Safe use of biological therapies for the treatment of rheumatoid arthritis and spondyloarthritides

Licia Maria Henrique da Mota Bóris Afonso Cruz Claiton Viegas Brenol Daniel Feldman Pollak Geraldo da Rocha Castelar Pinheiro Ieda Maria Magalhães Laurindo Ivânio Alves Pereira Jozélio Freire de Carvalho Manoel Barros Bertolo Marcelo de Medeiros Pinheiro Max Victor Carioca Freitas Nilzio Antônio da Silva Paulo Louzada-Júnior Percival Degrava Sampaio-Barros Rina Dalva Neubarth Giorgi Rodrigo Aires Corrêa Lima Luis Eduardo Coelho Andrade About the authors

The treatment of autoimmune rheumatic diseases has gradually improved over the last half century, which has been expanded with the contribution of biological therapies or immunobiopharmaceuticals. However, we must be alert to the possibilities of undesirable effects from the use of this class of medications. The Brazilian Society of Rheumatology (Sociedade Brasileira de Reumatologia) produced a document based on a comprehensive literature review on the safety aspects of this class of drugs, specifically with regard to the treatment of rheumatoid arthritis and spondyloarthritides. The themes selected by the participating experts, on which considerations have been established as the safe use of biological drugs, were: occurrence of infections (bacterial, viral, tuberculosis), infusion reactions, hematological, neurological, gastrointestinal and cardiovascular reactions, neoplastic events (solid tumors and hematologic neoplasms), immunogenicity, other occurrences and vaccine response. For didactic reasons, we opted by elaborating a summary of safety assessment in accordance with the previous themes, by drug class/mechanism of action (tumor necrosis factor antagonists, T-cell co-stimulation blockers, B-cell depletors and interleukin-6 receptor blockers). Separately, general considerations on safety in the use of biologicals in pregnancy and lactation were proposed. This review seeks to provide a broad and balanced update of that clinical and experimental experience pooled over the last two decades of use of immunobiological drugs for RA and spondyloarthritides treatment.

Rheumatoid arthritis; Spondyloarthritis; Biologicals; Immunobiologicals; Security


Sociedade Brasileira de Reumatologia Av Brigadeiro Luiz Antonio, 2466 - Cj 93., 01402-000 São Paulo - SP, Tel./Fax: 55 11 3289 7165 - São Paulo - SP - Brazil
E-mail: sbre@terra.com.br