ADEPT: The largest biologic trial in PsA1

ADEPT (Adalimumab Effectiveness in Psoriatic Arthritis Trial) studied 313 adult patients with moderately to severely active psoriatic arthritis who had an inadequate response to NSAID therapy1

Study design

ADEPT was a multinational, randomized, placebo-controlled, double-blind, 24-week, phase III trial. All patients who completed the 24-week protocol were eligible for long-term treatment in an open-label extension study.1

At baseline

Patient demographics and disease severity characteristics were comparable between treatment groups.1

HUMIRA 40 mg eow (n=151) Placebo
(n=162)

Demographics

Age (years)* 49 ± 13 49 ± 11

Sex (% male) 56 55

Race (% Caucasian) 97 94

Weight (kg)* 86 ± 21 86 ± 17

Disease Severity Characteristics

Duration of PsA (years)* 10 ± 8 9 ± 9

Duration of psoriasis (Ps) (years)* 17 ± 12 17 ± 13

Rheumatoid factor negative (%) 89 90

MTX use at baseline (%) 51 50

Number of previous DMARDs* 1.5 ± 1.2 1.5 ± 1.2

Swollen joint count (0-76)* 14 ± 12 14 ± 11

Tender joint count (0-78)* 24 ± 17 26 ± 18

DI (HAQ) (0-3)* 1.0 ± 0.6 1.0 ± 0.7

C-reactive protein (mg/dL)* 1.4 ± 2.1 1.4 ± 1.7

Number of patients with >3% BSA Ps at baseline 70 70

Values are mean ± SD.

Efficacy measures

Patients assessed for efficacy using ACR response criteria, PASI response in patients with >3% body surface area (BSA) involvement, and other clinical, radiographic, and quality-of-life assessment scales1

Primary endpoints included1

ACR20 response rate at Week 12
Mean change in modified Total Sharp Score at Week 24

Secondary/other endpoints included1

ACR20 response rate at Week 24
ACR50/70 response rates at Weeks 12 and 24
PASI 50/75 response rates at Weeks 12 and 24

Evaluating skin in PsA

PASI5
The Psoriasis Area and Severity Index (PASI) is a composite measure of skin erythema, induration, desquamation, and body surface area affected. Scores range from 0 (no psoriatic lesions at all) to 72 (complete erythroderma of the severest degree possible).

Calculation of a PASI score is based on:

Body divided into 4 areas—head, trunk, upper extremities, lower extremities

Extent of involvement and severity of psoriatic lesions are assessed using a numeric scale

PASI response

PASI responses are expressed as percent improvement in the degree and severity of psoriatic lesions from baseline.

Evaluating joints in PsA

ACR response6,7
The American College of Rheumatology (ACR) developed criteria for assessing improvement in rheumatoid arthritis, and these criteria are also used to assess patients with psoriatic arthritis. ACR20, ACR50, and ACR70 responses are defined as 20%, 50%, and 70% improvement in both tender and swollen joint counts plus 3 of the 5 following efficacy assessment parameters:

Patient global assessment

Physician global assessment

Patient assessment of pain

Patient self-assessed disability

Acute-phase reactant level (ESR or CRP)

06G-64C-Q352-7

HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HUMIRA can be used alone or in combination with methotrexate. HUMIRA is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in adult patients with psoriatic arthritis. HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Please see Important Safety Information. Serious and sometimes fatal side effects have been reported with HUMIRA, including tuberculosis and other serious infections.

Please see full prescribing information.

References: 1. Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52:3279-3289. 2. Enbrel full prescribing information. 3. Remicade full prescribing information. 4. HUMIRA full prescribing information. 5. Camisa C. Evaluation of psoriasis symptoms and disability. In: Handbook of Psoriasis. 2nd ed. Malden, Mass: Blackwell Publishing; 2004:88-89. 6. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis. 2002 update. Arthritis Rheum. 2002;46:328-346. 7. Gladman DD. Psoriatic arthritis. Dermatol Ther. 2004;17:350-363.

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