Risk of adverse events in psoriasis patients receiving classic systemic drugs and biologics in a 5-year observational study of clinical practice: 2008-2013 results of the Biobadaderm registry

Journal of the European Academy of Dermatology and Venereology

Volumn 29, Issue 1, 2015, Pages 156-163

  Carretero, G ^a   Ferrandiz, C ^b   Dauden, E ^c   Vanaclocha Sebastian F ^d   Gomez Garcia F J ^e   Herrera Ceballos, E ^f   De La Cueva Dobao, P ^g   Belinchon I ^h   Sanchez Carazo J L ⁱ   Alsina Gibert, M ^j   Lopez Estebaranz J L ^k   Ferran M ^l   Torrado, R ^a   Carrascosa, J M ^b   Carazo, C ^c   Rivera, R ^d   Jimenez Puya R ^e   Garcia Doval I ^m,n  

^a HOSPITAL UNIVERSITARIO DE GRAN CANARIA DR NEGRÍN   (Spain)

^b HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^c HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^d HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^e HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^f HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

^g HOSPITAL UNIVERSITARIO INFANTA LEONOR   (Spain)

^h HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

ⁱ HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA   (Spain)

^j HOSPITAL CLÍNIC   (Spain)

^k HOSPITAL UNIVERSITARIO FUNDACIÓN ALCORCÓN   (Spain)

^l HOSPITAL DEL MAR   (Spain)

^m Research Unit   (Spain)

ⁿ UNIVERSITY HOSPITAL COMPLEX OF VIGO   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; CYCLOSPORIN; EFALIZUMAB; ETANERCEPT; ETRETIN; INFLIXIMAB; METHOTREXATE; USTEKINUMAB; BIOLOGICAL PRODUCT; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENT; KERATOLYTIC AGENT; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT; TNFR-FC FUSION PROTEIN; TUMOR NECROSIS FACTOR RECEPTOR;

ADULT; ADVERSE DRUG REACTION; AORTA DISSECTION; ARTICLE; BENIGN TUMOR; BREAST DISEASE; CEREBROVASCULAR ACCIDENT; CONGENITAL DISORDER; CONNECTIVE TISSUE DISEASE; DRUG FATALITY; DRUG SAFETY; EAR DISEASE; ENDOCRINE DISEASE; EYE DISEASE; FAMILIAL DISEASE; FEMALE; GASTROINTESTINAL DISEASE; GENETIC DISORDER; GENITAL SYSTEM DISEASE; HAZARD RATIO; HEART DISEASE; HEMATOLOGIC DISEASE; HEPATOBILIARY DISEASE; HUMAN; IMMUNOPATHOLOGY; INFECTION; INFESTATION; INJURY; INNER EAR DISEASE; INTOXICATION; KIDNEY DISEASE; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; METABOLISM; MIDDLE AGED; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NON SMALL CELL LUNG CANCER; NUTRITIONAL DISORDER; PNEUMONIA; PREGNANCY DISORDER; PRESCRIPTION; PSORIASIS; REGISTER; RESPIRATORY TRACT DISEASE; RISK FACTOR; SIDE EFFECT; SKIN DISEASE; STOMACH CANCER; SUBCUTANEOUS FAT DISORDER; THORAX DISEASE; URINARY TRACT DISEASE; VASCULAR DISEASE; AGED; COMPARATIVE STUDY; PROPORTIONAL HAZARDS MODEL; PROSPECTIVE STUDY; RISK ASSESSMENT; SPAIN;

ACITRETIN; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; BIOLOGICAL PRODUCTS; CYCLOSPORINE; FEMALE; HUMANS; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENTS; KERATOLYTIC AGENTS; MALE; METHOTREXATE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; PSORIASIS; RECEPTORS, TUMOR NECROSIS FACTOR; REGISTRIES; RISK ASSESSMENT; SPAIN;

