title: Safety of resuming biologic DMARDs in patients who develop tuberculosis after anti-TNF treatment.
abstract: To estimate the incidence of tuberculosis (TB) in rheumatoid arthritis (RA) patients treated with tumor necrotizing factor inhibitor (TNFI) and evaluate the safety of resuming biologic disease-modifying anti-rheumatic drugs (DMARDs) in patients who developed TB after anti-TNF treatment.
  
  
  
  We conducted an inception cohort study of RA patients in the Korean Healthcare Claims Database who started TNFI as the first biologic DMARD between January 2009 and December 2013. The incidence rate (IR) of TB was estimated among total TNFI starters and a nested case-control analysis was performed to compare the characteristics of patients who developed TB and those did not. Patients diagnosed with relapsed TB after resuming biologic DMARDs were identified and their features were described.
  
  
  
  We included 4638 RA patients who started TNFI, contributing 8542 PYs of follow-up. The IR of TB in TNFI users was 1.10 (CI: 0.86-1.34) per 100 PYs. After the initial 6 months, the IR was highest at 1.56 (CI: 1.02-2.10) and decreased gradually over time. Among the 81 patients who developed TB, 30 patients (37.0%) resumed biologic DMARDs with a mean interval of 3.3 months after TB development. Two cases of TB were detected among 30 patients with an observational period of 45.7 PY.
  
  
  
  The IR of TB in RA patients who started TNFI was 1.10 per 100 PYs. This rate was highest during the first 6 months. Resumption of biologic DMARDs requires careful monitoring for TB relapse.
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Soo-Kyung
authors.initials: SK
authors.lastname: Cho
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Dam
authors.initials: D
authors.lastname: Kim
authors.affiliation: Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Soyoung
authors.initials: S
authors.lastname: Won
authors.affiliation: Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Minkyung
authors.initials: M
authors.lastname: Han
authors.affiliation: Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Jiyoung
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Information Statistics, Andong National University, Andong-si, South Korea.
authors.forename: Eun Jin
authors.initials: EJ
authors.lastname: Jang
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Hanyang University Guri Hospital, Guri-si, South Korea.
authors.forename: Tae-Hyung
authors.initials: TH
authors.lastname: Kim
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea. Electronic address: sungyk@hanyang.ac.kr.
authors.forename: Yoon-Kyoung
authors.initials: YK
authors.lastname: Sung
mesh_terms: D000367:Age Factors; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001688:Biological Products; D016022:Case-Control Studies; D015331:Cohort Studies; D015897:Comorbidity; D000068800:Etanercept / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012307:Risk Factors; D012737:Sex Factors; D014376:Tuberculosis / Q000139:chemically induced / Q000453:epidemiology*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha; D000068800:Etanercept
keywords: Biologic DMARDs; Rheumatoid arthritis; TNF inhibitor; Tuberculosis