PDF(Pubmed)
Abstract：
BACKGROUND: Treatments for atopic dermatitis (AD) often fail to achieve lasting disease control. In the CrisADe CONTROL phase III study (ClinicalTrials.gov: NCT04040192), participants aged ≥ 3 months with mild to moderate AD treated with once-daily (QD) crisaborole, following initial treatment success with crisaborole twice daily (BID), had longer periods of flare-free maintenance, a higher number of flare-free days, and a lower number of flares compared with those who received vehicle. The study was an exploratory analysis of data on the maintenance of response per Investigator\'s Static Global Assessment (ISGA; ISGA score of 0 [clear] or 1 [almost clear]) during the CrisADe CONTROL study through week 52.
METHODS: Exploratory endpoints were the time to ISGA response during the open-label run-in period, and the maintenance of ISGA response and the severity and duration of flares during the double-blind maintenance period. Outcomes were stratified by age (participants aged 3 months to < 12 years and ≥ 12 years) and duration of crisaborole BID treatment (< 4 weeks or ≥ 4 weeks) during the open-label run-in period.
RESULTS: During the open-label run-in period, the median time to ISGA response was 41.5 days. From week 4 to week 52 of the double-blind maintenance period, the proportion of participants who maintained ISGA response was greater with crisaborole versus vehicle, and this difference was statistically significant up to week 36 (P < 0.05). Duration of flare periods during the maintenance period were 54.1 and 54.0 days for the vehicle and crisaborole-treated groups, respectively. Numerically fewer crisaborole-treated participants experienced a flare with an ISGA score of ≥ 2 compared with vehicle-treated participants (64.8% vs. 74.4%, respectively). Findings were comparable across most subgroups.
CONCLUSIONS: Adult and pediatric participants with mild to moderate AD at baseline who had achieved responder criteria (treatment success) with crisaborole BID during the run-in period maintained response per ISGA with crisaborole QD during the double-blind maintenance period through week 52.
BACKGROUND: ClinicalTrials.gov: NCT04040192.
Atopic dermatitis is a skin disease that causes itchy, red, and dry patches of skin that can affect a person for a long time. Current treatments for atopic dermatitis often fail to keep the symptoms under control. Some creams and ointments applied to the skin (known as topical treatments) can ease the discomfort of atopic dermatitis. Crisaborole is a steroid-free ointment that has been shown to improve symptoms of atopic dermatitis in clinical studies. In a study called the CrisADe CONTROL trial, crisaborole was tested to see if it can keep atopic dermatitis symptoms under control. People who participated in the study were aged 3 months and older and they had mild-to-moderate atopic dermatitis. Participants were asked to use crisaborole on their itchy, red, and dry skin twice daily for 8 weeks. Patients were called “responders” if their symptoms became nearly clear or completely clear based on a doctor’s assessment called the Investigator’s Static Global Assessment, which rates atopic dermatitis between clear to severe. Some responders were asked to use crisaborole once daily for 52 weeks and another group of responders was asked to use a control (an ointment with no medicine) once daily for 52 weeks. Investigators looked at how long the skin remained nearly clear or completely clear during the 52 weeks. Results of this study showed that after initial treatment success with crisaborole twice daily, adult and pediatric participants who had mild-to-moderate atopic dermatitis were able to keep their skin nearly clear or completely clear with crisaborole once daily.
METHODS: Exploratory endpoints were the time to ISGA response during the open-label run-in period, and the maintenance of ISGA response and the severity and duration of flares during the double-blind maintenance period. Outcomes were stratified by age (participants aged 3 months to < 12 years and ≥ 12 years) and duration of crisaborole BID treatment (< 4 weeks or ≥ 4 weeks) during the open-label run-in period.
