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Abstract Number: 1424

Impact of Glucocorticoid Therapy on the Efficacy of SC Abatacept or Adalimumab in RA Patients with Inadequate Response to MTX: A Post Hoc Analysis of Data from a Head-to-Head Trial

Yannick Degboé1,2, Michael Schiff3, Michael Weinblatt4, Roy Fleischmann5, HA Ahmad6 and Arnaud Constantin2,7, 1Toulouse University Hospital, Toulouse, France, 2Université Paul Sabatier, Toulouse, France, 3University of Colorado, Denver, CO, 4Brigham and Women’s Hospital, Boston, MA, 5University of Texas Southwestern Medical Center, Dallas, TX, 6Bristol-Myers Squibb, Princeton, NJ, 7Purpan University Hospital, Toulouse, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Abatacept, Adalimumab, Early Rheumatoid Arthritis, glucocorticoids and remission

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Session Information

Date: Monday, November 6, 2017

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: In patients with RA, low-dose glucocorticoids (GCs) have been shown to increase clinical, functional and radiographic efficacy when combined with conventional synthetic DMARDs;1 however, evidence for potentiation of bDMARD efficacy is lacking. The objective was to assess the impact of low-dose GCs on the efficacy of SC abatacept or adalimumab in biologic-naïve patients with active RA and inadequate response to MTX enrolled in the AMPLE trial (NCT00929864).2,3 Methods: In this post hoc analysis, efficacy outcomes were compared based on GC therapy at baseline (≤10 mg/day vs no GC) in patients receiving abatacept or adalimumab. Outcomes assessed were: mean change from baseline in DAS28 (CRP), HAQ-DI and modified total Sharp score (mTSS) over time; CDAI and SDAI remission rates, proportion of patients with DAS28 (CRP) <2.6 and with improvement in HAQ-DI score ≥0.3, and radiographic non-progression rates (TSS ≤ SDC [2.2 points]) at Years 1 and 2. Results: The analysis included 317/318 patients treated with abatacept + MTX (161 GC, 156 no GC) and 326/328 treated with adalimumab + MTX (162 GC, 164 no GC). Baseline demographics and adverse events during follow-up were similar across groups. At baseline, patients treated with GC had more severe radiographic disease (mean [SD] TSS: abatacept/GC 23.9 [37.9] vs abatacept/no GC 15.8 [26.9], adalimumab/GC 22.8 [32.6] vs adalimumab/no GC 15.6 [23.7]). Baseline disease activity (mean [SD] DAS28 [CRP]) was similar across groups: abatacept/GC 5.7 (1.1) vs abatacept/no GC 5.3 (1.2), adalimumab/GC 5.6 (1.1) vs adalimumab/no-GC 5.5 (1.1). Mean change (95% CI) from baseline in DAS28 (CRP) was significantly greater in the abatacept/GC than in the abatacept/no-GC subgroup at Month 6 (–2.24 [–2.45, –2.04] vs –1.94 [–2.14, 1.74]; p=0.0293), but not at Year 1 or 2, and did not differ significantly by GC treatment in adalimumab-treated patients. The proportions of patients in CDAI or SDAI remission or with DAS28 (CRP) <2.6 were similar in GC and no GC subgroups for both treatments (Figure). Radiographic progression rates at Years 1 and 2 and mean change from baseline in mTSS over 2 years were the same regardless of GC use. The proportion of patients with improvement in HAQ-DI score ≥0.3 was higher in the abatacept/GC subgroup than the abatacept/no GC subgroup at 6 months (70.47 vs 57.64%; p=0.0289) but not at later time points and was not seen in adalimumab-treated patients.

Conclusion: The use of low-dose GC with abatacept or adalimumab in RA patients with inadequate response to MTX has no impact on short-term and medium-term outcomes. This finding could be because patients who entered this trial had active disease despite background GC use and they responded to the addition of an active medication.

1. Smolen J, et al. Ann Rheum Dis 2014;73:492–509.

2. Weinblatt ME, et al. Arthritis Rheum 2013;65:28–38.

3. Schiff M, et al. Ann Rheum Dis 2014;73:86–94.

   


Disclosure: Y. Degboé, None; M. Schiff, AbbVie, BMS, Eli Lilly, JNJ, UCB, 5,AbbVie, BMS, 8; M. Weinblatt, Amgen, BMS, Crescendo Bioscience, UCB, DxtTerity, Sanofi, 2,Amgen, BMS, Crescendo Bioscience, UCB, AbbVie, Lilly, Pfizer, Roche, 5; R. Fleischmann, AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene,EMD-Serono, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, 2,AbbVie, Amgen, BMS, Celgene, GSK, Janssen, Eli Lilly, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, 5; H. Ahmad, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1, 9; A. Constantin, AbbVie, BMS, Lilly, Pfizer, Procter and Gamble, Sanofi, UCB, 5.

To cite this abstract in AMA style:

Degboé Y, Schiff M, Weinblatt M, Fleischmann R, Ahmad H, Constantin A. Impact of Glucocorticoid Therapy on the Efficacy of SC Abatacept or Adalimumab in RA Patients with Inadequate Response to MTX: A Post Hoc Analysis of Data from a Head-to-Head Trial [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/impact-of-glucocorticoid-therapy-on-the-efficacy-of-sc-abatacept-or-adalimumab-in-ra-patients-with-inadequate-response-to-mtx-a-post-hoc-analysis-of-data-from-a-head-to-head-trial/. Accessed .
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