ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2452

In Real-World Clinical Practice, Patients Switching from IV to SC Abatacept Maintain Clinical Efficacy after Switch

Rieke Alten1, HM Lorenz2, X Mariette3, H Nüßlein4, M Galeazzi5, F Navarro6, M Chartier7, J Heitzmann8, C Rauch9 and M Le Bars7, 1Schlosspark-Klinik University Medicine, Berlin, Germany, 2University Hospital, Heidelberg, Germany, 3Université Paris-Sud, Paris, France, 4University of Erlangen-Nuremberg, Nuremberg, Germany, 5University of Siena, Siena, Italy, 6Hospital Universitario Virgen Macarena, Seville, Spain, 7Bristol-Myers Squibb, Rueil-Malmaison, France, 8Excelya, Boulogne-Billancourt, France, 9Bristol-Myers Squibb, Munich, Germany

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: , ,

Session Information

Date: Tuesday, November 7, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Patients (pts) with RA may be able to switch from IV to SC abatacept with no loss of efficacy or safety concerns, but data are inconclusive.1-4 ACTION (AbataCepT In rOutiNe clinical practice; NCT02109666) examined abatacept formulation switching and the impact on clinical efficacy over 2 years. Methods: ACTION is a 2-year, prospective, observational study of pts with moderate-to-severe RA who initiated IV abatacept in Europe and Canada between May 2008 and December 2013. Assessments in biologic-naïve and biologic-failure pts were: baseline characteristics, rates of/reasons for switching (IV to SC), re-switching to IV over 2 years and clinical efficacy outcomes in pts who switched. Descriptive data were generated: mean (SD) for continuous variables and n (%) for categorical variables. Rates of switching were estimated by Kaplan–Meier analysis. Owing to low numbers, cohorts were pooled to analyze further pts who switched.

Results: In total, 2350/2364 pts (99.4%) were evaluable for this analysis (673 [28.6%] biologic naïve, 1677 [71.4%] biologic failure); 728 (43.4%) biologic-failure pts had received 1, and 949 (56.6%) had received ≥2 previous biologics. Baseline characteristics in biologic-naïve and biologic-failure pts, respectively, were: mean (SD) age 59.9 (12.7) and 56.9 (12.5) years; mean (SD) RA duration 7.2 (8.22) and 12.1 (9.13) years; 496 (73.7%) and 1379 (82.2%) were women; 621 (92.3%) and 1552 (92.5%) had received prior MTX; and 533 (79.2%) and 1386 (82.6%) had received corticosteroids. Over 2 years, 195 pts switched from IV to SC abatacept (57 biologic naïve, 138 biologic failure; Figure). The primary reason for switch was pt wish (in 28/51 [54.9%] biologic-naïve and 75/121 [62.0%] biologic-failure pts with reason for switch available). Only 8 pts (4.1%) re-switched to IV abatacept (2 biologic naïve, 6 biologic failure). Reasons for re-switch were: pt wish (n=4), lack of efficacy (n=4), safety issue (n=1) and other (n=2). Clinical efficacy outcomes, stratified by prior treatment history, were generally similar at last follow-up before switching from IV to SC abatacept and at last follow-up on SC abatacept treatment (Table).

Conclusion: Over 2 years, in real-world clinical practice, of the pts who switched from IV to SC abatacept, less than 5% re-switched from SC abatacept to the IV formulation. No adverse clinical impact was observed following switching from IV to SC abatacept.