RESULTS: During the open-label run-in period, the median time to ISGA response was 41.5 days. From week 4 to week 52 of the double-blind maintenance period, the proportion of participants who maintained ISGA response was greater with crisaborole versus vehicle, and this difference was statistically significant up to week 36 (P < 0.05). Duration of flare periods during the maintenance period were 54.1 and 54.0 days for the vehicle and crisaborole-treated groups, respectively. Numerically fewer crisaborole-treated participants experienced a flare with an ISGA score of ≥ 2 compared with vehicle-treated participants (64.8% vs. 74.4%, respectively). Findings were comparable across most subgroups.
CONCLUSIONS: Adult and pediatric participants with mild to moderate AD at baseline who had achieved responder criteria (treatment success) with crisaborole BID during the run-in period maintained response per ISGA with crisaborole QD during the double-blind maintenance period through week 52.
BACKGROUND: ClinicalTrials.gov: NCT04040192.
Atopic dermatitis is a skin disease that causes itchy, red, and dry patches of skin that can affect a person for a long time. Current treatments for atopic dermatitis often fail to keep the symptoms under control. Some creams and ointments applied to the skin (known as topical treatments) can ease the discomfort of atopic dermatitis. Crisaborole is a steroid-free ointment that has been shown to improve symptoms of atopic dermatitis in clinical studies. In a study called the CrisADe CONTROL trial, crisaborole was tested to see if it can keep atopic dermatitis symptoms under control. People who participated in the study were aged 3 months and older and they had mild-to-moderate atopic dermatitis. Participants were asked to use crisaborole on their itchy, red, and dry skin twice daily for 8 weeks. Patients were called “responders” if their symptoms became nearly clear or completely clear based on a doctor’s assessment called the Investigator’s Static Global Assessment, which rates atopic dermatitis between clear to severe. Some responders were asked to use crisaborole once daily for 52 weeks and another group of responders was asked to use a control (an ointment with no medicine) once daily for 52 weeks. Investigators looked at how long the skin remained nearly clear or completely clear during the 52 weeks. Results of this study showed that after initial treatment success with crisaborole twice daily, adult and pediatric participants who had mild-to-moderate atopic dermatitis were able to keep their skin nearly clear or completely clear with crisaborole once daily.
