RA Treatment with HUMIRA: Information for Healthcare Professionals

Look at the difference the HUMIRA support program can make
	62% of HUMIRA + MTX–treated patients achieved ACR50 at 1 year vs 46% with MTX alone (P<0.001) Mean change in TSS at 1 year (primary endpoint) was 5.7 for MTX-treated patients vs 1.3 in HUMIRA + MTX treatment group (P<0.001) DAS28<2.6 was achieved by 43% of HUMIRA + MTX patients vs 21% of MTX-alone patients at 1 year (P<0.001) The safety profile of HUMIRA is consistent across RA, PsA, and AS clinical trials2-6 PREMIER was a 2-year, multicenter, randomized, double-blind study (N=799) evaluating the safety and efficacy of HUMIRA 40 mg SC every other week in subjects with moderate-to-severe early (less than 3 years' duration) rheumatoid arthritis (RA) who were methotrexate (MTX)-naïve. The primary efficacy endpoints included ACR50 response and change in modified Total Sharp Score (TSS) at Week 52 in patients receiving HUMIRA + MTX vs MTX alone. 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. HUMIRA full prescribing information. 3. 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. 4. 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(10):3279-3289. 5. Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 2007;56:476-488. 6. 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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Look at the difference the HUMIRA support program can make