Warwick Medical School, University of Warwick, Coventry, CV4 7AL, U.K.
Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, NG7 2NR, U.K.
Br J Dermatol. 2018 Feb;178(2):415-423. doi: 10.1111/bjd.16006. Epub 2018 Jan 15.
Bullous pemphigoid (BP) is an autoimmune blistering skin disorder associated with significant morbidity and mortality. Doxycycline and prednisolone to treat bullous pemphigoid were compared within a randomized controlled trial (RCT).
To compare the cost-effectiveness of doxycycline-initiated and prednisolone-initiated treatment for patients with BP.
Quality-of-life (EuroQoL-5D-3L) and resource data were collected as part of the BLISTER trial: a multicentre, parallel-group, investigator-blinded RCT. Within-trial analysis was performed using bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective.
In the base case, there was no robust difference in costs or QALYs per patient at 1 year comparing doxycycline- with prednisolone-initiated therapy [net cost £959, 95% confidence interval (CI) -£24 to £1941; net QALYs -0·024, 95% CI -0·088 to 0·041]. However, the findings varied by baseline blister severity. For patients with mild or moderate blistering (≤ 30 blisters) net costs and outcomes were similar. For patients with severe blistering (> 30 blisters) net costs were higher (£2558, 95% CI -£82 to £5198) and quality of life poorer (-0·090 QALYs, 95% CI -0·22 to 0·042) for patients starting on doxycycline. The probability that doxycycline would be cost-effective for those with severe pemphigoid was 1·5% at a willingness to pay of £20 000 per QALY.
Consistently with the clinical findings of the BLISTER trial, patients with mild or moderate blistering should receive treatment guided by the safety and effectiveness of the drugs and patient preference - neither strategy is clearly a preferred use of National Health Service resources. However, prednisolone-initiated treatment may be more cost-effective for patients with severe blistering.
大疱性类天疱疮(BP)是一种自身免疫性水疱性皮肤病,与较高的发病率和死亡率相关。在一项随机对照试验(RCT)中,比较了多西环素和泼尼松龙治疗大疱性类天疱疮的效果。
比较多西环素起始治疗和泼尼松龙起始治疗对 BP 患者的成本效益。
作为 BLISTER 试验的一部分,收集了生活质量(EuroQoL-5D-3L)和资源数据:一项多中心、平行组、研究者设盲 RCT。采用成本和质量调整生命年(QALY)的双变量回归进行试验内分析,对缺失数据进行多重插补,从卫生服务角度提供增量治疗成本效益的概率评估。
在基线时,与泼尼松龙起始治疗相比,多西环素起始治疗在 1 年时的患者成本或 QALY 无明显差异[净成本为 £959,95%置信区间(CI)为-£24 至 £1941;净 QALY 为-0·024,95%CI 为-0·088 至 0·041]。然而,研究结果因基线水疱严重程度而异。对于水疱程度较轻或中度(≤ 30 个水疱)的患者,净成本和结局相似。对于水疱程度严重(> 30 个水疱)的患者,多西环素起始治疗的净成本更高(£2558,95%CI 为-£82 至 £5198),生活质量更差(-0·090 QALY,95%CI 为-0·22 至 0·042)。在愿意支付每 QALY 20000 英镑的情况下,多西环素治疗严重类天疱疮的概率为 1.5%。
与 BLISTER 试验的临床结果一致,对于水疱程度较轻或中度的患者,应根据药物的安全性和有效性以及患者的偏好来指导治疗——两种策略都不是明确的 NHS 资源优先使用策略。然而,对于水疱程度严重的患者,泼尼松龙起始治疗可能更具成本效益。