Setting: Nationwide study in Japan.
Objective: To identify the clinical characteristics of and risk factors for tuberculosis (TB) in rheumatoid arthritis (RA) patients receiving adalimumab.
Design: A post hoc case-control study involving 7755 RA patients evaluated in an all-case post-marketing surveillance of adalimumab from 18 June 2008 to 20 January 2011 and spontaneous report of TB during adalimumab treatment.
Results: The analysis included 22 TB cases and 7733 non-TB controls. Despite the high frequency of extra-pulmonary TB (17/22, 77.3%), all 22 TB cases had pulmonary signs or symptoms. Of patients enrolled in all-case post-marketing surveillance, there were relatively high percentages of patients who had latent tuberculous infection (LTBI) at baseline. The percentage of patients who received prophylaxis was about six times higher in patients with LTBI than those without. Of those patients who received prophylaxis, none developed TB after treatment with adalimumab. Multivariate (non-matched and age-matched) and propensity score analyses identified age ⩾65 years (OR 4.59, 95%CI 1.52-13.89, P = 0.0070), moderate to severe RA (OR 4.61, 95%CI 1.07-20.00, P = 0.0408], past or current renal dysfunction (OR 4.65, 95%CI 1.47-14.71, P = 0.0089) and diabetes mellitus (OR 3.30, 95%CI 1.31-8.26, P = 0.0110) as potential risk factors for TB.
Conclusion: Screening, prophylaxis and monitoring for TB are essential to ensure the safety of adalimumab treatment.