ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1465

Adherence To The Recommended Dosing Regimen Of Abatacept In The Real-World Setting In The Action Study: Is There a Dose-Creep In Overweight Patients?

H Nüßlein1, R Alten2, M Galeazzi3, H M Lorenz4, D Boumpas5, M T Nurmohamed6, W G Bensen7, Gerd Burmester8, H-H Peter9, F Rainer10, K Pavelka11, M Chartier12, C Poncet13, C Rauch14 and M Le Bars15, 1University Erlangen, Nürnberg, Germany, 2Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany, 3University of Siena, Siena, Italy, 4University Hospital Heidelberg, Heidelberg, Germany, 5Panepistimio Kritis, Rethymnon, Greece, 6VU University Medical Center/Jan van Breeman Research Institute, Amsterdam, Netherlands, 7St. Joseph's Hospital/McMaster University, Hamilton, ON, Canada, 8Charité-Universitätsmedizin, Berlin, Germany, 9University of Freiburg, Freiburg, Germany, 10Hospital Barmherzige Brueder, Graz, Austria, 11Institute of Rheumatology, Prague, Czech Republic, 12Chiltern International, Neuilly, France, 13Docs International, Nanterre, France, 14Bristol-Myers Squibb, Munich, Germany, 15Bristol-Myers Squibb, Rueil-Malmaison, France

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy II

Session Type: Abstract Submissions (ACR)

Background/Purpose: Reduced efficacy for achieving DAS28 <2.6 has been observed for anti-TNF agents in obese patients following 12 months of therapy. The odds ratio (95% confidence interval) was 2.43 (1.21, 4.88; p=0.01) with initial body mass index [BMI] 20–30 kg/m2 versus >30 kg/m2,1 which in theory could induce dose increases to maintain efficacy. Here we explore adherence to abatacept over 6 months in patients categorized according to BMI. Methods: ACTION is an ongoing, 2-year, international, non-interventional, prospective cohort of patients with RA treated with IV abatacept. All patients on abatacept treatment for ≥6 months, and with data available for infusion (at initiation and at 6 months) and BMI (at initiation), were considered in this analysis. BMI calculated at abatacept initiation categorized patients into normal (<25 kg/m2), overweight (25–<30 kg/m2) or obese (≥30 kg/m2) subgroups. Within each BMI category, adherence to treatment was assessed in patients who received appropriate dosage by body weight at initiation. Increase in dose and frequency of administration was assessed over 6 months. Results: An even distribution of patients was observed across the BMI subgroups at abatacept initiation in the overall population (<25 kg/m2: 399/1048 [38.1%]; 25–<30 kg/m2: 363/1048 [34.6%]; ≥30 kg/m2: 286/1048 [27.3%]). Baseline disease characteristics were similar across BMI subgroups, except auto-antibody status, with fewer obese seropositive patients: rheumatoid factor-positive, <25 kg/m2: 228/315 (72.4%); 25–<30 kg/m2: 220/293 (75.1%); ≥30 kg/m2: 132/232 (56.9%); anti-cyclic citrullinated peptide-positive, <25 kg/m2: 152/213 (71.4%); 25–<30 kg/m2: 138/204 (67.6%); ≥30 kg/m2: 87/153 (56.9%). Overall, 737/1048 (70.3%) patients with BMI data available received abatacept for ≥6 months and had infusion data available at initiation and at 6 months. A large proportion of patients received appropriate dosage regardless of BMI: at initiation (<25 kg/m2: 236/290 [81.4%]; 25–<30 kg/m2: 224/245 [92.2%]; ≥30 kg/m2: 182/202 [91.0%]). Adherence over 6 months in patients receiving appropriate dosage at initiation is presented in the table.

  <25 kg/m2 (n=236) 25–<30 kg/m2 (n=224) ≥30 kg/m2 (n=182)
Appropriate dosage at 6 months* 203/215 (94.4%) 197/200 (98.5%) 154/161 (95.7%)
Dose increase over 6 months* 11/215 (5.1%) 2/200 (1.0%) 4/161 (2.5%)
7–9 infusions received** 203/236 (86.0%) 199/224 (88.8%) 150/182 (82.4%)
1 additional infusion received 6/236 (2.5%) 3/224 (1.3%) 2/182 (1.1%)
Increase in dose or in frequency 17/236 (7.2%) 5/224 (2.2%) 6/182 (3.3%)
*Some patients had missing data for dose reported at 6 months; **Corresponding to a ratio of actual to recommended infusions within range of 80–120%
No patient received more than 1 additional infusion. No patient had both a dose increase and an increase in frequency of administration over 6 months. Conclusion: Analysis of adherence to the recommended dosing regimen of IV abatacept in the ACTION study showed that a large proportion of patients had good adherence at initiation, regardless of BMI. Few patients had an increase in dosage or frequency of administration over 6 months and nobody had both. Overall, there was no evidence for dose creep in overweight and obese patients treated with IV abatacept over 6 months in routine clinical practice. 1. Gremese E, et al. Arthritis Care Res 2013;65:94–100.

Disclosure:

H. Nüßlein,

Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis and Roche,

5,

Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis and Roche,

8;

R. Alten,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

9;

M. Galeazzi,
None;

H. M. Lorenz,

Abbvie, Pfizer, MSD, Roche, GlaxoSmithKline, Bristol-Myers Squibb,

5;

D. Boumpas,
None;

M. T. Nurmohamed,

BMS, MSD, Roche, Abbott, Pfizer and UCB,

2,

BMS, MSD, Roche, Abbott, Pfizer and UCB,

5,

BMS, MSD, Roche, Abbott, Pfizer and UCB,

8;

W. G. Bensen,

Abbott, Amgen, BMS, Janssen, Merck , Lilly , Novartis, Pfizer, Proctor and Gamble, Roche, sanofi -aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth,

2,

Abbott, Amgen, BMS, Janssen, Merck , Lilly , Novartis, Pfizer, Proctor and Gamble, Roche, sanofi -aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth,

5,

Abbott, Amgen, BMS, Janssen, Merck , Lilly , Novartis, Pfizer, Proctor and Gamble, Roche, sanofi -aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth,

8;

G. Burmester,

AbbVie, BMS, Pfizer, Roche, UCB,

2,

AbbVie, BMS, MSD, Pfizer, Roche, UCB,

5,

AbbVie, BMS, MSD, Pfizer, Roche, UCB,

8;

H. H. Peter,
None;

F. Rainer,
None;

K. Pavelka,

MSD, Pfizer, Amgen, AbbVie, Roche,

2,

MSD, Pfizer, Amgen, AbbVie, Roche,

5;

M. Chartier,

Bristol-Myers Squibb,

5;

C. Poncet,

Bristol-Myers Squibb,

5;

C. Rauch,

Bristol-Myers Squibb,

3;

M. Le Bars,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3.

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