Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris

BACKGROUND: A two-compound ointment containing calcipotriol 50 micro g g-1 and betamethasone dipropionate 0.5 mg g-1 has recently been shown to be an effective treatment for psoriasis. OBJECTIVES: This study was designed to investigate efficacy and safety of different treatment regimens with the two-compound product (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 micro g g-1 ointment (Daivonex/Dovonex; LEO Pharma). METHODS: In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two-compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investigators' global assessments of disease severity. The primary response criteria were percentage reduction in PASI and proportion of patients with absent/very mild disease according to the investigators' global assessments after 8 weeks of treatment. RESULTS: The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73.3% for group 1, 68.2% for group 2 and 64.1% for group 3. The proportion of patients with absent/very mild disease at the end of 8 weeks of treatment was 55.3% for group 1, 47.7% for group 2 and 40.7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0.001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent/very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent/very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional/perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0.001): 10.9% in group 1, 11.5% in group 2 and 22.3% in group 3. CONCLUSIONS: Two different short-term treatment regimens employing a recently developed two-compound product (calcipotriol/betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris.     

Cost-effectiveness of once-daily treatment with calcipotriol/betamethasone dipropionate followed by calcipotriol alone compared with tacalcitol in the treatment of Psoriasis vulgaris

BACKGROUND: Daivobet is a once-daily treatment of psoriasis vulgaris containing betamethasone dipropionate and calcipotriol in a new ointment vehicle. OBJECTIVE: To assess the cost-effectiveness of once-daily treatment with Daivobet (4 weeks) followed by calcipotriol (4 weeks) compared to tacalcitol (8 weeks). METHODS: Resource utilization was assessed within a double-blind 8-week clinical trial (all treatments for psoriasis, adverse events and concomitant dermatological medication), estimated from the French societal perspective. RESULTS: Total direct medical costs for psoriasis were comparable (Daivobet: EUR 107.53 and tacalcitol EUR 113.50) despite a higher acquisition cost for Daivobet. The probability of > or =75% reduction in the Psoriasis Area and Severity Index (effectiveness criterion) was 46.6% with Daivobet and 13.9% with tacalcitol at 4 weeks, and 44.6 and 23.8%, respectively, at 8 weeks (both: p < 0.001). Over 8 weeks, Daivobet was almost twice as cost-effective as tacalcitol (EUR 241.22 per successful treatment vs. EUR 476.70); this result was robust to sensitivity assumptions. CONCLUSION: Daivobet is more effective and less costly than tacalcitol for treating psoriasis.     

Consistency of data in six phase III clinical studies of a two-compound product containing calcipotriol and betamethasone dipropionate ointment for the treatment of psoriasis

BACKGROUND: Calcipotriol and betamethasone dipropionate are both proven products in the topical treatment of psoriasis. The efficacy and tolerability of a new ointment containing these two compounds has been assessed in six phase III clinical studies. OBJECTIVE: To compare the results obtained in the clinical studies of the new calcipotriol/betamethasone dipropionate ointment. METHODS: A total of 6050 patients with psoriasis took part in the six randomized, double-blind studies. The two-compound product was compared with each of the active constituents, either in the new ointment vehicle or in the marketed formulation. RESULTS: After 4 weeks of treatment the mean reduction in the Psoriasis Area and Severity Index (PASI) ranged from 65 to 74% with the two-compound product applied once or twice daily, from 46 to 59% with calcipotriol alone and from 57 to 63% with betamethasone dipropionate alone. The tolerability profile of the two-compound product was similar to betamethasone dipropionate monotherapy and better than calcipotriol alone. CONCLUSION: The new two-compound product containing calcipotriol and betamethasone dipropionate was found to consistently provide rapid, highly effective treatment of psoriasis vulgaris.     

