ATLAS: A pivotal trial of HUMIRA for the treatment of ankylosing spondylitis (AS)1

ATLAS was a 24-week, randomized, placebo-controlled trial (N=315) evaluating the safety and efficacy of HUMIRA 40 mg every other week in patients with active ankylosing spondylitis (AS). The primary efficacy endpoint was ASAS20 response at Week 12. All patients who did not achieve ASAS20 during the
24-week blinded phase had the option at Weeks 12, 16, and 20 to receive active drug.

Primary endpoint

ASAS20^* at Week 12

Selected secondary endpoints

ASAS20 at Week 24; changes in BASDAI†, BASDAI 50, BASFI‡, BASMI§; and enthesitis scores (MASES)||

ATLAS trial in AS included an early escape option

During the 24-week blinded phase, all patients who did not achieve ASAS20 were given the option at Weeks 12, 16, and 20 to receive active drug (HUMIRA 40 mg SC eow)

ATLAS: Baseline characteristics of patients treated with HUMIRA vs. placebo

HUMIRA
(n=208) Placebo
(n=107)

Age (y), mean 41.7 43.4

Gender (% males) 75.5 73.8

Disease duration (y), mean 11.3 10.0

ASAS components (0-10 cm), mean

Patient's global assessment of disease activity 6.3 6.5

Total back pain 6.4 6.7

Inflammation 6.7 6.7

BASFI 5.2 5.6

BASDAI (0-10 cm), mean 6.3 6.3

Assessments in Ankylosing Spondylitis. ASAS20 components: patient’s global assessment of disease activity; total back pain; Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation.

†

Bath Ankylosing Spondylitis Disease Activity Index. Composite index including questions on severity of fatigue, spinal and peripheral joint pain, morning stiffness, and localized tenderness, measured on a 10 cm or 100 mm Visual Analog Scale (VAS).

‡

Bath Ankylosing Spondylitis Functional Index: assesses the degree of functional limitations. Visual Analog Scale (VAS): 0=normal physical function and 10=very severe physical limitations.

Bath Ankylosing Spondylitis Metrology Index. Composite index with a range from 0 to 10 (based on a 0-2 point scale: 0=mild disease involvement, 1=moderate disease, 2=severe disease) of 5 clinical measurements including tragus to wall, modified Schober’s test, cervical rotation, lumbar side flexion, and intermalleolar disease.

Maastricht AS Enthesitis Score: evaluates 13 tendon insertion points for pain (total score, 0-13).

06G-64C-Q352-8

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.

Reference: 1. van der Heijde D, Kivitz A, Schiff MH, et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006;54:2136-2146.

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