The Prevalence Of Biological Monotherapy Among Rheumatoid Arthritis Patients In Denmark: Results From The Danish Nationwide Danbio Registry

Tanja Schjoedt Joergensen¹, Lars-Erik Kristensen², Tove Lorenzen³, Jørgen Jensen⁴, Lida Zanjani⁵, Toke Laursen⁶, Sheraz Butt⁷, Mette Y. Dam⁸, Hanne M. Lindegaard⁹, Jakob Espesen¹⁰, Oliver Hendricks¹¹, Prabhat Kumar¹², Anita Kincses¹³, Line H. Larsen¹⁴, Marlene Andersen¹⁵, Esben K. Næser¹⁶, Dorte V. Jensen¹⁷, Jolanta Grydehøj¹⁸, Barbara Unger¹⁹, Ninna Dufour²⁰, Vibeke N. Sørensen²¹, Sara Vildhøj²², Inger Marie J. Hansen²³, Johnny Raun²⁴ and Merete Lund Hetland²⁵, ¹The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen F, Denmark, ²Dept of Clinical Sciences, Lund, Section for Rheumatology, Lund University, Faculty of Medicine, Malmö, Sweden, ³Department of Rheumatology, Region Hospital Silkeborg, Silkeborg, Denmark, ⁴Department of Rheumatology, Køge, Denmark, ⁵Department of Rheumatology, Glostrup, Denmark, ⁶Department of Rheumatology, Gentofte, Denmark, ⁷Department of Rheumatology, Frederiksberg, Denmark, ⁸Department of Rheumatology, Aarhus, Denmark, ⁹Department of Rheumatology, Odense University Hospital, Odense, Denmark, ¹⁰Department of Rheumatology, Vejle, Denmark, ¹¹Department of Rheumatology, Gråsten, Denmark, ¹²Department of Rheumatology, Esbjerg, Denmark, ¹³Department of Rheumatology, Copenhagen, Denmark, ¹⁴Department of Rheumatology, Aalborg, Denmark, ¹⁵Department of Rheumatology, Aalborg University, Hjørring, Denmark, ¹⁶Department of Rheumatology, Silkeborg, Denmark, ¹⁷Department of Rheumatology, Rønne, Denmark, ¹⁸Department of Rheumatology, Viborg, Denmark, ¹⁹Department of Rheumatology, Horsens, Denmark, ²⁰Department of Rheumatology, Helsingør, Denmark, ²¹Department of Rheumatology, Randers, Denmark, ²²Department of Rheumatology, Holstebro, Denmark, ²³Department of Rheumatology, Svendborg, Denmark, ²⁴Department of Rheumatology, Fredericia, Denmark, ²⁵Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, The Danish Rheumatologic Database (DANBIO), Glostrup Hospital., Copenhagen, Denmark

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Biologic agents, biologic drugs and rheumatoid arthritis (RA)

Session Information

Session Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy II

Session Type: Abstract Submissions (ACR)

Background/Purpose:

It is estimated that between 10 and 30% of rheumatoid arthritis (RA) patients are methotrexate (MTX)-intolerant and discontinuation is common in clinical practice. For RA patients’ requiring biological treatment and not tolerating MTX, the options are either combination therapy with other disease-modifying antirheumatic drugs (DMARDs) or biological monotherapy. In Denmark it is mandatory to register the patients in the national database, DANBIO. The objective of the present study was to elucidate the prevalence of Danish RA patients currently on biological monotherapy.

Methods:

All RA patients, treated with biologics, that were registered in DANBIO, as receiving biological treatment as monotherapy during the period May 1^st 2011 to April 30^th 2013 were eligible for inclusion. All files of individual patients were reviewed for inconsistence with the treatment registration in DANBIO. Results are presented as descriptive statistics, with no adjustments or statistical models applied.

Results:

Twenty-one of 25 Danish rheumatology departments participated in the study. In total 4,744 RA patients were registered in DANBIO as being in biological treatment, of which 4,151 (87.5%, Figure) were treated in the participating departments. Of these, 1,000 (24.1%) were registered as receiving biological monotherapy. 225 (22.5%) of the 1000 were excluded after file review due to use of concomitant conventional DMARDs not registered in DANBIO, leaving 775 (18.7%) in verified currently biological monotherapy. Etanercept, adalimumab, tocilizumab and rituximab were the biological drugs that most often were given in monotherapy (Table).

Conclusion:

In Denmark, 18.7% of biological treatments for RA are prescribed as monotherapy, i.e. without concomitant DMARDS. Monotherapy is prevalent across all biologics, while with a preponderance with adalimumab, etanercept, and tocilizumab, all three having the indication monotherapy.

Acknowledgement:

This study was supported by the Oak Foundation and Roche Denmark

Figure: Flow diagram

Table: The distribution of various biologics.

	Numbers treated (N=775)	% of total
Abatacept	17	2.2
Adalimumab	165	21.3
Anakinra	3	0.4
Certolizumab	26	3.4
Etanercept	284	36.6
Golimumab	21	2.7
Infliximab	48	6.2
Rituximab	92	11.9
Tocilizumab	119	15.3

Disclosure:

T. S. Joergensen,

Roche Pharmaceuticals,

L. E. Kristensen,

Pfizer, Wyeth, Abbott, BMS, MSD and Schering-Plough.,

T. Lorenzen,

Advisory Board member of Roche and Pfizer,

J. Jensen,
None;

L. Zanjani,
None;

T. Laursen,
None;

S. Butt,
None;

M. Y. Dam,
None;

H. M. Lindegaard,

Lilly, MSD, Nordpharma and Roche,

J. Espesen,
None;

O. Hendricks,
None;

P. Kumar,
None;

A. Kincses,
None;

L. H. Larsen,
None;

M. Andersen,
None;

E. K. Næser,
None;

D. V. Jensen,
None;

J. Grydehøj,
None;

B. Unger,
None;

N. Dufour,
None;

V. N. Sørensen,
None;

S. Vildhøj,
None;

I. M. J. Hansen,
None;

J. Raun,
None;

M. L. Hetland,

Pfizer, ROche og MSD.,

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