Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Rheumatoid arthritis (RA) has a substantial impact on patient quality of life (QOL), physical functioning, and other outcomes important to patients. This subanalysis of the GO-MORE study aimed to evaluate patient-reported outcomes (PROs) and their associations with disease characteristics in RA patients receiving add-on subcutaneous (SC) golimumab (GLM).
Methods: GO-MORE was a large, open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2) despite nonbiologic disease-modifying antirheumatic drug (DMARD) treatment. Patients received 50-mg SC GLM once monthly for 6 months in addition to their current DMARD treatments. Clinical responses and PROs were assessed, including Health Assessment Questionnaire-Disability Index (HAQ-DI); patient’s global assessment (PGA) of disease activity; patient assessments of pain, disease state, and fatigue; EuroQol 5-dimension (EQ-5D) index and health state; and patient acceptable symptom state (PASS). Associations between PROs and several baseline disease and treatment history characteristics were tested with chi-square tests.
Results: After 6 months of add-on GLM therapy, 82.1% of 3280 efficacy-evaluable patients attained a good or moderate EULAR response. Substantial improvement occurred in pain/discomfort, disease activity, fatigue, and QOL at month 6 (table). 37.4% of patients achieved minimal or no functional impairment (HAQ-DI ≤0.5), and the percentage of patients with PASS improved from 13.9% at baseline to 66.0% at month 6. Patients in the upper 2 tertiles of baseline rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) had greater improvements in PASS and EQ-5D health state than patients in the lowest tertile. Most of these effects met the predefined P<.001 criterion early in treatment, but not at month 6. Early in treatment, the PASS rate was highest in patients with the longest disease duration (>10 years).
Table. Patient-Reported Outcomes at Baseline and After 6 Months of SC GLM Treatment
|
|
Baseline, |
Month 6, |
|
HAQ-DI |
1.44 (0.672) |
0.88 (0.690) |
|
PGA Disease Activity (0–100 mm VAS) |
65.5 (19.50) |
35.4 (25.37) |
|
Pain/Discomfort (0–100 mm VAS) |
64.5 (20.55) |
34.9 (26.54) |
|
Fatigue (1-4 scale) |
2.9 (0.86) |
2.2 (0.89) |
|
Disease State (1–5 scale) |
4.1 (0.90) |
2.7 (1.14) |
|
EQ-5D QOL Index (index range –0.59 to 1.0) |
0.42 (0.33) |
0.67 (0.262) |
|
EQ-5D Health State (0–100 mm VAS) |
46.6 (21.12) |
68.7 (22.20) |
Note: Lower scores indicate better outcomes, except for the EQ-5D. VAS, visual analog scale.
Conclusion: In patients with active RA despite DMARD treatment, 6 months of add-on GLM treatment led to substantial improvement in PROs, including QOL, pain, fatigue, PASS, and functioning. Higher baseline levels of RF and anti-CCP may be associated with better early response to GLM as assessed by PROs.
Disclosure:
B. Dasgupta,
EULAR, ACR, Health Technology Assessment, British Heart Foundation, Research for Patient Benefit UK, and Napp,
2,
Schering Plough, Merck, Roche, Mundipharma, Astra Zeneca,
8,
Schering Plough, Merck, Roche, Mundipharma, Astra Zeneca,
5;
P. Bertin,
MSD,
8;
L. Settas,
None;
J. Fonseca,
MSD, Pfizer, Roche, UCB, Abbott Immunology, BMS, Servier,
2,
MSD, Pfizer, Roche, UCB, Abbott Immunology, BMS, Servier,
8;
V. Wolff,
None;
R. Yao,
Merck Sharp & Dohme,
3;
M. Govoni,
Merck Sharp & Dohme,
3;
N. Vastesaeger,
Merck Sharp & Dohme,
3;
H. Weng,
Merck Sharp & Dohme,
3.
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