UNITED KINGDOM, ³Rheumatology Department, Cannock Chase Hospital, Cannock, UNITED KINGDOM, ⁴Medical, Abbvie Ltd, Maidenhead, UNITED KINGDOM, ⁵Rheumatology Department, Peter Maddison Rheumatology Centre, Llandudno, UNITED KINGDOM.

 

Background: Treat to Target (T2T) recommendations are designed to inform rheumatologists and patients about strategies to enable optimal outcomes in rheumatoid arthritis (RA) based on evidence and expert opinion. This real world, prospective audit has a patient cohort with >12 months’ follow up data allowing assessment of the impact of T2T.

Methods: Since April 2012, 48 NHS rheumatology services have enrolled newly diagnosed RA patients prospectively into the T2T audit. Data on disease management, treatments and outcomes are collected when the patient is reviewed in clinic. Here we present results of a cohort of patients who have been followed up for 12 months from diagnosis.

Results: By August 2015, 1470 patients had been enrolled into the audit, with a cohort of 460(31%) with data at ≥12 months from diagnosis.

Within this cohort, median (IQR) age at symptom onset was 61 years, 32% male. 74%(342/460) had a target of remission (Disease Activity Score [DAS]28 <2.6 ) and 7%(33/460) had a target of low disease activity state (LDAS, DAS28 2.6-<3.2) set at diagnosis. Where data were available, 45%(135/301) had DAS28 performed at each visit. 210/342 patients with a DAS28 remission target, and 21/33 with a LDAS target, had both baseline and 12 month DAS28. Mean (SD) number of visits over a year was 4(3.1).

After 12 months, 56%(182/325), 35%(114/325) and 5%(15/325) of patients were on DMARD mono, dual and triple therapy, respectively. 117/210(56%) achieved remission and 6/21(29%) achieved LDAS. The median (IQR) DAS28 score achieved was 2.38 and 3.89 in the remission and LDAS groups, respectively.

21%(51/248) of patients were in sustained remission (3 consecutive visits) at 1 year. Of these, 59%(30/51) received monotherapy, 39%(20/51) dual and 0%(0/51) triple therapy. 9%(42/460) of patients were eligible for a biologic (2 consecutive DAS scores >5.1, failure of 2 DMARDS); of these, 45%(19/42) were prescribed a biologic.

Among the cohort of patients aged <60years, the % in employment changed from 57%(125/221) at baseline to 46%(77/169) at 12 months. Among those aged ≥60 years, 8%(19/239) and 4%(7/156) were employed at baseline at 12 months respectively. There was a reduction in patient reported work difficulties from 40%(34/84) at baseline to 16%(8/49) at 12 months.

Conclusion: Greater than 50% of patients in the remission target group were in remission by 12 months; however, despite the T2T approach, there is still an unmet need in terms of achieving sustained remission. This is highlighted by relatively low numbers of DAS28 assessments, triple therapy rarely being introduced before 12 months, and the proportion of biologic eligible patients not receiving them. It would be interesting to compare the employment data against a cohort treated with conventional strategies to determine the societal and patient impact of T2T in RA.