The efficacy of methotrexate plus pioglitazone vs. methotrexate alone in the management of patients with plaque‐type psoriasis: a single‐blinded randomized controlled trial

Recently, thiazolidinediones have shown to be efficacious with a favorable safety profile when used in the treatment of chronic plaque‐type psoriasis. The aim of this study was to evaluate and compare the efficacy and safety of a combination of methotrexate plus pioglitazone and methotrexate alone in plaque‐type psoriasis. A total of 44 adult patients with plaque‐type psoriasis were included in the study. Patients were randomized to treatment with methotrexate alone (group A) or methotrexate plus pioglitazone (group B) for 16 weeks. The primary efficacy outcome measure was psoriasis area and severity index (PASI) score change between the study groups at week 16 relative to baseline. The secondary efficacy outcome measure was dermatology life quality index (DLQI) score change between the two groups at week 16 relative to baseline. The PASI 75 score was also measured. After 16 weeks of therapy, the percentage of reduction in the mean PASI score was 70.3% in group B and 60.2% in group A. PASI 75 was achieved in 14 patients (63.6%) in group B compared with two patients (9.1%) in group A within 16 weeks, which was significant (P < 0.001). At 16 weeks from the baseline, a 63.6% decrease in the mean DLQI score of group B was seen, while the decrease for group A was 56.9%. Pioglitazone enhances the therapeutic effect of methotrexate in plaque‐type psoriasis, as demonstrated by a reduction in the mean PASI scores. In terms of DLQI, there was no extra benefit by the addition of pioglitazone to methotrexate therapy.     

Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis

OBJECTIVE: To assess the efficacy and safety of a 24-week course of efalizumab. DESIGN: Phase 3, randomized, double-blind, parallel-group, placebo-controlled 12-week study followed by a 12-week open-label study. SETTING: Outpatient dermatology clinics.Patients A total of 556 patients with moderate to severe chronic plaque psoriasis who were seeing an outpatient dermatologist were included in the study.Intervention For weeks 1 to 12, the 556 patients were randomized to receive 1 mg/kg of efalizumab weekly or placebo subcutaneously. For weeks 13 to 24, 516 of these patients received 1 mg/kg of efalizumab weekly. MAIN OUTCOME MEASURES: Proportion of patients with a 75% or greater improvement in Psoriasis Area and Severity Index (PASI-75), a 50% or greater improvement in PASI (PASI-50), static Physician's Global Assessment (sPGA) rating of minimal or clear, and improvements in Dermatology Life Quality Index (DLQI), itching scale, and Psoriasis Symptom Assessment (PSA) frequency and severity scores at weeks 12 and 24. Safety was evaluated by reviewing adverse events, laboratory parameters, vital signs, and anti-efalizumab antibodies. RESULTS: At week 12, 26.6% of efalizumab-treated patients achieved PASI-75 and 58.5% achieved PASI-50. After 24 weeks of continuous efalizumab therapy, PASI responses increased: 43.8% of patients achieved PASI-75 and 66.6% achieved PASI-50. The percentage of patients who achieved an sPGA rating of minimal or clear increased from 25.7% to 35.9%. The mean percentage of improvement in all patient-reported outcomes (DLQI, itching scale, and PSA frequency and severity scores) at week 12 was maintained at week 24 (DLQI, 49.2%; itching scale, 42.2%; PSA frequency, 47.6%; PSA severity, 47.3%). There was a decline in overall reported adverse events from weeks 1 to 12 (80.4%) to weeks 13 to 24 (63.2%) without evidence of cumulative toxic effects.Conclusion Extending efalizumab treatment from 12 to 24 weeks leads to improved efficacy and maintenance of quality of life with no evidence of cumulative toxic effects noted in patients with moderate to severe chronic plaque psoriasis.     

