Adalimumab Plus Methotrexate

The ARMADA (Anti-TNF Research Study Program of the Monoclonal Antibody Adalimumab) trial was a randomized, double-blind, placebo-controlled, multicenter trial that evaluated 271 patients with active RA who had failed therapy with one to four DMARDs and had an inadequate response to MTX. Patients received MTX plus adalimumab 20, 40, or 80 mg or MTX plus placebo e.o.w. for 24 weeks. Significant improvement in disease activity was demonstrated in patients receiving adali-mumab plus MTX compared with those receiving placebo plus MTX (see Table 3.2). The addition of adalimu-mab to MTX substantially improved measures of functional parameters, fatigue scales, and quality of life scores in RA patients not adequately responding to MTX alone, as evidenced by the approximately 35-40 % reduction with the addition of adalimumab in the Disability Index of the Health Assessment Questionnaire (HAQ), clinically meaningful (>10 point changes) in 6 domains of the Short Form-36 (SF-36) for adalimumab plus MTX as compared with 2 domains for placebo plus MTX, and clinically important differences between ada-limumab plus MTX and placebo plus MTX in Functional Assessment of Chronic Illness Therapy fatigue scores. Levels of acute-phase reactants (e.g., C-reactive protein) also were markedly reduced (Weinblatt et al. 2003). The open-label extension of this study is ongoing. Of the patients completing 5 years of treatment, clinical efficacy was sustained, with 76%, 64%, and 39% of patients achieving ACR20,50,70 responses; 52 % achieving clinical remission; and 28 % having no physical limitations (Weinblatt et al. 2004, 2005). Furthermore, the majority of these patients were able to reduce corticosteroid and/ or MTX dosages without adversely affecting long-term efficacy (Weinblatt et al. 2005).

DE019 was a randomized, double-blind, placebo-controlled, multicenter study assessing the ability of adalimumab to inhibit radiographic progression and reduce disease activity in 619 RA patients with active disease despite therapy with MTX. Patients received MTX plus either adalimumab 40 mg e.o.w., adalimu mab 20 mg weekly or placebo for 52 weeks. ACR20, 50, and 70 responses were significantly higher among patients treated with adalimumab plus MTX at Week 52 (see Table 3.2). Importantly, statistically significantly less radiographic progression occurred, as measured by the change in Total Sharp Score (TSS), in patients receiving 40 mg e.o.w. adalimumab plus MTX versus the placebo group, with a mean progression of 2.7 Sharp units seen in the placebo group at 1 year, and 0.1 Sharp units in the adalimumab-treated group. Additionally, at 1 year, 72% of treated patients receiving adalimumab plus MTX had no radiographic progression from baseline. Functional improvement and QOL, as measured by the HAQ and SF-36, were also significantly improved in the combination group versus placebo, with approximately 40% decreases in HAQ scores with the combination versus 17% with placebo and clinically meaningful improvement in the SF-36 for the combination versus placebo (Keystone et al. 2004a). In an OLE of this study, 40 mg adalimumab was administered e.o.w. to 457 of the patients who completed DE019. At 3 years, 61 % of patients had no radiographic disease progression; moreover, significant clinical responses were sustained with 58%, 42%, and 23% of patients achieving ACR20, 50, and 70 responses, respectively. Patients treated with placebo in the randomized controlled trial who had significant disease progression at 52 weeks experienced inhibition of radiographic progression and improved clinical responses when treated with adalimumab during the OLE (Keystone et al. 2004b, 2005).

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