title: Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest.
abstract: The German Psoriasis Registry PsoBest was conducted in 2008 in order to investigate the long-term outcomes and safety of systemic treatments for moderate-to-severe psoriasis. Safety analysis of antipsoriatic drugs with special focus on serious adverse events (SAE) for infections, malignancies and major cardiac events (MACE) was done. Nationwide non-interventional patient treatment registry conducted in 251 active dermatology centers. Until June 2012, n = 2444 patients [40 % female; mean age 47.3 (SD 14.1) years; mean duration of disease 18.2 (SD 14.7) years] were recruited, including n = 1791 patients (3842 patient years) with conventional systemic drugs and n = 908 (3442 patient years) with biological drugs. Mean PASI (Psoriasis Area and Severity Index) at inclusion was 14.7, mean DLQI (Dermatology Life Quality Index) 11.1, mean BMI (Body Mass Index) 28.2. The overall rate of SAE per 100 patient years were 1.3 (SD 0.9) per 100 patient years in conventional systemic and 1.5 (SD 1.2) in biologics (p > 0.5, no significant difference). The rates per 100 patient years for single severe adverse events were as follows (systemic/biologics): serious infections, 0.33/0.65 [CI (confidence interval) 0.13-0.54/0.35-0.98]; MACE, 0.56/0.77 (CI 0.29-0.97/0.41-1.31); malignancies (except non-melanoma skin cancer), 0.46/0.49 (CI 0.22-0.84/0.21-0.97). There were no significant differences between single drugs in any of the safety parameters. The conventional systemic and biologic drugs for psoriasis show satisfying safety under routine psoriasis care in Germany with respect to infections, MACE and malignancies.
authors.affiliation: Dermatologikum Hamburg, Hamburg, Germany. reich@dermatologikum.de.
authors.forename: K
authors.initials: K
authors.lastname: Reich
authors.affiliation: Department of Dermatology, Venereology and Allergy, Psoriasis Center, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Mrowietz
authors.affiliation: Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: M A
authors.initials: MA
authors.lastname: Radtke
authors.affiliation: Excellence Center for Inflammation Medicine, University Medical Center Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Thaci
authors.affiliation: Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: S J
authors.initials: SJ
authors.lastname: Rustenbach
authors.affiliation: Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Spehr
authors.affiliation: Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Augustin
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use; D001688:Biological Products / Q000009:adverse effects* / Q000627:therapeutic use; D001691:Biological Therapy / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000453:epidemiology; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced* / Q000453:epidemiology; D011565:Psoriasis / Q000188:drug therapy*; D012042:Registries; D000069549:Ustekinumab / Q000627:therapeutic use
chemical_list: D001688:Biological Products; D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000069549:Ustekinumab; D000068879:Adalimumab; D000068800:Etanercept; D008727:Methotrexate
keywords: Biologic treatment; Drug safety; Pharmacovigilance; Psoriasis; Registry; Systemic treatment