复方氟米松软膏治疗寻常性银屑病临床观察

目的观察复方氟米松软膏治疗寻常性银屑病的疗效和安全性。方法72例寻常性银屑病患者随机分为治疗组和对照组各36例。治疗组外用复方氟米松软膏,对照组外用他扎罗汀乳膏,两组疗程均为6周。结果治疗组有效率88.89%,对照组为66.67%,两组疗效差异有显著性(P<0.05);治疗组的不良反应发生率为5.56%,对照组为22.22%,两者差异有显著性(P<0.05)。结论复方氟米松软膏治疗寻常性银屑病疗效好,安全性高。     

不同浓度配比的他扎罗汀倍他米松乳膏治疗寻常型银屑病的疗效观察

【摘要】 目的 探索不同浓度配比的他扎罗汀倍他米松乳膏治疗寻常型银屑病的疗效和安全性，筛选人体使用的最佳药物配比浓度。方法 采用多中心、随机、双盲、多剂量对照研究设计，2008年12月至2009年4月，中国医学科学院皮肤病医院等7个研究中心共纳入180例寻常型银屑病患者，按1∶1∶1∶1∶1比例随机分配进入4个试验组（他扎罗汀/二丙酸倍他米松浓度配比分别为0.025%/0.025%、0.05%/0.025%、0.025%/0.05%、0.05%/0.05%，简称为试验1、2、3和4组）和对照组（基质），每日用药1次，持续4周。用药后第1、2、4周分别评价各组药物的疗效和安全性。多组计量资料比较采用方差分析和LSD-t检验，多组分类资料的比较用χ2检验或Fisher精确概率检验，采用CMH法分析各组的银屑病皮损面积和严重程度指数（PASI）反应率数据。结果 用药4周，试验1、2、3、4组和对照组改善达PASI75的患者分别为11例（30.56%）、12例（33.33%）、12例（33.33%）、19例（52.78%）和2例（5.56%），各试验组达PASI75的患者比例均显著高于对照组（均P < 0.012 7）；此外，试验药物1、2、4组达PASI90的患者比例亦显著高于对照组（均P < 0.012 7）。用药4周，试验1、2、3、4组PASI评分下降率分别达59.52% ± 26.79%、57.19% ± 31.98%、56.85% ± 30.46%和68.21% ± 37.20%，均显著高于对照组（20.07% ± 28.55%）（LSD-t = 5.36、5.05、5.00、6.55，均P < 0.001）。试验4组的综合疗效表现更突出。试验1、2、3、4组和对照组药物耐受性良好，分别发生不良反应11例（30.56%）、8例（22.22%）、2例（5.56%）、4例（11.11%）和2例（5.56%），试验1组不良反应发生率显著高于对照组（P = 0.012），试验2、3、4组与对照组比较差异无统计学意义（均P > 0.05）。结论 0.05%/0.05%他扎罗汀倍他米松乳膏可作为后继治疗寻常型银屑病临床研究的推荐配比浓度。     

Transitioning patients from efalizumab to alternative psoriasis therapies: findings from an open-label, multicenter, Phase IIIb study

BACKGROUND: Rebound in psoriasis is, by definition, a rapid worsening of disease following the discontinuation of therapy for psoriasis; it occurs following the abrupt discontinuation of many therapies. To prevent rebound on discontinuation of efalizumab, this study evaluated the effectiveness of transitioning patients to an alternative psoriasis therapy. METHODS: Patients (n = 130) received subcutaneous efalizumab 1 mg/kg/week for 12 weeks. Efalizumab was discontinued at 12 weeks; patients were evaluated for improvement from baseline in the Psoriasis Area and Severity Index (PASI) and a 12-week transition period was begun. Patients who achieved PASI improvement of 75% or more (PASI-75) at week 12 of efalizumab treatment were observed during the transition period and treated only if psoriasis recurred. Patients who did not attain PASI-75 at week 12 of efalizumab treatment were immediately transitioned to an alternative psoriasis therapy at the physician's discretion. All patients were evaluated for signs of rebound following efalizumab discontinuation. RESULTS: Rebound was not observed in any PASI-75 responder (n = 46). Rebound was observed in two of 32 patients who achieved between PASI-50 and PASI-75, and was more common in nonresponders (14/49). Rebound was observed in none of the eight patients treated with cyclosporine and in two of the 12 patients treated with methotrexate during the transition period. CONCLUSIONS: These results suggest that efalizumab-responsive patients are less likely to experience rebound than nonresponders and may not require treatment until disease recurrence following efalizumab discontinuation. Efalizumab nonresponders are at higher risk of developing rebound and thus should be considered for transition to an appropriate psoriasis therapy immediately following efalizumab discontinuation.     

