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The seroconversion rate of QuantiFERON-TB Gold In-Tube test in psoriatic patients receiving secukinumab and ixekizumab, the anti-interleukin-17A monoclonal antibodies


Autoři: Chen-Yu Wu aff001;  Hsien-Yi Chiu aff002;  Tsen-Fang Tsai aff002
Působiště autorů: Department of Dermatology, Cathay General Hospital, Taipei, Taiwan aff001;  Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan aff002;  Department of Dermatology, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan aff003
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0225112

Souhrn

Background

For psoriatic patients receiving biologics, the concern of tuberculosis (TB) infection exists. Although the TB risk of anti-interleukin (IL)-17A agents is generally considered very low, more real-world data are needed to support the safety.

Objectives

This study aims to provide the real-world experience of using serial QuantiFERON-TB Gold In-Tube (QFT-GIT) test among patients treated with secukinumab or ixekizumab in Taiwan, an intermediate TB burden country, for the detection of latent TB infection (LTBI) reactivation or newly acquired TB infection.

Methods

This retrospective review evaluated 100 consecutive patients with psoriasis receiving anti-IL-17A therapies who were checked with at least twice QFT-GIT between 2016 and 2019 in National Taiwan University Hospital, Taipei and Hsin-Chu, Taiwan.

Results

Among the 100 patients, the baseline QFT-GIT results were negative in 81.0% (81/100), positive in 18.0% (18/100), and indeterminate in 1.0% (1/100) of patients. The overall outcomes in patients receiving at least 6 months of cumulative exposure to anti-IL-17A agents were persistently seronegative in 80 patients (80.0%), persistently seropositive in 14 patients (14.0%), seroconversion in 1 patient (1.0%), seroreversion in 3 patients (3.0%), and others in 2 patients (2.0%). In patients with at least 11 months of cumulative exposure, the seroconversion rate was 1.3% (1/79). The only case with seroconversion had a positive QFT-GIT result previously. No case of TB reactivation or newly acquired TB infection was identified during the follow-up.

Conclusions

In patients treated with anti-IL-17A monoclonal antibodies for psoriasis, routine serial repeat QFT-GIT testing was associated with lower seroconversion rate compared to real-world data of tumor necrosis factor-α inhibitors and anti-IL-12/23 antibody in Taiwan and in pivotal studies. Because clinical TB symptoms and signs are often preceded by QFT-GIF seroconversion, this result further supports the safety of anti-IL-17A agents in patients with psoriasis for LTBI.

Klíčová slova:

Antibodies – Cytokines – Monoclonal antibodies – Screening guidelines – Taiwan – Tuberculosis – Psoriasis


Zdroje

1. Kaushik SB, Lebwohl MG. Review of safety and efficacy of approved systemic psoriasis therapies. Int J Dermatol. 2019;58: 649–658. doi: 10.1111/ijd.14246 30246393

2. Cho YT, Chen CH, Chiu HY, Tsai TF. Use of anti-tumor necrosis factor-α therapy in hepatitis B virus carriers with psoriasis or psoriatic arthritis: a case series in Taiwan. J Dermatol. 2012;39: 269–73. doi: 10.1111/j.1346-8138.2011.01434.x 22077677

3. Chiu HY, Chen CH, Wu MS, Cheng YP, Tsai TF. The safety profile of ustekinumab in the treatment of patients with psoriasis and concurrent hepatitis B or C. Br J Dermatol. 2013;169: 1295–303. doi: 10.1111/bjd.12461 23746170

4. Chiu HY, Hui RC, Huang YH, Huang RY, Chen KL, Tsai YC, et al. Safety Profile of Secukinumab in Treatment of Patients with Psoriasis and Concurrent Hepatitis B or C: A Multicentric Prospective Cohort Study. Acta Derm Venereol. 2018;98: 829–834. doi: 10.2340/00015555-2989 29972221

5. Tsai YC, Tsai TF. A review of clinical trials of biologic agents and small molecules for psoriasis in Asian subjects. G Ital di Dermatologia e Venereol. 2016;151: 412–431.

6. Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CE, Nakanishi AM, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152: 1304–12. doi: 10.1111/j.1365-2133.2005.06688.x 15948997

7. Li CR, Mao QX, Chen M, Jia WX, Yao X, Feng SY, et al. Acquired latent tuberculosis infection in psoriasis patients treated with etanercept in the People’s Republic of China. Drug Des Devel Ther. 2015;9: 5591–5594. doi: 10.2147/DDDT.S87260 26508833

8. Mori T, Sakatani M, Yamagishi F, Takashima T, Kawabe Y, Nagao K, et al. Specific Detection of Tuberculosis Infection: An Interferon-Gamma-based Assay Using New Antigens. Am J Resp. 2004;170: 59–64. doi: 10.1164/rccm.200402-179OC 15059788

9. Lein AD, von Reyn CF, Ravn P, Horsburgh CR, Alexander LN, Andersen P. Cellular immune responses to ESAT-6 discriminate between patients with pulmonary disease due to Mycobacterium avium complex and those with pulmonary disease due to Mycobacterium tuberculosis. Clin Diagn Lab Immunol. 1999;6: 606–609. 10391871

10. Diel R, Loddenkemper R, Meywald-Walter K, Niemann S, Nienhaus A. Predictive value of a whole blood IFN-γ assay for the development of active tuberculosis disease after recent infection with Mycobacterium tuberculosis. Am J Respir Crit Care Med. 2008;177: 1164–1170. doi: 10.1164/rccm.200711-1613OC 18276940

11. Gisondi P, Pezzolo E, LoCascio G, Girolomoni G. Latent tuberculosis infection in patients with chronic plaque psoriasis who are candidates for biological therapy. Br J Dermatol. 2014;171: 884–890. doi: 10.1111/bjd.13130 24863903

12. Centers for Disease Control, Ministry of Health and Welfare, R.O.C.(Taiwan). 2015 Centers for disease control annual report. http://www.cdc.gov.tw/uploads/files/201509/0cc797c3-5252-477f-bd33-91b68c62238d.pdf.

13. Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001;345: 1098–104. doi: 10.1056/NEJMoa011110 11596589

14. Gómez-Reino JJ, Carmona L, Valverde VR, Mola EM, Montero MD; BIOBADASER Group. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: A multicenter active-surveillance report. Arthritis Rheum. 2003;48: 2122–2127. doi: 10.1002/art.11137 12905464

15. Mohan AK, Coté TR, Block JA, Manadan AM, Siegel JN, Braun MM. Tuberculosis following the Use of Etanercept, a Tumor Necrosis Factor Inhibitor. Clin Infect Dis. 2004;39: 295–299. doi: 10.1086/421494 15306993

16. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: Systematic review and meta-analysis of rare harmful effects in randomized controlled trials. J Am Med Assoc. 2006;295: 2275–2285. doi: 10.1001/jama.295.19.2275 16705109

17. Ahn CS, Dothard EH, Garner ML, Feldman SR, Huang WW. To test or not to test? An updated evidence-based assessment of the value of screening and monitoring tests when using systemic biologic agents to treat psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2015;73: 420–428.e1. doi: 10.1016/j.jaad.2015.06.004 26184440

18. Sivamani RK, Goodarzi H, Garcia MS, Raychaudhuri SP, Wehrli LN, Ono Y, et al. Biologic therapies in the treatment of psoriasis: A comprehensive evidence-based basic science and clinical review and a practical guide to tuberculosis monitoring. Clin Rev Allergy Immunol. 2013;44: 121–140. doi: 10.1007/s12016-012-8301-7 22311162

19. Chen DY, Shen GH, Hsieh TY, Hsieh CW, Lan JL. Effectiveness of the combination of a whole-blood interferon-gamma assay and the tuberculin skin test in detecting latent tuberculosis infection in rheumatoid arthritis patients receiving adalimumab therapy. Arthritis Care Res. 2008;59: 800–806. doi: 10.1002/art.23705 18512714

