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/SBR) 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 (RA) 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.