复方丙酸氯倍他索软膏治疗寻常性银屑病临床疗效观察

目的:观察复方丙酸氯倍他索软膏治疗寻常性银屑病的疗效和安全性。方法:将入组的360例寻常性银屑病患者分为治疗组(复方丙酸氯倍他索软膏组120例)、对照1组(0.02%丙酸氯倍他索霜组120例)和对照2组(0.05%全反式维A酸霜组120例),采用多中心、随机双盲、平行对照的方法对寻常性银屑病患者连续用药4周。结果:3组患者的痊愈率分别为48.33%、18.33%和3.48%,有效率分别为92.50%、50.83%和31.30%。组间比较(试验组与对照1组比较,试验组与对照2组比较)显示,痊愈率和有效率差异均有显著性(P<0.01)。试验组和对照1组的不良反应发生率较轻微,对照2组不良反应发生率为11.67%,有3例因不良反应较重中途停止治疗。结论:复方丙酸氯倍他索软膏是一种安全有效的治疗寻常性银屑病的外用药,其疗效优于单用丙酸氯倍他索霜或全反式维A酸霜。     

CLinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international randomized, placebo-controlled trial

BACKGROUND: Efalizumab (anti-CD11a), a humanized monoclonal antibody, blocks multiple T-cell-dependent functions implicated in the pathogenesis of psoriasis, including T-cell activation, migration to the skin, reactivation in psoriatic skin and interactions with keratinocytes. OBJECTIVES: This multinational, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the safety and efficacy of subcutaneous efalizumab 1.0 mg kg-1 once weekly for 12 weeks compared with placebo in a population that included high-need patients, defined as those for whom at least two systemic therapies were unsuitable because of lack of efficacy, intolerance or contraindication. PATIENTS/METHODS: Patients with moderate-to-severe plaque psoriasis [involvement of >or=10% of total body surface area and Psoriasis Area and Severity Index (PASI)>or=12.0 at screening] were randomized in a 2:1 ratio to receive efalizumab or placebo. The primary efficacy endpoint was the proportion of patients achieving >or=75% PASI improvement (PASI-75 response) at week 12 in the intention-to-treat population; secondary endpoints included changes in PASI, static Physician's Global Assessment, Physician's Global Assessment of change from baseline and percentage of body surface area affected. Results We enrolled 793 patients (529 received efalizumab and 264 placebo), including 526 high-need patients (342 received efalizumab and 184 placebo). Week 12 PASI-75 rates were 29.5% for efalizumab compared with 2.7% for placebo among high-need patients (P<0.0001) and 31.4% for efalizumab compared with 4.2% for placebo in the full study population (P<0.0001). RESULTS: for all secondary efficacy endpoints showed superiority of efalizumab over placebo in both the high-need and the full populations. Efalizumab demonstrated a favourable safety profile, without evidence of systemic toxicity, in both the high-need group and the overall study population. CONCLUSIONS: The efficacy and safety of efalizumab therapy were comparable between high-need patients and the more general moderate-to-severe psoriasis patient population. In view of its demonstrated efficacy and safety profile, efalizumab represents a valuable option for the treatment of adult patients with moderate-to-severe plaque psoriasis, including high-need patients.     

Safety and efficacy of a fixed-dose cyclosporin microemulsion (100 mg) for the treatment of psoriasis

Cyclosporin is a second-line modality for the treatment of psoriasis. The long-term efficacy of cyclosporin and potential adverse side-effects, however, are a concern to patients. Therefore, a cyclosporin microemulsion (Neoral), which is steadily absorbed at an ultra-low dosage (1-2 mg/kg per day) or low dosage (2-3 mg/kg per day), is currently recommended. The dose must be calculated based on patient bodyweight and the blood concentration monitored regularly, which is time-consuming. Furthermore, the concentration is related to the safety profile, but not to efficacy. We examined whether a fixed-dose cyclosporin microemulsion (100 mg/day) is effective for treating psoriasis. Enrolled patients (n = 40) were given either 100 mg cyclosporin emulsion once daily (group A) or 50 mg twice daily (group B), regardless of patient weight and condition, before meals in a randomized controlled study. Patient bodyweight ranged 50-80 kg. We assessed the serum cyclosporin concentration 1 h after administrating the medicine (C1 score), Psoriasis Area and Severity Index (PASI) score, quality of life, and the results of regular blood examinations. The improvement rate was 69.4 ± 4.8% in group A and 73.4 ± 4.3% in group B. PASI-50 was achieved by 82% in group A and 84% in group B. At 6 weeks, the number of patients with PASI-50 was significantly higher in group A than in group B. PASI-75 and -90 were also achieved in both groups with no significant difference between groups. Administration of a fixed-dose cyclosporin microemulsion (100 mg/day) is practical for second-line psoriasis treatment.     

