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Supplementary Table 2. Cohort studies of cancers associated with biologic DMARD use in patients with rheumatoid arthritis. Article Country Main Comparator Outcome Finding Newuser design Morgan 2014S53 Solomon 2014S54 UK Etanercept Traditional DMARDs No elevated risk of malignancy was found. No USA Methotrexate Yes Sweden Traditional DMARDs Invasive melanoma No Yes USA Adalimumab Etanercept, Infliximab Fatal infections (secondary) Reduced cancer risk was observed among TNF inhibitors and Traditional bDMARDs compared to methotrexate. 50% increase risk of invasive melanoma was observed. Rates of fatal infections were similar among three agents. No Raascho u 2013S55 Thyagara jan 2012S16 VenturaRíos 2012S18 Mercer 2012S56 Koike 2011S24 Slimani 2011S57 Dixon 2010S58 Strangfel d 2010S59 Askling 2009S60 Pallavicin i 2010S61 Wolfe 2007S62 Setoguch i 2006S63 Geborek 2005S64 TNF inhibitors, Traditional DMARDs, Rituximab, Abatacept TNF inhibitors Long-term safety including cancer Cancer Activecompar ator design Yes Yes Yes Mexico Biological DMARDs Traditional DMARDs Safety including infections Higher infection risk than traditional bDMARDs. No Yes UK TNF inhibitors Traditional DMARDs No Tocilizumab - Yes No France Rituximab - Yes No UK Traditional DMARDs with prior malignancy Traditional DMARDs with prior malignancy Traditional DMARDs Cancer No Yes Recurrent cancer Yes Yes Sweeden TNF inhibitors with prior malignancy Biological DMARDs with prior malignancy TNF inhibitors Risk was not elevated compared to Traditional bDMARDs. Most frequent serious adverse events were infections. Overall cancer rate was comparable to historical Traditional DMARD cohorts. Among the selected population studied, no increased risk was observed. No increased risk was observed. No Japan Keratinocyte skin cancer Safety including infections Cancer Cancer No elevated risk of malignancy was found. Yes Yes Italy TNF inhibitors - Cancer No No USA TNF inhibitors Lymphoma No Yes USA, Canada Sweeden TNF inhibitors Traditional DMARDs or none Methotrexate No elevated risk for overall cancer was found, however, lymphoma risk was elevated. No increased risk was observed. Malignancies No elevated risk of malignancy was found. Yes Yes TNF inhibitors Traditional DMARDs Malignancies No elevated risk for overall cancer was found, however, lymphoma risk was elevated. No Yes Germany -1- References: S16.Thyagarajan, V., Norman, H., Alexander, K. A., Napalkov, P. & Enger, C. Risk of mortality, fatal infection, and fatal malignancy related to use of anti-tumor necrosis factor-alpha biologics by rheumatoid arthritis patients. Semin Arthritis Rheum 42, 223–233 (2012). S18.Ventura-Rios, L. et al. Patient survival and safety with biologic therapy. Results of the Mexican National Registry Biobadamex 1.0. Reumatol Clin 8, 189– 194 (2012). S24.Koike, T. et al. Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients. Ann Rheum Dis 70, 2148– 2151 (2011). S53.Morgan, C. L. et al. Treatment of rheumatoid arthritis with etanercept with reference to disease-modifying anti-rheumatic drugs: long-term safety and survival using prospective, observational data. Rheumatology (Oxford) 53, 186–194 (2014). S54.Solomon, D. H. et al. Comparative cancer risk associated with methotrexate, other non-biologic and biologic disease-modifying anti-rheumatic drugs. Semin Arthritis Rheum 43, 489–497 (2014). S55.Raaschou, P., Simard, J. F., Holmqvist, M. & Askling, J. Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma: nationwide population based prospective cohort study from Sweden. BMJ 346, (2013). S56.Mercer, L. K. et al. The influence of anti-TNF therapy upon incidence of keratinocyte skin cancer in patients with rheumatoid arthritis: longitudinal results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 71, 869–874 (2012). S57.Slimani, S., Lukas, C., Combe, B. & Morel, J. Rituximab in rheumatoid arthritis and the risk of malignancies: report from a French cohort. Joint Bone Spine 78, 484–487 (2011). S58.Dixon, W. G. et al. Influence of anti-tumor necrosis factor therapy on cancer incidence in patients with rheumatoid arthritis who have had a prior malignancy: results from the British Society for Rheumatology Biologics Register. Arthritis Care Res (Hoboken) 62, 755–763 (2010). S59.Strangfeld, A. et al. Risk of incident or recurrent malignancies among patients with rheumatoid arthritis exposed to biologic therapy in the German biologics register RABBIT. Arthritis Res Ther 12, (2010). S60.Askling, J. et al. Cancer risk in patients with rheumatoid arthritis treated with anti-tumor necrosis factor alpha therapies: does the risk change with the time since start of treatment? Arthritis Rheum 60, 3180–3189 (2009). S61.Pallavicini, F. B. et al. Tumour necrosis factor antagonist therapy and cancer development: analysis of the LORHEN registry. Autoimmun Rev 9, 175–180 (2010). S62.Wolfe, F. & Michaud, K. The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19,562 patients during 89,710 person-years of observation. Arthritis Rheum 56, 1433–1439 (2007). S63.Setoguchi, S. et al. Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis. Arthritis Rheum 54, 2757–2764 (2006). S64.Geborek, P. et al. Tumour necrosis factor blockers do not increase overall tumour risk in patients with rheumatoid arthritis, but may be associated with an increased risk of lymphomas. Ann Rheum Dis 64, (2005). -2-