The impact of a two-compound product containing calcipotriol and betamethasone dipropionate (Daivobet/ Dovobet) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial

BACKGROUND: Psoriasis is a common disease and may have a significant impact on patients' quality of life (QoL). OBJECTIVES: To assess the impact on QoL of a new two-compound product (TCP) (Daivobet/Dovobet; LEO Pharma) which combines the topical vitamin D analogue calcipotriol (50 microg g(-1)) and the World Health Organization group III corticosteroid betamethasone dipropionate (0.5 mg g(-1)) in a single ointment vs. calcipotriol monotherapy using a placebo-controlled study design. METHODS: The Psoriasis Disability Index and the EuroQoL 5D questionnaire and visual analogue scale (VAS) were used in this study, which enrolled 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. These QoL instruments were completed by patients before and after treatment with the TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily. RESULTS: The TCP used once or twice daily and calcipotriol used twice daily were found to have statistically significant beneficial effects on patients' QoL over the course of treatment, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice daily in terms of reductions on the EuroQoL 5D questionnaire and VAS. CONCLUSIONS: The results suggest that calcipotriol twice daily and the new TCP applied twice daily have a substantial effect on QoL. Once-daily application of the TCP is superior to calcipotriol twice daily terms of QoL, which reflects the superior efficacy of this combination and the advantage of once-daily application when compared with twice-daily application.     

A two-compound product containing calcipotriol and betamethasone dipropionate provides rapid, effective treatment of psoriasis vulgaris regardless of baseline disease severity

BACKGROUND: A two-compound product containing calcipotriol and betamethasone dipropionate (Daivobet/Dovobet) has been evaluated in a large clinical trial programme, providing a wealth of data on the treatment of psoriasis vulgaris. OBJECTIVE: To determine the effectiveness of the two-compound product in patients with mild, moderate and severe psoriasis vulgaris. METHODS: Data from over 1,534 patients with psoriasis vulgaris who received the two-compound product once daily for at least 4 weeks in four randomised, double-blind studies were pooled. A meta-analysis of the pooled data is presented. Severity of psoriasis at baseline was determined by investigator assessment and Psoriasis Area and Severity Index (PASI) score. RESULTS: For patients with severe disease defined by PASI score (PASI baseline > or = 17), the mean reduction in PASI after up to 4 weeks of treatment was 71.6% compared with 68.9 and 67.2% for those with moderate (PASI baseline 5.1-16.0) and mild disease (PASI baseline < or = 5). Corresponding reductions for investigator-assessed severity were 72.6, 69.1 and 68.7%, respectively. CONCLUSION: Although the meta-analysis of the data from these four studies was performed post hoc, we may conclude that the two-compound product provided highly effective treatment of psoriasis, regardless of the category of baseline disease severity.     

Calcipotriol/Betamethasone Dipropionate

The two-compound product containing calcipotriol 50 microg/g plus betamethasone dipropionate 0.5 mg/g (Dovobet, Daivobet) [referred to here as calcipotriol/betamethasone dipropionate], is a topical treatment for psoriasis vulgaris, combining a vitamin D analog and a corticosteroid. For most adult patients with psoriasis vulgaris on the trunk and limbs, up to 4 weeks of therapy with calcipotriol/betamethasone dipropionate provides an effective and well tolerated treatment. In clinical trials, patients with a mean baseline psoriasis area and severity index (PASI) of 9.5-10.9 experienced a mean 65.0-74.4% PASI improvement within 4 weeks, significantly better than improvements with calcipotriol 50 microg/g monotherapy, betamethasone dipropionate 0.5 mg/g monotherapy, or placebo. In addition, in 6.4%-20.1% of patients, lesions cleared. In patients who were subsequently treated with calcipotriol maintenance therapy, benefits were retained for at least 4 weeks. The safety of calcipotriol/betamethasone dipropionate in patients treated for up to 1 year was generally good; fewer than 5% of patients experienced adverse events possibly associated with long-term corticosteroid use.     

A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris

BACKGROUND: The calcipotriol/betamethasone dipropionate two-compound product Dovobet/Daivobet/Taclonex(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. OBJECTIVES: To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. METHODS: Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of calcipotriol (calcipotriol group). Treatments in all groups were used once daily when required. RESULTS: Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. CONCLUSIONS: Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment.     

