Early Rheumatoid Arthritis

Current evidence suggests that early, aggressive combination treatment of RA achieves superior long-term outcomes (O'Dell 2002; Keystone et al. 2003a, 2003b, 2003c, 2005; Weinblatt et al. 2003). The PREMIER Study was a randomized, double-blind, active comparator-controlled, multicenter study designed to compare the efficacy and safety of adalimumab plus MTX versus adalimumab monotherapy or MTX monotherapy in 799 MTX-naive RA patients with early (<3 years), aggressive disease. Patients received adalimumab

40 mg e.o.w. plus MTX, adalimumab 40 mg e.o.w. monotherapy, or MTX monotherapy (rapidly escalated to 20 mg/week after study start) for 2 years. Patients had a mean disease duration of 0.7 years. The coprima-ry efficacy endpoints compared combination therapy with MTX monotherapy with regard to proportion of patients who achieved an ACR50 response and the mean change from baseline in modified TSS. In all measured outcomes, combination therapy was superior to both MTX and adalimumab monotherapy (see Table 3.2). More patients receiving combination therapy (62%) achieved an ACR50 response than patients who received adalimumab (41%, P < 0.001) or MTX monotherapy (46%, P < 0.001) (Fig. 3.4a). This trend also was observed for ACR20,70, and 90 response rates

Adalimumab Adalimumab + MTX

Adalimumab Adalimumab + MTX

Fig. 3.4. Results from the PREMIER study: a American College of Rheumatology 50 (ACR50) response at years 1 and 2. *P < 0.001 for adalimumab + MTX versus MTX alone and adalimumab + MTX versus adalimumab alone. b Mean change from baseline in total Sharp scores over time. *P < 0.001 for adalimumab + MTX versus MTX and adalimumab alone. +P <0.001 for adalimumab + MTX versus MTX alone and P = 0.002 for adalimumab + MTX versus adalimumab alone. *P < 0.001 for adalimumab versus MTX alone. MTX methotrexate. (Reproduced with permission from Breedveld et al. 2006)

Fig. 3.4. Results from the PREMIER study: a American College of Rheumatology 50 (ACR50) response at years 1 and 2. *P < 0.001 for adalimumab + MTX versus MTX alone and adalimumab + MTX versus adalimumab alone. b Mean change from baseline in total Sharp scores over time. *P < 0.001 for adalimumab + MTX versus MTX and adalimumab alone. +P <0.001 for adalimumab + MTX versus MTX alone and P = 0.002 for adalimumab + MTX versus adalimumab alone. *P < 0.001 for adalimumab versus MTX alone. MTX methotrexate. (Reproduced with permission from Breedveld et al. 2006)

at 1 and 2 years. Significantlyless radiographic progression occurred in the combination arm at both years 1 and 2 than in either the MTX arm or the adalimumab arm. Despite similar ACR50 response rates at 1 year in both the monotherapy arms, adalimumab-treated patients experienced significantly less radiographic progression than MTX-treated patients at 6 months, 1 year, and 2 years (Fig. 3.4b). At 2 years, 49 % of patients receiving combination therapy achieved clinical remission (DAS28 < 2.6) and 49% achieved a major clinical response (ACR70 maintained > 6 months), a rate approximately twice that of either monotherapy arm. These results suggest that combination therapy with adalimumab plus MTX is significantly superior to MTX or adalimumab monotherapy in patients with early, aggressive RA, improving disease activity and achieving clinical remission (Breedveld et al. 2005, 2006).

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