Safety of secukinumab in the treatment of patients with axial spondyloarthritis and concurrent hepatitis B virus infection or latent tuberculosis infection.
Axial spondyloarthritis
Hepatitis B virus infection
Latent tuberculosis infection
Reactivation
Safety
Secukinumab
Journal
Clinical rheumatology
ISSN: 1434-9949
Titre abrégé: Clin Rheumatol
Pays: Germany
ID NLM: 8211469
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
received:
31
10
2022
accepted:
07
05
2023
revised:
21
04
2023
medline:
10
8
2023
pubmed:
23
5
2023
entrez:
23
5
2023
Statut:
ppublish
Résumé
To evaluate the safety of secukinumab (SEC) in the treatment of patients with axial spondyloarthritis (axSpA) and concurrent hepatitis B virus (HBV) infection or latent tuberculosis infection (LTBI). This is a retrospective cohort study. Adult axSpA patients with HBV infection or LTBI receiving SEC treatment for at least 3 months from March 2020 to July 2022 in Guangdong Provincial People's Hospital were included. Patients were screened for HBV infection and LTBI before SEC treatment. During follow-up, reactivation of HBV infection and LTBI was monitored. Relevant data were collected and analyzed. A total of 43 axSpA patients with HBV infection or LTBI were included, of whom 37 were with HBV infection, 6 were with LTBI. Six out of thirty-seven (16.2%) patients with axSpA and concurrent HBV infection exhibited HBV reactivation after 9.0 ± 5.7 months of SEC treatment. Among them, 3 patients had chronic HBV infection and received anti-HBV prophylaxis, 2 patients had chronic HBV infection but did not receive anti-HBV prophylaxis, and 1 patient had occult HBV infection and did not receive antiviral prophylaxis. None of the 6 axSpA patients with LTBI developed reactivation of LTBI, whether received anti-TB prophylaxis or not. HBV reactivation can occur in axSpA patients with different types of HBV infection undergoing SEC treatment, whether receive antiviral prophylaxis or not. Close monitoring of HBV reactivation in axSpA patients with HBV infection undergoing SEC treatment is mandatory. Anti-HBV prophylaxis may be beneficial. In contrast, SEC may be safe in axSpA patients with LTBI, even in patients not receiving anti-TB prophylaxis. Key Points •Currently, most evidence about the safety of SEC in patients with HBV infection and LTBI were from patients with psoriasis. Our study adds data about the safety of SEC in Chinese axSpA patients with concurrent HBV infection or LTBI in real-world clinical setting. •Our study showed that HBV reactivation can occur in axSpA patients with different types of HBV infection undergoing SEC treatment, whether receive antiviral prophylaxis or not. •Close monitoring of serum HBV markers, HBV DNA load, and liver function is mandatory in axSpA patients with chronic, occult, and resolved HBV infection undergoing SEC treatment. Anti-HBV prophylaxis may be beneficial in all HBsAg-positive patients and HBsAg-negative, HBcAb-positive patients at high risk of HBV reactivation who are receiving SEC therapy. •None of the axSpA patients with LTBI, whether received anti-TB prophylaxis or not, developed reactivation of LTBI in our study. SEC may be safe in axSpA patients with LTBI, even in patients not receiving anti-TB prophylaxis.
Identifiants
pubmed: 37219751
doi: 10.1007/s10067-023-06630-8
pii: 10.1007/s10067-023-06630-8
doi:
Substances chimiques
secukinumab
DLG4EML025
Hepatitis B Surface Antigens
0
Antiviral Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2369-2376Informations de copyright
© 2023. The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR).
