The Efficacy of Alefacept in the Treatment of Chronic Plaque Psoriasis

With the completion of several phase 2 and phase 3 clinical studies, the efficacy and tolerability of alefacept in patients with chronic plaque psoriasis is now well studied. The majority of patients treated with a single course of intravenous or intramuscular alefacept experienced a clinically meaningful response. The efficacy of alefacept correlated with its ability to selectively target and reduce the number of pathogenic memory T cells. A second course of alefacept resulted in further clinical improvement, with increasing response rates and prolonged response duration following treatment cessation. Subpopulation analyses demonstrated that alefacept is effective in a broad spectrum of patients with psoriasis, regardless of disease severity, history of and response to prior antipsoriatic treatment, or whether patients are refractory to or have contraindications to other systemic psoriasis therapies or phototherapy.     

The Efficacy and Tolerability of Clobetasol Propionate Foam 0.05% in the Treatment of Mild to Moderate Plaque-type Psoriasis of Nonscalp Regions

Background: Clobetasol propionate foam 0.05% (Connetics Corporation, Palo Alto, CA) is approved by the United States Food and Drug Administration for the treatment of corticosteroid-responsive scalp dermatoses, but there is only limited data available for its efficacy and tolerability in treating dermatoses which affect nonscalp sites. Objective: The efficacy and tolerability of clobetasol propionate foam (clobetasol foam) in treating psoriatic lesions at nonscalp sites was evaluated in a multicenter, randomized, double-blinded, placebo-controlled study of 279 patients with mild to moderate plaque-type psoriasis. Methods: The patients applied clobetasol foam or placebo to the psoriatic lesions twice daily for two weeks. In addition to receiving clinical evaluations, the study patients completed a questionnaire evaluating various characteristics of the foam formulation, including their preference for its use and their projected likelihood to comply with similar therapy in a nonstudy environment. Results: At Week 2 (or end of treatment), 68% (94/139) of patients who received clobetasol foam had a Physicians Static Global Assessment score of 0 (clear, except for minor residual discoloration) or 1 (majority of lesions have individual scores for plaque thickness, erythema, and scaling that averages 1). This was significantly more than the 21% (30/140) observed in the placebo group (P < 0.0001). Similar results were obtained for the Patients Global Assessment score at Week 2 and in changes (from Baseline to Week 2) in the scores for the signs of psoriasis at a target lesion and for pruritus. Adverse effects were generally limited to mild and transient burning or other application site reactions in only a few patients in each treatment group. In the patients poststudy questionnaire (completed at Week 2, or end of treatment) a majority of patients rated the characteristics of the foam formulation very highly. The patients ranked the foam formulation as superior to other topical formulations based on factors impacting their quality of life and indicated they would be more likely to comply with a recommended course of therapy with the foam formulation than with other topical formulations. Conclusion: Clobetasol propionate foam 0.05% is safe and effective for the treatment of plaque-type psoriasis on scalp and nonscalp areas, when applied twice daily for two weeks. As it is understood that patient dissatisfaction with select topical formulations affects their compliance with therapy, which necessarily affects the effectiveness of the therapy, the results of the patients poststudy questionnaire suggest that there are multiple and integrated benefits for the use of clobetasol foam in the treatment of psoriasis of nonscalp sites.

