Abstract | BACKGROUND: This study assessed the impact of simultaneous achievement of clinical, functional and structural efficacy, herein referred to as comprehensive disease control (CDC), on short-term and long-term work-related outcomes, health-related quality of life (HRQoL), pain and fatigue. METHODS: Data were pooled from three randomised trials of adalimumab plus methotrexate for treatment of early-stage or late-stage rheumatoid arthritis (RA). CDC was defined as 28-joint Disease Activity Score using C reactive protein <2.6, Health Assessment Questionnaire <0.5 and change from baseline in modified Total Sharp Score ≤0.5. Changes in scores at weeks 26 and 52 for work-related outcomes, Short Form 36 (SF-36) physical (PCS) and mental component scores (MCS), a Visual Analogue Scale measuring pain (VAS- Pain) and Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) were compared between patient groups defined by achievement of CDC at week 26 using linear regression with adjustment for baseline scores. RESULTS: Patients with RA who achieved CDC at week 26 (n=200) had significantly greater improvements in VAS- Pain (46.9 vs 26.9; p<0.0001), FACIT-F (13.3 vs 7.5; p<0.0001), SF-36 PCS (19.7 vs 8.9; p<0.0001) and SF-36 MCS (8.1 vs 5.0; p=0.0004) than those who did not (n=1267). Results were consistent at week 52 and among methotrexate-naive patients with early RA, methotrexate-experienced patients with late-stage RA and patients with inadequate response to methotrexate. CONCLUSIONS: Patients with RA who achieved CDC at week 26 had improved short-term and long-term HRQoL, pain, fatigue and work-related outcomes compared with patients who do not. These results demonstrate that the joint achievement of all CDC components provides meaningful benefits to patients. TRIAL REGISTRATION NUMBERS:
DE019: NCT00195702, PREMIER: NCT00195702, OPTIMA: NCT00195702.
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Authors | Paul Emery, Arthur Kavanaugh, Yanjun Bao, Arijit Ganguli, Parvez Mulani |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 74
Issue 12
Pg. 2165-74
(Dec 2015)
ISSN: 1468-2060 [Electronic] England |
PMID | 25139667
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ |
Chemical References |
- Antirheumatic Agents
- Adalimumab
- Methotrexate
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Topics |
- Adalimumab
(therapeutic use)
- Antirheumatic Agents
(therapeutic use)
- Arthritis, Rheumatoid
(drug therapy)
- Disability Evaluation
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Humans
- Male
- Methotrexate
(therapeutic use)
- Middle Aged
- Quality of Life
- Severity of Illness Index
- Treatment Outcome
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