Abstract

ABATACEPT IMPROVES DISEASE ACTIVITY STATUS OVER TIME IN PATIENTS WITH RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE

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Background: The time course of response to biologic therapies in RA can differ. Understanding the likelihood of achieving and maintaining/improving a clinical response, once a certain disease state is reached, enables rheumatologists to optimize biologic use and manage patient expectations. Here we present patient-level abatacept data to assess the likelihood of achieving a DAS28 status and maintaining/improving that disease state from Month 3 over 6 or 12 months, in patients with RA and an inadequate response to MTX. Methods: This was a post-hoc analysis of patients randomized to abatacept in the AIM (Abatacept in Inadequate responders to MTX) trial who completed the 1-year double-blind period and entered the open-label long-term extension (abatacept $∼ $10 mg/kg according to weight, once monthly). DAS28 status was assessed for patients with high disease activity (>5.1), Moderate Disease Activity State (MDAS; but not Low Disease Activity State [LDAS] or remission [>3.2 to ≤5.1]), LDAS (but not remission [≥2.6 to ≤3.2]) or remission (<2.6). Analyses are based on patients with available data at the visit of interest (as-observed). Results: In total 376 abatacept-treated patients were included in this analysis. At baseline, mean disease duration was 8.4 years and mean DAS28 (CRP) was 6.4. Of the patients who achieved MDAS (but not LDAS/remission) at Month 3, 64 and 50% maintained this status at Months 6 and 12, respectively; 16 and 22% achieved LDAS; and 11 and 21% achieved remission (Table). Thus, more than 90% of patients with MDAS at Month 3 maintained/improved their disease status at Months 6 and 12. Of the patients who achieved LDAS (but not remission) at Month 3, 29 and 22% maintained LDAS at Months 6 and 12, respectively; 34 and 41% achieved remission (Table). For the patients with high disease activity at Month 3, 50% improved their disease status by Month 6, and 72% improved their disease status by Month 12. Shift in DAS28 status over time TotalHigh disease activityMDAS*LDAS**Remission Month 3 to 6, n (%) High disease activity82 (22.7)41 (50.0)37 (45.1)2 (2.4)2 (2.4) MDAS*202 (56.0)17 (8.4)130 (64.4)32 (15.8)23 (11.4) LDAS**38 (10.5)1 (2.6)13 (34.2)11 (28.9)13 (34.2) Remission39 (10.8)0 (0)7 (17.9)8 (20.5)24 (61.5) Month 3 to 12, n (%) High disease activity85 (23.6)24 (28.2)43 (50.6)11 (12.9)7 (8.2) MDAS*200 (55.6)14 (7.0)100 (50.0)44 (22.0)42 (21.0) LDAS**37 (10.3)2 (5.4)12 (32.4)8 (21.6)15 (40.5) Remission38 (10.6)0 (0)4 (10.5)5 (13.2)29 (76.3) *But not LDAS/remission; **But not remission. Conclusion: In this post-hoc analysis of patients with RA and an inadequate response to MTX, the majority of patients maintained/improved their disease status over time; in particular, a large proportion of patients who achieved MDAS at Month 3 maintained/improved their disease status by Month 12. These data suggest that, consistent with other biologics, 3-6 months of treatment is an appropriate timeframe to assess the response to abatacept treatment. Disclosure of Interest: MD:Wyeth,BMS,Abbott,Grant Support(GS)/Speakers Bureau(SB)/Consultant;Centocor,Schering-Plough(SP),GS/Consultant JMK:Abbott,Amgen,BMS,Centocor,Genentech,Merck,Pfizer,Roche,GS/Consultant MLB:BMS,Shareholder/Employee DMR:BMS,Shareholder/Employee SP:BMS,Employee GV:BMS,Shareholder/Employee/Patent holder SK:BMS,Shareholder/Employee/Pension XZ:BMS,Employee PE:Amgen,SP,Centocor,BMS,Roche,Consultant RW:BMS,SP,Consultant/SB;UCB,GS MS:BMS,GS/ConsultantCitation: Annals of the Rheumatic Diseases, volume 68, supplement 3, year 2009, page 573Session: Rheumatoid arthritis Other biologic treatment (Poster Presentations )

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