Comparative Efficacy of Biologics in Psoriasis

Background: Psoriasis is a chronic, immune-mediated skin disease that also has systemic manifestations. Safe and effective long-term treatments are needed. Biologic treatments that inhibit the immunopatho-genesis of psoriasis have helped meet this need. Purpose: The purpose of this study was to compare the efficacy of biologic therapies used for psoriasis. Methods: A literature search was performed using PubMed and the keywords ‘(PASI-75 OR efficacy) AND psoriasis AND (adalimumab OR alefacept OR etanercept OR infliximab OR ustekinumab).’ Randomized, double-blind, and placebo-controlled studies on US FDA-approved biologics were selected. Studies assessing the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI-75) within a 12-week period were included. Studies on pediatric populations and psoriatic arthritis were excluded. The weighted average of PASI-75 for each reported regimen was calculated to determine the efficacy of biologic agents used for moderate-to-severe psoriasis. Tolerance and secondary efficacy measures were also examined for the selected studies. Results: FDA-approved regimens of adalimumab, infliximab, ustekinumab, and alefacept were effective in treating moderate-to-severe psoriasis. Weighted average PASI-75 scores for infliximab, ustekinumab, adalimumab, etanercept, and alefacept were 78.6%, 72.1%, 70.5%, 48.1%, and 21%, respectively. Limitations: The comparative efficacy of biologic agents data was limited to 12 weeks, thus generalizing the results to longer treatment periods may not be accurate. Conclusions: Various biologic agents for psoriasis were effective at 12 weeks in placebo-controlled trials. Available data cannot fully account for situations in clinical practice, in which combination and longer duration of therapy may be required. When choosing the most effective or best agent, multiple factors should be considered including patient preference, cost, tolerance, adverse effects, dosing schedule, and mode of administration.     

Efalizumab: results of a 3-year continuous dosing study for the long-term control of psoriasis

BACKGROUND: Efalizumab, a T-cell-targeted, recombinant, humanized, monoclonal IgG1 antibody, inhibits key T-cell-mediated steps in the pathogenesis of psoriasis. Efalizumab is approved for the treatment of moderate-to-severe chronic plaque psoriasis in adults in more than 50 countries. OBJECTIVES: To evaluate the efficacy and safety of long-term, continuous efalizumab therapy in patients with psoriasis. METHODS: This open-label, multicentre phase III study enrolled 339 patients with moderate-to-severe chronic plaque psoriasis. During the initial 3-month phase, patients received subcutaneous efalizumab 2 mg kg(-1) weekly with randomization to receive concomitant fluocinolone acetonide or placebo ointment during month 3. The second phase was a long-term observational period; patients achieving a >or=50% improvement in the Psoriasis Area and Severity Index (PASI) score were eligible to receive efalizumab 1 mg kg(-1) weekly for up to 33 months. The final 3-month treatment period was an optional transition period for patients who completed the 33-month segment before efalizumab became commercially available. RESULTS: After 3 months, 41.3% of patients achieved a >or=75% improvement in PASI (PASI-75) and 13.0% achieved a >or=90% improvement (PASI-90). Continued improvement was observed: 45.4% and 24.5% achieved PASI-75 and PASI-90, respectively, at the end of the observational phase. The safety profile was stable, with no new or no increase in common events over 36 months of treatment. CONCLUSIONS: This was the longest continuous study using a biologic therapy for psoriasis. Clinical benefit of efalizumab improved over the first 18 months and was maintained during 36 months of continuous therapy. Long-term efalizumab therapy is appropriate for many patients with plaque psoriasis.     

