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Abstract Number: 1838

No Increased Risk of Developing a First Invasive Melanoma in Rheumatoid Arthritis Patients Treated with Biologics: Results of a Collaborative Project of 11 European Biologics Registers

Louise Mercer1, Johan Askling2, Pauline Raaschou3, William Dixon1, Lene Dreyer4, Merete Lund Hetland5, Lene Mellemkjær6, Anja Strangfeld7, Angela Zink8, Florenzo Iannone9, Axel Finckh10, Jakub Zavada11, Helena Canhao12, Fernando Martins13, Xavier Mariette14, Jacques Morel15, Jacques-Eric Gottenberg16, Adele Green1, Victoria Hernández17, Florence Tubach18, Piet van Riel19, Kimme Hyrich20 and Joachim Listing7, 1The University of Manchester, Manchester, United Kingdom, 2Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden, 3Karolinska Institutet, Stockholm, Sweden, 4Copenhagen University Hospital at Gentofte, Gentofte, Denmark, 5On behalf of all Depts of Rheumatology in Denmark, DANBIO, Glostrup Hospital, Glostrup, Denmark, 6Virus, Lifestyle and Genes, The Danish Cancer Society, Copenhagen, Denmark, 7German Rheumatism Research Center, Berlin, Germany, 8German Rheumatism Research Centre and Charité University Medicine, Berlin, Germany, 9Reumatologia Universita e Policlinico di Bari, Bari, Italy, 10Department of Medical Specialities, University of Geneva, Geneva, Switzerland, 11Charles University, Prague, Czech Republic, 12Rheumatology Research Unit, Instituto de Medicina Molecular, Universidade de Lisboa, Lisbon, Portugal, 13Instituto de Medicina, Universidade de Lisboa, Lisbon, Portugal, 14rheumatology, Université Paris-Sud, Le Kremlin Bicêtre, France, 15Universite´ Montpellier, Montpellier, France, 16Department of rheumatology CHU, Strasbourg, France, 17BIOBADASER Registry, Madrid, Spain, 18INSERM, Universite Paris Diderot, Paris, France, 19Radboud University Medical Centre, Nijmegen, Netherlands, 20Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, United Kingdom

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Adverse events, epidemiologic methods and rheumatoid arthritis (RA)

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Session Information

Session Title: Rheumatoid Arthritis - Clinical Aspects III: Malignancies, Vaccinations, Pregnancy and Surgery

Session Type: Abstract Submissions (ACR)

Background/Purpose: Swedish and Danish national biologics registers (*) have reported a possible increase in melanoma risk with TNF inhibitors.  Since melanomas are uncommon, the association is difficult to evaluate in other individual registers. We therefore planned a EULAR collaborative project.

Methods: Patients with RA from 11 European biologics registers in 9 countries were included. Patients were followed prospectively from start of a new biologic treatment until the occurrence of first invasive histology-confirmed cutaneous melanoma, using an ever-exposed approach. For the TNFi cohort, prior exposure to biologic drugs was not permitted. Prior exposure to TNFi was allowed for other biologic drugs. For each register, incidence rates and standardized incidence ratios (SIR) of melanoma were calculated by using age- sex- and calendar year-specific rates from the general population of the corresponding country as reference. Poisson regression models were used to summarize the register-specific SIRs to overall SIR estimates. Rates of melanoma in biologic exposed patients were compared to those in biologic-naïve patients enrolled in participating registers by calculating incidence rate ratios (IRR). Overall SIRs and IRRs were calculated, taking the size of the registers into account.

Results: Overall, 114,291 patients were available for analysis: mean age 58 years; 74% female. 287 developed a first invasive melanoma. Background population rates varied due to differences in the incidence by country, calendar years and differences in the age and sex distribution of the corresponding RA cohorts (Table). The SIRs for biologic naϊve patients were similar across the registers whereas there was variation in SIRs between TNFi cohorts (table). The overall IRRs did not show a significantly increased melanoma risk for any of the biologic therapies compared to biologic-naïve patients. Similar results were found with other drug exposure models (data not shown).