20. Pratt A, Nicholl K, Kay L. Use of the QuantiFERON TB Gold test as part of a screening programme in patients with RA under consideration for treatment with anti-TNF- agents: the Newcastle (UK) experience. Rheumatology. 2007;46: 1035–1036. doi: 10.1093/rheumatology/kem064 17409126

21. Ponce de Leon D, Acevedo-Vasquez E, Alvizuri S, Gutierrez C, Cucho M, Alfaro J, et al. Comparison of an interferon-gamma assay with tuberculin skin testing for detection of tuberculosis (TB) infection in patients with rheumatoid arthritis in a TB-Endemic population. J Rheumatol. 2008;35: 776–781. 18398944

22. Matulis G, Jüni P, Villiger PM, Gadola SD. Detection of latent tuberculosis in immunosuppressed patients with autoimmune diseases: Performance of a Mycobacterium tuberculosis antigen-specific interferon γ assay. Ann Rheum Dis. 2008;67: 84–90. doi: 10.1136/ard.2007.070789 17644549

23. Aydin V, Akici A, Isli F, Aksoy M, Aydin M, Gursoz H. Relative risk of tuberculosis in patients with rheumatic diseases managed with anti-tumour necrosis factor-alpha therapy: A nationwide cohort study. J Clin Pharm Ther. 2019; doi: 10.1111/jcpt.12814 30763469

24. Kim KH, Lee SW, Chung WT, Kim BG, Woo KS, Han JY, et al. Serial interferon-gamma release assays for the diagnosis of latent tuberculosis infection in patients treated with immunosuppressive agents. Korean J Lab Med. 2011;31: 271–278. doi: 10.3343/kjlm.2011.31.4.271 22016681

25. Garcovich S, Ruggeri A, D’Agostino M, Ardito F, DeSimone C, Delogu G, et al. Clinical applicability of Quantiferon-TB-Gold testing in psoriasis patients during long-term anti-TNF-alpha treatment: A prospective, observational study. J Eur Acad Dermatology Venereol. 2012;26: 1572–1576. doi: 10.1111/j.1468-3083.2011.04220.x 21923840

26. Hatzara C, Hadziyannis E, Kandili A, Koutsianas C, Makris A, Georgiopoulos G, et al. Frequent conversion of tuberculosis screening tests during anti-tumour necrosis factor therapy in patients with rheumatic diseases. Ann Rheum Dis. 2015;74: 1848–1853. doi: 10.1136/annrheumdis-2014-205376 24854354

27. Bartalesi F, Goletti D, Spinicci M, Cavallo A, Attala L, Mencarini J, et al. Serial QuantiFERON TB-Gold in-tube testing during LTBI therapy in candidates for TNFi treatment. J Infect. 2013;66: 346–356. http://dx.doi.org/10.1016/j.jinf.2012.10.017 23103667

28. Sauzullo I, Mengoni F, Marocco R, Potenza C, Skroza N, Tieghi T, et al. Interferon-γ release assay for tuberculosis in patients with psoriasis treated with tumour necrosis factor antagonists: In vivo and in vitro analysis. Br J Dermatol. 2013;169: 1133–1140. doi: 10.1111/bjd.12544 23909256

29. Chung J, Aronson AB, Srikantha R, Vogelgesang SA, Wanat KA. Low conversion rate of QuantiFERON-TB Gold screening tests in patients treated with tumor necrosis factor inhibitors: A retrospective cohort study identifying an important practice gap. J Am Acad Dermatol. 2018;79: 169–171. doi: 10.1016/j.jaad.2018.03.025 29588247

30. Cheng CY, Hui CY, Hu S, Hsieh MH, Huang YH. Serial QuantiFERON-TB Gold In-Tube testing for psoriatic patients receiving antitumor necrosis factor-alpha therapy. Dermatologica Sin. 2015;33: 124–129. doi: 10.1016/j.dsi.2014.12.005

31. Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58: 826–850. doi: 10.1016/j.jaad.2008.02.039 18423260

32. Ohtsuki M, Terui T, Ozawa A, Morita A, Sano S, Takahashi H, et al. Japanese guidance for use of biologics for psoriasis (the 2013 version). J Dermatol. 2013;40: 683–695. doi: 10.1111/1346-8138.12239 24033880

33. Nast A, Gisondi P, Ormerod AD, Saiag P, Smith C, Spuls PI, et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris—Update 2015—Short version—EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29: 2277–94. doi: 10.1111/jdv.13354 26481193

34. Hsiao CY, Chiu HY, Wang TS, Tsai TF. Serial QuantiFERON-TB Gold testing in patients with psoriasis treated with ustekinumab. PLoS One. 2017;12. doi: 10.1371/journal.pone.0184178 28886099

35. Tsai TF, Chiu HY, Song M, Chan D. A case of latent tuberculosis reactivation in a patient treated with ustekinumab without concomitant isoniazid chemoprophylaxis in the PEARL trial. Br J Dermatol. 2013;168: 444–446. doi: 10.1111/j.1365-2133.2012.11162.x 22816505

36. Sánchez-Moya AI, Daudén E. Peripheral Lymph Node Recurrence of Tuberculosis After Ustekinumab Treatment. Arch Dermatol. 2012;148: 1332. doi: 10.1001/archdermatol.2012.2958 23165852

37. Errichetti E, Piccirillo A. Latent tuberculosis reactivation in a patient with erythrodermic psoriasis under treatment with ustekinumab and a low dose steroid, Despite isoniazid chemoprophylaxis. Eur J Dermatology. 2014;24: 508–509. doi: 10.1684/ejd.2014.2386 25120233

38. Kaushik SB, Lebwohl MG. Psoriasis: Which therapy for which patient: Focus on special populations and chronic infections. J Am Acad Dermatol. 2019;80: 43–53. doi: 10.1016/j.jaad.2018.06.056 30017706

39. van de Kerkhof PC, Griffiths CE, Reich K, Leonardi CL, Blauvelt A, Tsai TF, et al. Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75: 83–98.e4. doi: 10.1016/j.jaad.2016.03.024 27180926

40. Riedl E, Winkler S, Xu W, Agada N, Lebwohl M. P1827 No reactivation of tuberculosis in psoriasis patients with latent tuberculosis infection while on ixekizumab treatment: a report from 11 clinical studies. 27th Eur Acad Dermatology Venereol Congr 2018, Paris. 2018.

41. Kammüller M, Tsai TF, Griffiths CE, Kapoor N, Kolattukudy PE, Brees D, et al. Inhibition of IL-17A by secukinumab shows no evidence of increased Mycobacterium tuberculosis infections. Clin Transl Immunol. 2017;6. doi: 10.1038/cti.2017.34 28868144

42. Segueni N, Tritto E, Bourigault ML, Rose S, Erard F, Le Bert M, et al. Controlled Mycobacterium tuberculosis infection in mice under treatment with anti-IL-17A or IL-17F antibodies, in contrast to TNFα neutralization. Sci Rep. 2016;6: 36923. doi: 10.1038/srep36923 27853279

43. Wu NL, Hsu CJ, Sun FJ, Tsai TF. Efficacy and safety of secukinumab in Taiwanese patients with moderate to severe plaque psoriasis: Subanalysis from ERASURE phase III study. J Dermatol. 2017;44: 1129–1137. doi: 10.1111/1346-8138.13900 28493369

44. Chiu HY, Cheng YP, Tsai TF. T helper type 17 in psoriasis: From basic immunology to clinical practice. Dermatologica Sin. 2012;30: 136–141. doi: 10.1016/j.dsi.2012.08.002

45. Chiu HY, Hui RC, Huang YH, Huang RY, Chen KL, Tsai YC, et al. Safety profile of secukinumab in treatment of patients with psoriasis and concurrent hepatitis B or C: A multicentric prospective cohort study. Acta Derm Venereol. 2018;98: 829–834. http://dx.doi.org/10.2340/00015555-2989 29972221