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Antécédents: La Food and Drug Administration, aux États-Unis, a approuvé lusage de la mousse de propionate de clobétasol à 0,05% (Connetics Corporation, Palo Alto, California) dans le traitement des dermatoses du cuir chevelu qui sont sensibles aux corticostéroïdes. Cependant, les données sur son efficacité et le degré de tolérabilité dans le traitement dautres dermatoses sont limitées. Objectifs: Lefficacité et la tolérabilité de la mousse de propionate de clobétasol (mosse clobétasol) dans le traitement des lésions de psoriasis qui ne sont pas localisées dans le cuir chevelu ont été évaluées dans une étude multicentrique, randomisée à double insu, contrôlée contre placebo, sur 279 patients souffrant de psoriasis doux à modéré. Méthodes: Pendant deux semaines, les patients appliquaient soit la mousse de clobétasol, soit le placebo, deux fois par jour sur les lésions de psoriasis. En plus de lévaluation clinique, les patients ont rempli un questionnaire dévaluation des différentes caractéristiques de la mousse, y compris leur préférence dutilisation et jusquà quel point ils pensent pouvoir observer le traitement en-dehors de létude. Résultats: À la fin de la deuxiéme semaine (fin du traitement), 68% des patients (soit 94/139) qui ont reçu la mousse de clobétasol ont eu un score de 0 (guéri, sauf pour une décoloration résiduelle mineure) ou de 1 (la plupart des lésions présentent un score individuel moyen de 1 pour lépaisseur, lérythème et la desquamation). Ce pourcentage est bien supérieur aux 21% (30/140) du groupe placebo (P < 0,0001). Des résultats similaires ont été obtenus dans lévaluation générale du patient à la deuxiéme semaine, ainsi que dans le changement du score (état de base/2 semaines) des signes du psoriasis et du prurit. Les effets indésirables se limitaient généralement à des brûlures faibles et passagères, ou à dautres réactions sur le site de lapplication chez seulement quelques patients dans chaque groupe. Dans le questionnaire que les patients ont rempli à la fin de letude, une majorité a donné une note élevée aux caractéristiques de la préparation en mousse. Les patients ont mieux classé cette préparation que les autres préparations topiques en ce qui concerne leffet sur la qualité de vie et ont indiqué quils seraient plus enclins à observer un traitement à la mousse quun traitement avec dautres préparations topiques. Conclusion: Lefficacité et linnocuité de la mousse de propionate de clobétasol à 0,05 % sont prouvées dans le traitement du psoriasis en plaques, touchant ou non le cuir chevelu, lorsque la préparation est appliquée deux fois par jour pendant deux semaines. Sachant que le mécontentement des patients envers une préparation topique donnée affecte lobservation du traitement, qui nuit par le fait même à lefficacité du médicament, les résultats du questionnaire suggèrent que les avantages de lutilisation de la mousse de clobétasol dans le traitement du psoriasis qui naffecte pas le cuir chevelu sont multiples.

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Financial support for this study provided by Connetics Corporation     

Spotlight on Ustekinumab in Moderate To Severe Plaque Psoriasis

Ustekinumab (Stelara?) is a human monoclonal antibody that binds to the p40 subunit common to both interleukin (IL)-12 and IL-23. It is indicated in the US for use in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In the EU, it is indicated for those who failed to respond to, have a contraindication to, or are intolerant of other systemic therapies or phototherapy. In well designed, randomized clinical trials, regimens of subcutaneous ustekinumab 45 or 90?mg provided a rapid and durable improvement in Psoriasis Area and Severity Index scores for patients with moderate to severe plaque psoriasis. Treatment with ustekinumab 45 or 90?mg also improved health-related quality-of-life scores from baseline. More limited data indicate that ustekinumab also improves the symptoms of arthritis in patients with plaque psoriasis and psoriatic arthritis. Subcutaneous ustekinumab was generally well tolerated in clinical trials; most adverse events were mild in intensity and did not require dosage adjustment. A pooled analysis of clinical trial data indicated no specific patterns of infection for recipients of ustekinumab and that infection rates remained stable following cumulative exposure to the agent. Thus, subcutaneous ustekinumab provides an effective and well tolerated alternative for the symptomatic treatment of patients with moderate to severe plaque psoriasis.     

Safety and Efficacy of a Milk-derived Extract in the Treatment of Plaque Psoriasis:An Open-label Study

Background

XP-828L is a nutraceutical compound obtained by the extraction of a growth factors-enriched protein fraction from bovine milk. XP-828L may improve psoriasis.

Objectives

An open-label study was performed to determine the efficacy, tolerability and safety of XP-828L in the treatment of plaque psoriasis.

Methods

Eleven adult patients with chronic, stable plaque psoriasis on 2% or more of body surface area (BSA) received 5 g of oral XP-828L twice daily for 56 days.

Results

All 11 patients completed the 56 days of treatment. At day 28, 6 of the 11 patients showed a reduction in PASI score. At 56 days, seven subjects had a decrease in PASI score ranging from 9.5% to 81.3%. Eight (8) out of 11 patients agreed to participate in an additional 8-week extension treatment phase. Improvement of psoriasis was maintained during the extension period. No clinically significant adverse events or laboratory abnormalities occurred.

Conclusion

XP-828L may improve psoriasis in patients with mild-to-moderate psoriasis.     