1. Keystone EC, et al. Ann Rheum Dis 2012;71:857–61.

2. Mueller R, et al. Arthritis Rheumatol 2015;67(Suppl. 10):651–2.

3. Reggia R, et al. J Rheumatol 2015;42:193–5.

4. Monti S, et al. J Rheumatol 2015;42:1993–4.
  

Table. Efficacy of Abatacept at Last Follow-up Before Switching From IV to SC Formulation and at Last Follow-up Under SC Treatment (Overall Analysis Population)
  Last follow-up before switching from IV to SC Last follow-up under SC treatment
  Biologic-naïve cohort (n=51) Biologic-failure cohort (n=122) Biologic-naïve cohort (n=45) Biologic-failure cohort (n=97)
DAS28 (ESR), mean (SD) 3.0 (1.2)
(n=42) 		3.5 (1.2)
(n=107) 		2.8 (1.1)
(n=34) 		3.5 (1.2)
(n=69)
DAS28 (ESR) remission, n (%) 17 (40.5)
(n=42) 		27 (25.2)
(n=107) 		19 (55.9)
(n=34) 		16 (23.2)
(n=69)
DAS28 (CRP), mean (SD) 2.8 (1.1)
(n=40) 		3.2 (1.2)
(n=105) 		2.4 (0.9)
(n=37) 		3.2 (1.3)
(n=69)
DAS28 (CRP) remission, n (%) 22 (55.0)
(n=40) 		35 (33.3)
(n=105) 		25 (67.6)
(n=37) 		25 (36.2)
(n=69)
EULAR response (ESR/CRP) good or moderate, n (%) 38 (90.5)
(n=42) 		75 (70.1)
(n=107) 		33 (89.2)
(n=37) 		55 (75.3)
(n=73)
CDAI, mean (SD) 8.0 (7.7)
(n=39) 		11.9 (9.5)
(n=94) 		7.6 (7.5)
(n=39) 		11.6 (10.2)
(n=72)
CDAI LDA/remission, n (%) 26 (66.7)
(n=39) 		49 (52.1)
(n=94) 		27 (69.2)
(n=39) 		40 (55.6)
(n=72)
SDAI, mean (SD) 9.5 (8.6)
(n=33) 		12.9 (9.8)
(n=86) 		7.3 (6.3)
(n=33) 		13.3 (10.8)
(n=61)
SDAI LDA/remission, n (%) 22 (66.7)
(n=33) 		41 (47.7)
(n=86) 		25 (75.8)
(n=33) 		30 (49.2)
(n=61)
Patient Global Assessment (mm), mean (SD) 28.9 (22.4)
(n=49) 		35.3 (23.8)
(n=116) 		26.5 (22.6)
(n=44) 		39.7 (24.3)
(n=84)
HAQ-DI, mean (SD) 0.6 (0.6)
(n=32) 		1.0 (0.7)
(n=87) 		0.7 (0.7)
(n=36) 		1.1 (0.8)
(n=73)
Boolean remission criterion, n (%) 10 (25.0)
(n=40) 		9 (8.6)
(n=105) 		9 (24.3)
(n=37) 		5 (7.2)
(n=69)

 

 

Disclosure: R. Alten, Bristol-Myers Squibb, 2; H. Lorenz, AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer, Actelion, 5; X. Mariette, Bristol-Myers Squibb, LFB, Pfizer, GSK, UCB, 9,Biogen, Pfizer, UCB, 2; H. Nüßlein, AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, 5; M. Galeazzi, None; F. Navarro, Pfizer, MSD, AbbVie, Bristol-Myers Squibb, Roche, 2,Pfizer, MSD, Roche, UCB, AbbVie, Bristol-Myers Squibb, 8,Pfizer, MSD, Roche, UCB, AbbVie, Bristol-Myers Squibb, Janssen, Lilly, 5; M. Chartier, Bristol-Myers Squibb, 3; J. Heitzmann, Bristol-Myers Squibb, 3; C. Rauch, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 9; M. Le Bars, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1, 9.

To cite this abstract in AMA style:

Alten R, Lorenz H, Mariette X, Nüßlein H, Galeazzi M, Navarro F, Chartier M, Heitzmann J, Rauch C, Le Bars M. In Real-World Clinical Practice, Patients Switching from IV to SC Abatacept Maintain Clinical Efficacy after Switch [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/in-real-world-clinical-practice-patients-switching-from-iv-to-sc-abatacept-maintain-clinical-efficacy-after-switch/. Accessed .

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