Once daily treatment of psoriasis with tacalcitol compared with twice daily treatment with calcipotriol. A double-blind trial

Once daily topical treatment of psoriasis with tacalcitol ointment (4μ/g) was compared with twice daily treatment with calcipotriol ointment (50μg/g) in a double-blind, randomized study over a treatment period of 8 weeks. The severity of pruritus, erythema, infiltration and scaling was scored on a scale from 0 to 4. These features were scored at the initiation of treatment, after 2,4,6 and 8 weeks of treatment, and at 4 weeks after discontinuation of treatment. The sum score was the total score for erythema, infiltration and scaling. Serum levels of calcium, phosphate, ionized calcium and intact parathyroid hormone were used as safety parameters. Two hundred and eighty-seven adults with stable plaque psoriasis participated and were treated at least once. Both tacalcitol and calcipotriol ointments effectively reduced the severity of psoriasis. The mean reduction in the sum score in the intention-to-treat population of 287 patients was 4.03 in the group treated with tacalcitol compared with 5.05 in the group treated with calcipotriol. The mean baseline sum scores were 7.64 and 7.45, respectively. The acceptability of both ointments was excellent, and none of the patients had adverse effects in terms of increased serum calcium or other alterations in calcium metabolism. Although less effective than calcipotriol ointment used twice daily, tacalcitol ointment is an effective and useful once daily treatment of chronic plaque psoriasis.     

Retrospective assessment of PASI 50 and PASI 75 attainment with a calcipotriol/betamethasone dipropionate ointment

BACKGROUND: The US National Psoriasis Foundation recently recommended that PASI 50 and PASI 75 response rates be used in clinical trials to enable comparisons across studies of different psoriasis therapies. To date, these response rates have not been reported for the two-compound ointment containing calcipotriol and betamethasone dipropionate (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark). Further, in order to compare Daivobet with other therapeutics recently presented to the European regulatory authorities and the FDA, comparison with the biologicals, efalizumab, etanercept and alefacept, were also made. OBJECTIVES: To present the PASI 50 and PASI 75 results for the two-compound ointment containing calcipotriol and betamethasone dipropionate. METHODS: Data from six phase III studies conducted with the two-compound ointment were pooled and the PASI 50 and PASI 75 response rates calculated for patients with severe (PASI>or=17) or less severe disease (PASI<17) at treatment commencement. Results for the biological therapies, efalizumab, etanercept and alefacept, were obtained from relevant published phase III studies. RESULTS: PASI 50 and PASI 75 were achieved by more patients treated with the two-compound ointment than with the individual components. In patients with severe disease, the PASI 50 response rate after 4 weeks' treatment was 88.8% with the two-compound ointment, 69.2% with betamethasone dipropionate, 53.8% with calcipotriol, and 30.0% with ointment vehicle. In comparison, 12 weeks' treatment with the biologicals resulted in PASI 50 response rates of 59% with efalizumab, 74% with etanercept, and 56% with alefacept. CONCLUSIONS: The two-compound ointment is effective, producing a PASI 50 and PASI 75 response in greater than 80% and 50% of patients, respectively, regardless of psoriasis severity.     

Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris

BACKGROUND: The calcipotriol/betamethasone dipropionate two-compound product is safe and effective in the short-term treatment of psoriasis. OBJECTIVE: The primary objective was to investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks. The efficacy results are presented here. METHODS: Six hundred and thirty-four patients were randomised double-blind to treatment (once daily, when required) with either: 52 weeks of two-compound product (two-compound group), 52 weeks of alternating 4-week periods of two-compound product and calcipotriol (alternating group), or 4 weeks of two-compound product followed by 48 weeks of calcipotriol (calcipotriol group). RESULTS: There was a trend towards a difference between treatments from the overall treatment effect for the percentage of satisfactory responses for each patient during the study (p = 0.071). This appeared to be due to the comparison of the two-compound and calcipotriol groups (p = 0.025). CONCLUSION: There was a trend towards the efficacy of the two-compound product used for up to 52 weeks being better than that of 4 weeks of the two-compound product followed by 48 weeks of calcipotriol.     

