Patient reports of the frequency and severity of adverse reactions associated with biological agents prescribed for psoriasis in Brazil

Bibliography

• Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet 2007;370(9583):263-71
   PubMed Web of Science ®Google Scholar
• Zachariae H. Prevalence of joint disease in patients with psoriasis: implications for therapy. Am J Clin Dermatol 2003;4(7):441-7
   PubMed Web of Science ®Google Scholar
• Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999;41(3 Pt 1):401-7
   PubMed Web of Science ®Google Scholar
• Schmid-Ott G, Malewski P, Kreiselmaier I, Mrowietz U. Psychosocial consequences of psoriasis – an empirical study of disease burden in 3753 affected people. Der Hautarzt 2005;56(5):466-72
   PubMed Web of Science ®Google Scholar
• NICE. Psoriasis: The assessment and management of psoriasis. Clinical Guideline. 2012. Avaliable from: http://publicationsniceorguk/psoriasis-cg153/about-this-guideline [Accessed in 7th June 2014]
   Google Scholar
• Naldi L, Rzany B. Psoriasis (chronic plaque). Clin Evid 2009;1706(1):1-109, [online]
   Google Scholar
• Lee S, Coleman CI, Limone B, et al.Biologic and nonbiologic systemic agents and phototherapy for treatment of chronic plaque psoriasis [Internet]. Agency for Healthcare Research and Quality (US), Rockville (MD); 2012. (Comparative Effectiveness Reviews, No. 85.) Available from: http://www.ncbi.nlm.nih.gov/books/NBK115091/
   Google Scholar
• Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions. J Am Acad Dermatol 2011;65(1):137-74
   PubMed Web of Science ®Google Scholar
• Murdaca G, Colombo BM, Cagnati P, et al. Update upon efficacy and safety of TNF-alpha inhibitors. Expert Opin Drug Saf 2012;11(1):1-5
   PubMed Web of Science ®Google Scholar
• Weger W. Current status and new developments in the treatment of psoriasis and psoriatic arthritis with biological agents. Br J Pharmacol 2010;160(4):810-20
   PubMed Web of Science ®Google Scholar
• Reich K, Burden AD, Eaton JN, Hawkins NS. Efficacy of biologics in the treatment of moderate to severe psoriasis: a network meta-analysis of randomized controlled trials. Br J Dermatol 2012;166(1):179-88
   PubMed Web of Science ®Google Scholar
• Brimhall AK, King LN, Licciardone JC, et al. Safety and efficacy of alefacept, efalizumab, etanercept and infliximab in treating moderate to severe plaque psoriasis: a meta-analysis of randomized controlled trials. Br J Dermatol 2008;159(2):274-85
   PubMed Web of Science ®Google Scholar
• Girolomoni G, Altomare G, Ayala F, et al. Safety of anti-TNFα agents in the treatment of psoriasis and psoriatic arthritis. Immunopharmacol Immunotoxicol 2012;34(4):548-60
   PubMed Web of Science ®Google Scholar
• Lucka TC, Pathirana D, Sammain A, et al. Efficacy of systemic therapies for moderate-to-severe psoriasis: a systematic review and meta-analysis of long-term treatment. J Eur Acad Dermatol Venereol 2012;26(11):1331-44
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Mariette X, Matucci-Cerinic M, Pavelka K, et al. Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis. Ann Rheum Dis 2011;70(11):1895-904
   PubMed Web of Science ®Google Scholar
• 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(4):463-70
   PubMed Web of Science ®Google Scholar
• Murdaca G, Spano F, Contatore M, et al. Efficacy and safety of etanercept in chronic immune-mediated disease. Expert Opin Drug Saf 2014;13(5):649-61
   PubMed Web of Science ®Google Scholar
• Bardazzi F, Odorici G, Virdi A, et al. Autoantibodies in psoriatic patients treated with anti-TNF-alpha therapy. J Dtsch Dermatol Ges 2014;12(5):401-6, doi: 10.1111/ddg.12339
   PubMed Web of Science ®Google Scholar
• Lee SJ, Kavanaugh A. Adverse reactions to biologic agents: focus on autoimmune disease therapies. J Allergy Clin Immunol 2005;116(4):900-5
   PubMed Web of Science ®Google Scholar
• Joyau C, Veyrac G, Dixneuf V, Jolliet P. Anti-tumour necrosis factor alpha therapy and increased risk of de novo psoriasis: is it really a paradoxical side effect? Clin Exp Rheumatol 2012;30(5):700-6
   PubMed Web of Science ®Google Scholar
• Murdaca G, Spano F, Cagnati P, Puppo F. Free radicals and endothelial dysfunction: potential positive effects of TNF-alpha inhibitors. Redox Rep 2013;18(3):95-9
   PubMed Web of Science ®Google Scholar
• Murdaca G, Spano F, Puppo F. Current therapies for the treatment of systemic sclerosis-related pulmonary arterial hypertension: efficacy and safety. Expert Opin Drug Saf 2014;13(3):295-305
   PubMed Web of Science ®Google Scholar
• Hausmann OV, Seitz M, Villiger PM, Pichler WJ. The complex clinical picture of side effects to biologicals. Med Clin North Am 2010;94(4):791-804; xi-ii
   PubMed Web of Science ®Google Scholar
• SIGN. Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults. A national clinical guideline. Scottish Intercollegiate Guidelines Network (SIGN); Edinburgh (Scotland): 2010. p. 121:65
   Google Scholar
• Nast A, Boehncke WH, Mrowietz U, et al. S3 - Guidelines on the treatment of psoriasis vulgaris (English version). Update. J Dtsch Dermatol Ges 2012;10(Suppl 2):S1-95
