Abstract
Purpose
To investigate the real-world dose of systemic corticosteroids in the treatment of non-infectious uveitis (NIU) in Japan.
Study design
A retrospective, observational study.
Methods
Patients newly registered at the Japan Medical Data Center health insurance claims database with a diagnosis of NIU who received systemic corticosteroids were identified, and their systemic corticosteroid dose (prednisolone equivalent) was assessed over 12 months of treatment (data extraction period: January 2008 to May 2017).
Results
The mean cumulative systemic corticosteroid dose in 12 months in 1641 new patients with NIU who received systemic corticosteroids was 593.7 mg. The mean systemic corticosteroid dose was highest at month 1 (10.7, 218.1, 16.7, and 23.0 mg/day in Behçet’s disease [BD]–associated NIU [n = 19], Vogt-Koyanagi-Harada [VKH] disease–associated NIU [n = 49], sarcoidosis-associated NIU [n = 27], and “undifferentiated NIU” [NIU without specific primary disease information, n = 1545], respectively) and decreased over time. Systemic corticosteroids were prescribed at month 12 to 68.4%, 22.4%, 44.4%, and 5.6% of patients with BD–associated NIU, VKH disease–associated NIU, sarcoidosis-associated NIU, and undifferentiated NIU, respectively (mean dose, 6.0–14.3 mg/day). Multivariate regression analysis identified female sex, middle age (30 to < 40 years), VKH disease, and immunosuppressive agent use as background factors associated with higher systemic corticosteroid dose.
Conclusions
The systemic corticosteroid dose was highest at month 1 and decreased over time in all disease categories. This database research revealed that some patients with NIU continued being prescribed systemic corticosteroids for at least 1 year.
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References
Rothova A, Suttorp-van Schulten MS, Frits Treffers W, Kijlstra A. Causes and frequency of blindness in patients with intraocular inflammatory disease. Br J Ophthalmol. 1996;80:332–6.
Dick AD, Tundia N, Sorg R, Zhao C, Chao J, Joshi A, et al. Risk of ocular complications in patients with noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Ophthalmology. 2016;123:655–62.
Iwase A, Araie M, Tomidokoro A, Yamamoto T, Shimizu H, Kitazawa Y, Tajimi Study Group. Prevalence and causes of low vision and blindness in a Japanese adult population: the Tajimi study. Ophthalmology. 2006;113:1354–62.
Takeuchi M, Kanda T, Kaburaki T, Tanaka R, Namba K, Kamoi K, et al. Real-world evidence of treatment for relapse of noninfectious uveitis in tertiary centers in Japan: a multicenter study. Med (Baltim). 2019;98:e14668.
Takahashi R, Yoshida A, Inoda S, Okubo A, Kawashima H. Uveitis incidence in Jichi Medical University Hospital, Japan, during 2011–2015. Clin Ophthalmol. 2017;11:1151–6.
Kotake S, Furudate N, Sasamoto Y, Yoshikawa K, Goda C, Matsuda H. Characteristics of endogenous uveitis in Hokkaido, Japan. Graefes Arch Clin Exp Ophthalmol. 1996;234:599–603.
Hikita S, Sonoda KH, Hijioka K, Fujimoto T, Ito T, Ishibashi T. Incidence of uveitis in the northern Kyushu region of Japan–comparison between the periods of 1996–2001 and 2003–2008. Nippon Ganka Gakkai zasshi. 2012;116:847–55. [in Japanese].
Iwata D, Mizuuchi K, Aoki K, Horie Y, Kase S, Namba K, et al. Serial frequencies and clinical features of uveitis in Hokkaido, Japan. Ocul Immunol Inflamm. 2017;25(Sup 1):15–8.
Nakahara H, Kaburaki T, Takamoto M, Okinaga K, Matsuda J, Konno Y, et al. Statistical analyses of endogenous uveitis patients (2007–2009) in central Tokyo area and comparison with previous studies (1963–2006). Ocul Immunol Inflamm. 2015;23:291–6.
Nakahara H, Kaburaki T, Tanaka R, Takamoto M, Ohtomo K, Karakawa A, et al. Frequency of uveitis in the central Tokyo area (2010–2012). Ocul Immunol Inflamm. 2017;25(Sup 1):8–14.
