Background/Purpose: To elucidate the safety and feasibility of a treat-to-target (T2T) strategy aimed at achieving a simplified disease activity index (SDAI) of ≤3.3 while administering entecavir (ETV) in patients with rheumatoid arthritis (RA) complicated by hepatitis B virus (HBV).

Methods: Written informed consent was obtained from patients with rheumatoid arthritis who satisfied with SDAI>3.3, alanine aminotransferase (ALT) ≤30 and unidentified HBV –DNA under medicating with ETV for HBV. The time of enrolment was set as the baseline (BL) and the time of observation two years later was set as the endpoint (EP). SDAI was measured at once every three months, and in accordance with the modified strategy of T-4 study (1), treatment was intensified with a target SDAI of ≤3.3. HBV-DNA was measured on a monthly basis from BL. SDAI, health assessment questionnaire disability index (HAQDI), and modified total Sharp score (mTSS) were measured one and two year after the enrolment. Primary, secondary and outcome measures consisted of the proportions of patients showing rate of absence of HBV-DNA reactivation (HBV-DNA>2.1 log copies/mL), clinical remission (SDAI≤3.3), normal liver function (ALT≤30), lack of radiological progression (DmTSS≤0.5), normal physical function (HAQDI=0), or comprehensive disease remission defined as the combination of clinical remission, lack of radiological progression, and normal physical function.

Results:

Subjects comprised 14 patients (mean age, 61.0 ± 8.9 years; mean disease duration, 7.8 ± 7.8 years; mean SDAI, 8.7 ± 5.4; mean HAQDI, 0.2 ± 0.3; mean ALT, 21 ± 6), 8 of whom were women (57%). Among these subjects, five were carriers and 9 experienced reactivation of a resolved HBV. Treatment after the enrolment consisted of 31% of patients taking an antirheumatic drug (bucillamine, n=4;; leflunomide, n=1), 43% taking glucocorticoids (GCs) with a mean GCs dose (prednisolone equivalent of 3.4mg/day (maximum dose; 9mg/day), 57% taking methotrexate (MTX) with a mean MTX dose of 7.1 mg/week, 50% taking folic acid, and 50% taking biological drugs (etanercept, n=4; abatacept, n=2; tocilizumab, n=1). At 2 years, the rate of absence of  HBV-DNA reactivation, SDAI≤3.3, ALT≤30, DmTSS≤0.5, HAQDI=0, and comprehensive disease remission were follows, 100%, 50%, 93%, 43%, 64% and 21%. ALT, SDAI, ΔmTSS and HAQDI at EP was 19 ± 7, 4.3±4.5, 0.8±2.2 and 0.2±0.3, respectively. No significant differences were observed between BL and EP for value of ALT, SDAI or HAQDI. No patient had ALT value in excess of 100 IU/L during the observation period. All of the 7patients who had HAQDI=0 at BL also had HAQDI=0 at EP.

Conclusion: T2T aimed at achieving SDAI≤3.3 is also possible safety in patients with RA complicated by HBV by performing ETV administration and appropriate HBV-DNA monitoring.

Reference

1. Urata  Y et al. Treating to target matrix metalloproteinase 3 normalisation together with disease activity score below 2.6 yields better effects than each alone in rheumatoid arthritis patients: T-4 Study. Ann Rheum Dis. 2012;71:534-40.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-safety-and-feasibility-of-a-treat-to-target-strategy-aimed-at-achieving-a-simplified-disease-activity-index-of-u3-3-while-administering-entecavir-in-rheumatoid-arthritis-complicated-by-hepat/