摘要：
背景：特应性皮炎（AD）的治疗通常无法实现持久的疾病控制。在CrisADe控制III期研究中（ClinicalTrials.gov：NCT04040192），年龄≥3个月的轻度至中度AD患者，每天一次（QD）接受瑞舒托治疗，在初次治疗成功后，每天两次（BID），有更长时间的无耀斑维护，更多的无耀斑天数，与接受车辆的人相比，耀斑的数量更少。该研究是对CrisADeCONTROL研究至第52周期间根据研究者的静态全球评估（ISGA；ISGA评分为0[clear]或1[几乎clear]）维持反应的数据进行的探索性分析。
方法：探索性终点是开放标签磨合期ISGA响应的时间，以及双盲维持期间ISGA反应的维持以及耀斑的严重程度和持续时间。结果按年龄（3个月至<12岁和≥12岁的参与者）和在开放标签磨合期期间接受crisaboroleBID治疗的持续时间（<4周或≥4周）进行分层。
结果：在开放标签运行期间，ISGA缓解的中位时间为41.5天.从双盲保养期的第4周到第52周，与车辆相比，保持ISGA反应的参与者比例更大，到第36周，差异有统计学意义（P<0.05）。车辆和接受crisaborole治疗的组维持期间的耀斑持续时间分别为54.1天和54.0天，分别。与接受车辆治疗的参与者相比，接受crisaborole治疗的参与者经历了ISGA评分≥2的耀斑（64.8％vs.74.4%,分别)。大多数亚组的研究结果具有可比性。
结论：在基线时患有轻度至中度AD的成人和儿科参与者，在磨合期期间达到了使用crisaboroleBID的应答标准（治疗成功），在双盲维持期内，根据ISGA和crisaboroleQD维持至第52周。
背景：ClinicalTrials.gov：NCT04040192。
特应性皮炎是一种引起瘙痒的皮肤病，红色,和干燥的皮肤斑块，可以影响一个人很长一段时间。目前特应性皮炎的治疗通常不能控制症状。应用于皮肤的一些乳膏和软膏（称为局部治疗）可以缓解特应性皮炎的不适。Crisamborole是一种不含类固醇的软膏，在临床研究中已被证明可以改善特应性皮炎的症状。在一项名为CrisADe控制试验的研究中，对crisaborole进行了测试，看看它是否可以控制特应性皮炎的症状。参与研究的人年龄在3个月及以上，他们患有轻度至中度特应性皮炎。参与者被要求在发痒时使用crisaborole，红色,皮肤干燥，每天两次，持续8周。如果根据医生的评估称为“研究者的静态全局评估”，患者的症状变得几乎清晰或完全清晰，则将其称为“反应者”。特应性皮炎的发病率介于明显到严重之间。一些响应者被要求每天使用一次crisaborole，持续52周，另一组响应者被要求每天使用一次对照（不含药物的软膏），持续52周。研究人员观察了在52周内皮肤保持接近透明或完全透明的时间。这项研究的结果表明，在初次治疗成功后，每天两次使用crisaborole，患有轻度至中度特应性皮炎的成人和儿童参与者每天使用一次cribororole能够保持皮肤接近透明或完全透明.
方法：探索性终点是开放标签磨合期ISGA响应的时间，以及双盲维持期间ISGA反应的维持以及耀斑的严重程度和持续时间。结果按年龄（3个月至<12岁和≥12岁的参与者）和在开放标签磨合期期间接受crisaboroleBID治疗的持续时间（<4周或≥4周）进行分层。
结果：在开放标签运行期间，ISGA缓解的中位时间为41.5天.从双盲保养期的第4周到第52周，与车辆相比，保持ISGA反应的参与者比例更大，到第36周，差异有统计学意义（P<0.05）。车辆和接受crisaborole治疗的组维持期间的耀斑持续时间分别为54.1天和54.0天，分别。与接受车辆治疗的参与者相比，接受crisaborole治疗的参与者经历了ISGA评分≥2的耀斑（64.8％vs.74.4%,分别)。大多数亚组的研究结果具有可比性。
结论：在基线时患有轻度至中度AD的成人和儿科参与者，在磨合期期间达到了使用crisaboroleBID的应答标准（治疗成功），在双盲维持期内，根据ISGA和crisaboroleQD维持至第52周。
背景：ClinicalTrials.gov：NCT04040192。
特应性皮炎是一种引起瘙痒的皮肤病，红色,和干燥的皮肤斑块，可以影响一个人很长一段时间。目前特应性皮炎的治疗通常不能控制症状。应用于皮肤的一些乳膏和软膏（称为局部治疗）可以缓解特应性皮炎的不适。Crisamborole是一种不含类固醇的软膏，在临床研究中已被证明可以改善特应性皮炎的症状。在一项名为CrisADe控制试验的研究中，对crisaborole进行了测试，看看它是否可以控制特应性皮炎的症状。参与研究的人年龄在3个月及以上，他们患有轻度至中度特应性皮炎。参与者被要求在发痒时使用crisaborole，红色,皮肤干燥，每天两次，持续8周。如果根据医生的评估称为“研究者的静态全局评估”，患者的症状变得几乎清晰或完全清晰，则将其称为“反应者”。特应性皮炎的发病率介于明显到严重之间。一些响应者被要求每天使用一次crisaborole，持续52周，另一组响应者被要求每天使用一次对照（不含药物的软膏），持续52周。研究人员观察了在52周内皮肤保持接近透明或完全透明的时间。这项研究的结果表明，在初次治疗成功后，每天两次使用crisaborole，患有轻度至中度特应性皮炎的成人和儿童参与者每天使用一次cribororole能够保持皮肤接近透明或完全透明.
