Risk of tuberculosis in patients with immune-mediated diseases on biological therapies: a population-based study in a tuberculosis endemic region.

OBJECTIVE: Real-world epidemiological data on the risk of tuberculosis (TB) in patients with immune-mediated diseases treated with biologics are scarce in TB endemic areas. We investigated the incidence of TB in a population-based setting and stratified the risk of TB among different biological therapies. METHODS: We collected medical data from a territory-wide computerized database in Hong Kong. We reported the incidence of TB in patients treated with various classes of biologics, and calculated standardized incidence ratio by comparing with the general population. Subgroup analyses were performed based on disease subtypes and biological drugs. RESULTS: Among 2485 subjects with immune-mediated diseases (82.5% rheumatology diseases; 10.6% IBD; 6.9% dermatology diseases), 54 subjects developed active TB during 6921 person-years of follow-up. The mean age (±s.d.) was 43 (14) years, and the median follow-up duration was 24.9 months (interquartile range 4.9-45.0). The overall standardized incidence ratio of TB was 10.91 (95% CI 8.00-13.82), and patients treated with infliximab had a nearly 26 times increased risk of TB compared with the general population (standardized incidence ratio 25.95; 95% CI 17.23-34.67). The risk of TB with TNF inhibitor was higher than with a non-TNF biologic (hazard ratio 4.34; 95% CI 1.31-14.39), while the risk of infliximab was higher than etanercept and adalimumab (hazard ratio: 4.10 and 2.08, respectively). CONCLUSION: The risk of TB is much higher in patients with immune-mediated diseases on biological therapy compared with the general population, and infliximab is associated with the highest risk of TB among the biologics analysed.

Endoscopic and Histological Mucosal Healing in Ulcerative Colitis in the First Year of Diagnosis: Results from a Population-based Inception Cohort from Six Countries in Asia.

BACKGROUND AND AIMS: Mucosal healing is associated with improved long-term clinical outcomes in patients with ulcerative colitis. This population-based study assessed endoscopic and histological mucosal healing within the first year of diagnosis. METHODS: Consecutive patients diagnosed with ulcerative colitis from six countries in Asia were prospectively enrolled. Clinical demographics, blood markers and inflammatory activity were assessed at baseline. Mayo score and Nancy index were used to assess endoscopic and histological activities, respectively. Clinical, endoscopic and histological evaluations were repeated at 1 year. Logistic regression was performed to identify predictors of mucosal healing. RESULTS: Of 433 ulcerative colitis patients, 202 [46.7%] underwent colonoscopy at 1 year. In total, 68 [38.2%] achieved endoscopic mucosal healing and 35 [23.1%] achieved histological mucosal healing. On multivariate analysis, an elevated erythrocyte sedimentation rate [ESR] at diagnosis (odds ratio [OR], 0.332; 95% confidence interval (CI), 0.133-0.830; p = 0.018) was a significant negative predictor of endoscopic mucosal healing at 1 year, while histological features of ulceration [OR, 0.156; 95% CI, 0.028-0.862; p = 0.033] and being an ex-smoker [OR, 0.067; 95% CI, 0.005-0.965; p = 0.047] were significant negative predictors of histological healing at 1 year. Both endoscopic and histological mucosal healing were associated with less steroid use [p < 0.001 and p = 0.001, respectively] and hospitalization [p = 0.002 and p = 0.01, respectively]. CONCLUSIONS: Mucosal healing was achieved in fewer than half of patients with ulcerative colitis in the first year of diagnosis. An elevated ESR predicted less likelihood of endoscopic mucosal healing, while histological features of ulceration and being an ex-smoker at diagnosis predicted less likelihood of histological healing.