Artikel
Body Mass Index Does Not Influence the Efficacy of Abatacept in Patients With PsA: Results From the ASTRAEA Trial
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Veröffentlicht: | 4. September 2017 |
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Background: Obesity is a risk factor for the development and severity of psoriatic arthritis (PsA) [1], [2]. Patients with increased BMI are less likely to achieve sustained minimal disease activity (MDA) compared with those with normal BMI, independent of treatment [3]. Moreover, obese patients with PsA respond less favourably to TNFα inhibitors than those with normal BMI [4], [5]. In the Phase III ASTRAEA trial (NCT01860976) [6], abatacept significantly improved disease activity and was well tolerated; the primary endpoint of ACR20 at 24 weeks (W) was met.[REF6] The objective of this study was to evaluate post hoc the relationship between BMI and abatacept response in ASTRAEA.
Methods: Patients were randomized (1:1) to weekly SC abatacept 125 mg or placebo for 24W. Patients without ≥20% improvement in joint counts at W16 were switched to open-label abatacept (early escape). Patients designated as early escape or with missing data were imputed as non-responders. ACR20/50/70 responses and percentages of patients 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 abatacept vs placebo 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 abatacept- and 210 placebo-treated patients had available baseline BMI status. For abatacept vs placebo, 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 abatacept and placebo groups, neither overweight nor obese patients had a significantly lower ACR20 response compared with underweight/normal patients in the univariate model. These results were confirmed in the multivariate models in overweight and obese patients, vs underweight/normal patients: abatacept group: OR (95% CI) 1.215 (0.437, 3.378), p=0.7087 and 0.446 (0.162, 1.228), p=0.1181; placebo group: 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 1 [Fig. 1]).
Conclusion: As in RA, BMI does not appear to affect the efficacy of abatacept in PsA across both objective and patient-reported outcome measures. Given that 1 in 3 patients with PsA are overweight/obese, these data strongly suggest an advantage of abatacept therapy in this debilitating disease.
References
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