A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris

BACKGROUND: Topical corticosteroids and calcipotriol have been used separately for many years to treat psoriasis. A new combination ointment has been formulated, which contains both calcipotriol and the corticosteroid betamethasone dipropionate. OBJECTIVE: To compare the combination ointment with betamethasone dipropionate ointment, calcipotriol ointment and ointment vehicle in patients with psoriasis vulgaris. METHODS: 1,603 patients were randomised to one of the 4 double-blind treatments used once daily for 4 weeks. RESULTS: The mean percentage change in the PASI at the end of treatment was -71.3 (combination), -57.2 (betamethasone), -46.1 (calcipotriol) and -22.7 (vehicle). The mean difference of combination minus betamethasone was -14.2 (95% CI: -17.6 to -10.8, p < 0.001), of combination minus calcipotriol -25.3 (95% CI: -28.7 to -21.9, p < 0.001) and of combination minus vehicle -48.3 (95% CI: -53.2 to -43.4, p < 0.001). 6.0% of patients (combination) reported local adverse reactions compared to 4.9% (betamethasone), 11.4% (calcipotriol) and 13.6% (vehicle). CONCLUSION: Calcipotriol/betamethasone dipropionate combination ointment used once daily is well tolerated and more effective than either active constituent used alone.     

The atrophogenic potential and dermal tolerance of calcipotriol/betamethasone dipropionate ointment compared with betamethasone dipropionate ointment

BACKGROUND: Recently, a combination product (Daivobet) ointment: calcipotriol 50 micro g/g, betamethasone dipropionate 0.5 mg/g) has been developed for the treatment of psoriasis. OBJECTIVE: This study aimed to demonstrate that the atrophogenic potential of Daivobet is less or equal to the skin thinning produced by Diprosone (betamethasone dipropionate 0.05 mg/g). METHODS: The forearms of 45 subjects were treated with Daivobet and Diprosone or Daivobet and its vehicle twice daily over a 4-week period. Sonographic measurements for full skin thickness, clinical assessments and biopsies were carried out. RESULTS: A confidence interval approach was used to establish that skin thinning following treatment with Daivobet was equal to or less than thinning with Diprosone. Histological results did not suggest differences between Daivobet and Diprosone. Clinical signs of atrophy or irritation were not observed. CONCLUSIONS: The atrophogenic potential of Daivobet and Diprosone was similar following twice daily application over a 4-week treatment period. Skin irritation was not observed.     

钙泊三醇倍他米松软膏外用治疗寻常性银屑病的随机、双盲、对照研究

目的 探讨钙泊三醇倍他米松软膏外用治疗稳定期寻常性银屑病患者的临床疗效和安全性。方法 随机、双盲、阳性药物平行对照、多中心临床试验,入组320例寻常性银屑病患者,随机纳入试验组或对照组,疗程4周。试验组早晨外用模拟剂软膏基质,晚间外用钙泊三醇倍他米松软膏;对照组早晚单用卡泊三醇软膏。于首次用药后第1、2、4周观察临床疗效及安全性。结果 治疗4周后试验组PASI评分较基线下降百分比（79.23%）大于对照组（70.43%）,两组比较,P < 0.01;且在治疗1周后的疗效优于对照组。治疗4周后,PASI评分较基线下降≥75%的患者频数百分比比较,试验组有效率为73.03%,对照组为48.32%,P < 0.01,两组差异有统计学意义。治疗1、2、4周后试验组靶皮损红斑、浸润、鳞屑单独积分以及皮损总面积百分比等指标改善方面均优于对照组。320例受试者中不良事件发生率为18.1%,不良反应发生率为13.1%,两组间差异无统计学意义。药物不良反应主要为与皮肤有关的轻中度反应如瘙痒、毛囊炎、红斑等。结论 钙泊三醇倍他米松软膏治疗稳定期寻常性银屑病患者具有起效快、疗效好和用药方便、相对安全的特点。     

钙泊三醇倍他米松软膏联合卡泊三醇软膏序贯治疗寻常型银屑病疗效评价

目的：评价钙泊三醇倍他米松软膏联合卡泊三醇软膏治疗寻常型银屑病的临床疗效。方法：30例银屑病患者全身左右侧皮损随机分为治疗组或对照组。治疗组外用钙泊三醇倍他米松软膏和卡泊三醇软膏;对照组外用卡泊三醇软膏。治疗第2、4、8周末进行疗效评价。结果：治疗2、4、8周后治疗组有效率（53.33%、70%和86.67%）均明显高于对照组（30%、46.67%和66.67%）,组间差异均有统计学意义（P〈0.05）。结论：钙泊三醇倍他米松软膏联合卡泊三醇软膏治疗寻常型银屑病疗效较单独使用卡泊三醇好。     

Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized,double-blind,vehicle-controlled clinical trial

BACKGROUND: Calcipotriol and betamethasone dipropionate are both widely used, effective treatments for psoriasis. Vitamin D analogues and topical corticosteroids have different mechanisms of action in the treatment of psoriasis. A new vehicle has been developed in order to contain both calcipotriol (50 micro g g-1) and betamethasone dipropionate (0.5 mg g-1) in an ointment form. By using calcipotriol and a corticosteroid together, greater efficacy may be achieved than by using either compound alone. OBJECTIVES: The present study was conducted in order to compare the clinical efficacy and safety of the combined ointment formulation used once daily with the vehicle ointment used twice daily, calcipotriol ointment used twice daily and the combined formulation used twice daily in psoriasis vulgaris. METHODS: This was an international, multicentre, prospective, randomized, double-blind, vehicle-controlled, parallel group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. Patients were randomized to one of four treatment groups: combined formulation once daily, combined formulation twice daily, calcipotriol twice daily or vehicle twice daily. Efficacy and safety were assessed. RESULTS: There was no statistically significant difference in the mean percentage change in the Psoriasis Area and Severity Index (PASI) from baseline to end of treatment between the two combined formulation groups, but the difference in PASI reduction was significantly higher in the combined formulation groups (68.6% once daily, 73.8% twice daily) than in both the twice daily calcipotriol group (58.8%) and the vehicle group (26.6%). Safety data showed the frequency of adverse events to be less in the combined formulation groups than in both the calcipotriol group and the vehicle group. The proportion of patients with lesional/perilesional adverse reactions was less in the combined formulation groups and vehicle group than in the calcipotriol group (9.9% combined formulation once daily, 10.6% combined formulation twice daily, 19.8% calcipotriol, 12.5% vehicle). CONCLUSIONS: No statistically significant nor clinically relevant difference in efficacy was seen between the combined formulation used once daily and twice daily. When compared to vehicle ointment or calcipotriol ointment alone, the combined formulation was shown to be clearly more efficacious.     

A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris

In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone) and calcipotriol ointment (Daivonex) in patients with psoriasis vulgaris; 1106 patients were randomized to twice daily double-blind treatment with combination, betamethasone dipropionate or calcipotriol for 4 weeks. Patients then received twice daily calcipotriol, unblinded, for a further 4 weeks. Mean percentage change in PASI at end of the double-blind phase was -74.4 (combination group), -61.3 (betamethasone group) and -55.3 (calcipotriol group). Mean difference (95% Cl) combination-betamethasone was -13.1 (-16.9 to -9.3, p < 0.001) and for combination-calcipotriol -19.0 (-22.8 to -15.2, p <0.001). The differences in PASI were also statistically significant after 1 week. In the double-blind phase, 8.1% of patients (combination) reported lesional/ perilesional adverse reactions compared to 4.7% (betamethasone) and 12.0% (calcipotriol). In the combination group, mean PASI at the end of the double-blind phase was 2.5, and at end of the unblinded phase 3.6, compared with 3.9 and 4.1 (betamethasone) and 4.4 and 3.7 (calcipotriol). Calcipotriol/betamethasone combination is more effective and has a more rapid onset of action than either active constituent used alone, and is well tolerated. It is safe to transfer patients from combination to calcipotriol, with maintenance of clinical effect.     

Spotlight on Calcipotriene/Betamethasone Dipropionate in Psoriasis Vulgaris of the Trunk, Limbs, and Scalp

