FRI0199 In patients with established RA, abatacept efficacy is independent of baseline annual radiographic progression rate

• Published in: Annals of the rheumatic diseases Vol. 71; no. Suppl 3; pp. 380 - 381
• Main Authors: Emery, P., Westhovens, R., Dougados, M., Alten, R., Gaillez, C., Poncet, C., Le Bars, M., Elegbe, A., Genant, H.
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and European League Against Rheumatism 01.06.2013; BMJ Publishing Group LTD
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2012-eular.2656

Background In the Phase III, double-blind, placebo (PBO)-controlled AIM study, abatacept (ABA)+ MTX significantly inhibited structural damage progression vs PBO+MTX in pts with established RA and inadequate response to MTX.1Sustained inhibition of radiographic progression was seen up to yr 5.2 Previous data in pts with early RA showed a benefit of ABA in pts with faster progression.3 Objectives To assess clinical outcomes at 1 yr according to annual radiographic progression rate (ARPR) by quartile at baseline (BL) in pts with established RA in AIM. Methods BL characteristics were similar between ABA 10 mg/kg+MTX (n=433) and PBO+MTX (n=219). ARPR was defined as total Genant-modified Sharpscore divided by disease duration. Pts were categorized into four quartiles according to ARPR at BL (Q1: ≤2.78; Q2: 2.78 to ≤4.64; Q3: 4.64 to ≤8.04; Q4: >8.04). For each quartile, treatment benefit was assessed post hoc by outcomes: DAS28(CRP)-derived criteria (remission <2.6; LDAS ≤3.2), Simplified Disease Activity Index Low Disease Activity (SDAI ≤11) and ACR50 response. Results Mean (SD) BL ARPR was 8.13 (18.11) for ABA+MTX and 5.87 (5.36) for PBO+MTX. For ABA+MTX vs PBO+MTX, the percentage of pts achieving an outcome at yr 1 by ARPR quartile is shown, with treatment differences (table). 95% CI of ABA vs PBO estimate of treatment difference did not cross zero for most ARPR quartiles. For LDAS (assessed by DAS28[CRP] or SDAI) and ACR50, there was a numerically higher treatment difference for pts in some of the higher quartiles (Q3/Q4). Table 1 % (95% CI)ARPR Q1Q2Q3Q4 ABA+MTX (n=84)ABA+MTX (n=90)ABA+MTX (n=94)ABA+MTX (n=103) MTX (n=43)MTX (n=41)MTX (n=39)MTX (n=32) DAS28LDASABA+MTX42.9 (32.3, 53.4)38.9 (28.8, 49.0)45.7 (35.7, 55.8)40.8 (31.3, 50.3) MTX14.0 (3.6, 24.3)19.5 (7.4, 31.6)2.6 (0, 7.5)6.3 (0, 14.6) Tx Δ28.9 (9.9, 48.0)19.4 (0.3, 38.5)43.2 (23.8, 62.6)34.5 (13.9, 55.2) <2.6ABA+MTX29.8 (20.0, 39.5)18.9 (10.8, 27.0)23.4 (14.8, 32.0)26.2 (17.7, 34.7) MTX2.3 (0, 6.8)4.9 (0, 11.5)0 (0, 0)3.1 (0, 9.2) Tx Δ27.4 (10.8, 44.0)14.0 (-0.8, 28.8)23.4 (7.7, 39.1)23.1 (5.0, 41.2) SDAILDASABA+MTX52.4 (41.7, 63.1)43.3 (33.1, 53.6)44.7 (34.6, 54.7)44.7 (35.1, 54.3) MTX20.9 (8.8, 33.1)24.4 (11.2, 37.5)7.7 (0, 16.1)6.3 (0, 14.6) Tx Δ31.5 (11.6, 51.3)18.9 (-0.7, 38.6)37.0 (17.5, 56.5)38.4 (17.4, 59.4) ACR50ABA+MTX61.4a (51.0, 71.9)50.6b (40.2, 60.9)54.3 (44.2, 64.3)48.5 (38.9, 58.2) MTX31.0c (17.0, 44.9)22.0 (9.3, 34.6)25.6 (11.9, 39.3)12.5 (1.0, 24.0) Tx Δ30.5 (10.1, 50.8)28.6 (8.6, 48.6)28.6 (8.2, 49.0)36.0 (14.6, 57.5) Values are proportion of pts (%), except Tx Δ = treatment difference. an=83; bn=89; cn=42. Conclusions Over 1 yr, pts with established RA achieved better outcomes with abatacept +MTX than PBO+MTX across all quartiles. Pts with rapid radiographic progression (Q4) showed numerically greater clinical benefits in LDAS, SDAI and ACR50 compared with Q1 pts, extending previous findings in early RA.3 References Kremer J et al. Ann Intern Med 2006;144:865–76. Schiff M. Rheum 2011;50:437–49. Westhovens R et al. Ann Rheum Dis2011;70(Suppl 3):617. Disclosure of Interest P. Emery Grant/Research support from: Abbott Immunology Pharmaceuticals, Abbott Laboratories, BMS, Centocor Research and Development, Inc., Merck Pharmaceuticals, Pfizer Inc, Roche, UCB, Inc., Consultant for: Abbott Laboratories, Amgen Inc., BMS, Centocor Research and Development, Inc., Lilly USA, LLC., Merck Pharmaceuticals, Pfizer Inc, Roche, Schering-Plough, Takeda Pharmaceuticals North America, Wyeth Pharmaceuticals, UCB, Inc., Speakers Bureau: Abbott Immunology Pharmaceuticals, BMS, Centocor Research and Development, Inc., Merck Pharmaceuticals, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, UCB, Inc., R. Westhovens Grant/Research support from: Roche, UCB, Consultant for: Bristol-Myers Squibb, Centocor, Roche, Schering-Plough, Speakers Bureau: Bristol-Myers Squibb, M. Dougados Grant/Research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Speakers Bureau: Bristol-Myers Squibb, R. Alten Grant/Research support from: BMS, Merck Pharma GmbH, Wyeth Pharmaceuticals, Pfizer, Consultant for: Abbott Laboratories, Horizon Pharma, Merck Pharma GmbH, Nitec Pharma GmbH, Novartis Pharmaceuticals Corporation, Roche, Speakers Bureau: Abbott Laboratories, BMS, Horizon Pharma, Merck Pharma GmbH, Novartis Pharmaceuticals Corporation, Roche, C. Gaillez Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, C. Poncet: None Declared, M. Le Bars Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, A. Elegbe Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, H. Genant Shareholder of: Synarc, Inc., Grant/Research support from: Bristol-Myers Squibb, GSK, Roche, Genentech, Pfizer, Consultant for: Bristol-Myers Squibb, GSK, Roche, Genentech, Amgen, Merck, Servier, Pfizer, Lilly, Employee of: Synarc, Inc.