46. Chiu HY, Chan CC, Tsai TF. The impact of long-term secukinumab treatment on Epstein-Barr virus and cytomegalovirus loads in patients with psoriasis. Int J Dermatol. 2016;55: e600–e602. doi: 10.1111/ijd.13346 27261186

47. Chiu HY, Tsai TF. The impact of secukinumab treatment on the prevalence of human papillomavirus in patients with psoriasis: A pilot study. J Am Acad Dermatol. 2016;75: 224–226. doi: 10.1016/j.jaad.2016.02.1168 27317524

48. Hohenberger M, Cardwell LA, Oussedik E, Feldman SR. Interleukin-17 inhibition: role in psoriasis and inflammatory bowel disease. J Dermatolog Treat. 2018;29: 13–18. doi: 10.1080/09546634.2017.1329511 28521565

49. TorradoE CooperAM. IL-17 and Th17 cells in tuberculosis. Cytokine Growth Factor Rev. 2010;21: 455–462. doi: 10.1016/j.cytogfr.2010.10.004 21075039

50. Mourik BC, Lubberts E, de Steenwinkel JEM, Ottenhoff THM, Leenen PJM. Interactions between type 1 interferons and the Th17 response in tuberculosis: Lessons learned from autoimmune diseases. Front Immunol. 2017;8. doi: 10.3389/fimmu.2017.00294 28424682

51. Domingo-Gonzalez R, Prince O, Cooper A, Khader SA. Cytokines and Chemokines in Mycobacterium tuberculosis Infection. Microbiol Spectr. 2016;4. doi: 10.1128/microbiolspec.TBTB2-0018-2016 27763255

52. Das S, Khader S. Yin and yang of interleukin-17 in host immunity to infection. F1000Research. 2017;6: 741. doi: 10.12688/f1000research.10862.1 28713557

53. Robinson RT, Huppler AR. The Goldilocks model of immune symbiosis with Mycobacteria and Candida colonizers. Cytokine. 2017;97: 49–65. doi: 10.1016/j.cyto.2017.05.015 28570933

54. Cruz A, Ludovico P, Torrado E, Gama JB, Sousa J, Gaifem J, et al. IL-17A promotes intracellular growth of Mycobacterium by inhibiting apoptosis of infected macrophages. Front Immunol. 2015;6. doi: 10.3389/fimmu.2015.00498 26483789

55. Menter A, Strober BE, Kaplan DH, Kivelevitch D, Prater EF, Stoff B, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80: 1029–1072. doi: 10.1016/j.jaad.2018.11.057 30772098

56. Nast A, Spuls PI, van der Kraaij G, Gisondi P, Paul C, Ormerod AD, et al. European S3-Guideline on the systemic treatment of psoriasis vulgaris—Update Apremilast and Secukinumab—EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2017;31: 1951–1963. doi: 10.1111/jdv.14454 28895202

57. Johnson JL, Geldenhuys H, Thiel BA, Toefy A, Suliman S, Pienaar B, et al. Effect of isoniazid therapy for latent TB infection on QuantiFERON-TB gold in-tube responses in adults with positive tuberculin skin test results in a high TB incidence area: a controlled study. Chest. 2014;145: 612–7. doi: 10.1378/chest.13-1232 24135768

58. Centers for Disease Control and Prevention. Severe isoniazid associated liver injuries among persons being treated for latent tuberculosis infection—United States, 2004–2008. MMWR Morb Mortal Wkly Rep 2010;59: 224–229. 20203555

59. Comstock GW, Ferebee SH. How much isoniazid is needed for prophylaxis? Am Rev Respir Dis 1970;101: 780–782. 4910642

60. Kobashi Y, Shimizu H, Ohue Y, Mouri K, Obase Y, Miyashita N, et al. False negative results of QuantiFERON TB-2G test in patients with active tuberculosis. Jpn J Infect Dis. 2009;62: 300–2. 19628910


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