Sixth report of adverse events with biological treatments in Argentina. BIOBADASAR registry report

Author:

Gómez G.1,Pons-Estel G.1,Citera G.1,Soriano E.1,Saurit V.1,Benavidez F.1,Velozo E.1,Dubinsky D.1,Exeni I.1,Gobi C.1,Gómez G.1,Díaz M.1,Granel A.1,Smichowsky A.1,Garate G.1,Quinteros A.1,Cavillon E.1,Petkovic I.1,Larroude M.S.1,de la Sota M.1,Cappuccio A.M.1,Berbotto G.1,Alvarez A.1,Papasidero S.1,Lazaro A.1,Garcia M.1,Sacnun M.1,Soares de Souza S.1,Bertoli A.1,Bejarano V.1,Rillo O.1,Kerzberg E.1,Quintana R.1,Agüero S.1,Somma L.1,Cruzat V.1,Battaglitti C.1,Perez Dávila A.1,Gallardo M.1,Pereira D.1,Verando M.1,Paira S.1,Martinez L.1,Aste N.1,Pisoni C.1,Catay E.1,Graf C.1,Casado G.1,de la Vega M.1

Affiliation:

1. Argentine Society of Rheumatology, Autonomous City of Buenos Aires, Argentina

Abstract

Objective: update the results of the BIOBADASAR registry on safety, duration and causes of treatment interruption after 8 years of follow-up. Methods: BIOBADASAR is a safety record of biological therapies established by the Argentine Society of Rheumatology. The description of BIOBADASAR 3.0 is presented, a cohort of 53 centers in Argentina followed prospectively from August 2010 to January 2018.

Publisher

Editorial Biotecnologica S.R.L.

Reference11 articles.

1. M de la Vega, et al. Primer reporte de eventos adversos de tratamientos biológicos en Argentina. Informe de Registro BIOBADASAR. Rev Arg Reumatol. 2011; 22(4):40-54.

2. Braun J, Kalden JR. Biologics in the treatment of rheumatoid arthritis and ankylosing spondylitis. Clin Exp Rheumatol. 2009; 27(4 supple 55):S164-7.

3. MA Descalzo, L Carmona y grupo de estudio BIOBADASER. Biobadaser 2.0: análisis y tendencias en 2009. Reumatol Clin. 2010; 6(5):240-243.

4. W orldHealthOrganization. Guidelines On Evaluation Of Similar Biotherapeutic Products (SBPs). 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR _WEB_22APRIL2010.pdf

5. European Medicines Agency. Guide line on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf

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