Références
Sieper J, Poddubnyy D (2017) Axial spondyloarthritis. Lancet 390:73–84. https://doi.org/10.1016/s0140-6736(16)31591-4
doi: 10.1016/s0140-6736(16)31591-4
pubmed: 28110981
Robinson PC, van der Linden S, Khan MA, Taylor WJ (2021) Axial spondyloarthritis: concept, construct, classification and implications for therapy. Nat Rev Rheumatol 17:109–118. https://doi.org/10.1038/s41584-020-00552-4
doi: 10.1038/s41584-020-00552-4
pubmed: 33361770
Ward MM, Deodhar A et al (2019) 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol 71:1599–1613. https://doi.org/10.1002/art.41042
doi: 10.1002/art.41042
pubmed: 31436036
pmcid: 6764882
Baeten D, Sieper J et al (2015) Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med 373:2534–2548. https://doi.org/10.1056/NEJMoa1505066
doi: 10.1056/NEJMoa1505066
pubmed: 26699169
van der Heijde D, Ramiro S et al (2017) 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis 76:978–991. https://doi.org/10.1136/annrheumdis-2016-210770
doi: 10.1136/annrheumdis-2016-210770
pubmed: 28087505
Cantini F, Nannini C et al (2015) Guidance for the management of patients with latent tuberculosis infection requiring biologic therapy in rheumatology and dermatology clinical practice. Autoimmun Rev 14:503–509. https://doi.org/10.1016/j.autrev.2015.01.011
doi: 10.1016/j.autrev.2015.01.011
pubmed: 25617816
Cannizzaro MV, Franceschini C, Esposito M, Bianchi L, Giunta A (2017) Hepatitis B reactivation in psoriasis patients treated with anti-TNF agents: prevention and management. Psoriasis 7:35–40. https://doi.org/10.2147/ptt.S108209
doi: 10.2147/ptt.S108209
pubmed: 29387606
pmcid: 5774605
Pauly MP, Tucker LY et al (2018) Incidence of hepatitis B virus reactivation and hepatotoxicity in patients receiving long-term treatment with tumor necrosis factor antagonists. Clin Gastroenterol Hepatol 16:1964-1973.e1. https://doi.org/10.1016/j.cgh.2018.04.033
doi: 10.1016/j.cgh.2018.04.033
pubmed: 29702293
Elewski BE, Baddley JW et al (2021) Association of secukinumab treatment with tuberculosis reactivation in patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis. JAMA Dermatol 157:43–51. https://doi.org/10.1001/jamadermatol.2020.3257
doi: 10.1001/jamadermatol.2020.3257
pubmed: 33001147
Fowler E, Ghamrawi RI, Ghiam N, Liao W, Wu JJ (2020) Risk of tuberculosis reactivation during interleukin-17 inhibitor therapy for psoriasis: a systematic review. J Eur Acad Dermatol Venereol 34:1449–1456. https://doi.org/10.1111/jdv.16254
doi: 10.1111/jdv.16254
pubmed: 32012384
Chiu HY, Hui RC et al (2018) Safety profile of secukinumab in treatment of patients with psoriasis and concurrent hepatitis B or C: a multicentric prospective cohort study. Acta Derm Venereol 98:829–834. https://doi.org/10.2340/00015555-2989
doi: 10.2340/00015555-2989
pubmed: 29972221
Zheng B, Li T et al (2012) Prevalence of hepatitis B surface antigen in patients with ankylosing spondylitis and its association with HLA-B27: a retrospective study from south China. Rheumatol Int 32:2011–2016. https://doi.org/10.1007/s00296-011-1934-7
doi: 10.1007/s00296-011-1934-7
pubmed: 21479602
Liu YJ, Xu J et al (2019) The prevalence of latent tuberculosis infection in patients with inflammatory arthritis and the diagnostic efficacy of different screening methods. Zhonghua Yi Xue Za Zhi 99:20–24. https://doi.org/10.3760/cma.j.issn.0376-2491.2019.01.005
doi: 10.3760/cma.j.issn.0376-2491.2019.01.005
pubmed: 30641659
Rudwaleit M, van der Heijde D et al (2009) The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis 68:777–783. https://doi.org/10.1136/ard.2009.108233
doi: 10.1136/ard.2009.108233
pubmed: 19297344