Shirahama S, Kaburaki T, Nakahara H, Tanaka R, Takamoto M, Fujino Y, et al. Epidemiology of uveitis (2013–2015) and changes in the patterns of uveitis (2004–2015) in the central Tokyo area: a retrospective study. BMC Ophthalmol. 2018;18:189.
Ohguro N, Sonoda KH, Takeuchi M, Matsumura M, Mochizuki M. The 2009 prospective multi-center epidemiologic survey of uveitis in Japan. Jpn J Ophthalmol. 2012;56:432–5.
Goto H, Mochizuki M, Yamaki K, Kotake S, Usui M, Ohno S. Epidemiological survey of intraocular inflammation in Japan. Jpn J Ophthalmol. 2007;51:41–4.
Japanese Ocular Inflammation Society. Guideline for treatment of uveitis (June 10, 2019). Nippon Ganka Gakkai zasshi. 2019;123:635–96. [in Japanese].
Mishima S, Masuda K, Izawa Y, Mochizuki M, Namba K. The eighth Frederick H. Verhoeff lecture. Behçet’s disease in Japan: ophthalmologic aspects. Trans Am Ophthalmol Soc. 1979;77:225–79.
Committee for the Preparation of Clinical Treatment of Ocular Lesions Related to Behçet’s Disease. Guidelines for the clinical management of ocular Behçet’s disease. Nippon Ganka Gakkai zasshi. 2012;116:394–426. [in Japanese].
Sakane T, Takeno M, Suzuki N, Inaba G. Behçet’s disease. N Engl J Med. 1999;341:1284–91.
Herbort CP Jr, Abu El Asrar AM, Yamamoto AM, Pavésio JH, Gupta CE, Khairallah VM, et al. Reappraisal of the management of Vogt-Koyanagi-Harada disease: sunset glow fundus is no more a fatality. Int Ophthalmol. 2017;37:1383–95.
Japan Society of Sarcoidosis and other Granulomatous Disorders. Guidance on sarcoidosis treatment. 2018. https://www.jssog.com/journal. Accessed 1 February 2022. [in Japanese].
Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term systemic corticosteroid exposure: a systematic literature review. Clin Ther. 2017;39:2216–29.
Yasir M, Goyal A, Bansal P, Sonthalia S. Corticosteroid adverse effects. Treasure Island (FL): StatPearls Publishing LLC; 2021.
Strehl C, Bijlsma JWJ, de Wit M, Boers M, Caeyers N, Cutolo M, et al. Defining conditions where long-term glucocorticoid treatment has an acceptably low level of harm to facilitate implementation of existing recommendations: viewpoints from an EULAR task force. Ann Rheum Dis. 2016;75:952–7.
Nakahara H, Kaburaki T, Tanaka R, Yoshida A, Takamoto M, Kawata M, et al. Comparisons of clinical features in Japanese patients with Behçet’s uveitis treated in the 1990s and the 2000s. Ocul Immunol Inflamm. 2020;28:262–9.
Umazume A, Ohguro N, Okada AA, Namba K, Sonoda K, Tsuruga H, et al. Prevalence and incidence rates and treatment patterns of non-infectious uveitis in Japan: real-world data using a claims database. Jpn J Ophthalmol. 2021;65:657–65.
Kimura S, Sato T, Ikeda S, Noda M, Nakayama T. Development of a database of health insurance claims: standardization of disease classifications and anonymous record linkage. J Epidemiol. 2010;20:413–9.
Statistics Bureau, Ministry of Internal Affairs and Communications. Result of the Population Estimates. https://www.stat.go.jp/english/data/jinsui/2.html. Accessed 1 February 2022.
O’Keefe GAD, Rao NA. Vogt-Koyanagi-Harada disease. Surv Ophthalmol. 2017;62:1–25.
Grossmann C, Scholz T, Rochel M, Bumke-Vogt C, Oelkers W, Pfeiffer AFH, et al. Transactivation via the human glucocorticoid and mineralocorticoid receptor by therapeutically used steroids in CV-1 cells: a comparison of their glucocorticoid and mineralocorticoid properties. Eur J Endocrinol. 2004;151:397–406.
