Safety profile across RA clinical trials1,2

Adverse events in the PREMIER trial in moderate-to-severe
early RA1

PREMIER TRIAL

Adverse Events
(per 100 patient years [PY]) HUMIRA + MTX
(n=268)
482 PY HUMIRA
(n=274)
435 PY MTX
(n=257)
428.5 PY

Serious infections 2.9 0.7 1.6

Tuberculosis (TB) 0.2 0 0

Demyelinating diseases 0 0 0

Lymphoma 0 0 0.2

Malignancy 0.4 0.9 0.9

Serious adverse events in long-standing moderate-to-severe RA trials2

Serious Adverse Events
(per 100 patient years [PY]) Long-Standing
RA Trials
as of Aug 31, 2002
N=2468
4870 PY Long-Standing
RA Trials
as of Apr 15, 2005
N=10,050
12,506 PY

Serious infections 4.90 5.10

TB 0.27 0.27

Lymphoma 0.21 0.12

Demyelinating diseases 0.08 0.08

SLE/Lupus-like syndrome 0.08 0.10

Congestive heart failure 0.29 0.28

Histoplasmosis 0.06 0.03

Data from long-standing trials with HUMIRA including open-label extensions and ACT and ReACT early access programs.

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, for the PREMIER Investigators. 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. Schiff MH, Burmester GR, Kent JD, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis. 2006;65:889-894.

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Safety profile across RA clinical trials1,2

Adverse events in the PREMIER trial in moderate-to-severe early RA1

Serious adverse events in long-standing moderate-to-severe RA trials2

Adverse events in the PREMIER trial in moderate-to-severe
early RA1