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

Kim Hørslev-Petersen; Merete Lund Hetland; Peter Junker; Jan Pødenphant; Torkell Ellingsen; Palle Ahlquist; Hanne Lindegaard; Asta Linauskas; Annette Schlemmer; Mette Yde Dam; Ib Hansen; Hans Christian Horn; Christian Gytz Ammitzbøll; Anette Jørgensen; Sophine Boysen Krintel; Johnny Raun; Julia S Johansen; Mikkel Østergaard; Kristian Stengaard-Pedersen; OPERA Study-Group

doi:10.1136/annrheumdis-2012-202735

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

Kim Hørslev-Petersen, Merete Lund Hetland, Peter Junker, Jan Pødenphant, Torkell Ellingsen, Palle Ahlquist, Hanne Lindegaard, Asta Linauskas, Annette Schlemmer, Mette Yde Dam, Ib Hansen, Hans Christian Horn, Christian Gytz Ammitzbøll, Anette Jørgensen, Sophine Boysen Krintel, Johnny Raun, Julia S Johansen, Mikkel Østergaard, Kristian Stengaard-Pedersen, OPERA Study-Group

76 Citations (Scopus)

Abstract

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% (0.0008<p<0.014, number-neededto-treat: 4.0-5.4). Twelve months HAQ, SF12PCS and EQ-5D improvements were most pronounced in the adalimumab group. Treatments were well tolerated. Conclusions: 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.

Original language	English
Journal	Annals of the Rheumatic Diseases
Volume	73
Issue number	4
Pages (from-to)	654-661
Number of pages	8
ISSN	0003-4967
DOIs	https://doi.org/10.1136/annrheumdis-2012-202735
Publication status	Published - Apr 2014

Keywords

Adult
Aged
Antibodies, Monoclonal, Humanized
Antirheumatic Agents
Arthritis, Rheumatoid
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Female
Humans
Injections, Intra-Articular
Male
Methotrexate
Middle Aged
Quality of Life
Remission Induction
Severity of Illness Index
Treatment Outcome
Triamcinolone

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Hørslev-Petersen, K., Hetland, M. L., Junker, P., Pødenphant, J., Ellingsen, T., Ahlquist, P., Lindegaard, H., Linauskas, A., Schlemmer, A., Dam, M. Y., Hansen, I., Horn, H. C., Ammitzbøll, C. G., Jørgensen, A., Krintel, S. B., Raun, J., Johansen, J. S., Østergaard, M., Stengaard-Pedersen, K., & OPERA Study-Group (2014). 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. Annals of the Rheumatic Diseases, 73(4), 654-661. https://doi.org/10.1136/annrheumdis-2012-202735

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 et al.

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

Hørslev-Petersen, K, Hetland, ML, Junker, P, Pødenphant, J, Ellingsen, T, Ahlquist, P, Lindegaard, H, Linauskas, A, Schlemmer, A, Dam, MY, Hansen, I, Horn, HC, Ammitzbøll, CG, Jørgensen, A, Krintel, SB, Raun, J, Johansen, JS , Østergaard, M, Stengaard-Pedersen, K & OPERA Study-Group 2014, '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', Annals of the Rheumatic Diseases, vol. 73, no. 4, pp. 654-661. https://doi.org/10.1136/annrheumdis-2012-202735

Hørslev-Petersen K, Hetland ML, Junker P, Pødenphant J, Ellingsen T, Ahlquist P et al. 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. Annals of the Rheumatic Diseases. 2014 Apr;73(4):654-661. doi: 10.1136/annrheumdis-2012-202735

Hørslev-Petersen, Kim ; Hetland, Merete Lund ; Junker, Peter et al. / 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. In: Annals of the Rheumatic Diseases. 2014 ; Vol. 73, No. 4. pp. 654-661.

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title = "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",

abstract = "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)-na{\"i}ve 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% (0.0008",

keywords = "Adult, Aged, Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Arthritis, Rheumatoid, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Injections, Intra-Articular, Male, Methotrexate, Middle Aged, Quality of Life, Remission Induction, Severity of Illness Index, Treatment Outcome, Triamcinolone",

author = "Kim H{\o}rslev-Petersen and Hetland, {Merete Lund} and Peter Junker and Jan P{\o}denphant and Torkell Ellingsen and Palle Ahlquist and Hanne Lindegaard and Asta Linauskas and Annette Schlemmer and Dam, {Mette Yde} and Ib Hansen and Horn, {Hans Christian} and Ammitzb{\o}ll, {Christian Gytz} and Anette J{\o}rgensen and Krintel, {Sophine Boysen} and Johnny Raun and Johansen, {Julia S} and Mikkel {\O}stergaard and Kristian Stengaard-Pedersen and {OPERA Study-Group}",

year = "2014",

month = apr,

doi = "10.1136/annrheumdis-2012-202735",

language = "English",

volume = "73",

pages = "654--661",

journal = "Annals of the Rheumatic Diseases",

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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% (0.0008

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% (0.0008

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

SN - 0003-4967

VL - 73

SP - 654

EP - 661

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 4

ER -