Talk: The Influence of Anti-TNF Therapy Upon Incidence of Non-Melanoma Skin Cancer (NMSC) in Patients with Rheumatoid Arthritis (RA): Results From the BSR Biologics Register (BSRBR) (2009 ACR/ARHP Annual Scientific Meeting)

Wednesday, October 21, 2009: 12:15 PM

108 B (Pennsylvania Convention Center)

L. K. Mercer¹, J. B. Galloway¹, M. Lunt¹, W. G. Dixon¹, K. D. Watson¹, , D. P. Symmons¹, K. L. Hyrich¹ and On behalf of the BSRBR¹, ¹arc Epidemiology Unit, University of Manchester, Manchester, United Kingdom

Presentation Number: 2062

Purpose:

RA is associated with an increased risk of NMSC. Anti-TNF therapy may intensify this risk, although evidence to date is conflicting. Our aim was to explore the influence of anti-TNF therapy on the incidence of NMSC using data from the BSRBR, a prospective cohort study set up in 2001 to monitor the long-term safety of anti-TNF therapy in the UK.

Method:

11757 consecutive anti-TNF treated patients with RA were followed 6 monthly and compared to 3515 biologic-naīve subjects with active RA receiving traditional disease modifying therapy (DMARD). Patients were followed until 12/31/2008 or death, whichever came first. Incident NMSC were identified from consultant and patient questionnaires and record linkage with the UK national register for cancer. Local recurrence was included but carcinoma-in-situ (Bowen's disease) excluded as an incident NMSC. NMSC occurring after stopping anti-TNF was attributed to the most recently received anti-TNF drug. The rates of NMSC in the anti-TNF and DMARD cohorts were compared using multivariate Cox proportional hazards models adjusted for age, gender, disease duration, disease activity, HAQ, baseline steroid use, number of prior DMARDs, smoking and year of registration.

Results:

221 NMSC were verified: 175 in 149 anti-TNF patients (4.2/1000 pyrs) and 46 in 40 DMARD patients (5.1/1000 pyrs). Histology data were received for 135 NMSC in the anti-TNF patients of which 122 (90%) were basal cell carcinoma (BCC) and 12 (9%) squamous cell carcinoma (SCC). A similar ratio of BCC:SCC was seen in the DMARD cohort. The strongest predictor for NMSC was prior NMSC (HR 9.8 (95% CI 5.6, 17.0)), with other known risk factors (age, male gender and steroids) also associated with increased risk. Limiting the analysis to patients with no prior NMSC the fully adjusted hazard ratio (aHR) for anti-TNF vs. DMARD was 1.7 (0.9, 3.4). The aHR was 1.7 (0.8, 3.4) for etanercept (ETA), 2.9 (1.4, 6.1) for infliximab (INF) and 1.1 (0.5, 2.5) for adalimumab (ADA).

Conclusion:

In patients with no prior NMSC, the risk of NMSC was increased by 70% in patients with RA treated with anti-TNF therapy, although this was not significant. INF was associated with an almost 3 fold increase in risk of NMSC in this group. Vigilance for NMSC should be maintained in all patients with RA, especially when treated with anti-TNF therapy.

Table:

No of patients ever received the drug

DMARD
N=3515

All Anti-TNF
N=11757

ETA

INF

ADA

Person years follow up

9058

41716

18133

11212

12371

No of patients with prior NMSC (%)

83 (2.4)*

159 (1.4)*

64 (1.6)

38 (1.1)

57 (1.4)

Rate / 1000 pyrs (95% CI) in patients with no prior NMSC

2.4 (1.5, 3.6)

3.5 (2.9, 4.1)

3.0 (2.2, 3.9)

5.5 (4.2, 7.1)

2.4 (1.6, 3.4)

Crude HR in patients with no prior NMSC (95% CI)

Ref

1.0 (0.6, 1.6)

0.8 (0.5, 1.4)

1.8 (1.0, 3.1)

0.7 (0.4, 1.2)

Fully adjusted, limited to patients without prior NMSC (95% CI)

Ref

1.7 (0.9, 3.4)

1.7 (0.8, 3.4)

2.9 (1.4, 6.1)

1.1 (0.5, 2.5)

*p <0.001

2062 - The Influence of Anti-TNF Therapy Upon Incidence of Non-Melanoma Skin Cancer (NMSC) in Patients with Rheumatoid Arthritis (RA): Results From the BSR Biologics Register (BSRBR)