Calcipotriene (calcipotriol)/betamethasone dipropionate (calcipotriene 50 mg/g and betamethasone 0.5 mg/g) is a fixed-dose combination of a vitamin D₃ analog and a corticosteroid indicated for the oncedaily, topical treatment of psoriasis vulgaris of the trunk, limbs, and scalp in adults. Both the ointment (Daivobet®;Dovobet®) and gel (Xamiol®; Daivobet® Gel; Dovobet® Gel) formulations of calcipotriene/betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriene/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacologic properties. Calcipotriene/betamethasone dipropionate has low systemic absorption and displays local antiinflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation. In large, well designed clinical trials, calcipotriene/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4–8 weeks, was more effective than placebo, calcipotriene, or tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriene/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp. Long-term, once-daily, when required therapy with calcipotriene/betamethasone dipropionate for 52 weeks was more effective than calcipotriene alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriene for 48 weeks after 4 weeks of calcipotriene/betamethasone dipropionate or alternating between calcipotriene/betamethasone dipropionate and calcipotriene every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriene/betamethasone dipropionate also improved health-related quality of life. Calcipotriene/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriene/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriene or tacalcitol and did not appear to be associated with a higher incidence of corticosteroid-related adverse events during long-term therapy. Pharmacoeconomic analyses predicted calcipotriene/betamethasone dipropionate to be more cost effective than other topical therapies. Thus, calcipotriene/betamethasone dipropionate is an important, effective, once-daily, topical therapy for the symptomatic treatment of psoriasis vulgaris of the trunk, limbs, and scalp.     

Topical maxacalcitol for the treatment of psoriasis vulgaris: a placebo-controlled, double-blind, dose-finding study with active comparator

1alpha, 25-Dihydroxy-22-oxacalcitriol (maxacalcitol) is a vitamin D3 analogue which displays approximately 10 times greater efficacy at suppressing keratinocyte proliferation in vitro than calcipotriol and tacalcitol. To determine clinical efficacy, a phase II double-blind, randomized, left vs. right, concentration-response study was performed with once-daily topical maxacalcitol in patients with mild to moderate chronic plaque psoriasis. Primary efficacy parameters were psoriasis severity index (PSI) based on sum of scores for erythema, scaling and induration and investigators' overall assessment of patients' response to therapy at 8 weeks of treatment. One hundred and forty-four patients participated. All concentrations of maxacalcitol ointment (6, 12.5, 25 and 50 microg/g) were significantly more effective at reducing PSI than placebo (P < 0.01), with greatest effect noted for maxacalcitol 25 microg/g. Calcipotriol ointment 50 microg/g once daily as active comparator had a similar effect. Marked improvement or clearance of psoriasis was greatest for maxacalcitol 25 microg/g (55% of subjects) which compared favourably with calcipotriol (46%). Improvement continued throughout the study period, with no plateau at week 8. Investigators' and patients' side preference (secondary efficacy parameters) rated maxacalcitol more effective than placebo and 25 microg/g maxacalcitol better than calcipotriol (P < 0.05 for investigators' assessment). Twelve patients withdrew from the study due to adverse events, of which four were judged to be due to study medication. This study indicates that once-daily maxacalcitol ointment is effective in the management of plaque psoriasis, with greatest effect noted at 25 microg/g. As no response plateau was noted at 8 weeks, these data suggest that further benefit might be obtained if maxacalcitol ointment were applied for longer. Finally, investigators' overall assessment and side preference suggest that maxacalcitol 25 microg/g may be more effective than once-daily calcipotriol.     

钙泊三醇倍他米松软膏与卡泊三醇软膏联合NB-UVB治疗稳定期寻常性银屑病疗效比较

目的观察钙泊三醇倍他米松软膏和卡泊三醇软膏分别联合窄谱中波紫外线(NB-UVB)照射治疗寻常性银屑病的疗效与安全性。方法将入选的60例患者随机分为2组,各30例。治疗组每晚用钙泊三醇倍他米松软膏外搽皮损1次,对照组每日早、晚分别予卡泊三醇软膏外搽皮损1次,且两组同时予NB-UVB照射治疗,3次/周。两组患者的疗程均为4周。分别于治疗过程中每周观察1次疗效。结果治疗2周时,治疗组有效率(33.33%)高于对照组(10.00%),差异有统计学意义(P<0.05)。治疗4周时,治疗组有效率和对照组差异不显著(P>0.05)。主要不良反应为瘙痒和毛囊炎。结论钙泊三醇倍他米松软膏或卡泊三醇软膏联合NB-UVB治疗寻常性银屑病均安全有效,但钙泊三醇倍他米松软膏起效快于卡泊三醇软膏。