Screening is important in managing the risk of TB activation

Chart depicting “Screening and TB Rates in Clinical Trials”

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

DEO18 + ReAct.

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DEO19 + DEO20 + ACT.

Patients receiving HUMIRA should be monitored for signs and symptoms of active tuberculosis (TB), including patients who are TB skin test negative. Active TB has developed in patients receiving HUMIRA whose screening for latent TB infection was negative.

Serious infection rates consistent in long-term RA extension trials1-3

Chart depicting “Serious Infection Rates in Clinical Trials”

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The incidence of serious infections was 0.04 per patient year in HUMIRA-treated patients
and 0.02 per patient year in placebo-treated patients.

The total infection rate (serious and nonserious) in placebo-controlled RA trials was
1 per patient year with HUMIRA vs 0.9 per patient year with placebo4
RA population serious infection rates range from 3.1 to 9.6 per 100 PY2,3

Data from HUMIRA pivotal trials and open-label extension studies.1

Range of serious infections in RA population based on rates reported in literature for RA population. One study investigating the relationship between serious infections and immunosuppressive use in RA patients reported an overall rate of 3.1 events per 100 patient years. Another population-based study reported a rate of infections requiring hospitalization of 9.57 events per 100 patient years.2,3

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. 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. 2. Singh G, Ramey DR, Rausch PL, Schettler JD. Serious infections in rheumatoid arthritis: relationship to immunosuppressive use. Presented at: American College of Rheumatology Annual Scientific Meeting; November 1999; Boston, Mass. 3. Doran MF, Crowson CS, Pond GR, O’Fallon M, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002;46:2287-2293. 4. HUMIRA full prescribing information.

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