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Abstract Number: 2492

Does Body Mass Index Impact Long-Term Retention with Abatacept in Patients with RA Who Have Received at Least One Prior Biologic Agent? 2-Year Results from a Real-World, International, Prospective Study

H Nüßlein1, R Alten2, M Galeazzi3, HM Lorenz4, MT Nurmohamed5, WG Bensen6, Gerd Burmester7, H-H Peter8, P Peichl9, K Pavelka10, M Chartier11, C Poncet12, C Rauch13 and M Le Bars14, 1Internistische Schwerpunktpraxis, Nürnberg, Germany, 2Schlosspark-Klinik University Medicine, Berlin, Germany, 3University of Siena, Siena, Italy, 4University Hospital, Heidelberg, Germany, 5VU Univ Medical Center/Jan van Breeman Research Institute, Amsterdam, Netherlands, 6St Josephs Hospital and McMaster University, Hamilton, ON, Canada, 7Charité-Universitätsmedizin, Berlin, Germany, 8University of Freiburg, Freiburg, Germany, 9Evangelisches Krankenhaus, Vienna, Austria, 10Institute of Rheumatology, Charles University, Prague, Czech Republic, 11Chiltern International, Neuilly, France, 12Docs International, Nanterre, France, 13Bristol-Myers Squibb, Munich, Germany, 14Bristol-Myers Squibb, Rueil-Malmaison, France

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Abatacept, obesity, rheumatoid arthritis (RA) and treatment

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Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Therapeutic Strategies, Biomarkers and Predictors of Outcomes in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose: In RA, reduced efficacy with anti-TNF therapy1 and dose escalation2 have been reported for obese patients (pts) compared with non-obese pts. Clinical trials have shown that BMI does not affect abatacept (ABA) efficacy or pharmacodynamics3 and real-world data show that short-term ABA retention, dosing and treatment outcomes are unaffected by BMI.4–6 We assessed the impact of BMI on the long-term retention of pts using IV ABA who had previously failed ≥1 biologic in clinical practice across Europe and Canada.

 

Methods: ACTION was a 2-year, non-interventional, international, multicenter, cohort study that evaluated the retention and effectiveness of IV ABA in adults with moderate-to-severe RA. Pts who received ≥1 prior biologic and enrolled in countries with sufficient pt numbers to explore between-country effects were included in this analysis. Pts were stratified by their baseline BMI.7 Crude 2-year retention rate was estimated using the Kaplan–Meier method. The effect of BMI was analyzed through a multivariate Cox proportional hazard model clustered for site effects with conditional imputation of missing data for covariates. Hazard ratios and corresponding 95% CI were adjusted for socio-demographic variables, disease characteristics, comorbidities at initiation and treatment characteristics. Pts were considered adherent to ABA if the ratio of the number of infusions received to the number expected was between 80 and 120%.   Results: 1009/1131 (89.2%) evaluable pts had received ≥1 prior biologic; 995 were included in the analysis. Pts with higher BMI had shorter disease duration, more severe disease (assessed by TJC, DAS28, HAQ-DI), were more likely to have comorbidities, but were less likely to be RF or anti-cyclic citrullinated peptide positive. Crude retention rates and adjusted HR are shown in Table 1. Similar proportions of pts were considered adherent to ABA therapy in all BMI groups as follows: BMI <25 kg/m2 = 82.8%, BMI 25–<30 kg/m2 = 79.5%, BMI 30–<35 kg/m2 = 85.0%, BMI ≥35 kg/m2 = 84.1%.   Table 1

BMI class7 n (%) Crude retention rate, % (95% CI) Adjusted hazard ratio 95% CI p-value
Underweight/normal <25 kg/m2 359 (36.1) 53.8 (48.3, 59.0) 1    
Overweight 25–<30 kg/m2 324 (32.5) 57.4 (51.5, 62.8)

0.90

0.72, 1.13 0.365
Obese class I 30–<35 kg/m2 168 (16.9) 50.5 (42.4, 58.1)

0.96

0.71, 1.31 0.815
Obese class II/III ≥35 kg/m2 85 (8.5) 53.2 (41.3, 63.7)

0.86

0.58, 1.26 0.437

Conclusion: In this analysis of the real-world ACTION study, BMI did not impact long-term retention of IV abatacept in pts who had previously received ≥1 biologic, when adjusted on differences in disease severity and comorbidities between BMI classes. Increased BMI was not associated with an increased number of infusions, indicating that IV abatacept can be an effective treatment option irrespective of BMI, without need for dose adjustment.

1.      Gremese E, et al. Arthritis Care Res 2013;65:94–100.

2.      Ariza-Ariza R, et al. Rheumatology (Oxford) 2007;46:529–32.

3.      Schiff M, et al. Rheumatology 2013;52:986–97.

4.      Nüßlein H, et al. Ann Rheum Dis 2013;72(Suppl 3):A616.

5.      Nüßlein H, et al. Ann Rheum Dis 2013;72(Suppl 3):A453.

6.      Iannone F, et al. Ann Rheum Dis 2014;73(Suppl 2):FRI0313.

7.      WHO Global Database on BMI Management retrieved June 2014.

 


Disclosure:

H. Nüßlein,

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

5;

R. Alten,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

5;

M. Galeazzi,
None;

H. Lorenz,

Bristol-Myers Squibb,

5;

M. Nurmohamed,

BMS, Janssen,

5,

Roche, Abbvie, Pfizer, UCB,

8,

Roche, Abbvie, Pfizer, MSD, UCB, BMS,

2;

W. Bensen,

BMS, Abbvie, Amgen, Celgene, Janssen, Pfizer, Roche, UCB, AstraZeneca, Servier,

2,

BMS, Abbvie, Amgen, Janssen, Pfizer, Roche, AstraZeneca,

5;

G. Burmester,

AbbVie, Pfizer, Roche, UCB,

2,

AbbVie, BMS, MSD, Medimmune, Novartis, Pfizer, Roche, Sandoz, UCB,

5,

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

8;

H. H. Peter,
None;

P. Peichl,
None;

K. Pavelka,

MSD, AbbVie, Pfizer, UCB, Roche, Amgen, Menarini, BMS,

5;

M. Chartier,
None;

C. Poncet,

Bristol-Myers Squibb,

9;

C. Rauch,

Bristol-Myers Squibb,

3;

M. Le Bars,

Bristol-Myers Squibb,

3,

Bristol-Myers Squibb,

1.

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