他扎罗汀凝胶联合地奈德乳膏治疗寻常性斑块状银屑病的疗效观察

目的探讨他扎罗汀凝胶联合地奈德乳膏治疗斑块状银屑病的疗效。方法将84例患者随机分为他扎罗汀凝胶组、地奈德乳膏组和联合治疗组。联合治疗组晚上外用他扎罗汀1次,早上再用地奈德乳膏1次;地奈德组单用地奈德乳膏,2次/d;他扎罗汀组则仅晚上外用他扎罗汀1次,疗程均为4周。结果地奈德和联合治疗组的有效率分别为71.43%和64.29%,高于他扎罗汀组的35.71%(P<0.05),但联合组和地奈德组间差异无统计学意义。3组患者复发率依次为地奈德组25.00%、他扎罗汀组20.00%、联合治疗组11.11%,3组间比较差异无统计学意义(P>0.05)。观察期间均未发生严重不良反应。结论地奈德治疗寻常性斑块状银屑病疗效优于他扎罗汀,两者联合应用可减少激素的用量,减轻了药物的局部不良反应,且可能降低银屑病的复发率,使用安全。     

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis

Guselkumab (Tremfya^®) is a human immunoglobulin G1 λ (IgG1λ) monoclonal antibody (mAb) that blocks the interleukin-23 (IL-23)-mediated signalling pathway and is the first in its class to be approved in adults with moderate to severe plaque psoriasis in several countries, including the USA and EU. In the VOYAGE trials, guselkumab was superior to placebo and to adalimumab at week 16 in terms of the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0/1 and ≥ 90% improvement from baseline in Psoriasis Area and Severity index score (PASI 90 response), with benefits of guselkumab over adalimumab maintained at week 24. To date, the beneficial effects of guselkumab treatment in these trials were maintained for up to 2 years. Inadequate responders to ustekinumab who were then randomized to guselkumab in NAVIGATE showed better responses than those randomized to ustekinumab between weeks 28–40, with a significantly greater mean number of visits at which patients had IGA 0/1 and ≥ 2-grade improvement in IGA score, as well as higher proportions of patients achieving PASI 90 and PASI 100 at week 52. Treatment with guselkumab improved health-related quality of life (HR-QOL) and patient-reported outcomes in all trials and was generally well tolerated. Guselkumab, administered by subcutaneous injection, is a useful new option for patients with moderate to severe plaque psoriasis.     

他扎罗汀凝胶和卤米松乳膏联合治疗斑块型银屑病的疗效观察

目的观察他扎罗汀凝胶和卤米松乳膏联合治疗斑块型银屑病的疗效。方法采用随机开放法,进行疗效观察。结果治疗斑块型银屑病有效率为69.4%,观察期间未见严重不良反应。结论他扎罗汀凝胶和卤米松乳膏联合治疗斑块型银屑病安全、有效。     

Topical Halobetasol Propionate in the Treatment of Plaque Psoriasis

Halobetasol propionate (HP) 0.5% ointment and cream are class I topical corticosteroids. We review the efficacy and tolerability of HP for treatment of plaque psoriasis in the English language literature. The efficacy of HP ointment and cream is consistently superior to other super-potent topical corticosteroids. Local adverse events associated with topical HP are similar to those experienced with other super-potent corticosteroids. Combination therapy with calcipotriene (calcipotriol) and tazarotene appears to be superior to monotherapy with topical HP.     

英夫利昔单抗治疗中、重度斑块状银屑病系统评价

目的系统评价英夫利昔单抗治疗中重度斑块状银屑病的疗效和安全性。方法检索MEDLINE、Cochrane图书馆、EMBASE、ISI、CNKI、CBM和VIP,收集所有关于英夫利昔单抗治疗银屑病的随机对照试验。根据纳入与排除标准筛选文献、评价质量、提取资料,采用RevMan5.0软件进行Meta分析。结果共纳入5个随机对照试验,包括1 549例患者。Meta分析结果显示:静滴英夫利昔单抗能显著提高达到PASI 75的例数(P<0.001);静滴英夫利昔单抗与安慰剂组比较,在1个或多个不良反应的发生率方面有统计学意义(P<0.001),而在严重不良反应的发生率方面无统计学意义(P=0.22)。结论现有证据表明,静滴英夫利昔单抗对中重度斑块状银屑病具有良好的疗效和较好的耐受性。     

美能治疗斑块型银屑病38例疗效观察

目的评价美能注射液治疗泛发性斑块型银屑病的疗效和安全性。方法治疗组38例,以美能注射液40ml静滴,1次/d,并以口服迪银片作为对照组(38例)。疗程2月。结果美能治疗组有效率89.5%,平均起效时间2.3周,优于对照组60.5%和4.1周。结论美能注射液治疗泛发性斑块型银屑病副作用小、疗效好。     

The MARCOPOLO Study of Ustekinumab Utilization and Efficacy in a Real-World Setting: Treatment of Patients with Plaque Psoriasis in Asia-Pacific Countries

