ASIS for Enbrel in Plaque Psoriasis

"For Left Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs.~Gadolinium Magnevist® (gadopentetate dimeglumine)~.1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."

"For Left Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs.~Gadolinium Magnevist® (gadopentetate dimeglumine)~.1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."

For Left Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

"sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque."

"sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque."

"sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque."

"sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque."

"sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque."

"sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque."

PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

Adverse Reactions of Enbrel subcutaneously at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.

Adverse Reactions of Enbrel subdermally at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.

"For Right Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs.~Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."

"For Right Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs.~Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."

For Right Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.