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Introduction: The use of anti-tumour necrosis factor (anti-TNF) therapy is increasing in the treatment of rheumatoid arthritis (RA), spondyloarthropathy, psoriasis and inflammatory bowel disease. It is being debated whether treatment of patients with rheumatic diseases with anti-TNF therapy is associated with an increased cancer incidence., Material and Methods: A descriptive study of cancer cases among 3,688 patients with rheumatic diseases who received anti-TNF therapy was performed. The patients were identified in the nationwide database DANBIO and had a total number of treatment years of 6,092 years. All cancer cases were identified and the cancer diagnoses were subsequently confirmed by medical record review., Results: A total of 30 cancers in 28 of 3,688 patients were registered in the DANBIO after initiation of anti-TNF therapy in the period from October 2000 to June 2007. Among these six men and 20 women had RA, and two men had Morbus Becterew. The following cancer types were observed: malignant lymphoma 2 (7%), lung 4 (13%), plicae vocalis 2 (7%), breast 4 (13%), pancreatic 3 (10%), colorectal 2 (7%), prostate 1 (3%), malignant melanoma 3 (10%) and non-melanoma skin cancer 9 (30%)., Conclusion: In our descriptive study from the nationwide database DANBIO, a total of 30 cancers were observed in 3,688 patients with rheumatic diseases within a cumulated period of treatment with anti-TNF of 6,092 years. Follow-up for anti-rheumatic and adverse effects in patients in the DANBIO database will continue. Future studies must reveal whether anti-TNF therapy is associated with an increased cancer risk. Planned Danish studies will include relevant control groups and adjustment for confounders.

All of the three well-known TNF alpha inhibitors (infliximab, adalimumab and etanercept) have a rapidly occurring and long-lasting effect in ankylosing spondylitis (AS). The IL-1 antagonist, anakinra, has been investigated in two open label studies with partially conflicting results. Apart from infusion reactions and local reactions which rarely are of clinical importance, infections appear significantly more often in the TNF alpha inhibitor groups compared to placebo groups. Most of the infections observed have been minor, but serious infections, including tuberculosis, have been described.

Psoriasis is an immune-mediated inflammatory skin disease which may be associated with psoriatic arthritis. Biological therapy is indicated in patients who do not respond to, or are intolerant to, or have contraindication against traditional therapy. TNFalpha antagonists are used for both skin and joint disease, while efalizumab, which targets T lymphocytes, is only indicated for the skin disease. Registration of the treated patients in quality databases is an essential instrument in the surveillance of beneficial and adverse events during biological therapy.

Basiliximab and daclizumab are analogous immunosuppressive agents approved for clinical renal transplantation. Both drugs are gene manipulated chimeric human/murine monoclonal antibodies with specificity against the alpha-chain of the interleukin-2 receptor (IL-2R) on activated T lymphocytes. By combining the drugs with calcineurin inhibitor based immunosuppression, an inhibition of the interleukin-2 (IL-2) synthesis as well as the IL-2/IL-2R reception is obtained. Consequently, the allogeneic immune response is suppressed and the risk of acute rejection of the transplant is reduced. By treatment with basiliximab or daclizumab in the recommended doses, a blockade of the IL-2R is obtained for up to 12 weeks. The incidence of acute rejection episodes is reduced by approx. 33%. The incorporation of human amino acid sequences has almost eliminated the immunogenicity of the drugs and reduced their rates of elimination. The side effects of prophylactic treatment with basiliximab/daclizumab do not differ from those of placebo.