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Cost efficacy comparison of biologics in the treatment of psoriasis
P697
P699
LOCAL TOLERABILTY OF TISOCALCITATE OINTMENT IN HUMANS Angelika Jahreis, Eugene O’Keefe, Schering AG, Center of Dermatology, Berlin, Germany Background: Vitamin D analogues are first line treatment options for plaque type psoriasis. Tisocalcitate ointment contains a novel Vitamin D derivative. Objective: To evaluate the local tolerability (irritant potential) of Tisocalcitate ointment compared with 50 g/g calcipotriol ointment (reference product) and vehicle. Methods: A double-blind, single-center, reference- and vehicle-controlled study over a period of 21 days on healthy skin of 26 volunteers was performed. Twenty-six healthy volunteers underwent 15 occlusive applications (5 times a week for 3 weeks) of the investigational products (Tisocalcitate ointment 25 and 50 g/g in combination with urea 0%, 5%, 10% or 20% w/w), 50 g/g calcipotriol ointment (reference product) and vehicle. Finn Chambers (8-mm diameter) were applied to the skin of the back containing 0.02 mL ointment. Irritation was assessed clinically using a visual 5-point scale as follows from 1 ⫽ no reaction to 5 ⫽ marked erythema, strong infiltration, papules or vesicles. A cumulative irritancy index (CI) was calculated for each product and each subject. Results: Twenty-four volunteers were included in the intent-to-treat analysis and completed the study. The mean of the CI for the 8 Tisocalcitate ointment treated areas varied between 2.5 and 4.3, whereas for the calcipotriol ointment treated areas the mean of the CI was 9.5 showing that the reference product had the highest irritant potential. All Tisocalcitate ointment formulations had a significantly better local tolerability than the reference ointment (Dunnett’s 2-sided t test, ␣ ⫽ 0.05). Conclusions: All Tisocalcitate ointment formulations had a significantly better local tolerability than the reference ointment (Dunnett’s 2-sided t test, ␣ ⫽ 0.05). In summary, Tisocalcitate ointments were tolerated well and were safe to use on healthy skin in this study.
COST EFFICACY COMPARISON OF BIOLOGICS IN THE TREATMENT OF PSORIASIS Lee A. Wanke, MS, Amgen, Thousand Oaks, CA; Daniel Malone, PhD; University of Arizona, Tucson, AZ; Chiun-Fang Chiou, PhD; Zynx Health, Cerner Corporation, Beverly Hills, CA; Michael Woolley, PhD, Amgen, Thousand Oaks, CA Objective: To compare the cost-efficacy of biologics in the treatment of psoriasis using the Psoriasis Area and Severity Index (PASI) response criteria as the efficacy endpoint. Methods: A cost-efficacy analysis was conducted comparing biologics used in the treatment of psoriasis. This aspect focuses on alefacept 7.5mg IV weekly (qw) or 15mg IM qw and etanercept 25mg subcutaneous (SQ) twice weekly (biw) or 50mg SQ biw. The perspective of this analysis was a US managed care organization. A three-month time horizon was chosen based on the availability of efficacy data (PASI-50 and PASI-75) from comparable clinical trials. Medication costs were based on US average wholesale price (AWP). Other direct costs, including those for physician office visits, laboratory monitoring, and drug administration, were based on Medicare reimbursement rates and the MEDSTAT DRG Guide. Adverse events were assumed to be equal for all treatment arms based on reporting in package inserts; they were grouped into mild, moderate or severe for calculation of their treatment costs. It was assumed that 5% of patients dropped out of each treatment arm at 6 weeks due to severe adverse events. Sensitivity analyses were conducted on drug costs, adverse event rates and efficacy measures. Results: The total cost for each regimen over the three-month time course, adjusted for the dropout rate, was: etanercept 25mg ⫽ $4130; etanercept 50mg ⫽ $7945; alefacept IV ⫽ $9504; alefacept IM ⫽ $12850. Efficacy measures for each regimen were: etanercept 25mg, PASI-50 ⫽ 0.44 and PASI-75 ⫽ 0.30; etanercept 50mg, PASI-50 ⫽ 0.0.60 and PASI-75 ⫽ 0.45; alefacept IV, PASI-50 ⫽ 0.28 and PASI-75 ⫽ 0.10; alefacept IM, PASI-50 ⫽ 0.24 and PASI-75 ⫽ 0.16. The cost per PASI-50 responder for alefacept 7.5mg IV qw and 15mg IM qw were $33939 and $53542, respectively. The cost per PASI-50 responder for etanercept 25mg SQ biw and 50mg SQ biw were $9386 and $13240 respectively. The cost per PASI-75 responder for alefacept 7.5mg IV qw and 15mg IM qw were $95030 and $80313, rsepectively. The cost per PASI-75 responder for etanercept 25mg SQ biw and 50mg SQ biw were $13767 and $17653 respectively. The results were sensitive to both drug cost and efficacy rate. Etanercept dominated alefacept in each analysis (that is, had lower cost and higher efficacy). Results from analyses with other biologics will also be presented. Conclusions: Results suggest that etanercept is associated with a lower cost per PASI-50 and PASI-75 responder and therefore is more cost-efficacious compared to alefacept for the treatment of psoriasis.
