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THU0491 PREDICTING CLINICAL OUTCOMES AT 24 WEEKS IN PATIENTS WITH ANKYLOSING SPONDYLITIS M. Dougados 1,*, K. Patra 2, F. Lavie 3 1Hospital Cochin, Paris, France, 2Abbott, Abbott Park, United States, 3Abbott, Rungis, France Background: Acceptable treatment targets that
predict long-term treatment outcomes are lacking for patients (pts)
with ankylosing spondylitis (AS). Objectives: To assess probabilities of achieving favorable clinical outcomes after 24 weeks of adalimumab (ADA) treatment, based on clinical response and disease state targets at week 8, 12 and 16. Methods: The ATLAS study was a phase 3 study
that included an initial 24 week randomized, controlled period of
ADA 40 mg every other week vs placebo in patients with active AS
who had failed at least one NSAID. Results: At 24 wks, 36%, 74%, and 75% of pts
randomized to ADA achieved ASAS PR, ASDAS <2.1, and
BASDAI <3, respectively. Results show that for many
patients who achieve low disease activity (ASDAS<2.1
or BASDAI<4), the probability to reach ASAS PR
remains low, indicating that ASAS PR may be a difficult outcome to
achieve in this population of long standing AS pts. The
probabilities of achieving either ASDAS <2.1 or
BASDAI <3 with 24 weeks of ADA treatment were 61-79%
across earlier time points when utilizing change in disease
activity as the predictor (table). When using various cut-offs of
disease activity measurements as predictors, ASDAS≥3.5 at weeks 8,
12 and16 was associated with a <15% probability of
achieving ASDAS <2.1 or BASDAI <3 at
week 24. However, a considerable proportion of patients with BASDAI
values ≥6 at week 16 were still able to reach ASDAS
<2.1 at week 24, reinforcing the need for
multiple="multiple" assessments prior to considering treatment
adjustment. Conclusions: Effective treatment with ADA is seen
in these established AS patients who failed prior
NSAIDs. Disclosure of Interest: M. Dougados Grant / Research support from: Abbott, Pfizer, UCB, BMS, Roche, Consultant for: Abbott, Pfizer, UCB, BMS, Roche, K. Patra Shareholder of: Abbott, Employee of: Abbott, F. Lavie Shareholder of: Abbott, Employee of: Abbott
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强柱的治疗目标_24周疗效预测因素 M. Dougados , KEULAR 2011. Present No: THU0491 背景：强直性脊柱炎（AS）患者缺乏合适的可预测长期预后的治疗目标。 目的：基于阿达木单抗（ADA）治疗8周，12周和16周的临床反应和疾病状态，评价治疗24周后达到有利临床效果的概率。 方法：ATLAS研究是个包括三个时期的研究，包括最初的24周随机、对照入组，对至少一种非甾体类抗炎药治疗无效的活动性AS患者每二周给予40mg阿达木单抗或安慰剂治疗，对这一时期用阿达木单抗治疗的患者使用事后分析来评估其观察的结果。基于从基线起，疾病活动度的各种不同变化（ΔASDAS ≤1.1 或BASDAI 50），或者在8周，12周和16周截点时的疾病活动度数据（ASDAS≥3.5 或BASDAI≥4或≥6）来计算24周治疗达到ASAS部分缓解（ASAS PR），ASDAS<2.1 或BASDAI<3的概率。如果在24周达到低疾病活动性的概率少于15%，则提示需要尽早在8-16周调整治疗。 结果：在24周，36%, 74%, 和75%的随机分入阿达木单抗组的病人分别达到ASAS部分缓解，ASDAS<2.1 和BASDAI<3。结果显示尽管许多患者达到了低疾病活动性 (ASDAS<2.1 or BASDAI<4)，但达到ASAS部分缓解的概率仍然较低。提示对长病程的AS患者，获得ASAS部分缓解是一个很难达到的目标。 如果使用疾病活动性变化值作为预测因素，包括较早的时间点，阿达木单抗治疗24周达到ASDAS <2.1 或 BASDAI <3的概率为61-79%。（表） 如果用不同截点的疾病活动度测量值作为预测因素时，在8周，12周和16周与24周时 如果ASDAS≥3.5，则24周达到ASDAS <2.1 或 BASDAI <3的概率<15%。然而，即使在16周BASDAI 值 ≥6，这部分患者仍有相当比例有可能在24周达到ASDAS <2.1，这强调了在考虑调整治疗前进行多种评价的必要性。 结论：对确诊的先前非甾体类抗炎药治疗无效的AS患者，阿达木单抗治疗有效。达到ASAS部分缓解可能难以用来作为治疗的靶向目标，而其他指标如ASDAS可能用于指导是否需要进行治疗的调整。
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