K-1416. Risk Factors for Tuberculosis (TB) in Patients (pts) with Anti-TNF:. The French 3-Year Prospective RATIO Observatory
Session: Poster Session: Infections in BMT, Cancer and Neutropenic Patients
Sunday, October 26, 2008: 12:00 AM
Room: Hall C
A 3-year prospective study investigated incidence and risk factors of TB in pts treated with anti-TNFα in France. Methods: 490 departments declared TB cases in pts treated with anti TNF from 2/04 to 2/07. A case-control study involved 2/1 controls (paired by gender and underlying disease). Incidence rate was estimated through the number of therapeutic units sold. Results: 66 TB occurred, median was 60 (19-83). 43% were pleuro-pulmonary, 39% disseminated. Diagnosis relied on BAAR identification (Ziehl staining: 20, culture: 24), histology (14), Quantiferon-TB° (1), response to therapy (6). Indication for anti TNF was a rheumatoid disease (n=54), Crohn’s disease (n=7), other (n=6). Mean duration of inflammatory disease before TB was 8.6 yrs (0.8-34.3). Last anti-TNF administered was infliximab (INF) in 34, adalimumab (ADA) in 27, etanercept (ETA) in 5 pts. Median anti TNF duration before TB diagnosis was 52 (6-321) weeks. 77% pts received > 1 other immunosuppressive drug, and 63% prednisone. Overall, 75% pts had at least one risk factor for TB: TST > 5 mm in 14 pts, abnormal pulmonary Xray in 6, history of TB exposure in 10, origin from endemic area in 14. After a median follow-up of 17 months, anti TNF therapy was restarted in 20% of cured pts without TB relapse.
In multivariate analysis, age (OR: 1.7 [1.1-2.5], p=0.009), origin from endemic area (OR: 6.9 [1.7-27.7], p=0.007), time between antiTNF initiation and TB (OR: 0.94 [0.92-0.97] , p=0.0002), last anti TNF used : mo Ab (INF or ADA) vs soluble receptor (ETA) (OR: 13.5 [2.5-72.7], p=0.002) were risk factors for TB. Adjusted incidence of TB in pts treated with anti TNF during this period was 111.4/100,000 (9.3/100,000 with etanercept, 193.6/100,000 with INF or ADA) whereas it was 8.7/100,000 in the general French population. Conclusion: TB remains an issue in pts treated with antiTNF and incidence is higher with antiTNF mo AB than with the soluble receptor.
The RATIO Study Group, Catherine Leport, MD, PhD2, Daniel Vittecoq, MD, PhD2, Dominique Salmon, MD, PhD3, Florence Tubach, MD4, Olivier Lortholary, MD, PhD3, Philippe Ravaud, MD, PhD2, Pierre Dellamonica, MD, PhD5, Rose Marie Chichemanian, MD6, Stéphane Bretagne, MD, PhD2, Xavier Mariette, MD, PhD7 and  D. Salmon, None., (1)APHP, (2)AP-HP; Univ. Paris V, (3)Unité de Recherche Clinique, Hôpital Bichat, (4)Univ. Nice, (5)CHU, (6)AP-HP; Univ. Paris Sud


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