Adalimumab is indicated for the treatment of moderate to severe active RA in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX has been inadequate, and for the treatment of severe, active, and progressive RA in adults not previously treated with MTX. It also is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate. Most recently, regulatory agencies in both the United States and European Union added an indication for AS to the adalimumab labeling (EU Humira SPC 2006; US Humira PI 2006; Abbott Laboratories 2006) (Table 3.1). Adalimumab can be used as monotherapy or in combination with MTX. Future indications currently under investigation include psoriasis (Langley et al. 2005), Crohn's disease (Hanauer et al. 2006; Sandborn et al. 2005a), and juvenile idiopathic arthritis (Lovell et al. 2004).
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