Disclosure not available at press time.
Supported by Amgen.
P698 SAFETY OF LARGE AREA APPLICATION OF A NOVEL VITAMIN D ANALOGUE (TISOCALCITATE OINTMENT) IN PATIENTS WITH CHRONIC PLAQUE TYPE PSORIASIS Marion Schneider, Thomas Staks, Schering AG, Clinical Pharmacology, Berlin, Germany, Angelika Jahreis, Eugene O’Keefe, Schering AG, Center of Dermatology, Berlin, Germany Background: Vitamin D analogues are first line treatment options for plaque type psoriasis. One of the drawbacks of therapy with topical vitamin D analogues is their potential to influence calcium metabolism. Objective: To determine the safety of ascending doses of Tisocalcitate ointment in patients with plaque type psoriasis, with special focus on the effects on calcium homeostasis. Methods: Single-center, randomized, double blind, placebo-controlled, dose-escalation, interindividual study to investigate the safety of ascending doses of Tisocalcitate ointment for 14 days under highly standardized study conditions. Ten male and female patients of non-childbearing potential were allocated to each dose group, 7 patients were treated with Tisocalcitate ointment and 3 patients were treated with placebo ointment. A dose range from 525 g Tisocalcitate/day to 2100 g Tisocalcitate/day on 45% BSA was evaluated applied as 25 g/g of Tisocalcitate ointment on 45% BSA, 50 g/g of Tisocalcitate ointment on 45% BSA and twice daily 50 g/g of Tisocalcitate ointment on 45% BSA. Results: Thirty patients with psoriasis were treated for 14 days. All 3 doses were well tolerated by the patients. Serum calcium was within the normal range for all patients during the study. No tendency towards an increase in serum calcium levels or 24-hour urine calcium excretion was observed for any single value or the mean value. There was no change in PTH levels during the study. There were no serious adverse events reported. Conclusions: Tisocalcitate ointment, containing a novel vitamin D analogue, shows an excellent systemic safety profile. There was no tendency of Tisocalcitate ointment to have an effect upon single values or mean values of calcium metabolism during large area application of up to 50 g/g Tisocalcitate ointment twice daily over 45% BSA in patients with chronic plaque type psoriasis. Disclosure not available at press time.
MARCH 2004
J AM ACAD DERMATOL
P179
P699
LOCAL TOLERABILTY OF TISOCALCITATE OINTMENT IN HUMANS Angelika Jahreis, Eugene O’Keefe, Schering AG, Center of Dermatology, Berlin, Germany Background: Vitamin D analogues are first line treatment options for plaque type psoriasis. Tisocalcitate ointment contains a novel Vitamin D derivative. Objective: To evaluate the local tolerability (irritant potential) of Tisocalcitate ointment compared with 50 g/g calcipotriol ointment (reference product) and vehicle. Methods: A double-blind, single-center, reference- and vehicle-controlled study over a period of 21 days on healthy skin of 26 volunteers was performed. Twenty-six healthy volunteers underwent 15 occlusive applications (5 times a week for 3 weeks) of the investigational products (Tisocalcitate ointment 25 and 50 g/g in combination with urea 0%, 5%, 10% or 20% w/w), 50 g/g calcipotriol ointment (reference product) and vehicle. Finn Chambers (8-mm diameter) were applied to the skin of the back containing 0.02 mL ointment. Irritation was assessed clinically using a visual 5-point scale as follows from 1 ⫽ no reaction to 5 ⫽ marked erythema, strong infiltration, papules or vesicles. A cumulative irritancy index (CI) was calculated for each product and each subject. Results: Twenty-four volunteers were included in the intent-to-treat analysis and completed the study. The mean of the CI for the 8 Tisocalcitate ointment treated areas varied between 2.5 and 4.3, whereas for the calcipotriol ointment treated areas the mean of the CI was 9.5 showing that the reference product had the highest irritant potential. All Tisocalcitate ointment formulations had a significantly better local tolerability than the reference ointment (Dunnett’s 2-sided t test, ␣ ⫽ 0.05). Conclusions: All Tisocalcitate ointment formulations had a significantly better local tolerability than the reference ointment (Dunnett’s 2-sided t test, ␣ ⫽ 0.05). In summary, Tisocalcitate ointments were tolerated well and were safe to use on healthy skin in this study.