BackgroundUstekinumab is a fully human monoclonal antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults. However, factors including efficacy, tolerability, ease of use, and cost burden may affect ustekinumab utilization. Noncompliance may, in turn, affect treatment response.ObjectiveTo evaluate ustekinumab utilization in the real-world setting in Asia-Pacific countries.MethodsIn this phase 4 observational study conducted in Indonesia, Malaysia, Singapore, Korea, and Taiwan, adults with plaque psoriasis receiving ustekinumab were followed for up to 52 weeks. Study endpoints were the proportion of all patients using ustekinumab according to label-recommended intervals and the proportion of Korean patients who achieved a psoriasis area severity index 75 response at week 16. Safety was assessed by monitoring adverse events.ResultsOverall, 169 patients received ustekinumab (Korea, n=102; other countries, n=67). Just over half (56.2%) of patients used ustekinumab with the label-recommended interval from baseline to week 40; the proportion was higher in Korea (73.5%) than in other countries (29.9%), probably because ustekinumab was provided without charge for Korean patients up to week 40. Noncompliance increased after week 40 in Korea and from week 28 in other Asia-Pacific countries, with cost cited as the most common reason. At week 16, 56.9% of Korean patients achieved a Psoriasis Area Severity Index 75 response. Safety results were in line with those seen in previous studies.ConclusionMore than half of all patients in Asia-Pacific countries used ustekinumab as per the label-recommended dose interval, but reimbursement variations between countries may have confounded overall results.     

阿维A联合他扎罗汀治疗斑块状银屑病疗效观察

目的评价阿维A胶囊联合他扎罗汀凝胶治疗斑块状银屑病的临床疗效。方法172例患者随机分为治疗组及对照组,治疗组采用阿维A和维生素E口服,外用他扎罗汀凝胶;对照组采用迪银片和维生素E口服,外用蒽林霜。结果两组有效率分别为72.09%和31.40%,治疗组皮损改善优于对照组(P<0.01)。结论阿维A与他扎罗汀联合治疗斑块状银屑病有显著的疗效。     

Efficacy and Safety of the Betamethasone Valerate 0.1% Plaster in Mild-to-Moderate Chronic Plaque Psoriasis

Background: Corticosteroids are a versatile option for the treatment of mild-to-moderate psoriasis due to their availability in a wide range of potencies and formulations. Occlusion of the corticosteroid is a widely accepted procedure to enhance the penetration of the medication, thereby improving its effectiveness. Betamethasone valerate (BMV) is a moderately potent corticosteroid that is available as a cream, ointment, and lotion. A ready-to-use occlusive dressing, which provides a continuous sustained release of BMV, has been developed for the treatment of psoriasis. Objective: To evaluate the efficacy and safety of a new BMV 0.1% plaster compared with a BMV 0.1% cream in patients with mild-to-moderate chronic plaque psoriasis. Methods: This was a prospective, randomized, assessor-blind, parallel-group, active-controlled, multicenter, phase III study. Eligible outpatients (aged ≥18 years) with a diagnosis of stable, chronic plaque psoriasis vulgaris with two to four plaques on extensor surfaces of limbs were randomized to receive BMV 0.1% plaster or BMV 0.1% cream for 3–5 weeks; patients with resolution of target plaques then entered a 3-month, treatment-free, follow-up period. The number of patients showing clearing of plaques (remission) at 3 weeks (primary endpoint) and at 5 weeks was independently evaluated from digitized images of target plaques by two blinded assessors, and also assessed by the investigator and patient. Additional endpoints were (i) change from baseline in target plaque size and in Psoriasis Global Assessment (PGA) score, as evaluated by the blinded assessors, investigator, and patient; (ii) change from baseline in symptom (itching, soreness) severity; (iii) treatment satisfaction and ease of use; (iv) clearing and relapse during the follow-up period; and (v) adverse events (AEs). Results: Patients (n = 231) were screened and randomized to treatment with BMV 0.1% plaster (n = 116) and BMV 0.1% cream (n = 115). Significantly more patients achieved clearing after 3 weeks’ treatment with BMV plaster than with BMV cream (Cochran-Mantel-Haenszel test, p < 0.001); this difference was maintained at 5 weeks. The total plaque area decreased to a larger extent for the BMV plaster group compared with the BMV cream group (analysis of covariance [ANCOVA] model, p = 0.017 at week 5). PGA scores were significantly lower after 3 and 5 weeks’ treatment with BMV plaster (ANCOVA model, all p ≤ 0.016 vs BMV cream). Both treatments reduced itching and soreness to a similar degree, and the incidences of relapse during the follow-up period were comparable between treatment groups. There were no significant differences in AEs between treatment groups. Conclusions: BMV 0.1% plaster is more efficacious than BMV 0.1% cream in the treatment of patients with mild-to-moderate chronic plaque psoriasis in a clinical setting resembling daily clinical practice. Clinical trial number: ISRCTN68864186     