Piaserico S, Messina F, Russo FP (2019) Managing psoriasis in patients with HBV or HCV infection: practical considerations. Am J Clin Dermatol 20:829–845. https://doi.org/10.1007/s40257-019-00457-3
doi: 10.1007/s40257-019-00457-3
pubmed: 31222626
Chee CBE, Reves R, Zhang Y, Belknap R (2018) Latent tuberculosis infection: opportunities and challenges. Respirology 23:893–900. https://doi.org/10.1111/resp.13346
doi: 10.1111/resp.13346
pubmed: 29901251
Cantini F, Nannini C et al (2017) Risk of tuberculosis reactivation in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis receiving non-anti-TNF-targeted biologics. Mediators Inflamm 2017:8909834. https://doi.org/10.1155/2017/8909834
doi: 10.1155/2017/8909834
pubmed: 28659665
pmcid: 5474286
Haas MK, Belknap RW (2019) Diagnostic tests for latent tuberculosis infection. Clin Chest Med 40:829–837. https://doi.org/10.1016/j.ccm.2019.07.007
doi: 10.1016/j.ccm.2019.07.007
pubmed: 31731987
Lee E, Holzman RS (2002) Evolution and current use of the tuberculin test. Clin Infect Dis 34:365–370. https://doi.org/10.1086/338149
doi: 10.1086/338149
pubmed: 11774084
Pai M, Riley LW, Colford JM Jr (2004) Interferon-gamma assays in the immunodiagnosis of tuberculosis: a systematic review. Lancet Infect Dis 4:761–776. https://doi.org/10.1016/s1473-3099(04)01206-x
doi: 10.1016/s1473-3099(04)01206-x
pubmed: 15567126
Shi Y, Zheng M (2020) Hepatitis B virus persistence and reactivation. Bmj 370:m2200. https://doi.org/10.1136/bmj.m2200
doi: 10.1136/bmj.m2200
pubmed: 32873599
Gong W, Wu X (2021) Differential diagnosis of latent tuberculosis infection and active tuberculosis: a key to a successful tuberculosis control strategy. Front Microbiol 12:745592. https://doi.org/10.3389/fmicb.2021.745592
doi: 10.3389/fmicb.2021.745592
pubmed: 34745048
pmcid: 8570039
Megna M, Patruno C et al (2022) Hepatitis virus reactivation in patients with psoriasis treated with secukinumab in a real-world setting of hepatitis B or hepatitis C infection. Clin Drug Investig 42:525–531. https://doi.org/10.1007/s40261-022-01163-5
doi: 10.1007/s40261-022-01163-5
pubmed: 35633470
pmcid: 9188589
Qin H, Liu N et al (2022) Safety and efficacy of secukinumab in psoriasis patients infected with hepatitis B virus: a retrospective study. Eur J Dermatol 32:394–400. https://doi.org/10.1684/ejd.2022.4263
doi: 10.1684/ejd.2022.4263
pubmed: 36065536
EASL (2017) Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol 67:370–398. https://doi.org/10.1016/j.jhep.2017.03.021
doi: 10.1016/j.jhep.2017.03.021
Megna M, Patruno C et al (2022) Lack of reactivation of tuberculosis in patients with psoriasis treated with secukinumab in a real-world setting of latent tuberculosis infection. J Dermatolog Treat 33:2629–2633. https://doi.org/10.1080/09546634.2022.2062280
doi: 10.1080/09546634.2022.2062280
pubmed: 35385362
Shu D, Zhang Z, Zhou EY, Ma X, Zhao Y (2020) Is chemoprophylaxis necessary for all latent tuberculosis infection patients receiving IL-17 inhibitors? A cohort study. Dermatol Ther 33:e14512. https://doi.org/10.1111/dth.14512
doi: 10.1111/dth.14512
pubmed: 33166023
Segueni N, Tritto E et al (2016) Controlled Mycobacterium tuberculosis infection in mice under treatment with anti-IL-17A or IL-17F antibodies, in contrast to TNFα neutralization. Sci Rep 6:36923. https://doi.org/10.1038/srep36923
doi: 10.1038/srep36923
pubmed: 27853279
pmcid: 5113257
Huang Z, van Velkinburgh JC, Ni B, Wu Y (2012) Pivotal roles of the interleukin-23/T helper 17 cell axis in hepatitis B. Liver Int 32:894–901. https://doi.org/10.1111/j.1478-3231.2012.02764.x
doi: 10.1111/j.1478-3231.2012.02764.x
pubmed: 22340646