Abstract
ABATACEPT IMPROVES DISEASE ACTIVITY STATUS OVER TIME IN PATIENTS WITH RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE
Full text
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 )
7 organizations
Organization
Hosp Cochin, Descartes Univ, Paris, FranceOrganization
Bristol-Myers Squibb, Rueil-Malmaison, FranceOrganization
Bristol-Myers Squibb, NJ, United StatesOrganization
Univ of Leeds, Leeds, United KingdomOrganization
UZ Gasthuisberg, KU Leuven, Leuven, BelgiumOrganization
Univ of Colorado, Denver, CO, United States