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[1929] - Continued Efficacy of Infliximab in the
Treatment of HLA B27 Positive Very Early Ankylosing Spondylitis
Following Its Discontinuation; Clinical and Imaging Results of the
40 Week Follow-Up Study of a Three Month, Randomised,
Placebo-Controlled Trial.
Nick
Barkham, MB ChB1,Helen Keen2,Laura
Coates2,phil o'connor3,Elizabeth
Hensor2,Dennis McGonagle2,Helena
Marzo-Ortega2,Paul Emery, MA, MD, FRCP4.
1Leeds University, Leeds, Yorkshire,2Leeds
University,3Leeda University,4Academic Unit
of Musculoskelet, Chapel Allerton Hospital,
Leeds
Objective: Treatment of early inflammatory back pain (AS in
evolution) with infliximab, was shown to be efficacious during a 3
month treatment period. The current report describes the clinical
and imaging outcomes following discontinuation of infliximab
treatment.
Methods: Following an initial randomised, placebo controlled
trial, all patients who had received either infliximab or placebo
for 3 months discontinued treatment and were followed up to week 40
or time of clinical flare (BASDAI>4).
MRI scans of the spine and sacroiliac joints were performed at
baseline, week 16, and week 40 or time of clinical flare. MRIs were
scored by 2 observers blinded to treatment group and order using
the Leeds 0-3 MRI grading system.
Results: In the placebo group, 17/19 patients (89.5%) had a
high BASDAI at some point between the end of treatment (12 weeks)
and the end of observation (40 weeks), compared to 12/19 (60.0%) in
the infliximab group (Chi-square=4.44, df=1, P=0.035). Time to
BASDAI>4 was shorter in patients who had received
placebo [median (IQR) 5.0 weeks (4.0 to 16.0)] than those who had
received infliximab [20.0 weeks (7.9 to 28.0), Log-rank
Chi-square=5.77, P=0.016]. Between baseline and endpoint (at first
BASDAI>=4 or week 40), infliximab patients showed
significantly greater improvements in ASQoL(p=0.05), BASFI
(p=0.033) and BASDAI (p=0.045).
Considering MRI lesions >= grade 2 (lesions not seen
in normal spine MRI scans), in the 10 patients who reached week 40
without clinical flare (8 infliximab treated, 2 placebo), there was
only one lesion >= grade 2 present at week 16 and no
new lesions developed on the follow-up scan. In the 11 patients who
flared between wk 16 and week 40 (6 infliximab 5 placebo) there
were 8 grade>1 lesions present at week 16 and 12 new
lesions developed.
Conclusions: A short course of infliximab treatment results
in prompt suppression of disease activity and improvement in
quality of life in early AS, which is sustained on withdrawal of
therapy. Fewer patients who had received active therapy flared by
week 40, and those who did not flare demonstrated no progression of
grade>1 lesions on MRI. This raises the possibility
that the “remission induction” approach could work in a subset of
patients with early AS. As previously reported for the SIJ, the
prognostic value of persistent >=grade 2 lesions is
demonstrated, and MRI could allow early identification of patients
with subclinical disease prior to the onset of clinical
flare.
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HLA B27阳性的极早期AS患者停用TNF拮抗剂后疗效持续: 3个月随机安慰剂对照试验后随访40周的临床与影像学结果
Barkham N, et al. ACR 2010. Present No: 1929.
目的：早期炎性下背痛患者使用TNF拮抗剂3个月疗效良好。本文旨在研究停用TNF拮抗剂后的临床和影像学结局。
方法：患者接受TNF拮抗剂或安慰剂治疗3个月后停止治疗，随访至第40周或临床复发（BASDAI>4）。
在基线期、第16周、第40周或临床复发时进行脊柱和骶髂关节MRI扫描。2名阅片者采用Leeds 0-3级分级系统，对MRI进行盲态评分。
结果：在安慰剂组，17/19例（89.5%）患者从末次治疗(第12周末)到末次观察点（第40周末）之间出现BASDAI升高，而TNF拮抗剂组仅有12/19例（60.0%)患者出现病情活动（x2=4.44, df=1, P=0.035）。安慰剂组患者（平均5.0周，IQR 4.0-16.0）达到BASDAI>4的时间短于TNF拮抗剂组（平均20.0周，IQR 7.9-28.0, Log-rank x2
=5.77，P=0.016）。从基线期到终点（首次出现BASDAI≥4或第40周末），TNF拮抗剂患者在以下参数的改善更明显：ASQoL（p=0.05）、BASFI（p=0.033）和BASDAI（p=0.045）。
有10例患者完成40周随访且无临床复发（8例使用TNF拮抗剂，2例安慰剂），这些患者在第16周仅有1个≥2级的MRI病变（这些病变不会出现于正常脊柱的MRI扫描），且在40周的随访期间未出现新发病变。11例患者在第16周至40周之间复发（6例使用TNF拮抗剂，5例安慰剂），他们在第16周有8个>1级的病变，且随访期内出现12个新发病变。
结论：TNF拮抗剂短期治疗早期AS，能快速控制疾病活动，改善生活质量，且停药后疗效持续。TNF拮抗剂治疗组在第40周复发者更少，未复发患者在随访期内没有出现>1级的MRI病变。对于某些早期AS患者，似乎可以采用“诱导缓解“的治疗策略。正如之前有关骶髂关节炎相关研究, 本研究也证实了≥2级病变持续存在的预后价值, MRI可以在临床病情复发前及早发现亚临床型患者。
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