title: Adverse reactions during biological drug therapy in psoriasis:clinical series and a review of the literature.
abstract: OBJECTIVE
  Psoriasis is a chronic, inflammatory skin disorder, histologically characterized by epidermal hyperplasia, anomalous keratinocyte differentiation, angiogenesis, and by inflammatory cell infiltrate. Psoriasis has a significant impact on quality of life and is often associated with serious psychological effects. The use of biological agents is expanding worldwide as alternative treatment for chronic inflammatory diseases including psoriasis. The European Medicines Agency (EMEA) approved the use of Efalizumab, Etanercept, Infliximab and Adalimumab in the treatment of psoriasis on the basis of the positive findings obtained from well-designed clinical trials. The ongoing monitoring of tolerability and possible side-effects of these drugs has, however, recently lead to the EMEA suspending Efalizumab on the grounds that the possible risks of its use outweighed the benefits.
  
  
  METHODS
  Fifty-four patients treated with the two classes of biological drug (Efalizumab and anti-TNF-α) were studied. The choice of biological drug therapy was conditioned by the extent and seriousness of the disease and by the presence of concomitant pathologies.
  
  
  RESULTS
  Nineteen patients presented adverse reactions, of which 9 necessitated interruption in treatment (6 Efalizumab and 3 anti-TNF-α).
  
  
  CONCLUSIONS
  This work reports the adverse reactions to these biological therapies found in our patients along with a review of the literature concerning adverse reactions in psoriasis treatment. From our experience and basing ourselves on the literature reporting studies conducted in large centres, we feel that it is indispensable to continue monitoring any reactions during biological drug treatment. In this way, there is more likelihood of preventing, where possible, or better managing any reactions linked to the use of these drugs.
authors.affiliation: Department of Dermatology, University of Sassari, Sassari, Italy. mmontesu@uniss.it
authors.forename: M A
authors.initials: MA
authors.lastname: Montesu
authors.forename: G M
authors.initials: GM
authors.lastname: Addis
authors.forename: R
authors.initials: R
authors.lastname: Satta
authors.forename: F
authors.initials: F
authors.lastname: Cottoni
mesh_terms: D000068879:Adalimumab; D000368:Aged; D000974:Antibodies, Antinuclear / Q000097:blood; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015535:Arthritis, Psoriatic / Q000150:complications / Q000188:drug therapy / Q000276:immunology; D001691:Biological Therapy / Q000009:adverse effects*; D003875:Drug Eruptions / Q000209:etiology*; D000068800:Etanercept; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D016867:Immunocompromised Host; D007074:Immunoglobulin G / Q000009:adverse effects* / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000209:etiology*; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000974:Antibodies, Antinuclear; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept; C472181:efalizumab