The incidence of tuberculosis in patients treated with certolizumab pegol across indications: impact of baseline skin test results, more stringent screening criteria and geographic region

摘要: Objectives We report the incidence of tuberculosis (TB) across certolizumab pegol (CZP) clinical trials in rheumatoid arthritis (RA), psoriasis, psoriatic (PsA) and axial spondyloarthritis (axSpA), before after introduction stricter TB screening. Methods rates (IRs) were assessed stratified according to screening guidelines used at time CZP trials. Before 2007 ( original trials), purified protein derivative (PPD) tuberculin skin test positivity varied local standards (induration ≥5 up ≥20 mm). Since 2007, all trial protocols have been amended, including spanning intermediate ) initiated current ), mandating that any patient with PPD≥5 mm receives treatment for latent infection (LTBI). All cases suspected or PPD≥5 mm, pooled data from 5402 patients 2012, underwent blinded central review by independent experts. Results 44 confirmed RA (IR 0.47/100PY, patient-years) no Japanese (J-RAPID, HIKARI). Single psoriasis axSpA (RAPID-axSpA), PsA (RAPID-PsA). IR was 0.51/100PY 0.18/100PY The majority occurred Eastern 1.02/100PY) Central Europe 0.58/100PY). Of 242/370 who received 9 months isoniazid (INH) (LTBI), none developed TB, versus 7.8% 128 untreated patients. Conclusions Implementation more stringent LTBI screening, plus LTBI, reduced even when INH administered starting therapy.