Conclusion: This large European collaborative project of 11 registers from 9 countries did not confirm an increased risk of melanoma following exposure to TNFi, although an association cannot be completely ruled out with these data.

Table. Number of melanomas, standardized incidence ratios and incidence rate ratios in different treatment groups of RA

 

 

Person years

Pop. rate/ 100,000

N Obs.

N

Exp.

SIR (95% CI)

(Obs/Exp)

IRR (95% CI)

(SIR bDMARD/ SIR Ref.)

Biologic-naïve

total

300011

48

160

144.3

1.11 (0.9, 1.4)

Referent

 

Sweden

222496

52

133

115.5

1.15 (0.96, 1.4)

Ref. (Sweden)

 

BSRBR, UK

22972

35

9

8.0

1.12 (0.5; 2.1)

Ref. (UK)

 

DANBIO, Denmark

27469

57

14

15.7

0.89 (0.5;1.5)

Ref. (Denmark)

 

RABBIT, Germany

9916

33

4

3.3

1.22 (0.3, 3.1)

Ref. (Germany)

TNF ever-exposed

Total

242814

35

106

85.5

1.24 (0.99, 1.6)

1.14 (0.8, 1.6)

 

ARTIS, Sweden

59166

44

39

26.0

1.50 (1.1; 2.1)

1.30 (0.9; 1.9)

 

BSRBR, UK

90259

31

31

28.1

1.10 (0.8, 1.6)

0.98 (0.5, 2.3)

 

DANBIO, Denmark

22972

49

18

11.3

1.59 (0.9, 2.5)

1.79 (0.8, 3.9)

 

RABBIT, Germany

23103

31

7

7.1

0.99 (0.4;2.0 )

0.81 (0.2, 3.8)

 

GISEA, Italy

16180

40

6

6.4

0.94 (0.3; 2.0)

n.a.

 

SCQM, Switzerland

15605

26

3

4.1

0.74 (0.2; 2.2)

n.a.

 

ATTRA, Czech Republic

8441

22

1

1.8

0.55 (0;3.0)

n.a.

 

Reuma.pt, Portugal

7088

9

1

0.7

1.49 (0; 8.3)

n.a.

RTX ever-exposed

total

29619

35

13

10.3

1.26 (0.6, 2.5)

1.14 (0.5, 2.9)

TOC ever-exposed

total

5798

33

5

1.9

2.65 (0.8, 8.4)

2.39 (0.6,10.1)

ABA ever-exposed

total

4858

29

2

1.4

1.47 (0.1, 30.9)

1.33 (0.2; 7.6)

Table: Person-years, incidence rate in the general population(s) (Pop. rate), observed (obs.) and expected (exp.) melanoma cases, SIRs, and IRRs for biologic-naive, anti-TNF (TNF), rituximab (RTX), tocilizumab (TOC), and abatacept (ABA) exposed RA patients; n.a. not available (no biologic naïve cohort)         

(*)Raaschou P et al., BMJ 2013;346:f1939; Dreyer L et al. Ann Rheum Dis 2013;72:79-82


Disclosure:

L. Mercer,
None;

J. Askling,

AstraZeneca; Pfizer;,

2;

P. Raaschou,
None;

W. Dixon,
None;

L. Dreyer,
None;

M. L. Hetland,
None;

L. Mellemkjær,
None;

A. Strangfeld,
None;

A. Zink,
None;

F. Iannone,
None;

A. Finckh,
None;

J. Zavada,
None;

H. Canhao,
None;

F. Martins,
None;

X. Mariette,
None;

J. Morel,

Roche Pharmaceuticals,

5,

Pfizer Inc,

5,

Bristol-Myers Squibb,

5,

Union Chimique Belge,

5,

Merck Pharmaceuticals,

5,

Abbott Laboratories,

5;

J. E. Gottenberg,
None;

A. Green,
None;

V. Hernández,
None;

F. Tubach,
None;

P. van Riel,
None;

K. Hyrich,
None;

J. Listing,
None.

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