卡泊三醇与氯氟舒松联合外用治疗寻常型银屑病

目的 观察卡泊三醇与氯氟舒松联合分用组，氯氟舒松组及卡泊三醇单用组外用治疗寻常型银屑病的疗效与安全性。方法 患者随机分入三个治疗组，对治疗1，4周后银屑病区严重度指数(PASI)之平均百分变化率进行比较。结果 通过比较显示卡泊三醇与氯氟舒松联合分用组治疗1，4周后的PASI平均百分变化率(PASI改善率)显著高于氯氟舒松组及卡泊三醇单用组，且副反应少于单纯卡泊三醇组。结论 卡泊三醇与氯氟舒松联合外用治疗寻常型银屑病优于卡泊三醇或氯氟舒松单用疗法。     

皮肤镜观察外用药物治疗寻常性银屑病的效果及分析

目的皮肤镜动态观察寻常性银屑病外用卤米松乳膏、卡泊三醇软膏和卤米松乳膏/卡泊三醇软膏治疗后的疗效,及皮损血管的改变和临床评分mPASI的相关性。方法选择2018年6月-2018年9月在本院就诊的30例寻常性银屑病患者,随机分为2组,一组给予卤米松乳膏外用,另一组给予卡泊三醇软膏外用,30例患者的一侧上肢皮损给予卤米松乳膏/卡泊三醇软膏外用。患者于治疗0、2、4及6周使用皮肤镜观察皮损处血管的变化,同时对观察皮损做mPASI评分并记录,比较3种治疗方法的皮损mPASI评分与血管指标的差异及治疗后mPASI评分与血管直径随时间的关系。结果卤米松乳膏/卡泊三醇软膏的局部治疗皮损临床评分和皮肤镜血管变化(血管直径及血管密度)与单独外用卤米松乳膏、卡泊三醇软膏的恢复更明显。银屑病皮损临床评分mPASI与血管球直径随时间的变化趋势一致。结论卤米松乳膏/卡泊三醇软膏局部外用治疗寻常性银屑病的效果优于单独应用;皮肤镜在银屑病皮损恢复情况及临床药物疗效的观察中具有临床价值。     

复方消银膏治疗轻中度寻常型银屑病临床观察

目的观察复方消银膏治疗轻中度寻常型银屑病的临床疗效及安全性。方法采取随机分组法,将符合入选标准的轻中度寻常型银屑病患者92例随机分为复方消银膏组、丙酸氯倍他索乳膏组、消银膏组。在治疗开始前及治疗开始后第1周、2周、4周、8周,对患者皮损进行评估和银屑病皮损面积和严重程度指数(PASI)评分,最终比较3者临床疗效指数、不良反应发生情况。结果 3种药物均在治疗第2周起效,且复方消银膏与激素药膏起效速度相当,均优于消银膏。结论复方消银膏治疗银屑病安全有效,与丙酸氯倍他索乳膏疗效相当,均优于消银膏。     

A prospective,randomized clinical trial comparing topical aloe vera with 0.1% triamcinolone acetonide in mild to moderate plaque psoriasis

Background Topical aloe vera (AV) has been used to treat various skin conditions, including psoriasis, with good results. Objectives This study aims to compare the efficacy of AV and 0.1% triamcinolone acetonide (TA) in mild to moderate plaque psoriasis. Methods A randomized, comparative, double‐blind, 8‐week study was designed. Eighty patients randomly received AV or 0.1% TA cream and their clinical response were evaluated using the Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI). Results After 8 weeks of treatment, the mean PASI score decreased from 11.6 to 3.9 (–7.7) in the AV group and from 10.9 to 4.3 (–6.6) in the TA group. Between‐group difference was 1.1 (95% confidence interval –2.13, –0.16, P = 0.0237). The mean DLQI score decreased from 8.6 to 2.5 (–6.1) in the AV group and from 8.1 to 2.3 (–5.8) in the TA group. Between‐group difference was 0.3 (95% confidence interval –1.18, –0.64, P = 0.5497). There was no follow‐up period after the 8‐week treatment. Conclusions AV cream may be more effective than 0.1% TA cream in reducing the clinical symptoms of psoriasis; however, both treatments have similar efficacy in improving the quality of life of patients with mild to moderate psoriasis.     

