Etanercept Earns High Marks as Scalp Psoriasis Treatment

SEOUL, SOUTH KOREA – Nearly two-thirds of patients treated with etanercept for scalp psoriasis had a 90% improvement in Psoriasis Scalp Severity Index score at week 12, compared with just 7% of controls, in a phase IV, double-blind, placebo-controlled randomized trial.

Topical scalp psoriasis treatments are often messy and inconvenient, and earn low marks for patient satisfaction and compliance. That is why Dr. Stephen K. Tyring said he and his coinvestigators conducted the phase IV trial of the tumor necrosis factor inhibitor etanercept (Enbrel) for moderate-to-severe scalp psoriasis.

The 124 participants had a baseline mean 64% scalp surface area involvement with a Psoriasis Scalp Severity Index (PSSI) score of 34.5, a 22.3% body surface area involvement, and a Psoriasis Area and Severity Index of 17.5.

Half of the subjects were randomized to etanercept at 50 mg twice weekly for 12 weeks, followed by once-weekly etanercept at 50 mg plus a subcutaneous placebo injection for another 12 weeks. The controls got 12 weeks of twice-weekly placebo injections, followed by 12 weeks of twice-weekly etanercept at 50 mg per dose.

The prespecified primary study end point was the mean percentage improvement in PSSI from baseline through week 12, which was 87% in the etanercept arm and 20% among controls. At week 12, 63% of the etanercept group had a PSSI 90 response – that is, at least a 90% improvement in PSSI – compared with just 7% of controls. A significant difference between the two study arms was evident as early as week 4, Dr. Tyring reported at the World Congress of Dermatology.

A week 12 PSSI 75 response was noted in 86% of the etanercept group, compared with 11% of controls. The etanercept group had a mean 74% reduction in PASI score at week 12, versus an 11% improvement among controls.

The improvement in scalp itch seen with etanercept was particularly impressive, he said. At baseline, less than 2% of patients had a Scalp Pruritus Score of 0, but by week 12 this was the case for 42% of the etanercept group and 8% of controls, noted Dr. Tyring, a dermatologist at the University of Texas in Houston.

The improvements in scalp and skin psoriasis seen with 12 weeks of twice-weekly etanercept were maintained through week 24, despite the switch to a lower dose. Moreover, patients initially assigned to 12 weeks of placebo showed improvements at week 24 – after 12 weeks on etanercept – similar to those seen at 12 weeks among patients assigned to the tumor necrosis factor inhibitor from the start.

For example, at week 24 a PASI 90 was achieved in 68% of the all-etanercept group and 67% in patients on 12 weeks of placebo followed by etanercept. At week 24, PASI 75 response was noted in 69% of the all-etanercept group and 59% of those on etanercept after placebo. And at week 24, a Scalp Pruritus Score of 0 was documented in 47% of patients on etanercept throughout the study and 49% of those on the biologic alone for the last 12 weeks.

The most common adverse events among study participants were upper respiratory infections in 12%, nasopharyngitis in 8%, and injection site reactions in 6%.

The clinical trial was sponsored by Amgen. Dr. Tyring has received research funding from, and has been a speaker for, the company.

SEOUL, SOUTH KOREA – Nearly two-thirds of patients treated with etanercept for scalp psoriasis had a 90% improvement in Psoriasis Scalp Severity Index score at week 12, compared with just 7% of controls, in a phase IV, double-blind, placebo-controlled randomized trial.

Topical scalp psoriasis treatments are often messy and inconvenient, and earn low marks for patient satisfaction and compliance. That is why Dr. Stephen K. Tyring said he and his coinvestigators conducted the phase IV trial of the tumor necrosis factor inhibitor etanercept (Enbrel) for moderate-to-severe scalp psoriasis.

The 124 participants had a baseline mean 64% scalp surface area involvement with a Psoriasis Scalp Severity Index (PSSI) score of 34.5, a 22.3% body surface area involvement, and a Psoriasis Area and Severity Index of 17.5.

Half of the subjects were randomized to etanercept at 50 mg twice weekly for 12 weeks, followed by once-weekly etanercept at 50 mg plus a subcutaneous placebo injection for another 12 weeks. The controls got 12 weeks of twice-weekly placebo injections, followed by 12 weeks of twice-weekly etanercept at 50 mg per dose.

The prespecified primary study end point was the mean percentage improvement in PSSI from baseline through week 12, which was 87% in the etanercept arm and 20% among controls. At week 12, 63% of the etanercept group had a PSSI 90 response – that is, at least a 90% improvement in PSSI – compared with just 7% of controls. A significant difference between the two study arms was evident as early as week 4, Dr. Tyring reported at the World Congress of Dermatology.

