Body Mass Index Does Not Influence the Efficacy of Subcutaneous Abatacept in Patients with Psa: Results from a Phase III Trial

Iain B. McInnes¹, Gianfranco Ferraccioli², MA D'Agostino³, M Le Bars⁴, S Banerjee⁵, H Ahmad⁵, Y Elbez⁶, J Ye⁵ and Philip J Mease⁷, ¹University of Glasgow, Glasgow, Great Britain, ²Division of Rheumatology - Institute of Rheumatology and Affine Sciences, Catholic University of the Sacred Heart, Rome, Italy, ³Hôpital Ambroise Paré, Boulogne-Billancourt, France, ⁴Bristol-Myers Squibb, Rueil-Malmaison, France, ⁵Bristol-Myers Squibb, Princeton, NJ, ⁶Excelya, Boulogne-Billancourt, France, ⁷Swedish Medical Center and University of Washington, Seattle, WA

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Abatacept, body mass and psoriatic arthritis

Session Information

Date: Sunday, November 5, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster I

Session Type: ACR Poster Session A

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

Background/Purpose: Obesity is a risk factor for the development and severity of psoriatic arthritis (PsA).^1,2 Patients (pts) with increased BMI (overweight/obese) are less likely to achieve sustained minimal disease activity (MDA) vs those with normal BMI, independent of biologic and non-biologic DMARD use.³ Moreover, obese pts with PsA respond less favourably to TNFα inhibitors vs normal BMI pts.^4,5 In the Phase III ASTRAEA study (NCT01860976),⁶ abatacept (ABA) significantly improved disease activity and was well tolerated; the primary endpoint of ACR20 at 24 weeks (W) was met.⁶ We evaluated the relationship beween BMI and ABA response in a post hoc analysis of ASTRAEA. Methods: Pts were randomized (1:1) to weekly SC ABA 125 mg or placebo (PBO) for 24W. Pts without ≥20% improvement in joint counts at W16 were switched to open-label ABA (early escape; EE). Pts designated as EE or with missing data were imputed as non-responders. ACR20/50/70 responses and % of pts with DAS28 (CRP) ≤3.2 or <2.6, MDA, HAQ-DI response (change from baseline [CFB] ≥0.35) and radiographic non-progression (PsA-modified total Sharp/van der Heijde score, CFB ≤0) at W24 were compared for ABA vs PBO between three BMI subgroups (underweight/normal: <25 kg/m²; overweight: 25–30 kg/m²; obese: >30 kg/m²) using univariate and multivariate analyses. BMI <25 kg/m² subgroup was the reference and key potential confounding factors for treatment efficacy were included in the multivariate model. Odds ratios (ORs), 95% CIs and p values were calculated for each BMI subgroup comparison.

Results: Overall, 212 ABA- and 210 PBO-treated pts had available baseline BMI status. For ABA vs PBO, respectively, 31 (14.6%) vs 39 (18.6%) were underweight/normal, 77 (36.3%) vs 57 (27.1%) were overweight and 104 (49.1%) vs 114 (54.3%) were obese. In the ABA and PBO groups, neither overweight nor obese pts had a significantly lower ACR20 response vs underweight/normal pts in the univariate model. This was confirmed in the multivariate models in overweight and obese pts, respectively, vs underweight/normal pts: ABA: OR (95% CI) 1.215 (0.437, 3.378), p=0.7087 and 0.446 (0.162, 1.228), p=0.1181; PBO: OR (95% CI) 0.554 (0.189, 1.621), p=0.2811 and 0.460 (0.166, 1.271), p=0.1343. Similar results were observed for all other outcomes tested (Figure). Conclusion: As in RA, BMI does not appear to affect the efficacy of abatacept in PsA; this is consistent across both objective and pt-reported outcome measures. Given that 1 in 3 pts with PsA are overweight/obese, these data strongly suggest an advantage of abatacept therapy in this debilitating disease.

1. Kumar S, et al. J Eur Acad Dermatol Venereol 2013;27:1293–8.

2. Armstrong AW, et al. Nutr Diabetes 2012;2:e54.

3. Eder L, et al. Ann Rheum Dis 2015;74:813–7.

4. di Minno MN, et al. Arthritis Care Res (Hoboken) 2013;65:141–7.

5. Gremese E, et al. Front Immunol 2014;5:576.

6. Mease P, et al. Arthritis Rheumatol 2016;68(Suppl 10):[Abstract 1041].

Disclosure: I. B. McInnes, BMS, Celgene, Janssen, UCB, Roche, 2,BMS, Celgene, Janssen, Novartis, Pfizer, AbbVie, UCB, Lilly, 5; G. Ferraccioli, Roche, BMS, Pfizer, 2,MSD, UCB, Pfizer, AbbVie, Lilly, Cellgene, Novartis, Roche, 8; M. D'Agostino, BMS, AbbVie, Novartis, 8; M. Le Bars, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1, 9; S. Banerjee, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; H. Ahmad, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1, 9; Y. Elbez, None; J. Ye, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; P. J. Mease, AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2,AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Corrona, Demira, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, Zynerba, 5,AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Novartis, Pfizer, UCB, 8.

To cite this abstract in AMA style:

McInnes IB, Ferraccioli G, D'Agostino M, Le Bars M, Banerjee S, Ahmad H, Elbez Y, Ye J, Mease PJ. Body Mass Index Does Not Influence the Efficacy of Subcutaneous Abatacept in Patients with Psa: Results from a Phase III Trial [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/body-mass-index-does-not-influence-the-efficacy-of-subcutaneous-abatacept-in-patients-with-psa-results-from-a-phase-iii-trial/. Accessed .

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/body-mass-index-does-not-influence-the-efficacy-of-subcutaneous-abatacept-in-patients-with-psa-results-from-a-phase-iii-trial/