Pivotal Studies in Rheumatoid Arthritis

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The efficacy and safety of adalimumab were assessed in five randomized, double-blind, placebo-controlled pivotal studies in patients aged 18 years or older with

Table 3.1 Approved indications and indications under investigation for adalimumab (Abbott Laboratories 2006; Hanauer et al. 2006; Langley et al. 2005; Lovell et al. 2004; Sandborn et al. 2005a; van der Heijde et al. 2006)

Approved indication"


Rheumatoid arthritis

Humira (adalimumab) (Abbott Laboratories, Abbott Park, IL, USA), in combination with MTX, is indicated for:

• The treatment of moderate to severe active RA in adult patients when the response to DMARDs including MTX has been inadequate

• The treatment of severe, active and progressive RA in adults not previously treated with MTX

Adalimumab 40 mg e.o.w.; in combination with

MTX or as monotherapy

May increase to 40 mg weekly if not receiving


Humira can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate

Humira has been shown to reduce the rate of progression of joint damage as measured by radiograph and to improve physical function when given in combination with MTX

Treatment of active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate

Adalimumab 40 mg e.o.w.

Ankylosing spondylitis (van der Heijde et al. 2006) Reducing signs and symptoms in patients with active AS

Adalimumab 40 mg e.o.w.

Indications under investigation


Psoriasis (Langley et al. 2005) Under investigation (phase III)

Crohn's disease (Hanauer et al. 2006; Sandborn et al. 2005a) Under investigation (phase III)

Juvenile idiopathic arthritis (Lovell et al. 2004) Under investigation (phase III)

a Based on approved labeling from the European Agency for Evaluation of Medicinal Products; indications in other areas may differ AS ankylosing spondylitis, DMARDs disease-modifying antirheumatic drugs, EMEA European Agency for the Evaluation of Medicinal Products, e.o.w. every other week, FDA Food and Drug Administration, MTX methotrexate, PsA psoriatic arthritis, RA rheumatoid arthritis active RA diagnosed according to American College of Rheumatology (ACR) criteria (Table 3.2). Adalimumab was administered s.c. in combination with MTX (12.5-25 mg), as monotherapy, or with other DMARDs (Abbott Laboratories 2006).

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