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Abstract Number: 363

Risk Factors for Radiographic Progression During TNF-Inhibitor Treatment in 932 Rheumatoid Arthritis Patients Treated in Clinical Practice: Results From the Nationwide Danish Danbio Registry

Lykke Midtbøll Ørnbjerg1, Mikkel Østergaard1, Pernille Bøyesen2, Anja Thormann1, Ulrik Tarp1, Wolfgang Bøhme1, Ditte Dencker1, Hanne M. Lindegaard3, Uta Engling Poulsen1, Annette Hansen4, Vibeke Stevenius Ringsdal1, Annette Schlemmer5, Niels Graudal1, Anne Rødgaard Andersen1, Jakob Espesen1, Gina Kollerup1, Torben Grube Christensen1, Randi Pelck1, Bente Glintborg1, Ole Rintek Madsen1, Dorte Vendelbo Jensen1, Ole Majgaard1 and Merete L. Hetland6, 1DANBIO, On behalf of Depts of Rheumatology, North, South, Central, Zealand and Capital Region, Copenhagen, Denmark, 2Rheumatology, Diakonhjemmet Hospital, Olso, Norway, 3Department of Rheumatology, Odense University Hospital, Odense, Denmark, 4Department of Rheumatology, Gentofte University Hospital, Copenhagen, Denmark, 5Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, 6Copenhagen University Hospital Glostrup, Copenhagen, Denmark

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy, Prognostic factors and rheumatoid arthritis (RA)

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects I: Drug Studies/Drug Safety/Drug Utilization/Disease Activity & Remission

Session Type: Abstract Submissions (ACR)

Background/Purpose: : Despite treatment with tumour necrosis factor inhibitors (TNFi) some rheumatoid arthritis (RA) patients progress radiographically in randomised controlled trials and observational cohorts (1). Risk factors for radiographic progression during TNFi treatment in clinical practice have not been investigated. The aim of this study was to identify baseline risk factors for radiographic progression during 2 years follow-up of TNF-inhibitor treated RA patients in clinical practice.

Methods: X-rays of hands and wrists obtained at the start of TNFi (baseline) and approximately 2 years after (follow-up) were collected from 16 Danish departments, and linked with clinical data from the DANBIO registry. X-rays were blinded to chronology and scored according to the Sharp/van der Heijde method. Potential predictive baseline variables (28-joint Disease Activity Score(DAS28), C-reactive protein(CRP), 28 Swollen Joint Count(SJC), 28 Tender Joint Count(TJC), Health Assessment Questionnaire(HAQ), Total Sharp Score (TSS), age, gender, IgM Rheumatoid Factor (IgM-RF), disease duration, number of previous Disease-Modifying Anti-Rheumatic Drugs (DMARDs), concomitant methotrexate (MTX), concomitant prednisolone, type of TNFi drug) were investigated with univariate regression and significant variables (p < 0.05) included in a logistic regression analysis with +/- radiographic progression (change in TSS> 0) as dependent variable.

Results: 932 patients (75% women, 79% IgM-RF positive, age 57(19-88) years (median(range)); disease duration  6(1-70) years), DAS28 5.4(4.6-6.1) (median(inter-quartile range(IQR)), TSS 30(38) (mean(SD)) 14(2-44)(median(IQR))) had available X-rays. At baseline 59% of patients started treatment with infliximab, 18% with etanercept and 23% with adalimumab. 15% of patients received TNFi monotherapy, 76% combination therapy with MTX and 9% with other DMARDs. At follow-up (median 526, IQR 392-735days), 59% were treated with the initial TNFi, 29% had switched to another TNFi and 12% had withdrawn from TNFi.

Yearly change in TSS was 0.6(2.4) units (mean(SD)), 0.0(0.0-0.5)(median(IQR)). 27% of patients progressed radiographically (change in TSS >0) during TNFi treatment. Independent risk factors for progression were baseline TSS, age, IgM-RF and concomitant treatment with prednisolone (Table).

Table: Final model of logistic regression analysis (n = 932)

Predictors of X-ray progression

Odds Ratio

P value

TSS (pr. unit increase)

1.004

0.049

Age (pr. year increase )

1.03

0.0002

IgM RF (if positive)

1.75

0.006

Concomitant prednisolone (if treated)

1.39

0.03

Conclusion:

In this nationwide observational study of 932 RA patients, baseline TSS, age, IgM-RF and concomitant prednisolone were risk factors for radiographic progression during 2 years follow-up.

References:

(1) Ørnbjerg LM. Ann Rheum Dis Published Online First: 24 April 2012. doi: 10.1136/annrheumdis-2012-201319


Disclosure:

L. M. Ørnbjerg,

MSD,

8;

M. Østergaard,

Abbott Laboratories,

2,

Abbott Laboratories,

5,

Abbott Laboratories,

8,

Centocor, Inc.,

5,

Merck Pharmaceuticals,

5,

Merck Pharmaceuticals,

8,

Mundipharma,

8,

Novo Nordisk,

8,

Pfizer Inc,

5,

Pfizer Inc,

8,

Roche Pharmaceuticals,

5,

Roche Pharmaceuticals,

8,

UCB,

5,

UCB,

8;

P. Bøyesen,
None;

A. Thormann,
None;

U. Tarp,

Roche Pharmaceuticals,

5,

Roche Pharmaceuticals,

8,

MSD,

8;

W. Bøhme,
None;

D. Dencker,
None;

H. M. Lindegaard,

Roche, MSD,

8;

U. E. Poulsen,
None;

A. Hansen,

MSD,

5;

V. S. Ringsdal,
None;

A. Schlemmer,

MSD,

8;

N. Graudal,
None;

A. R. Andersen,
None;

J. Espesen,
None;

G. Kollerup,

Schering-Plough,

8;

T. G. Christensen,
None;

R. Pelck,
None;

B. Glintborg,
None;

O. Rintek Madsen,

Abbott Laboratories,

5,

MSD,

5,

Pfizer Inc,

5,

BMS,

5,

UCB,

5,

Abbott Laboratories,

6,

MSD,

6,

Pfizer Inc,

6,

BMS,

6,

MSD,

8;

D. V. Jensen,
None;

O. Majgaard,
None;

M. L. Hetland,

Roche Pharmaceuticals,

5,

Pfizer Inc,

8,

MSD,

8,

BMS,

8,

Abbott Laboratories,

8,

UCB,

8.

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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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