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Abstract Number: 846

Rheumatoid Arthritis, Anti-Tumor Necrosis Factor Therapy, and Risk of Squamous Cell and Basal Cell Skin Cancer- a Nationwide Population Based Prospective Cohort Study from Sweden

Pauline Raaschou1, Julia F Simard2, Charlotte Asker-Hagelberg3, Johan Askling4 and the ARTIS Study group5, 1Karolinska Institutet, Stockholm, Sweden, 2Division of Epidemiology, Health Research and Policy Department, and Division of Immunology & Rheumatology, Department of Medicine, Stanford School of Medicine, Stanford, CA, 3Swedish Medical Products Agency, SE-751 03 Uppsala, Sweden, 4Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, 5Karolinska Institutet och Svensk Reumatologisk förening, Solna, Sweden

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Cancer, rheumatoid arthritis (RA) and tumor necrosis factor (TNF), Safety issues

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Session Information

Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy I: Safety of Biologics and Small Molecules in Rheumatoid Arthritis - Malignancy and Infection

Session Type: Abstract Submissions (ACR)

Background/Purpose: There is a concern that tumor necrosis factor inhibitors (TNFi) may interplay with tumor biology and increase the risk of cancer, in particular cancer types already associated with states of immune perturbation, such as skin cancers. We therefore investigated the risk of first squamous cell (SCC) and basal cell (BCC) cancers in TNFi-treated rheumatoid arthritis (RA) compared to biologics-naïve RA, and also in biologics-naïve RA compared to the general population, taking several potential confounders into account.

Methods: Through register-linkages, we assembled a cohort of biologics-naïve patients with RA (n=54,450), one cohort of patients with RA starting TNFi-treatment as first biologic 1998-2011 (n=10,974), and a general population comparator cohort (matched 5:1 to the biologics-naïve RA-patients). Individuals with a history of organ transplantation and/or invasive malignancy were excluded. The primary outcome was defined as first in situ or invasive SCC (1998-2011), and first BCC (2004-2011) during follow-up. Hazard ratios (HR) were estimated adjusting for several potential confounders including invasive malignancy during follow-up, use of immuno-suppressive medications and history of non-melanoma skin cancer. We performed a series of sensitivity analyses using different definitions of the study population, risk window, and outcome.

Results: Comparing biologics-naïve RA to the general population, the HR of first in situ or invasive SCC in RA was 2.01 (95% CI 1.80-2.33). Based on 168 vs. 803 first invasive or in situ SCC, the adjusted HR was 1.20 (95% CI 0.96-1.51) comparing TNFi-treated to biologics-naïve RA. The HR of SCC was driven mainly by in situ lesions. Similarly, comparing biologics-naïve RA to the general population, the HR of first BCC was 1.22 (95% CI 1.23-1.34). Based on 169 vs. 1,439 first BCC, the adjusted HR was 1.01 (95% CI 0.85-1.21) comparing TNFi-treated to biologics-naïve RA.

Conclusion: RA (in the absence of TNFi-treatment) was associated with a doubled risk of SCC. TNFi-treatment was associated with a further 20% increase in the risk of in situ, but not invasive SCC. For BCC, RA (in the absence of TNFi treatment) was a much weaker risk factor, and TNFi treatment did not increased the risk of BCC. Whilst we cannot exclude surveillance bias as an explanation for our findings regarding SCC, the risks observed call for vigilance of skin lesions in RA, irrespective of treatment.

 Table 1. Occurrence and hazard ratios (HR) with 95% confidence intervals (CI), of squamous cell cancer (SCC) in 10,974 TNFi-treated, compared to 41,031biologics-naïve Swedish rheumatoid arthritis (RA)-patients.  Occurrence and hazard ratios (HR) with 95% confidence intervals (CI), of basal cell cancer (BCC) in 7,397 TNFi-treated, compared to 38,679 biologics-naïve Swedish RA-patients.

Squamous cell cancer

TNFi

(n events / person-years)

Biologics-naïve RA

(n events / person-years)

HR1

HR2

First during follow-up

168/ 66,010

803/221,081

1.24 (1.04-1.47)

1.20 (0.96-1.51)

Invasive

61/ 66,673

334/ 223,571

1.12 (0.84-1.50)

0.98 (0.71-1.35)

In situ

126/ 66,224

580/222,080

1.25 (1.03–1.53)

1.26 (1.02-1.57)

Basal cell cancer

First during follow-up

169/ 29,432

1,439/184,441

1.14 (0.97-1.36)

1.01 (0.85-1.21)

HR1   Stratified for sex, county and civil status. Adjusted for age

HR2 Stratified for sex, county, civil status, and education level. Adjusted for age, country of birth, co-morbidities during follow-up (chronic obstructive pulmonary disease, psoriatic disease, any benign skin disease,  non-melanoma skin cancer, malignant melanoma, all-site cancer, and joint surgery)solid  organ transplantation, ever use of cyclosporine, cyclophosphamide or azathioprine.



Disclosure:

P. Raaschou,
None;

J. F. Simard,
None;

C. Asker-Hagelberg,
None;

J. Askling,
None;

T. A. Study group,

Abbvie, Merck, BMS, Pfizer, SOBI, AstraZeneca, Roche, UCB,

9.

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