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Abstract Number: 1469

Treatment Paradigms in Real-World Practice: Biologic Agent Use Prior to and after Discontinuation of Abatacept

Rieke Alten1, H-M Lorenz2, X Mariette3, H Nüßlein4, M Galeazzi5, F Navarro6, M Chartier7, Y Elbez8, 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: Abatacept, Disease-modifying antirheumatic drugs, observation and treatment

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Session Information

Date: Monday, November 6, 2017

Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports

Session Type: ACR Poster Session B

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

Background/Purpose: ACTION is a 2-year, observational study of patients (pts) with moderate-to-severe RA who initiated IV abatacept in Canada and Europe (NCT02109666). The objective was to determine pt biologic (b)DMARD use prior to initiation and after discontinuation of abatacept overall and by treatment line in ACTION. Methods: Pts with RA initiated IV abatacept as first- or second-/further-line therapy. Biologic-naïve and biologic-failure pts were enrolled during three periods between May 2008 and December 2013. Pts could switch administration routes (IV to SC) during treatment. Crude retention rates (Kaplan–Meier) were compared by log-rank test.

Results: Of the 2364 pts enrolled, 2350 were evaluable for analysis: 673 (28.6%) were biologic naïve and 1677 (71.4%) biologic failures. Baseline characteristics differed: biologic-failure pts had longer RA duration, higher CRP levels and prevalence of radiographic erosions, and lower rates of chronic obstructive pulmonary disease and neoplasms vs biologic-naïve pts. Most biologic-failure pts (96.7%) had previously received ≥1 TNF inhibitor (TNFi): 48.7% had received 1 and 48.0% ≥2 TNFi; 56.6% had received ≥2 bDMARDs. The overall 2-year retention rate was 47.9% and was higher for biologic-naïve vs biologic-failure pts (54.5 vs 45.2%; p<0.001); the most common reasons for abatacept discontinuation were inefficacy (61.4 vs 67.7%) and safety (21.3 vs 21.2%). In pts who discontinued abatacept, 83.0% started a bDMARD ≤6 months after discontinuation (Table), most commonly abatacept IV. Mean (SD) days from stopping abatacept to starting a bDMARD was similar for biologic-naïve (93.4 [51.3]) and biologic-failure pts (93.6 [48.0]). Among pts who restarted abatacept, 62 (80.5%) biologic-naïve and 158 (85.0%) biologic-failure pts were considered to have discontinued as the time from last dose was >84 (IV) or >28 (SC) days, and thus were no longer temporary discontinuations, as predefined in the protocol. Three pts discontinued for bad compliance, 3 for lack of efficacy, 3 for remission/major improvement, 12 for safety and 15 for surgery. A good/moderate EULAR response was achieved by 76.7% of pts at the last follow-up before abatacept discontinuation and 58.3% at abatacept restart; mean (SD) DAS28 (CRP) was 3.2 (1.1) and 3.8 (1.4), respectively.   

Conclusion: Prior to abatacept treatment, over half of biologic-failure pts had received ≥2 bDMARDs and most had received a TNFi. After initial discontinuation (protocol defined), over one-third of pts restarted abatacept.

Original abstract © EULAR/BMJ. First presented at EULAR 2017 and published in Ann Rheum Dis 2017;76 (Suppl 2):AB0267. Any reprints, promotional options, education material etc have to be done through the original source (ARD/BMJ).

Table

 

bDMARD ≤6 months after abatacept discontinuation

bDMARD prior to initial abatacept treatment in pts who restarted abatacept

Biologic naïve

n=186

Biologic failure

n=526

Biologic failure

n=186

None

35 (18.8)

86 (16.3)

Abatacept

77 (41.4)

186 (35.4)

–

IV

71 (38.2)

170 (32.3)

SC

6 (3.2)

16 (3.0)

TNFi

41 (22.0)

74 (14.1)

181 (97.3)

Adalimumab

10 (5.4)

12 (2.3)

108 (58.1)

Etanercept

13 (7.0)

21 (4.0)

125 (67.2)

Infliximab

7 (3.8)

13 (2.5)

55 (29.6)

Certolizumab

7 (3.8)

17 (3.2)

5 (2.7)

Golimumab

4 (2.2)

11 (2.1)

2 (1.1)

Other bDMARD

33 (17.7)

180 (34.2)

51 (27.4)

Anakinra

1 (0.5)

4 (0.8)

5 (2.7)

Rituximab

6 (3.2)

58 (11.0)

30 (16.1)

Tocilizumab

26 (14.0)

118 (22.4)

21 (11.3)

Data are n (%)

bDMARD=biologic DMARD; TNFi=TNF inhibitor


 

Disclosure: R. Alten, Bristol-Myers Squibb, 2; H. M. Lorenz, AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer, Actelion, 5,AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer, Actelion, 9; 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,AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, 8; 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; Y. Elbez, None; C. Rauch, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1, 9; M. Le Bars, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1.

To cite this abstract in AMA style:

Alten R, Lorenz HM, Mariette X, Nüßlein H, Galeazzi M, Navarro F, Chartier M, Elbez Y, Rauch C, Le Bars M. Treatment Paradigms in Real-World Practice: Biologic Agent Use Prior to and after Discontinuation of Abatacept [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/treatment-paradigms-in-real-world-practice-biologic-agent-use-prior-to-and-after-discontinuation-of-abatacept/. Accessed January 31, 2023.
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