   Web of Science ®Google Scholar
• Singh JA, Christensen R, Wells GA, et al. Biologics for rheumatoid arthritis: an overview of Cochrane reviews. Cochrane Database Syst Rev 2009(4):Cd007848
   Google Scholar
• Nigil Haroon N, Sriganthan J, Al Ghanim N, et al. Effect of TNF-alpha inhibitor treatment on bone mineral density in patients with ankylosing spondylitis: A systematic review and meta-analysis. Semin Arthritis Rheum 2014; pii: S0049-0172(14)00078-X; doi: 10.1016/j.semarthrit.2014.05.008. [Epub ahead of print]
   Google Scholar
• Tang DH, Harrington AR, Lee JK, et al. A systematic review of economic studies on biological agents used to treat Crohn’s disease. Inflamm Bowel Dis 2013;19(12):2673-94
   PubMed Web of Science ®Google Scholar
• 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(3):670-5
   PubMed Web of Science ®Google Scholar
• WHO. The Uppsala Monitoring Centre. Glossary of Terms in Pharmacovigilance. Disponível em. Available from:http://www.who-umcorg/graphics/27400pdf [Accessed 30 June 2014]
   Google Scholar
• International conference on harmonisation: clinical safety data management: Definitions and standards for expedited reporting: E2a. Avaliable from. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065004.htm [Accessed 30 June 2014]
   Google Scholar
• LIPE. Researcher. Queries: what is CATI? 2014. Available from: http://www.lipe.com.br [Accessed 30 June 2014]
   Google Scholar
• INTELIGÊNCIA GI. Data collection. Several methods to meet your demand. Published in 28/04/2009 2009. Available from: http://wwwibopecombr [Accessed 30 June 2014]
   Google Scholar
• Papp K, Gulliver W, Lynde C, et al. Canadian guidelines for the management of plaque psoriasis: overview. J Cutan Med Surg 2011;15(4):210-19
   PubMed Web of Science ®Google Scholar
• Sociedade Brasileira de Dermatologia. Consenso Brasileiro de Psoríase 2012: guias de avaliação e tratamento. 2nd edition. Rio de Janeiro; 2012. Disponível em: http://www.ufrgs.br/textecc/traducao/dermatologia/files/outros/Consenso_Psoriase_2012.pdf [citado 2014 mar 31]
   Google Scholar
• Psoriasis: the assessment and management of psoriasis. National Institute for Health and Clinical Excellence - Clinical Guidelines. 2012. Available from: www.nice.org.uk/nicemedia/live/13938/61192/61192.pdf [Accessed in 30 June 2014]
   Google Scholar
• Drueke TB, Ritz E. Treatment of secondary hyperparathyroidism in CKD patients with cinacalcet and/or vitamin D derivatives. Clin J Am Soc Nephrol 2009;4(1):234-41
   PubMed Web of Science ®Google Scholar
• Smith CH, Anstey AV, Barker JNWN, et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009. Br J Dermatol 2009;161(5):987-1019
   PubMed Web of Science ®Google Scholar
• Pathirana D, Ormerod AD, Saiag P, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol 2009;23(Suppl 2):1-70
   PubMed Web of Science ®Google Scholar
• Silveira M. Monitoring the use of biological drugs supplied by court order to psoriasis patients in São Paulo. University of Sorocaba; Sorocaba: 2013
   Google Scholar
• Silveira MS, de Camargo IA, Osorio-de-Castro CG, et al. Adherence to guidelines in the use of biological agents to treat psoriasis in Brazil. BMJ Open 2014;4(3):e004179
   Google Scholar
• Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30(2):239-45
   PubMed Web of Science ®Google Scholar
• 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(3):545-54
   PubMed Web of Science ®Google Scholar
• Hernandez MV, Sanmarti R, Canete JD, et al. Cutaneous adverse events during treatment of chronic inflammatory rheumatic conditions with tumor necrosis factor antagonists: study using the Spanish registry of adverse events of biological therapies in rheumatic diseases. Arthritis Care Res 2013;65(12):2024-31
   Web of Science ®Google Scholar
• Common Terminology Criteria for Adverse Events v4.03, 2010 June 14. Available from: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf [Accessed in 2 July 2014]
   Google Scholar
• Gniadecki R, Kragballe K, Dam TN, Skov L. Comparison of drug survival rates for adalimumab, etanercept and infliximab in patients with psoriasis vulgaris. Br J Dermatol 2011;164(5):1091-6
   PubMed Web of Science ®Google Scholar
• Esposito M, Gisondi P, Cassano N, et al. Survival rate of antitumour necrosis factor-alpha treatments for psoriasis in routine dermatological practice: a multicentre observational study. Br J Dermatol 2013;169(3):666-72
   PubMed Web of Science ®Google Scholar
• Langley RG, Strober BE, Gu Y, et al. Benefit-risk assessment of tumour necrosis factor antagonists in the treatment of psoriasis. Br J Dermatol 2010;162(6):1349-58
   PubMed Web of Science ®Google Scholar
• Murdaca G, Spano F, Puppo F. Selective TNF-alpha inhibitor-induced injection site reactions. Expert Opin Drug Saf 2013;12(2):187-93
   PubMed Web of Science ®Google Scholar
• Micali G, Wilsmann-Theis D, Mallbris L, et al. Etanercept reduces symptoms and severity of psoriasis after cessation of cyclosporine therapy: results of the score study. Acta Derm Venereol 2014. [ Epub ahead of print]
   Web of Science ®Google Scholar