EID: 84919773683     PISSN: 09269959     EISSN: 14683083     Source Type: Journal    
DOI: 10.1111/jdv.12492     Document Type: Article

References (18)

1. Schmitt J, Rosumeck S, Thomaschewski G, Sporbeck B, Haufe E, Nast A,. Efficacy and safety of systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials. Br J Dermatol 2014; 170: 274-303.
2. Singh JA, Wells GA, Christensen R, et al,. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 2011; 2: CD008794.
3. Rustin MH,. Long-term safety of biologics in the treatment of moderate-to-severe plaque psoriasis: review of current data. Br J Dermatol 2012; 167 (Suppl 3): 3-11.
4. Nijsten T, Spuls PI, Naldi L, Stern RS,. The misperception that clinical trial data reflect long-term drug safety: lessons learned from Efalizumab's withdrawal. Arch Dermatol 2009; 145: 1037-1039.
5. Garcia-Doval I, Carretero G, Vanaclocha F, et al,. Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials. Arch Dermatol 2012; 148: 463-470.
6. Rowley-Jones D, Nicholson PA,. Development of medicines: full developement. In:, Griffin J. P., O'Grady J., D'Arcy P. F., eds. The textbook of pharmaceutical medicine. Belfast: Queen's University of Belfast; 1998. p. 233-250.
7. Kimball AB, Pariser D, Yamauchi PS, et al,. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol 2013; 68: 756-764.
8. Papp KA, Strober B, Augustin M, et al,. PSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents. J Drugs Dermatol 2012; 11: 1210-1217.
9. Driessen RJ, Boezeman JB, van de Kerkhof PC, de Jong EM,. Three-year registry data on biological treatment for psoriasis: the influence of patient characteristics on treatment outcome. Br J Dermatol 2009; 160: 670-675.
10. Rivera R, Garcia-Doval I, Carretero G, et al,. BIOBADADERM, the Spanish Registry of Adverse Events Associated With Biologic Drugs in Dermatology: first report. Actas Dermosifiliogr 2011; 102: 132-141.
11. Sanchez-Moya AI, Garcia-Doval I, Carretero G, et al,. Latent tuberculosis infection and active tuberculosis in patients with psoriasis: a study on the incidence of tuberculosis and the prevalence of latent tuberculosis disease in patients with moderate-severe psoriasis in Spain.BIOBADADERM registry. J Eur Acad Dermatol Venereol 2013; 27: 1366-1374.
12. International Conference on Harmonisation. Clinical Safety Data Management: definitions and standards for expedited reporting E2A. Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E2B/Step4/E2B-R2-Guideline.pdf. (last accessed: 18 November 2013, 1994).
13. Biobadaderm study group. Biobadaderm attribution methods. Available at: https://biobadaser.ser.es/biobadaderm/cgi-bin/upload/documentacion.aspx (last accessed: 7 November 2013, 2013).
14. Burden AD, Warren RB, Kleyn CE, et al,. The British Association of Dermatologists' Biologic Interventions Register (BADBIR): design, methodology and objectives. Br J Dermatol 2012; 166: 545-554.
15. Lecluse LL, Naldi L, Stern RS, Spuls PI,. National registries of systemic treatment for psoriasis and the European 'Psonet' initiative. Dermatology 2009; 218: 347-356.
16. Radtke MA, Rustenbach SJ, Reusch M, Stromer K, Augustin M,. Influenza vaccination rate among patients with moderate to severe psoriasis. J Dtsch Dermatol Ges 2013; 11: 837-844.
17. Schmitt-Egenolf M,. PsoReg-the Swedish registry for systemic psoriasis treatment. The registry's design and objectives. Dermatology 2007; 214: 112-117.
18. Garcia-Doval I, Rustenbach S, Stern R, et al,. Systemic psoriasis therapy shows high between-country variation: a sign of unwarranted variation? Cross-sectional analysis of baseline data from the PSONET registries Br J Dermatol 2013; 169: 710-714.