Segurança do uso de terapias biológicas para o tratamento de artrite reumatoide e espondiloartrites

Abstract

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.

Electrocardiographic changes in spondyloarthritis and use of anti-TNF-α drugs: a retrospective study with 100 patients

“…Pharmacological agents known as anti-TNFα are able to block this inflammatory mechanism and may be used for SpA treatment. ( 8 )…”

Ankylosing spondylitis and psoriatic arthritis: revisiting screening of latent tuberculosis infection and its follow-up during anti-tumor necrosis factor therapy in an endemic area

“…The great advantage of this study is the consistent and complete LTBI screening for all patients using a standard protocol recommended by Brazilian guidelines ( 11 ) and the national recommendation for TB control ( 12 , 13 ). The non-homogeneous use of an LTBI screening protocol in previous studies hampers the interpretation of their findings on the relevance of each risk factor.…”

Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS)

“…Our study also highlighted a large frequency of infections and neoplasms. Other studies have also reported these ADRs as major safety concerns associated with the use of biologic drugs [9,28,35,36,[39][40][41]; however, there is still no consensus on the actual risk and the role of individual differences regarding these drugs, which suggests that these safety issues are still not well established and require further investigation [8,42].…”

“…The association between this event and use of infliximab was highlighted as an important safety concern, especially in autoimmune diseases. Although the number of reports associated with infliximab was low, careful and intensive monitoring of PML cases associated with biologics is needed [8,42]. Several SDRs were identified in only one subgroup of patients, what suggests that the use of disproportionality analyses by subgroups can help to identify groups with greater susceptibility to specific adverse events in addition to increasing the sensitivity for the detection of SDRs compared with crude or stratified analyses [31].…”