Adalimumab added to a treat-to-target strategy with methotrexate and intra-articular triamcinolone in early rheumatoid arthritis increased remission rates, function and quality of life. The OPERA Study: an investigator-initiated, randomised, double-blind, parallel-group, placebo-controlled trial
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
Adalimumab added to a treat-to-target strategy with methotrexate and intra-articular triamcinolone in early rheumatoid arthritis increased remission rates, function and quality of life. The OPERA Study : an investigator-initiated, randomised, double-blind, parallel-group, placebo-controlled trial. / Hørslev-Petersen, Kim; Hetland, Merete Lund; Junker, Peter; Pødenphant, Jan; Ellingsen, Torkell; Ahlquist, Palle; Lindegaard, Hanne; Linauskas, Asta; Schlemmer, Annette; Dam, Mette Yde; Hansen, Ib; Horn, Hans Christian; Ammitzbøll, Christian Gytz; Jørgensen, Anette; Krintel, Sophine Boysen; Raun, Johnny; Johansen, Julia S; Østergaard, Mikkel; Stengaard-Pedersen, Kristian; OPERA Study-Group.
In: Annals of the Rheumatic Diseases, Vol. 73, No. 4, 04.2014, p. 654-661.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Adalimumab added to a treat-to-target strategy with methotrexate and intra-articular triamcinolone in early rheumatoid arthritis increased remission rates, function and quality of life. The OPERA Study
T2 - an investigator-initiated, randomised, double-blind, parallel-group, placebo-controlled trial
AU - Hørslev-Petersen, Kim
AU - Hetland, Merete Lund
AU - Junker, Peter
AU - Pødenphant, Jan
AU - Ellingsen, Torkell
AU - Ahlquist, Palle
AU - Lindegaard, Hanne
AU - Linauskas, Asta
AU - Schlemmer, Annette
AU - Dam, Mette Yde
AU - Hansen, Ib
AU - Horn, Hans Christian
AU - Ammitzbøll, Christian Gytz
AU - Jørgensen, Anette
AU - Krintel, Sophine Boysen
AU - Raun, Johnny
AU - Johansen, Julia S
AU - Østergaard, Mikkel
AU - Stengaard-Pedersen, Kristian
AU - OPERA Study-Group
PY - 2014/4
Y1 - 2014/4
N2 - OBJECTIVES: An investigator-initiated, double-blinded, placebo-controlled, treat-to-target protocol (Clinical Trials:NCT00660647) studied whether adalimumab added to methotrexate and intra-articular triamcinolone as first-line treatment in early rheumatoid arthritis (ERA) increased the frequency of low disease activity (DAS28CRP<3.2) at 12 months.METHODS: In 14 Danish hospital-based clinics, 180 disease-modifying anti-rheumatic drugs (DMARD)-naïve ERA patients (<6 months duration) received methotrexate 7.5 mg/week (increased to 20 mg/week within 2 months) plus adalimumab 40 mg every other week (adalimumab-group, n=89) or methotrexate+placebo-adalimumab (placebo-group, n=91). At all visits, triamcinolone was injected into swollen joints (max. four joints/visit). If low disease activity was not achieved, sulfasalazine 2 g/day and hydroxychloroquine 200 mg/day were added after 3 months, and open-label biologics after 6-9 months. Efficacy was assessed primarily on the proportion of patients who reached treatment target (DAS28CRP<3.2). Secondary endpoints included DAS28CRP, remission, Health Assessment Questionnaire (HAQ), EQ-5D and SF-12. Analysis was by intention-to-treat with last observation carried forward.RESULTS: Baseline characteristics were similar between groups. In the adalimumab group/placebo group the 12-month cumulative triamcinolone doses were 5.4/7.0 ml (p=0.08). Triple therapy was applied in 18/27 patients (p=0.17). At 12 months, DAS28CRP<3.2 was reached in 80%/76% (p=0.65) and DAS28CRP was 2.0 (1.7-5.2) (medians (5th/95th percentile ranges)), versus 2.6 (1.7-4.7) (p=0.009). Remission rates were: DAS28CRP<2.6: 74%/49%, Clinical Disease Activity Index≤2.8: 61%/41%, Simplified Disease Activity Index<3.3: 57%/37%, European League Against Rheumatism/American College of Rheumatology Boolean: 48%/30% (0.0008CONCLUSIONS: Adalimumab added to methotrexate and intra-articular triamcinolone as first-line treatment did not increase the proportion of patients who reached the DAS28CRP<3.2 treatment target, but improved DAS28CRP, remission rates, function and quality of life in DMARD-naïve ERA.
AB - OBJECTIVES: An investigator-initiated, double-blinded, placebo-controlled, treat-to-target protocol (Clinical Trials:NCT00660647) studied whether adalimumab added to methotrexate and intra-articular triamcinolone as first-line treatment in early rheumatoid arthritis (ERA) increased the frequency of low disease activity (DAS28CRP<3.2) at 12 months.METHODS: In 14 Danish hospital-based clinics, 180 disease-modifying anti-rheumatic drugs (DMARD)-naïve ERA patients (<6 months duration) received methotrexate 7.5 mg/week (increased to 20 mg/week within 2 months) plus adalimumab 40 mg every other week (adalimumab-group, n=89) or methotrexate+placebo-adalimumab (placebo-group, n=91). At all visits, triamcinolone was injected into swollen joints (max. four joints/visit). If low disease activity was not achieved, sulfasalazine 2 g/day and hydroxychloroquine 200 mg/day were added after 3 months, and open-label biologics after 6-9 months. Efficacy was assessed primarily on the proportion of patients who reached treatment target (DAS28CRP<3.2). Secondary endpoints included DAS28CRP, remission, Health Assessment Questionnaire (HAQ), EQ-5D and SF-12. Analysis was by intention-to-treat with last observation carried forward.RESULTS: Baseline characteristics were similar between groups. In the adalimumab group/placebo group the 12-month cumulative triamcinolone doses were 5.4/7.0 ml (p=0.08). Triple therapy was applied in 18/27 patients (p=0.17). At 12 months, DAS28CRP<3.2 was reached in 80%/76% (p=0.65) and DAS28CRP was 2.0 (1.7-5.2) (medians (5th/95th percentile ranges)), versus 2.6 (1.7-4.7) (p=0.009). Remission rates were: DAS28CRP<2.6: 74%/49%, Clinical Disease Activity Index≤2.8: 61%/41%, Simplified Disease Activity Index<3.3: 57%/37%, European League Against Rheumatism/American College of Rheumatology Boolean: 48%/30% (0.0008CONCLUSIONS: Adalimumab added to methotrexate and intra-articular triamcinolone as first-line treatment did not increase the proportion of patients who reached the DAS28CRP<3.2 treatment target, but improved DAS28CRP, remission rates, function and quality of life in DMARD-naïve ERA.
KW - Adult
KW - Aged
KW - Antibodies, Monoclonal, Humanized
KW - Antirheumatic Agents
KW - Arthritis, Rheumatoid
KW - Double-Blind Method
KW - Drug Administration Schedule
KW - Drug Therapy, Combination
KW - Female
KW - Humans
KW - Injections, Intra-Articular
KW - Male
KW - Methotrexate
KW - Middle Aged
KW - Quality of Life
KW - Remission Induction
KW - Severity of Illness Index
KW - Treatment Outcome
KW - Triamcinolone
U2 - 10.1136/annrheumdis-2012-202735
DO - 10.1136/annrheumdis-2012-202735
M3 - Journal article
C2 - 23434570
VL - 73
SP - 654
EP - 661
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
SN - 0003-4967
IS - 4
ER -
ID: 138414582