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THU0385 SAFETY OF TOFACITINIB THERAPY IN HBSAG CARRIERS WITH ANKYLOSING SPONDYLITIS: A PROSPECTIVE STUDY

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Background: Targeted synthetic DMARDs (ts-DMARDs) are becoming more available and affordable in developing countries, where the prevalence of hepatitis B virus (HBV) infection is still an important public health issue.… Click to show full abstract

Background: Targeted synthetic DMARDs (ts-DMARDs) are becoming more available and affordable in developing countries, where the prevalence of hepatitis B virus (HBV) infection is still an important public health issue. The safety of ts-DMARDs therapy in terms of the reactivation of hepatitis B virus (HBV) infection need more concern. Rare data from a prospective study focus on the use of ts-DMARDs in patients with concurrent ankylosing spondylitis (AS) and HBV infection were available by now. Objectives: To evaluate the influence of tofacitinib on reactivation of HBV infection in HBsAg carriers with AS. Methods: In this 52 weeks observation, HBsAg carriers with active AS (BASDAI ≥ 4) despite failed treatment with at least two NSAIDs and sulfasalazine (for patients with persistent peripheral arthritis) were studied. Patients must be positive for HBsAg and have a normal liver function prior to study. All patients received therapy with tofacitinib (5mg twice daily). Entecavir were prescribed preventively regardless of individual viral load. Pre-existing NSAIDs and sulfasalazine were allowed. Liver enzymes (AST/ALT) and HBV viral load were monitored every 4 weeks. Increased viral load and abnormal liver function were managed according to expert opinion. Results: Eleven patients (9 male) were recruited. Eight patients had a baseline viral load >2000 copy/ml (group 1), and the other 3 patients had a viral load ≤ 2000 copy/ml (group 2). Two patients from group 1 discontinued tofacitinib at week 12 due to ineffectiveness, and both continued taking Entecavir for another 3 months after the discontinuation of tofacitinib. One patients (male, 26 years old) from group 1 underwent a mild increase of both ALT and AST (67 and 56 IU/L, respectively) at week 16, but no elevated viral load (2.1e3 copies/ml, baseline 2.8e3) or a HBV YMDD mutant was found. The tofacitinib treatment continued. After prescription of polyene phosphatidyl choline, the liver enzyme of this patient decreased to normal range in 4 weeks and remained normal throughout the study. No reactivation of hepatitis B was observed in patients from group 2. Conclusion: Tofacitinib treatment may be a safe and effective option for HBsAg carriers with AS refractory to traditional treatment. Prophylaxis strategy with effective anti-viral drugs is recommended. References: [1]Chen YM, Huang WN, Wu YD, et al. Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study. Ann Rheum Dis 2018; 77:780-2. Disclosure of Interests: None declared

Keywords: hbsag; hbsag carriers; study; viral load; hbv

Journal Title: Annals of the Rheumatic Diseases
Year Published: 2020

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