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Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction: a 2-year investigator-initiated, double-blinded, randomised, controlled trial (OPERA).
- Source :
- Annals of the Rheumatic Diseases; Sep2016, Vol. 75 Issue 9, p1645-1653, 9p, 1 Diagram, 3 Charts, 2 Graphs
- Publication Year :
- 2016
-
Abstract
- <bold>Objectives: </bold>To study clinical and radiographic outcomes after withdrawing 1 year's adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647).<bold>Methods: </bold>Disease-modifying antirheumatic drug (DMARD)-naive patients with eRA started methotrexate (20 mg/week) and intra-articular triamcinolone (20 mg/ml) for 2 years. In addition, they were randomised to receive placebo adalimumab (DMARD group, n=91) or adalimumab (40 mg/every other week) (DMARD+adalimumab group, n=89) during the first year. Sulfasalazine and hydroxychloroquine were added if disease activity persisted after 3 months. During year 2, synthetic DMARDs continued. Adalimumab was (re)initiated if active disease reoccurred. Clinical response, remission, disability, quality of life and radiographic changes were assessed.<bold>Results: </bold>One year after adalimumab withdrawal, treatment profiles and clinical responses did not differ between groups. In the DMARD/DMARD+adalimumab groups, the median 2-year methotrexate dose was 20/20 mg/week (p=0.45), triple DMARD therapy had been initiated in 33/27 patients (p=0.49), adalimumab was (re)initiated in 12/12 patients and cumulative triamcinolone dose was 160/120 mg (p=0.15). The treatment target (disease activity score, 4 variables, C-reactive protein (DAS28CRP) ≤3.2 or DAS28>3.2 without swollen joints) was achieved at all visits in ≥85% of patients in year 2; remission rates were DAS28CRP<2.6:69%/66%; Clinical Disease Activity Index ≤2.8:55%/57%; Simplified Disease Activity Index <3.3:54%/49%; American College of Rheumatology/European League against Rheumatism (28 joints):44%/45% (p=0.66-1.00). Radiographic progression (Δtotal Sharp score/year) was similar 1.31/0.53 (p=0.12). Erosive progression (Δerosion score (ES)/year) was year 1:0.57/0.06 (p=0.02); year 2:0.38/0.05 (p=0.005). Proportion of patients without erosive progression (ΔES≤0) was year 1: 59%/76% (p=0.03); year 2:64%/79% (p=0.04).<bold>Conclusions: </bold>An aggressive triamcinolone and synthetic DMARD treat-to-target strategy in eRA provided excellent 2-year clinical and radiographic disease control independent of adalimumab induction therapy. ES progression was slightly less during and following adalimumab induction therapy.<bold>Trial Registration Number: </bold>NCT00660647. [ABSTRACT FROM AUTHOR]
- Subjects :
- ANTIRHEUMATIC agents
DRUG therapy
COMBINATION drug therapy
COMPARATIVE studies
DRUG administration
GLUCOCORTICOIDS
INTRA-articular injections
RESEARCH methodology
MEDICAL cooperation
METHOTREXATE
RADIOGRAPHY
RESEARCH
RHEUMATOID arthritis
TRIAMCINOLONE
EVALUATION research
RANDOMIZED controlled trials
TREATMENT effectiveness
DISEASE remission
BLIND experiment
SEVERITY of illness index
DISEASE progression
Subjects
Details
- Language :
- English
- ISSN :
- 00034967
- Volume :
- 75
- Issue :
- 9
- Database :
- Complementary Index
- Journal :
- Annals of the Rheumatic Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 117368901
- Full Text :
- https://doi.org/10.1136/annrheumdis-2015-208166