比较依那西普和柳氮磺胺吡碇治疗早期中轴脊柱关节炎1年后的停药缓解率和缓解时间－ESTHER试验的2年数据

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Frequency and Duration of Drug-Free Remission After One Year of Treatment with Etanercept Vs. Sulfasalazine in Early Axial Spondyloarthritis – 2 Year Data of the ESTHER Trial

 

 

Tuesday, November 8, 2011: 5:45 PM

W471b (McCormick Place Convention Center)

 

In-Ho Song¹, Kay-Geert Hermann², Hildrun Haibel¹, Christian Althoff², Denis Poddubnyy¹, Joachim Listing³, Anja Weiß³, Bruce Freundlich⁴, Martin Rudwaleit⁵ and Joachim Sieper¹, ¹Charité Medical University, Campus Benjamin Franklin, Berlin, Germany, ²Charite Medical School, Berlin, Germany, ³German Rheumatism Research Centre, Berlin, Germany, ⁴University of Pennsylvania, Philadelphia, PA, ⁵Ev. Krankenhaus Hagen-Haspe, Hagen, Germany

Presentation Number: 2534

 

Background/Purpose: In patients with early axial spondyloarthritis (SpA) with a disease duration of < 5 years and with active inflammation on magnetic resonance imaging (MRI) in the spine and/or sacroiliac joints (SIJ) on baseline who were treated with etanercept (ETA, n= 40) vs. sulfasalazine (SSZ, n= 36) for 48 weeks [1] to assess: a) the frequency and duration of drug-free remission and b) the efficacy of ETA after flare, and c) long-term response of ETA during year 2 in already ETA-treated patients (ETA treatment in year 1 and year 2).

Method: At week 48, patients who reached study remission (defined as reaching ASAS remission and being free of active inflammation on whole-body-MRI in the spine and sacroiliac joints) were followed every 6 weeks without active treatment. In case of a flare (defined as a BASDAI increase of 2 points compared to week 48) all patients were (re-)treated with ETA for another year up to week 108. Patients who were in study remission at week 48 and who did not flare were excluded from the study at the end of year 2 (permanent drug-free remission). All patients who were not in study remission at week 48 were treated with ETA in year 2.

Result: Study remission at week 48 was reached significantly more often by ETA- compared to SSZ-treated patients (13/40= 33% vs. 4/36= 11%, p= 0.03). Among patients reaching study remission (n= 17) 70% belonged to the non-radiographic axial SpA group and 30% to the AS group. 23% (9/40) of the ETA-group flared after a mean of 24.4 weeks and 8% (3/36) of the SSZ-group flared after 39.6 weeks (no significant difference for time to flare between both groups).Thus, 8% (3/40) of ETA-treated patients vs. 3% (1/36) of SSZ-treated patients reached drug-free remission. After initiation of ETA during year 2, flare-patients (n= 9) showed a significant (p< 0.001) response to ETA-treatment (table 1): 56% of flare-patients reached ASAS remission and 44% study remission as well as ASDAS inactive disease at week 108. 

Formerly ETA-treated patients (n= 22) who did not reach study remission at week 48 showed a good sustained clinical and MRI response at week 108 (50% ASAS remission; 5 additional patients reached ASAS remission at week 108 who were not in remission at week 48; table 1).

Conclusion: After one year of treatment with ETA 33% of patients with early axial SpA reached study remission, however 23% flared within 24 weeks while only 8% stayed in drug-free remission. Patients treated with ETA for 2 years showed continuously low disease activity with further improvement in a subgroup of patients.