A week 12 PSSI 75 response was noted in 86% of the etanercept group, compared with 11% of controls. The etanercept group had a mean 74% reduction in PASI score at week 12, versus an 11% improvement among controls.

The improvement in scalp itch seen with etanercept was particularly impressive, he said. At baseline, less than 2% of patients had a Scalp Pruritus Score of 0, but by week 12 this was the case for 42% of the etanercept group and 8% of controls, noted Dr. Tyring, a dermatologist at the University of Texas in Houston.

The improvements in scalp and skin psoriasis seen with 12 weeks of twice-weekly etanercept were maintained through week 24, despite the switch to a lower dose. Moreover, patients initially assigned to 12 weeks of placebo showed improvements at week 24 – after 12 weeks on etanercept – similar to those seen at 12 weeks among patients assigned to the tumor necrosis factor inhibitor from the start.

For example, at week 24 a PASI 90 was achieved in 68% of the all-etanercept group and 67% in patients on 12 weeks of placebo followed by etanercept. At week 24, PASI 75 response was noted in 69% of the all-etanercept group and 59% of those on etanercept after placebo. And at week 24, a Scalp Pruritus Score of 0 was documented in 47% of patients on etanercept throughout the study and 49% of those on the biologic alone for the last 12 weeks.

The most common adverse events among study participants were upper respiratory infections in 12%, nasopharyngitis in 8%, and injection site reactions in 6%.

The clinical trial was sponsored by Amgen. Dr. Tyring has received research funding from, and has been a speaker for, the company.

SEOUL, SOUTH KOREA – Nearly two-thirds of patients treated with etanercept for scalp psoriasis had a 90% improvement in Psoriasis Scalp Severity Index score at week 12, compared with just 7% of controls, in a phase IV, double-blind, placebo-controlled randomized trial.

Topical scalp psoriasis treatments are often messy and inconvenient, and earn low marks for patient satisfaction and compliance. That is why Dr. Stephen K. Tyring said he and his coinvestigators conducted the phase IV trial of the tumor necrosis factor inhibitor etanercept (Enbrel) for moderate-to-severe scalp psoriasis.

The 124 participants had a baseline mean 64% scalp surface area involvement with a Psoriasis Scalp Severity Index (PSSI) score of 34.5, a 22.3% body surface area involvement, and a Psoriasis Area and Severity Index of 17.5.

Half of the subjects were randomized to etanercept at 50 mg twice weekly for 12 weeks, followed by once-weekly etanercept at 50 mg plus a subcutaneous placebo injection for another 12 weeks. The controls got 12 weeks of twice-weekly placebo injections, followed by 12 weeks of twice-weekly etanercept at 50 mg per dose.

The prespecified primary study end point was the mean percentage improvement in PSSI from baseline through week 12, which was 87% in the etanercept arm and 20% among controls. At week 12, 63% of the etanercept group had a PSSI 90 response – that is, at least a 90% improvement in PSSI – compared with just 7% of controls. A significant difference between the two study arms was evident as early as week 4, Dr. Tyring reported at the World Congress of Dermatology.

A week 12 PSSI 75 response was noted in 86% of the etanercept group, compared with 11% of controls. The etanercept group had a mean 74% reduction in PASI score at week 12, versus an 11% improvement among controls.

The improvement in scalp itch seen with etanercept was particularly impressive, he said. At baseline, less than 2% of patients had a Scalp Pruritus Score of 0, but by week 12 this was the case for 42% of the etanercept group and 8% of controls, noted Dr. Tyring, a dermatologist at the University of Texas in Houston.

The improvements in scalp and skin psoriasis seen with 12 weeks of twice-weekly etanercept were maintained through week 24, despite the switch to a lower dose. Moreover, patients initially assigned to 12 weeks of placebo showed improvements at week 24 – after 12 weeks on etanercept – similar to those seen at 12 weeks among patients assigned to the tumor necrosis factor inhibitor from the start.

For example, at week 24 a PASI 90 was achieved in 68% of the all-etanercept group and 67% in patients on 12 weeks of placebo followed by etanercept. At week 24, PASI 75 response was noted in 69% of the all-etanercept group and 59% of those on etanercept after placebo. And at week 24, a Scalp Pruritus Score of 0 was documented in 47% of patients on etanercept throughout the study and 49% of those on the biologic alone for the last 12 weeks.

The most common adverse events among study participants were upper respiratory infections in 12%, nasopharyngitis in 8%, and injection site reactions in 6%.

The clinical trial was sponsored by Amgen. Dr. Tyring has received research funding from, and has been a speaker for, the company.