Long-term safety of brodalumab in Japanese patients with plaque psoriasis: An open-label extension study

Brodalumab, an interleukin-17 receptor A inhibitor, demonstrated rapid and robust efficacy with a favorable safety profile in patients with moderate to severe plaque psoriasis. Here, we present data from a multicenter, open-label extension study in patients with plaque psoriasis with/without psoriatic arthritis who completed 64 weeks of treatment with brodalumab (140 or 210 mg, every 2 weeks [Q2W]). Patients were enrolled to evaluate the long-term safety and efficacy of a modified dose of brodalumab. Eligible patients were switched to a reduced dose of brodalumab (140 mg every 4 weeks on day 1) in the extension study; the dose and dosing interval were modified sequentially at the physician’s discretion (minimum 140 mg every 8 weeks and maximum 210 mg Q2W) until drug approval, after which all patients were switched to 210 mg Q2W for postmarketing surveillance. Of the 129 patients enrolled, 107 (82.9%) completed the 108-week or more extension study. All patients had psoriasis that was well controlled with brodalumab treatment on day 1. Improvement in psoriasis-related symptoms, evaluated with the Psoriasis Area and Severity Index, Psoriasis Scalp Severity Index, Dermatology Life Quality Index, Nail Psoriasis Severity Index, and American College of Rheumatology 20, 50 and 70, was maintained during the 108-week extension study. Brodalumab treatment was well tolerated throughout, and no new safety signals were identified. The most commonly reported treatment-related adverse event was nasopharyngitis, followed by influenza and oral candidiasis. No cases of serious candida infection or Crohn’s disease were observed in this study. Serious treatment-related adverse events, such as appendicitis, brain abscess, bacterial meningitis, colon cancer, immunoglobulin A nephropathy and tubulointerstitial nephritis, were reported in one patient each. No anti-brodalumab-binding antibodies or brodalumab-neutralizing antibodies were detected in any patient throughout the extension study. Overall, the long-term efficacy and safety of brodalumab were demonstrated over 108 weeks.     

Ustekinumab in psoriasis: Five‐year real life experience from a single tertiary centre

The efficacy and safety of ustekinumab have been demonstrated in randomized clinical trials; however, there are few real‐life data evaluating ustekinumab. This observational, retrospective follow‐up study included 33 patients with moderate to severe psoriasis vulgaris. Patients were > 18 years old and received at least 16 weeks of ustekinumab. The efficacy of treatment was evaluated as PASI50, PASI75, and PASI90 response rates at 16, 28, 52, 76, and 100 weeks. Side effects associated with ustekinumab were recorded. Of 33 patients, 24 (72.7%) had received 45 mg ustekinumab and 9 (27.3%) 90 mg ustekinumab. At the 16th week of the treatment, 97% of the patients had PASI50, 57.6% had PASI75, and 33.3% had PASI90 response rates. At 16, 28, 52, 76, and 100 weeks, PASI50, 75, and 90 responses were generally higher in naive to biologics and in the 45 mg group than in nonnaive to biologics and in the 90 mg group but the differences were not statistically significant. In conclusion, ustekinumab is an effective and safe treatment option for patients with moderate to severe psoriasis vulgaris. It seems to be more effective in naive to biologics and patients with normal weight.     

0.05%地奈德乳膏治疗三种常见皮肤病的疗效观察

目的评价0.05%地奈德乳膏治疗特应性皮炎、脂溢性皮炎及寻常性银屑病的临床疗效及安全性。方法采用开放式研究。分别应用0.05%地奈德、1%丁酸氢化可的松及0.1%糠酸莫米松乳膏治疗特应性皮炎、脂溢性皮炎及寻常性银屑病。对患者治疗前后红斑、糜烂、浸润、丘疹、渗出/结痂、瘙痒及皮损面积的总积分进行评价。结果治疗2周后,地奈德组的临床疗效明显优于丁酸氢化可的松组,差异有显著性(P<0.05),两组均未见明显不良反应;地奈德组的疗效与糠酸莫米松组相当(P>0.05),但后者有1例出现瘙痒,1例出现红斑加重。结论应用0.05%地奈德乳膏治疗特应性皮炎、脂溢性皮炎及寻常性银屑病疗效可靠,临床使用安全。     

