Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR)

Abstract

BackgroundThe risk of tuberculosis (TB) in patients with rheumatoid arthritis (RA) is thought to be increased following anti-tumour necrosis factor (anti-TNF) therapy, with a proposed differential risk between the anti-TNF drugs etanercept (ETA), infliximab (INF) and adalimumab (ADA).ObjectiveTo compare directly the risk between drugs, to explore time to event, site of infection and the role of ethnicity.MethodsData from the British Society for Rheumatology Biologics Register (BSRBR), a national prospective observational study, were used to compare TB rates in 10 712 anti-TNF treated patients (3913 ETA, 3295 INF, 3504 ADA) and 3232 patients with active RA treated with traditional disease-modifying antirheumatic drugs.ResultsTo April 2008, 40 cases of TB were reported, all in the anti-TNF cohort. The rate of TB was higher for the monoclonal antibodies ADA (144 events/100 000 person-years) and INF (136/100 000 person-years) than for ETA (39/100 000 person-years). After adjustment, the incidence rate ratio compared with ETA-treated patients was 3.1 (95% CI 1.0 to 9.5) for INF and 4.2 (1.4 to 12.4) for ADA. The median time to event was lowest for INF (5.5 months) compared with ETA (13.4 months) and ADA (18.5 months). 13/40 cases occurred after stopping treatment. 25/40 (62%) cases were extrapulmonary, of which 11 were disseminated. Patients of non-white ethnicity had a sixfold increased risk of TB compared with white patients treated with anti-TNF therapy.ConclusionThe rate of TB in patients with RA treated with anti-TNF therapy was three- to fourfold higher in patients receiving INF and ADA than in those receiving ETA.

Differential Adverse Events Between TNF-α Inhibitors and IL-17 Axis Inhibitors for the Treatment of Spondyloarthritis

“…Based on the French Research Axed on Tolerance of bIOtherapies (RATIO) registry, which includes patients with a variety of inflammatory and autoimmune diseases on biologic therapies, 69 cases of TB were reported over a total of 57,711 patient-years; these cases were related to infliximab and adalimumab use, but none of them had received the currently recommended chemo-prophylactic treatment for latent TB [14]. The British Society for Rheumatology Biologics Register (BSRBR) confirmed similar results in a cohort of 10,712 patients over median 3.2 years, finding a 3-to 4-found higher rate of TB in RA patients on infliximab and adalimumab compared to etanercept [15].…”

Biological Therapy and Infection in Rheumatoid Arthritis Patients: Modern Aspects

“…Сходные данные представлены в Британском реги-стре биологических препаратов, где активная ТБ-инфек-ция была диагностирована у 40 больных, получавших иФНО-α. По сравнению с ЭТЦ риск развития ТВ возрас-тал в 2,84 раза для ИНФ и в 3,53 -для АДА [55]. Считается, что на ранних этапах лечения иФНО-α проис-ходит реактивация латентного ТБ-процесса, а в более поздние сроки -развитие ТБ-инфекции de novo.…”

The analysis of ankylosing spondylitis patients receiving biological therapies: data from TURKBIO registry

“…[19] TNF-α'n›n granülom oluflumundaki yap› tafllar›ndan biri olmas› nedeniyle bu sitokini engelleyen tedavilerin baflta tüberküloz (Tbc) olmak üzere granülomatöz infeksiyonlara e¤ilim yaratt›¤›n› bildirmifltir. [22,23] Yap›lan çal›flmalar Tbc riskinin monoklonal antikorlarda (‹NF ve ADA) ETA'ya göre daha fazla oldu¤unu öne sürmektedir. [24,25] Ülkemizde 2005 y›l›nda herhangi bir hastal›k nedeniyle anti-TNF-α tedavisi bafllanacak olan hastalarda Tbc infeksiyonu ile iliflkili de¤erlendirme ve tedaviye yönelik ulusal bir k›lavuz haz›rlanm›flt›r.…”