An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

• ABT-D2E7
• 휴미라

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

• 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
• 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
• 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
• 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
• 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
• 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.

The percentage of participants achieving a PGA score of clear (0) is reported.

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

• 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
• 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
• 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
• 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
• 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
• 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.

The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported.

The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

• 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
• 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
• 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
• 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
• 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
• 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.

The percentage of participants achieving a shift from Baseline to a less severe category is reported.

PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.

NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.

Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:

• 0 = none;
• 1 = present in 1/4 nail quadrants;
• 2 = present in 2/4 nail quadrants;
• 3 = present in 3/4 nail quadrants;
• 4 = present in 4/4 nail quadrants.

The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.

An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.

The investigator rated the severity of each AE as either:

Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities.

Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening.

A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.

Drug-related AEs are those assessed by the investigator as either probably or possibly related.

Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma.