Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Treat-To-Target for the Management of Rheumatoid Arthritis: A Validation Using Patient Reported Outcomes Data from Two Phase III Clinical Trials of Golimumab.
Keystone6, Ed C., Fleischmann4, Roy M., Han3, Chenglong, Emery2, Paul, Genovese5, Mark C., Gathany3, Timothy, Hsia1, Elizabeth C.
Centocor Research and Development, Inc./Univ. of Pennsylvania School of Medicine, Malvern, PA
Chapel Allerton Hospital, Leeds, United Kingdom
Johnson and Johnson Pharmaceutical Services, LLC
Rheumatology Associates, Dallas, TX
Stanford University, Sunnyvale, CA
University of Toronto, Toronto, ON, Canada
To assess the impact of disease remission, a treatment target in the management of rheumatoid arthritis (RA) recommended by the International Task Force, on patient reported outcomes 1.
The efficacy and safety of golimumab (GLM) were assessed in methotrexate (MTX)-naïve RA patients (GO-BEFORE, N=637), and RA patients with inadequate response to MTX (GO-FORWARD, N=444). In both trials, patients with active RA were randomly assigned to placebo (PBO) +MTX, GLM 100mg+PBO, or GLM (50 or 100mg) +MTX, q 4 weeks. Clinical remission was defined as DAS28 (ESR) <2.6. Patient reported outcomes included physical function, quality of life, fatigue, pain and work productivity as measured using instruments of Health Assessment Questionnaire (HAQ), 36-item short-form health survey (SF36 PCS and MCS), Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Pain Severity Score of Brief Pain Inventory (BPI-Pain) and a visual analogue scale of daily work productivity. An ANOVA on van der Waerden normal scores or Chi-square test were performed for between-group comparisons.
At week 24, a greater proportion of patients treated with GLM+MTX achieved DAS28<2.6 compared to patients treated with PBO+MTX (22.3% vs. 11.3% in GO- BEFORE, and 21.4% vs. 6.0% in GO-FORWARD, all p<0.01). GLM+MTX treated-patients had a greater improvement in patient reported outcomes than patients treated with PBO+MTX. The overall distribution of SF36-PCS shifted significantly towards a distribution observed in the normal population at week 24 through 104. Compared to patients without remission, more patients in remission at week 24 achieved a normal physical function (HAQ<=0.5) (75.3% vs. 27.3%), a SF-36 PCS>=50 (median value of general population) (48.3%, vs. 7.6%) and a SF-36 MCS>=50 (median value of general population) (66.3% vs. 40.3%), regained employability (43.5% vs. 27.6%) and achieved significant improvement in work productivity (80% vs. 28.3%) from baseline (all p-values<0.01). Greater improvements (median) in FACIT-Fatigue (week 24: 12.0 vs. 4.0) and in BPI-Pain score (week 14: 2.1 vs. 0.8) were observed among patients in remission than patients without remission.
This analysis indicates that controlling disease activity in patients with RA is crucial to regaining a normal life. Thus DAS28 remission may be a reasonable target in the management of RA.
To cite this abstract, please use the following information:
Keystone, Ed C., Fleischmann, Roy M., Han, Chenglong, Emery, Paul, Genovese, Mark C., Gathany, Timothy, et al; Treat-To-Target for the Management of Rheumatoid Arthritis: A Validation Using Patient Reported Outcomes Data from Two Phase III Clinical Trials of Golimumab. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1136