 

 

 

比较依那西普和柳氮磺胺吡碇治疗早期中轴脊柱关节炎1年后的停药缓解率和缓解时间－ESTHER试验的2年数据

 

In-Ho Song , et al. ACR 2011. Present No:2534

背景/目的: 基线时病程< 5年、脊柱和/或骶髂关节(SIJ) 在核磁共振成像(MRI)有活动性炎症的早期中轴脊柱关节炎患者，接受依那西普（ETA，n＝40）或柳氮磺胺吡碇 (SSZ,n = 36)治疗48周[1], 评估:停药缓解的比例和时间； b)复发后的ETA疗效；c)ETA治疗的患者2年内长期疗效 (第1年和第2年都用ETA治疗)。

方法:48周时,达到缓解的患者 (定义为达到DAS缓解并且全身MRI脊椎和骶髂关节无炎症表现)停药后每6周随访一次。一旦疾病复发(定义为与48周相比BASDAI增加2分),患者即再次ETA治疗1年直到108周。排除48周时达缓解并在2年终点时没有复发的患者，他们被认为是永久停药缓解）。 48周时所有未缓解的患者均在第2年接受ETA治疗。

结果:ETA治疗组患者在48周达到缓解的比例明显高于SSZ组(13/40 33% vs. 4/36 11%,p = 0.03)。缓解患者中有70% (n = 17)为无放射学表现的中轴SpA, 30%为AS患者。 ETA治疗组中有23%(9/40)患者在平均24.4周时复发，SSZ组中为8%(3/36)的患者在平均 39.6周时复发(两组间复发时间无显著差异)。因此,8%(3/40)的ETA组患者和3%(1/36)的 SSZ组患者达到停药缓解。第2年开始ETA治疗的患者（n＝9），复发后对ETA疗效显著增高(p < 0.001)（表1）；56％复发患者达到ASAS缓解，44％达到研究中定义的缓解以及在108周时保持ASDAS无活动。48周前ETA治疗而未达到缓解的患者（n＝22）在108周时表现出良好而持续的临床和MRI疗效（50％ASAS缓解，另外有5例48周未缓解的患者在108周达到ASAS缓解，表1）。

结论:经过一年的ETA治疗,33%早期中轴SpA患者达到研究中的缓解。然而23%患者在24周内复发，只有8％能维持停药缓解。ETA治疗2年的患者能持续维持疾病低活动度，并在部分患者中进一步改善病情。

Table 1.

 

		Remission-Flare-Group	Remission-Flare Group	Non-Remission-Group	Non-Remission-Group
Parameter (mean and standard deviation)	Study time point	ETA year 1- ETA year 2 (n= 9)	SSZ year 1- ETA year 2 (n= 3)	ETA year 1- ETA year 2 (n= 22)	SSZ year 1- ETA year 2 (n= 26)
BASDAI	Baseline	5.7 (1.8)	5.9 (1.6)	5.4 (1.1)	5.9 (1.2)
BASDAI	Week 48	1.1 (0.6)	2.0 (1.0)	2.6 (1.7)	4.7 (2.3)
BASDAI	Flare time point	5.0 (1.5)	4.5 (0.4)	Not applicable	Not applicable
BASDAI	Week 108	1.5 (1.4)	1.7 (1.6)	2.7 (2.3)	3.2 (2.6)
MRI SIJ	Baseline	12.0 (6.4)	3.2 (3.9)	8.6 (7.3)	6.5 (5.8)
MRI SIJ	Week 48	1.1 (1.4)	0 (0)	2.4 (3.3)	2.7 (3.2)
MRI SIJ	Week 108	0.4 (0.5)	0 (0)	2.9 (3.7)	1.6 (2.0)
MRI Spine	Baseline	0.2 (0.7)	0.7 (1.2)	3.4 (5.6)	1.3 (2.5)
MRI Spine	Week 48	0 (0)	0 (0)	1.3 (1.9)	1.0 (1.9)
MRI Spine	Week 108	0 (0)	0.3 (0.6)	1.0 (1.7)	0.7 (1.6)
ASAS remission, % (n)	Week 108	56% (5/9)	67% (2/3)	50% (11/22)	23.1% (6/26)
MRI remission,   % (n)	Week 108	56% (5/9)	67% (2/3)	13.6% (3/22)	26.1% (6/23)
Study remission, % (n)	Week 108	44% (4/9)	33% (1/3)	14% (3/22)	8% (2/26)
ASDAS inactive disease (< 1.3)	Week 108	44% (4/9)	66.7% (2/3)	38.1% (8/21)	28.0% (7/25)

[1] Song I.-H. et al.  2011. Ann Rheum Dis. 2011 Apr;70(4):590-6.