0.1％他克莫司软膏治疗青少年寻常型银屑病临床疗效观察

目的观察应用0.1%他克莫司软膏治疗青少年寻常型银屑病的临床疗效。方法选取我中心皮肤病性病门诊部治疗的寻常型银屑病未成年患者66例,利用随机数表法分为两组,每组33例,观察组应用0.1%他克莫司软膏治疗,对照组应用卤米松乳膏治疗,选取治疗前、治疗2周、治疗4周、治疗8周为观察点,比较两组患者皮损面积及严重程度的改善情况,并评价疗效。结果治疗2周、4周、8周,与治疗前相比,观察组患者的PASI(银屑病面积与严重性指数)改善水平均显著优于对照组(P <0.05);治疗期间,观察组不良反应率为6.1%,也明显低于对照组15.2%(P <0.05)。结论 0.1%他克莫司软膏用于治疗青少年寻常型银屑病安全有效,且副作用小,值得临床应用。     

Measurement of circulating miRNA-125a exhibits good value in the management of etanercept-treated psoriatic patients

This study aimed to explore the correlation of miR-125a with risk and severity of psoriasis, and further investigate the potential of miR-125a for predicting response to etanercept (ETN) treatment in psoriatic patients. Moderate to severe plaque psoriatic patients (n = 126) about to undergo ETN treatment for 6 months were recruited. Their plasma samples were obtained, and Psoriasis Area and Severity Index (PASI) scores and PASI-75 response rate were assessed at baseline (M0), and at 1 (M1), 3 (M3) and 6 months (M6) of treatment. Referring to PASI-75 response status at M6, patients were categorized as PASI-75 responders and PASI-75 non-responders. Healthy controls (HC, n =120) were also enrolled and their plasma samples were collected. In addition, plasma miR-125a was determined by quantitative polymerase chain reaction. miR-125a was decreased in psoriatic patients compared with HC; further, the receiver–operator curve (ROC) exhibited that miR-125a was of good value in differentiating psoriatic patients from HC with an area under the curve (AUC) of 0.802. In psoriatic patients, miR-125a was negatively associated with PASI score to some extent. Interestingly, baseline miR-125a was lower in PASI-75 responders than PASI-75 non-responders; further, ROC showed it predicted PASI-75 response at M6 to some extent with AUC of 0.672. Multivariate logistic regression also revealed that miR-125a was an independent predictive factor for worse PASI-75 response at M6. Furthermore, miR-125a expression was gradually increased during the treatment in PASI-75 responders, but unchanged in PASI-75 non-responders. Measurement of circulating miR-125a exhibits good value in the management of ETN-treated psoriatic patients.     

Impact of obesity on the efficacy of ustekinumab in Japanese patients with psoriasis: a retrospective cohort study of 111 patients

Obesity is thought to be involved in the pathogenesis of psoriasis, although its impact on the therapeutic response to systemic treatments remains unclear. The aim of this study was to examine the association of body mass index (BMI) with the efficacy of ustekinumab in Japanese patients with psoriasis. Clinical data from a cohort of 111 Japanese patients treated with ustekinumab 45 mg between July 2011 and March 2014 were retrospectively evaluated. The measured outcome was improvement in the psoriasis area and severity index (PASI) score at week 16. Patients with BMI ≥ 25 and BMI < 25 had comparable rates of ≥50 and 75 % improvement in PASI (PASI-50 and PASI-75, respectively), whereas patients with BMI ≥ 25 had significantly lower PASI-90 and PASI-100 response rates. Patients with BMI ≥ 25 also showed significantly lower percent reduction in PASI than those with BMI < 25 at week 16 (85 vs. 74 %, P < 0.004). BMI was negatively correlated with percent reduction in PASI, whereas body weight was not. These results show that a higher BMI, but not body weight, is associated with lower effectiveness of ustekinumab for psoriasis. BMI ≥ 25 could therefore be a negative predictor of achieving PASI-90 and PASI-100 in patients with psoriasis when starting ustekinumab.