阿维A联合NB-UVB治疗泛发性斑块状银屑病疗效观察

目的探讨阿维A联合窄谱中波紫外线(NB-UVB)照射治疗泛发性斑块状银屑病的疗效。方法将入选的65例患者分为两组,治疗组35例,予口服阿维A胶囊,同时行NB-UVB全身照射;对照组30例,仅予NB-UVB全身照射。两组疗程均为10周。结果治疗组有效率为91.43%,对照组为66.67%,两组有效率比较,差异有统计学意义(P<0.5),两组复发率比较,差异无统计学意义(P>0.05)。结论阿维A联合NB-UVB照射治疗泛发性重度斑块状银屑病疗效好,不良反应少。     

An Open Label Prospective Randomized Trial to Compare the Efficacy of Coal Tar-Salicylic Acid Ointment Versus Calcipotriol/Betamethasone Dipropionate Ointment in the Treatment of Limited Chronic Plaque Psoriasis

Background:Chronic plaque psoriasis is a common papulosquamous skin disorder, for which a number of topical agents are being used including coal tar, topical steroids and more recently topical calcipotriol/betamethasone dipropionate. There is no study comparing purified coal tar preparation with calcipotriol/betamethasone dipropionate ointment in limited chronic plaque psoriasis.Results:Mean PASI was significantly lower at week 2 (P = 0.01) and week 4 follow-up (P = 0.05) and the mean reduction in PASI was significantly higher at week 2 (P = 0.02) with calcipotriol/betamethasone than coal tar-salicylic acid, but this difference was not sustained at subsequent follow-up visits. Similarly, PGA scores at weeks 2 and 4 were significantly lower with calcipotriol/betamethasone dipropionate ointment (P = 0.003 and P = 0.007 respectively). There was no significant difference in any parameter during subsequent follow-up visits or at the end of the treatment phase (12 weeks).Conclusion:Topical nightly application of calcipotriol/betamethasone dipropionate ointment leads to an initial, more rapid reduction in disease severity, but the overall outcome parameters are comparable in the two treatment groups.     

Which Areas Are Still Left in Biologics Responsive Korean Patients with Moderate to Severe Plaque Psoriasis

BackgroundPsoriasis localized to certain body areas, such as the scalp, nails, palms, soles, intertriginous regions, and genital regions, is reportedly difficult to treat.ObjectiveTo investigate the biologics-resistant areas in South Korean patients with psoriasis treated with biologics.MethodsThe study included 50 patients with chronic moderate to severe plaque psoriasis from the Pusan National University Hospital and Chosun University Hospital between October 2019 and September 2020. The patients had at least one psoriatic lesion, were treated with biologics for more than six months, and exhibited a partial or good response (reaching a Psoriasis Area and Severity Index [PASI] score of 1~5 after biologics treatment).ResultsA total of 50 patients with psoriasis (32 male, mean±standard deviation 47.8±11 years), with a median PASI score of 1.8, were included. The most common biologics-resistant areas were the anterior lower leg (56.0%), followed by the knee (48.0%) and posterior lower leg (42.0%). The proportion of biologics-resistant areas were obtained for body regions traditionally considered as difficult-to-treat entities, including the fingernails (10.0%), toenails (14.0%), scalp (38.0%), palm (12.0%), sole (14.0%), and genital areas (10.0%).ConclusionThis study determined the biologics-resistant areas in South Korean patients, successfully treated with biologics, in a real-world clinical setting.     

复方甘草酸苷治疗寻常性银屑病疗效观察

目的观察复方甘草酸苷治疗银屑病的临床疗效。方法对63例寻常性进行期银屑病患者随机分为治疗组36例,对照组27例,对照组给予综合药物治疗4周;治疗组在对照组的基础上,同时静滴复方甘草酸苷20 m l,1次/d,共4周。观察两组患者临床疗效及不良反应。结果治疗组治愈率5 0%,有效率为6 9.4 4%。对照组分别为11.11%和40.74%。治愈率及有效率差异均具有显著性(P均<0.01)。两组均未见明显不良反应。结论在常规综合治疗基础上加用复方甘草酸苷,可显著提高治愈率,且无明显副作用。