COST EFFICACY COMPARISON OF BIOLOGICS IN THE TREATMENT OF PSORIASIS Lee A. Wanke, MS, Amgen, Thousand Oaks, CA; Daniel Malone, PhD; University of Arizona, Tucson, AZ; Chiun-Fang Chiou, PhD; Zynx Health, Cerner Corporation, Beverly Hills, CA; Michael Woolley, PhD, Amgen, Thousand Oaks, CA Objective: To compare the cost-efficacy of biologics in the treatment of psoriasis using the Psoriasis Area and Severity Index (PASI) response criteria as the efficacy endpoint. Methods: A cost-efficacy analysis was conducted comparing biologics used in the treatment of psoriasis. This aspect focuses on alefacept 7.5mg IV weekly (qw) or 15mg IM qw and etanercept 25mg subcutaneous (SQ) twice weekly (biw) or 50mg SQ biw. The perspective of this analysis was a US managed care organization. A three-month time horizon was chosen based on the availability of efficacy data (PASI-50 and PASI-75) from comparable clinical trials. Medication costs were based on US average wholesale price (AWP). Other direct costs, including those for physician office visits, laboratory monitoring, and drug administration, were based on Medicare reimbursement rates and the MEDSTAT DRG Guide. Adverse events were assumed to be equal for all treatment arms based on reporting in package inserts; they were grouped into mild, moderate or severe for calculation of their treatment costs. It was assumed that 5% of patients dropped out of each treatment arm at 6 weeks due to severe adverse events. Sensitivity analyses were conducted on drug costs, adverse event rates and efficacy measures. Results: The total cost for each regimen over the three-month time course, adjusted for the dropout rate, was: etanercept 25mg ⫽ $4130; etanercept 50mg ⫽ $7945; alefacept IV ⫽ $9504; alefacept IM ⫽ $12850. Efficacy measures for each regimen were: etanercept 25mg, PASI-50 ⫽ 0.44 and PASI-75 ⫽ 0.30; etanercept 50mg, PASI-50 ⫽ 0.0.60 and PASI-75 ⫽ 0.45; alefacept IV, PASI-50 ⫽ 0.28 and PASI-75 ⫽ 0.10; alefacept IM, PASI-50 ⫽ 0.24 and PASI-75 ⫽ 0.16. The cost per PASI-50 responder for alefacept 7.5mg IV qw and 15mg IM qw were $33939 and $53542, respectively. The cost per PASI-50 responder for etanercept 25mg SQ biw and 50mg SQ biw were $9386 and $13240 respectively. The cost per PASI-75 responder for alefacept 7.5mg IV qw and 15mg IM qw were $95030 and $80313, rsepectively. The cost per PASI-75 responder for etanercept 25mg SQ biw and 50mg SQ biw were $13767 and $17653 respectively. The results were sensitive to both drug cost and efficacy rate. Etanercept dominated alefacept in each analysis (that is, had lower cost and higher efficacy). Results from analyses with other biologics will also be presented. Conclusions: Results suggest that etanercept is associated with a lower cost per PASI-50 and PASI-75 responder and therefore is more cost-efficacious compared to alefacept for the treatment of psoriasis.
Disclosure not available at press time.
Supported by Amgen.
P698 SAFETY OF LARGE AREA APPLICATION OF A NOVEL VITAMIN D ANALOGUE (TISOCALCITATE OINTMENT) IN PATIENTS WITH CHRONIC PLAQUE TYPE PSORIASIS Marion Schneider, Thomas Staks, Schering AG, Clinical Pharmacology, Berlin, Germany, Angelika Jahreis, Eugene O’Keefe, Schering AG, Center of Dermatology, Berlin, Germany Background: Vitamin D analogues are first line treatment options for plaque type psoriasis. One of the drawbacks of therapy with topical vitamin D analogues is their potential to influence calcium metabolism. Objective: To determine the safety of ascending doses of Tisocalcitate ointment in patients with plaque type psoriasis, with special focus on the effects on calcium homeostasis. Methods: Single-center, randomized, double blind, placebo-controlled, dose-escalation, interindividual study to investigate the safety of ascending doses of Tisocalcitate ointment for 14 days under highly standardized study conditions. Ten male and female patients of non-childbearing potential were allocated to each dose group, 7 patients were treated with Tisocalcitate ointment and 3 patients were treated with placebo ointment. A dose range from 525 g Tisocalcitate/day to 2100 g Tisocalcitate/day on 45% BSA was evaluated applied as 25 g/g of Tisocalcitate ointment on 45% BSA, 50 g/g of Tisocalcitate ointment on 45% BSA and twice daily 50 g/g of Tisocalcitate ointment on 45% BSA. Results: Thirty patients with psoriasis were treated for 14 days. All 3 doses were well tolerated by the patients. Serum calcium was within the normal range for all patients during the study. No tendency towards an increase in serum calcium levels or 24-hour urine calcium excretion was observed for any single value or the mean value. There was no change in PTH levels during the study. There were no serious adverse events reported. Conclusions: Tisocalcitate ointment, containing a novel vitamin D analogue, shows an excellent systemic safety profile. There was no tendency of Tisocalcitate ointment to have an effect upon single values or mean values of calcium metabolism during large area application of up to 50 g/g Tisocalcitate ointment twice daily over 45% BSA in patients with chronic plaque type psoriasis. Disclosure not available at press time.
MARCH 2004
J AM ACAD DERMATOL
P179