ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2748

Evaluation of Patient-Reported Outcomes By Baseline Disease Duration: 6-Month Data from Two Clinical Trials of Patients with Early Rheumatoid Arthritis Treated with Abatacept

Daniel E. Furst1, VP Bykerk2, Gerd Burmester3, BG Combe4, T. W. J. Huizinga5, E Alemao6, A Johnsen6 and Paul Emery7, 1Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 2Weill Cornell Medical College, New York, NY, 3Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, 4Montpellier University, Montpellier, France, 5Leiden University Medical Center, Leiden, Netherlands, 6Bristol-Myers Squibb, Princeton, NJ, 7University of Leeds, Leeds, United Kingdom

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: ,

Session Information

Date: Tuesday, November 10, 2015

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster III

Session Type: ACR Poster Session C

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

Background/Purpose: Patients with RA and longer disease duration generally do
not respond as well to treatment with DMARDs as patients with shorter duration
of disease. It has been reported that long-term disease control can be improved
with earlier use of biologic DMARDs.1,2 Patient-reported outcomes
(PROs) that are of particular importance to those with RA were compared in patients
with varying lengths of disease duration enrolled in the AGREE (Abatacept study to Gauge Remission and joint
damage progression in MTX naïve patients with Early Erosive RA),1
and the AVERT (Assessing Very Early Rheumatoid
arthritis Treatment)3 trials. Both
studies evaluated the efficacy of abatacept + MTX versus MTX alone.   Methods: In each study, PROs
analyzed were fatigue (visual analog scale), HAQ-DI, activity limitation (Activity Participation
Questionnaire [APaQ]), and physical and
mental function (short form-36 health survey [SF-36]). This post hoc
analysis included all randomized and treated patients (last observation carried
forward). PROs were evaluated in patients with early RA and ≤3 months’ disease
duration compared with those with >3 months’ disease duration after
treatment with SC abatacept + MTX or MTX alone. The mean changes in PRO from baseline to Month 6 (Day 169) were
calculated for each trial with adjustment based on analysis of covariance, with
treatment as a factor and baseline value as a covariate. Combined weighted means were then calculated.

Results:  

Irrespective of baseline
disease duration, changes from baseline in PROs for fatigue, HAQ-DI response, activity
limitation (APaQ), and SF-36 physical component summary (PCS) and mental
component summary (MCS) scores for the AGREE and AVERT trial data were generally
greater for patients treated with abatacept + MTX than MTX alone at 6 months (Table).
Patients treated with abatacept + MTX with shorter disease duration (≤3 months)
demonstrated reduced fatigue, improved physical function (HAQ-DI) and mental
function (MCS) compared with those with longer disease duration (>3 months; Table).

Conclusion:

Although patients with RA of both short
and longer disease duration benefited, those with shorter disease duration (≤3 months) generally reported improved PROs
compared with those with longer duration (>3 months) following treatment with abatacept + MTX for 6 months. These results support
the use of abatacept earlier in the course of RA.

1. Westhovens R, et al. Ann
Rheum Dis 2009;68:1870–7.

2. Emery P, et al. Ann
Rheum Dis 2010;69:510–6.

3. Emery P, et al. Ann
Rheum Dis 2014;73(Suppl 2):69.  

 

Weighted average mean changes in PRO from AVERT and AGREE combined (Baseline to Month 6)
ABA + MTX ≤3 months MTX ≤3 months ABA + MTX >3 months MTX >3 months
Fatigue (n=156; 133; 23)

–30.47

(n=153; 119; 34)

–22.98

(n=184; 117; 67)

–25.69

(n=174; 128; 46)

–24.49

HAQ-DI (n=156; 133; 23)

–0.91

(n=157; 120; 37)

–0.67

(n=189; 117; 72)

–0.75

(n=177; 129; 48)

–0.58

Activity limitation (APaQ) (n=154; 131; 23)

–9.11

(n=156; 122; 34)

–7.29

(n=184; 117; 67)

–9.58

(n=174; 127; 47)

–7.09

PCS (SF-36) (n=164; 133; 31)

10.82

(n=161; 119; 42)

7.14

(n=192; 117; 75)

10.91

(n=182; 128; 54)

7.83

MCS (SF-36) (n=164; 133; 31)

8.44

(n=161; 119; 42)

6.17

(n=192; 117; 75)

6.21

(n=182; 128; 54)

5.82

n=total number of patients from both trials with available data; n from AGREE; n from AVERT
   
Disclosure: D. E. Furst, Gilead, 2,GlaxoSmithKline, 2,NIH, 2,Novartis Pharmaceutical Corporation, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,Genentech and Biogen IDEC Inc., 2,UCB, 2,Abbvie, 5,Actelion Pharmaceuticals US, 5,Amgen, 5,Bristol-Myers Squibb, 5,Cytori, 5,Janssen Pharmaceutica Product, L.P., 5,Gilead, 5,GlaxoSmithKline, 5,NIH, 5,Novartis Pharmaceutical Corporation, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,Genentech and Biogen IDEC Inc., 5,UCB, 5,Abbvie, 8,Actelion Pharmaceuticals US, 8,Bristol-Myers Squibb, 2,Amgen, 2,Actelion Pharmaceuticals US, 2,Abbvie, 2,UCB, 8; V. Bykerk, Genentech, BMS, UCB, BIPI, 2,Amgen, Abbvie, BMS, UCB, Antares, Regeneron, Genentech, 5,Novartis and Biogen, 3; G. Burmester, Abbvie, Pfizer, UCB, Roche, 2,Abbvie, BMS, Pfizer, Merck, MedImmune, UCB, Roche, 5,Abbvie, BMS, Pfizer, Merck, UCB, Roche, 8; B. Combe, Pfizer, Roche-Chugai, 2,BMS, Merck, Pfizer, Roche-Chugai, UCB, 8; T. W. J. Huizinga, Merck, UCB, BMS, Biotest AG, Pfizer, GSK, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boehringer, Takea, Zydus, and Eli Lilly., 5,Roche & Abbott, 9; E. Alemao, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1; A. Johnsen, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; P. Emery, Abbott/Abbvie, Bristol-Myers Squibb, Pfizer, UCB, MSD, Roche, Novartis, Samsung, Takeda, Lilly, 5.

To cite this abstract in AMA style:

Furst DE, Bykerk V, Burmester G, Combe B, Huizinga TWJ, Alemao E, Johnsen A, Emery P. Evaluation of Patient-Reported Outcomes By Baseline Disease Duration: 6-Month Data from Two Clinical Trials of Patients with Early Rheumatoid Arthritis Treated with Abatacept [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/evaluation-of-patient-reported-outcomes-by-baseline-disease-duration-6-month-data-from-two-clinical-trials-of-patients-with-early-rheumatoid-arthritis-treated-with-abatacept/. Accessed .

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