Medication | Case-Control/Cohort Study | Metaanalysis Data | Clinical Trials Data |
---|---|---|---|
Baseline evaluation | Survey study, n = 538 patients with BCC, n = 738 age, sex, and location matched controls; no association between psoriasis and BCC27 Danish cohort study of n = 6910 psoriasis patients mean followup 9.3 yrs, prior PUVA exposure unknown. SIR SCC men 3.86 (p < 0.05), women 4.7 (p < 0.05); SIR BCC men 2.16 (p < 0.05), women 2.33 (p < 0.05); melanoma men and women SIR 1.3, 95% CI 0.8–2.129 Case-control study, Western Canada Melanoma Study, n = 651 cases, 651 age and sex matched controls; RR of psoriasis (in melanoma cohort) 1.22, 95% CI 0.76–1.94; UV light exposure was not significantly different, although minimal in both cases and controls28 | ||
TNF-α inhibitors | Retrospective cohort study, n = 77 patients with severe psoriasis, treated with etanercept; total followup 48 wks; 0 BCC, 0 cutaneous SCC (1 mucosal SCC), 0 MM reported31 | Combined data from 36 global clinical trials of RA, PsA, ankylosing spondylitis, Crohn’s disease, psoriasis, juvenile idiopathic arthritis, n = 19,041 patients treated with adalimumab; comparing with National Cancer Institute dataset for controls, SIR for SCC in psoriasis 3.84, 95% CI 1.54–7.92; no longer significant when compared with either Arizona or Minnesota data as controls19 Combined clinical trial data of etanercept use in multiple disease indications (RA, juvenile idiopathic arthritis, PsA, ankylosing spondylitis, psoriasis), n = 13,977. Rate ratio NMSC in psoriasis 2.77, 95% CI 0.59–25.97. 70% SCC patients with history phototherapy (Gottlieb AB, Giannini EH, Mease PJ, Li J, Chi E, et al. Malignancies from patients receiving etanercept across approved indications [abstract]. Ann Rheum Dis 2008;67 Suppl II:322. | Randomized, double-blind trial, infliximab for psoriasis administered as intermittent or continuous dosing, n = 835, 50-wk followup. 9 BCC, 1 SCC, 0 MM. All patients with BCC or SCC with prior exposure to nbUVB (8 subjects, PUVA (2), or both (2); placebo group 0 BCC, 0 SCC, 0 MM identified30 |
Cyclosporine | Multicenter observational prospective 5-yr cohort study in severe psoriasis patients, n = 1252, controls from general population cancer registries in anticipating areas; 47% patients w/prior PUVA therapy; mean duration 1.9 yrs exposure, initial average dose 2.7–3.0 mg/kg. Overall SIR BCC 1.8, 95% CI 0.6–4.1, SCC 24.6, 95% CI 13.8–40.7, MM 4.7, 95% CI 0.6–17.032 Nested cohort crossover PUVA followup study, n = 28; with prior PUVA (> 200 sessions) and MTX use, incident rate ratio 3.1, 95% CI 2.6–3.733 Retrospective cohort study, n = 272 (n = 63 psoriatics) of cyclosporine in skin disease; 0 BCC, 0 SCC, 0 MM. Powered to exclude 2× increase in cancer risk w/power 90%, at paired 0.05 significance level; median followup 10.9 yrs, median treatment 8 mo; half of patients with prior “phototherapy” exposure34 | Multicenter study in severe psoriasis patients, treatment 6 to 30 mo with 3 mo post-treatment observation, n = 217; 2 BCC44 Combined data from 3 clinical trials of cyclosporine in psoriasis, n = 122; median treatment 21.5 mo. 1 metastatic SCC of neck noted after treatment in followup; > 70% with prior PUVA exposure45 | |
Methotrexate | Cohort study, n = 248 psoriatic, dose 5–25 mg, median followup 7 yrs; 1 SCC noted46 Nested case-control study of Finnish hospitalized psoriasis patients, n = 67 cases; RR MTX exposure 0.4, 95% CI 0.1–1.9; elevated rate of SCC in cohort likely associated with prior PUVA use47 Initial assessment, PUVA followup study, n = 1380, evaluate history of MTX use and NMSC; no association between MTX and NMSC in either PUVA-naive or treated patients48 PUVA followup cohort study, average followup 13.2 yrs, n = 1380, MTX exposure > 4 yrs, average at least 3 g (independent of PUVA exposure) RR SCC 2.0, 95% CI 1.4–2.835 | ||
Alefacept | Open-label trial of alefacept (up to 3 courses) in parallel with other chronic psoriasis thrapy (MTX, retinoids, UVB, cyclosporine, prednisone, topicals), n = 449; 4 BCC, 4 SCC, 0 MM37 Combined data from 13 trials in the alefacept clinical trial program, n = 1869; 39% with prior PUVA exposure. 36% of malignancies in trial were BCC or SCC; no specifics provided38 | ||
Ustekinumab | Double-blind, placebo-controlled RCT in psoriasis, n = 146, 52-wk followup; 1 BCC, 0 SCC, 0 MM39 PHOENIX 1: Double-blind, place bo controlled RCT in psoriasis, n = 766 76-wk followup; 2 BCC, 0 SCC, 0 MM40 PHOENIX 2: Double-blind, placebo controlled RCT in psoriasis, n = 1230, 52-wk followup; 0 BCC, 0 SCC, 0 MM41 Randomized trial ustekinumab vs etanercept in moderate to severe psoriasis, n = 903, 64-wk followup; 6 BCC, 1 SCC, 2 patients with BCC + SCC; no case of NMSC in etanercept-only group42 |
Abbreviations as in Table 1. PUVA: psoralen ultraviolet A; nbUVB: narrow-band ultraviolet B.