Medical Care Act. Law number: Act No. 205 of 1948. https://www.mhlw.go.jp/web/t_doc?dataId=80090000&dataType=0&pageNo=1. Accessed 1 February 2022. [in Japanese].
Sonoda KH, Hasegawa E, Namba K, Okada AA, Ohguro N, Goto H. JOIS (Japanese Ocular Inflammation Society) Uveitis Survey Working Group. Epidemiology of uveitis in Japan: a 2016 retrospective nationwide survey. Jpn J Ophthalmol. 2021;65:184–90.
Sakai JI, Usui Y, Sakai M, Yokoi H, Goto H. Clinical statistics of endogenous uveitis: comparison between general eye clinic and university hospital. Int Ophthalmol. 2010;30:297–301.
Wang Y, Chan CC. Gender differences in Vogt-Koyanagi-Harada disease and sympathetic ophthalmia. J Ophthalmol. 2014;2014:157803.
Vander Cruyssen B, Ribbens C, Boonen A, Mielants H, de Vlam K, Lenaerts J, et al. The epidemiology of ankylosing spondylitis and the commencement of anti-TNF therapy in daily rheumatology practice. Ann Rheum Dis. 2007;66:1072–7.
Sabri K, Saurenmann RK, Silverman ED, Levin AV. Course, complications, and outcome of juvenile arthritis-related uveitis. J AAPOS. 2008;12:539–45.
Stuck AE, Frey BM, Frey FJ. Kinetics of prednisolone and endogenous cortisol suppression in the elderly. Clin Pharmacol Ther. 1988;43:354–62.
Shionogi & Co., Ltd. Predonine® 5 mg tablets Japanese package insert, version 1 (revised. July 2020). https://www.info.pmda.go.jp/go/pack/2456001F1310_4_02/. Accessed 1 February 2022. [in Japanese].
Nishimura R, Kato H, Kisanuki K, Oh A, Hiroi S, Onishi Y, et al. Treatment patterns, persistence and adherence rates in patients with type 2 diabetes mellitus in Japan: a claims-based cohort study. BMJ Open. 2019;9:e025806.
Japanese Ophthalmological Society. Guidance and safety manual on the use of anti-TNF agents in non-infectious uveitis (revised version 2). Nippon Ganka Gakkai zasshi. 2019;123:697–705. [in Japanese].
Acknowledgements
This work was funded by AbbVie GK. AbbVie GK participated in the study design, data analysis and interpretation, and writing, reviewing, and approval of the publication. We thank Prof. Ishikawa of International University of Health and Welfare for his contribution as an advisor and database study expert and Motohiro Okayasu, Yoko Yoshinaga, and Masahiko Nakayama, past or current AbbVie employees, for their contribution to the design of this study. Data extraction and statistical analyses were performed by JMDC Co. Ltd. and funded by AbbVie GK. Medical writing support was provided by Mami Hirano, MS, of Cactus Life Sciences (part of Cactus Communications) and funded by AbbVie GK.
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A. Umazume, None; N. Ohguro, None; A. A. Okada, Grants (Bayer, Novartis, Santen, Mitsubishi Tanabe, Alcon, Kowa), Consulting fees (Bayer, AbbVie, Astellas, Biocon Biologics, Daiichi Sankyo, Allergan, Chugai, Novartis), Speaker fees (Bayer, Kowa, Novartis, Santen, Mitsubishi Tanabe, Senju, Alcon, Otsuka, Allergan); K. Namba, Grant (AbbVie, Mitsubishi Tanabe, Eisai, EP-CRSU), Speaker fees (Alcon, Pfizer, Novartis, Kowa, Senju, Mitsubishi Tanabe, Eisai, AbbVie, Santen, Celgene); K. Sonoda, None; H. Goto, None; H. Tsuruga and K. Morita are employees of AbbVie GK and may receive stocks.
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Umazume, A., Ohguro, N., Okada, A.A. et al. Use of systemic corticosteroids in patients newly registered at a claims database with a diagnosis of non-infectious uveitis: results from a real-world claims database analysis. Jpn J Ophthalmol 66, 394–404 (2022). https://doi.org/10.1007/s10384-022-00923-2
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DOI: https://doi.org/10.1007/s10384-022-00923-2