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, ...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 Daivobetwith 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≥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.展开更多
Background: Psoriasis is a common disease and may have a significant impact o n patients’quality of life (QoL). Objectives: To assess the impact on QoL of a new two-compound product (TCP) (Daivobet./Dovobet.; LEO Pha...Background: Psoriasis is a common disease and may have a significant impact o n patients’quality of life (QoL). Objectives: To assess the impact on QoL of a new two-compound product (TCP) (Daivobet./Dovobet.; LEO Pharma) which combin es the topical vitamin D analogue calcipotriol (50 μ g g- 1) and theWorld Heal th Organization group III corticosteroid betamethasone dipropionate (0- 5 mg g - 1) in a single ointment vs. calcipotriol monotherapy using a placebo-contro lled study design. Methods: The Psoriasis Disability Index and the EuroQoL 5D qu estionnaire and visual analogue scale (VAS) were used in this study, which enrol led 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. Th ese QoL instruments were completed by patients before and after treatment with t he TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily. Results: The TCP used on ce or twice daily and calcipotriol used twice dailywere found to have statistica lly significant beneficial effects on patients’QoL over the course of treatme nt, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice d aily in terms of reductions on the EuroQoL 5D questionnaire andVAS. 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 e fficacy of this combination and the advantage of once-daily application when c ompared with twice-daily application.展开更多
Background: A two-compound product containing calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g (Daivobet., Dovobet.)hasbeendemonstratedtobeaneffective,oncedaily, treatment for psoriasis vulgaris. Objectiv...Background: A two-compound product containing calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g (Daivobet., Dovobet.)hasbeendemonstratedtobeaneffective,oncedaily, treatment for psoriasis vulgaris. Objective: To compare the efficacy and safety of treatment with the two-compound product for 4 weeks followed by calcipotriol for 4 weeks, with that of tacalcitol for 8 weeks in patients with stable psoriasis vulgaris. Methods: 501 patients were randomised to double-blind treatment with the two-compound product followed by calcipotriol 50 μg/g once daily, or to tacalcitol 4 μg/g once daily. Results: Treatment with the two-compound product/calcipotriol was significantly more effective than tacalcitol in terms of mean percentage PASI reduction (65.0 vs. 33.3%at week 4 and 59.0 vs. 38.4%at week 8; P < 0.001 for both). Conclusion: A treatment regimen comprising calcipotriol/betamethasone ointment (Daivobet) for 4 weeks followed by calcipotriol for 4 weeks is superior to tacalcitol ointment for 8 weeks in patients with psoriasis vulgaris.展开更多
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 psor...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 ≥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 ≤5). Corresponding reductions for investigator-assessed severity were 72.6, 69.1 and 68.7%, respectively. Conclusion:Although the metaanalysis 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.展开更多
Background: Daivobetis 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 treatme...Background: Daivobetis 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 ≥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.展开更多
文摘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 Daivobetwith 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≥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.
文摘Background: Psoriasis is a common disease and may have a significant impact o n patients’quality of life (QoL). Objectives: To assess the impact on QoL of a new two-compound product (TCP) (Daivobet./Dovobet.; LEO Pharma) which combin es the topical vitamin D analogue calcipotriol (50 μ g g- 1) and theWorld Heal th Organization group III corticosteroid betamethasone dipropionate (0- 5 mg g - 1) in a single ointment vs. calcipotriol monotherapy using a placebo-contro lled study design. Methods: The Psoriasis Disability Index and the EuroQoL 5D qu estionnaire and visual analogue scale (VAS) were used in this study, which enrol led 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. Th ese QoL instruments were completed by patients before and after treatment with t he TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily. Results: The TCP used on ce or twice daily and calcipotriol used twice dailywere found to have statistica lly significant beneficial effects on patients’QoL over the course of treatme nt, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice d aily in terms of reductions on the EuroQoL 5D questionnaire andVAS. 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 e fficacy of this combination and the advantage of once-daily application when c ompared with twice-daily application.
文摘Background: A two-compound product containing calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g (Daivobet., Dovobet.)hasbeendemonstratedtobeaneffective,oncedaily, treatment for psoriasis vulgaris. Objective: To compare the efficacy and safety of treatment with the two-compound product for 4 weeks followed by calcipotriol for 4 weeks, with that of tacalcitol for 8 weeks in patients with stable psoriasis vulgaris. Methods: 501 patients were randomised to double-blind treatment with the two-compound product followed by calcipotriol 50 μg/g once daily, or to tacalcitol 4 μg/g once daily. Results: Treatment with the two-compound product/calcipotriol was significantly more effective than tacalcitol in terms of mean percentage PASI reduction (65.0 vs. 33.3%at week 4 and 59.0 vs. 38.4%at week 8; P < 0.001 for both). Conclusion: A treatment regimen comprising calcipotriol/betamethasone ointment (Daivobet) for 4 weeks followed by calcipotriol for 4 weeks is superior to tacalcitol ointment for 8 weeks in patients with psoriasis vulgaris.
文摘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 ≥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 ≤5). Corresponding reductions for investigator-assessed severity were 72.6, 69.1 and 68.7%, respectively. Conclusion:Although the metaanalysis 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.
文摘Background: Daivobetis 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 ≥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.
