Safety evaluated in ADEPT, the largest biologic trial in PsA

Common adverse events (>5%) in the ADEPT PsA trial and the open-label extension5

Double-blind
Weeks 0-24 Open-label Weeks 24-48

Adverse Events Placebo
eow, n=162
n (%) HUMIRA 40 mg
eow, n=151
n (%) HUMIRA 40 mg
eow, n=285
n (%)

Upper respiratory tract infection NOS* 24 (14.8) 19 (12.6) 39 (13.7)

Nasopharyngitis 15 (9.3) 15 (9.9) 31 (10.9)

Injection site reaction NOS 5 (3.1) 10 (6.6) 24 (8.4)

Headache NOS 14 (8.6) 9 (6.0) 18 (6.3)

Hypertension NOS 5 (3.1) 8 (5.3) 12 (4.2)

PsA aggravated 11 (6.8) 5 (3.3) 10 (3.5)

Ps aggravated 10 (6.2) 3 (2.0) 3 (1.1)

Diarrhea NOS 9 (5.6) 3 (2.0) 6 (2.1)

Arthralgia 9 (5.6) 3 (2.0) 10 (3.5)

NOS indicates not otherwise specified.

All patients who completed the 24-week trial were eligible for long-term treatment in an open-label extension (OLE) study.5
Patients in the placebo group switched to HUMIRA treatment from Week 24 to Week 48.

No cases of tuberculosis, demyelinating disease, SLE/lupus like syndrome, or congestive heart failure (CHF) were reported in patients treated with HUMIRA in the ADEPT trial and the OLE6

Serious adverse events in long-standing moderate-to-severe RA trials7

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

Tuberculosis 0.27 0.27

Lymphoma 0.21 0.12

Demyelinating disease 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-Q352-7

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. Mease P, Gladman D, Ritchlin C, Sasso E. Clinical efficacy, safety and inhibition of joint destruction of adalimumab in the treatment of moderate to severe psoriatic arthritis: 48-week results of the ADEPT trial. Presented at: American Academy of Dermatology Annual Meeting; March 2006; San Francisco, Calif. 6. Data on file. Abbott Laboratories. 7. 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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