Analysis Group, Inc., Boston, MA 02199, USA.
J Med Econ. 2013;16(4):479-89. doi: 10.3111/13696998.2013.768530. Epub 2013 Feb 7.
No head-to-head trial has compared the efficacy of adalimumab vs etanercept and infliximab for psoriatic arthritis (PsA). This study implements a matching-adjusted indirect comparison technique to address that gap.
Patient-level data from a placebo-controlled trial of adalimumab (ADEPT) were re-weighted to match average baseline characteristics from pivotal published trials of etanercept and infliximab. ADEPT patients were re-weighted by odds of enrollment in comparator trials, estimated using logistic regression. Matched-on characteristics included PsA duration, age, gender, severity, active psoriasis, and concomitant treatment. After matching, placebo-adjusted treatment arms were compared at weeks 12 (or 14) and 24. Outcomes included ACR20/50/70, PsARC, HAQ, and modified TSS. PASI50/75/90 were compared for patients with active psoriasis. Cost per responder (CPR) was assessed in the US and Germany using matching-adjusted end-points and drug list prices. Statistical significance was assessed using weighted t-tests.
After matching, adalimumab-treated patients had greater placebo-adjusted rates of ACR70 and PASI50/75/90 at week 24 compared with etanercept (all p < 0.05). Adalimumab patients had a higher placebo-adjusted rate of ACR70 than infliximab at week 14 (p = 0.034). Adalimumab treatment had lower CPR for ACR70 and PASI50/75/90 compared with etanercept at week 24, in both the US and Germany (all p < 0.02). Adalimumab had lower CPR than infliximab for all outcomes at week 24 (all p < 0.05).
Adalimumab is associated with higher ACR70 and PASI50/75/90 response rates than etanercept at week 24 and a higher ACR70 response rate than infliximab at week 14. Adalimumab has significant advantages over etanercept and infliximab in CPR across multiple end-points.
The matching-adjusted indirect comparison method cannot account for unobserved differences in patient characteristics across trials, and only a head-to-head randomized clinical trial can fully avoid the limitations of indirect comparisons. CPR findings are limited to the US and German markets, and may not be generalizable to other markets with different relative pricing.
尚无头对头试验比较阿达木单抗与依那西普和英夫利昔单抗治疗银屑病关节炎（PsA）的疗效。本研究采用匹配调整间接比较技术来填补这一空白。
对阿达木单抗（ADEPT）安慰剂对照试验的患者水平数据进行重新加权，以匹配依那西普和英夫利昔单抗关键性已发表试验的平均基线特征。通过逻辑回归估计比较试验入组的可能性对 ADEPT 患者进行重新加权。匹配特征包括 PsA 病程、年龄、性别、严重程度、活动性银屑病和伴随治疗。匹配后，在第 12 周（或第 14 周）和第 24 周比较安慰剂调整后的治疗组。结局包括 ACR20/50/70、PsARC、HAQ 和改良 TSS。比较有活动性银屑病患者的 PASI50/75/90。使用匹配调整终点和药物清单价格在美国和德国评估每个应答者的成本（CPR）。使用加权 t 检验评估统计学意义。
匹配后，与依那西普相比，阿达木单抗治疗的患者在第 24 周时的 ACR70 和 PASI50/75/90 安慰剂调整率更高（均 p<0.05）。与英夫利昔单抗相比，阿达木单抗治疗的患者在第 14 周时的 ACR70 安慰剂调整率更高（p=0.034）。在第 24 周时，在美国和德国，阿达木单抗治疗的 ACR70 和 PASI50/75/90 的 CPR 均低于依那西普（均 p<0.02）。在第 24 周时，阿达木单抗治疗的所有结局的 CPR 均低于英夫利昔单抗（均 p<0.05）。
与依那西普相比，阿达木单抗在第 24 周时 ACR70 和 PASI50/75/90 的缓解率更高，在第 14 周时 ACR70 的缓解率更高。与依那西普和英夫利昔单抗相比，阿达木单抗在多个终点的 CPR 方面具有显著优势。
匹配调整间接比较方法无法解释试验间患者特征的未观察到差异，只有头对头随机临床试验才能完全避免间接比较的局限性。CPR 结果仅限于美国和德国市场，可能不适用于其他相对定价不同的市场。
