Hepatitis B virus reactivation during therapy with etanercept in an HBsAg‐negative and anti‐HBs‐positive patient

Montiel, P Martínez; Solís, José Antonio Nieto; Chirinos, Juan Antonio; Casis, Begoń A; Sánchez, Fernando; Rodríguez, S.

doi:10.1111/j.1478-3231.2007.01665.x

Cited by 85 publications

(5 citation statements)

References 6 publications

(6 reference statements)

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“…In contrast to the above findings, several cases of HBV reactivation with viremia and emergence of HBsAg have been reported in patients with past HBV infection during immunosuppressive therapy for Crohn’s disease, ankylosing spondylitis, and RA [24–26]. Most recently, Urata et al [21] have reported a high prevalence of HBV reactivation with marked increases in viral load in Japanese patients with RA and resolved HBV infection.…”

Section: Discussionmentioning

confidence: 99%

Past hepatitis B virus infection in rheumatoid arthritis patients receiving biological and/or nonbiological disease-modifying antirheumatic drugs

Mori

2011

Modern Rheumatology

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To evaluate the prevalence of past infection with hepatitis B virus (HBV) in patients with rheumatoid arthritis (RA) and the incidence of its reactivation under treatment with biological and/or nonbiological diseasemodifying antirheumatic drugs (DMARDs), 239 patients receiving DMARD therapy were consecutively enrolled and tested for HBV-DNA, using a real-time polymerase chain reaction assay, HBV serology including hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc), and serum levels of aminotransferase. Data prior to DMARD therapy and during follow-up were examined by reviewing medical records. Two patients (0.8%) were positive for HBsAg at the start of therapy. Sixty patients (25.1%) showed HBsAg-negative and antiHBc-positive serology indicative of past HBV infection. Among these 60 patients, 2 patients (3.3%) experienced reactivation of viral replication (\2.1 log copies/ml) during DMARD therapy. One had been receiving tacrolimus, prednisolone, and methotrexate (MTX); the other had been treated with adalimumab, prednisolone, and MTX. Their serum aminotransferase levels remained normal, and HBsAg was negative. Ten weeks after reactivation of viral replication had been noted, the HBV-DNA titer in the former patient had increased to 2.9 log copies/ml, and HBsAg and hepatitis B e antigen had become weakly positive. In contrast, the latter patient had become negative for viral DNA without any antiviral prophylaxis. In conclusion, the use of biological and nonbiological DMARDs is relatively safe in most RA patients with past HBV infection, even when no anti-HBV prophylaxis is administered. Considering the high prevalence of past infection in RA patients and the high cost of prophylaxis against HBV reactivation, universal prophylaxis is impractical. Regular monitoring of serum viral DNA seems to be the most rational approach to preventing the development of clinically apparent hepatitis.

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Section: Discussionmentioning

confidence: 99%

Past hepatitis B virus infection in rheumatoid arthritis patients receiving biological and/or nonbiological disease-modifying antirheumatic drugs

Mori

2011

Modern Rheumatology

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“…Historically, etanercept has been associated with infectious risks in patients with other inflammatory conditions, including Crohn’s disease, rheumatoid arthritis, and psoriaris, and has been contraindicated in patients with sepsis syndrome [50–53]. Reactivation of latent hepatitis B, hepatitis C, and tuberculosis infections has been seen with prolonged etanercept usage in these patient populations [54–57]. Despite the intensity of immune suppression concurrently used in our study population, secondary infections were extremely rare during or following etanercept therapy.…”

Section: Discussionmentioning

confidence: 99%

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for Subacute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation

Yanik

Mineishi

Levine

et al. 2012

Biology of Blood and Marrow Transplantation

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Subacute lung disease, manifested as either obstructive (OLD) or restrictive (RLD) lung dysfunction, is a common complication following allogeneic stem cell transplantation. In each case, therapeutic options are limited, morbidity remains high, and long-term survival is poor. Between 2001 and 2008, 34 patients with noninfectious, obstructive (25) or RLD restrictive lung dysfunction (nine) received etanercept (Enbrel®, Amgen Inc.) 0.4 mg/kg/dose, subcutaneously, twice weekly, for 4 (group A) or 12 weeks (group B). Corticosteroids (if present at study entry) were kept constant for the initial 4 weeks of therapy and then tapered as tolerated. Thirty-one of 34 (91%) subjects were evaluable for response, and 10 (32%) met primary response criteria. There was no difference in response based on the duration of treatment (29% group A versus 35% group B; P =.99), the presence of RLD or OLD (33% versus 32%; P =.73), or the severity of pulmonary disease at study onset. Estimated 5-year overall survival rates following therapy were 61% (95% confidence interval, 46%–80%) for all subjects and 90% (95% confidence level, 73% –100%) for the 10 who met the primary response criteria. Five-year survival estimates for subjects treated with RLD was 44%, compared with 67% for those treated for OLD (P =.19). Etanercept was well tolerated, with no bacteremia or viremia observed. Pathogens were noted on posttherapy bronchoalveolar lavage in two cases. These data support the development of expanded clinical trials to study etanercept as a therapeutic agent for subacute lung injury after allogeneic stem cell transplantation.

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“…Up to 40% of AS patients experience an inadequate response or intolerance (IR) to anti-TNF therapies, and cases of relapse have also been reported, specifically in Asian patients, after completion of short-term treatment with anti-TNF therapies (9)(10)(11)(12). Long-term studies with anti-TNF agents have shown a high incidence of tuberculosis and hepatitis B virus infections, as well as immunogenicity in Asian patients with AS (13)(14)(15).…”

Section: Introductionmentioning

confidence: 99%

Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1

et al. 2020

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ObjectivesTo present the long-term (4-year) efficacy and safety of secukinumab in Taiwanese patients with active AS in the MEASURE 1 extension study.MethodsThis post hoc analysis reports data from Taiwanese patients originally randomized to subcutaneous secukinumab 150 or 75mg or placebo every 4 weeks (following intravenous loading dose) who were invited to enter the 3-year extension study. Assessments at Week 208 included ASAS20/40 responses and other clinically relevant endpoints. Efficacy data are presented as observed. Safety analyses included all patients who received ≥1 dose of secukinumab.ResultsOf the 57 Taiwanese patients in the core trial, 48 entered the extension study and 87.5% patients (42/48) completed 4 years of treatment. Thirteen Taiwanese patients (including placebo-switchers) were escalated from 75 to 150mg (approved dose) at some point starting from Week 172. ASAS20/40 responses were sustained through 4 years in the Taiwanese patients who were originally randomized to secukinumab 150mg. Clinical responses were improved in those patients who received dose-escalation from 75 to 150mg during the study. No unexpected safety signals were reported.ConclusionSecukinumab 150mg demonstrated sustained efficacy over 4 years in Taiwanese patients with active ankylosing spondylitis. The safety profile of secukinumab was consistent with previous reports.ClinicalTrials.gov identifierNCT01863732.

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Hepatitis B virus reactivation during therapy with etanercept in an HBsAg‐negative and anti‐HBs‐positive patient

Cited by 85 publications

References 6 publications

Past hepatitis B virus infection in rheumatoid arthritis patients receiving biological and/or nonbiological disease-modifying antirheumatic drugs

Past hepatitis B virus infection in rheumatoid arthritis patients receiving biological and/or nonbiological disease-modifying antirheumatic drugs

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for Subacute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation

Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1

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