PREMIER: Pivotal trial of HUMIRA for use in recent-onset, moderate-to-severe RA

Why is PREMIER unique?1

Measured and met ACR50 as a primary endpoint at 1 year
Was blinded for 2 years
Compared combination treatment with HUMIRA to each of 2 monotherapies
Enrolled only patients with no prior MTX experience

Chart depicting “Premier Study Design”

Escalated to 20 mg/wk by Week 8, as needed/as tolerated.

Coprimary endpoints

ACR50 responses and inhibition of radiographic progression (mean change in TSS†) for HUMIRA + MTX vs MTX alone at 1 year1

†

Total Sharp Score.

Secondary endpoints included

ACR50 response rates and mean change from baseline in modified TSS at Week 104
Clinical remission (DAS28<2.6) rates at Week 521

Study of MTX-naïve patients with recent-onset disease

PREMIER: Baseline characteristics of patients treated with HUMIRA + MTX, HUMIRA alone, and MTX alone1,2

HUMIRA + MTX
(n=268) HUMIRA
(n=274) MTX
(n=257)

Disease duration (months) 8.4 8.4 9.6

TJC (0-68), mean 31 32 32

SJC (0-66), mean 21 22 22

DI (HAQ), mean 1.5 1.6 1.5

DAS28, mean 6.3 6.4 6.3

CRP (mg/dL) 3.9 4.1 4.0

TSS, mean 18.1 18.8 21.9

% with joint erosions 93 94 96

% RF positive 87 83 81

TSS/Duration RA (years) 25.6 26.7 27.4

06G-64C-Q352-6

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. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26-37. 2. Pavelka K, Landewe R, Weisman MH, et al. Radiographic progression during the first 6 months of disease in recent-onset rheumatoid arthritis (RA): the PREMIER study of adalimumab (HUMIRA^®) therapy in early RA. Presented at: European League Against Rheumatism Annual Scientific Meeting; June 2005; Vienna, Austria.

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