Tuberculosis risk in patients treated with non-anti-tumor necrosis factor-α (TNF-α) targeted biologics and recently licensed TNF-α inhibitors: data from clinical trials and national registries.
This review aimed to evaluate the risk of active tuberculosis (TB) occurrence in patients with rheumatic disorders receiving non-anti-tumor necrosis factor (TNF) targeted biologics anakinra (ANK), tocilizumab (TCZ), rituximab (RTX), abatacept (ABA), and recently approved anti-TNF golimumab (GOL), and certolizumab pegol (CTP). In recent findings, no cases of active TB were recorded in patients with rheumatoid arthritis (RA) and other rheumatic conditions treated with anti-CD20+ RTX and anti-CD28 ABA. No patient receiving anti-interleukin 1 (IL-1) ANK developed active TB, and an increased risk was excluded in a Canadian database. In contrast, 8 active TB cases were observed in 21 trials of patients with RA receiving anti-IL-6 TCZ, while no increased TB risk resulted from Japanese postmarketing surveillance. Among GOL-treated and CTP-treated patients, 8 and 10 active TB cases occurred, respectively, while no data are available from registries. However, all but 1 TB case recorded in patients treated with TCZ, GOL, and CTP occurred in TB-endemic countries. No TB risk resulted for ANK, RTX, and ABA, suggesting pretreatment screening procedures for latent TB infection detection are unnecessary. Because all TB cases occurred in countries at high risk for TB, where TB exposure could have occurred during treatment, no definitive conclusions can be drawn for TCZ, GOL, and CTP.
Address correspondence to Dr. Cantini, Rheumatology Division, Hospital of Prato, Piazza Ospedale 1, 59100 Prato, Italy. E-mail: fbrzcantini@gmail.com.
Fabrizio
F
Cantini
Laura
L
Niccoli
Delia
D
Goletti
D000069594:Abatacept; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000068582:Certolizumab Pegol; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use; D053590:Interleukin 1 Receptor Antagonist Protein / Q000009:adverse effects / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012216:Rheumatic Diseases / Q000188:drug therapy; D012306:Risk; D000069283:Rituximab; D014376:Tuberculosis / Q000209:etiology*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D018796:Immunoconjugates; D007140:Immunoglobulin Fab Fragments; D053590:Interleukin 1 Receptor Antagonist Protein; D014409:Tumor Necrosis Factor-alpha; D011092:Polyethylene Glycols; D000069283:Rituximab; D000069594:Abatacept; C529000:golimumab; C502936:tocilizumab; D000068582:Certolizumab Pegol
ANTI-TUMOR NECROSIS FACTOR; CERTOLIZUMAB PEGOL; GOLIMUMAB; NON-ANTI-TNF BIOLOGICS; TUBERCULOSIS