Efficacy and Safety of Anti-Tumor Necrosis Factor- Alpha Agents for Patients with Intestinal Behcet’s Disease: A Systematic Review and Meta-Analysis
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Purpose: Intestinal Behcet’s disease (BD) is a systemic autoimmune disease for which treatment options are limited. As a prospectivetherapeutic strategy for intestinal BD, anti-tumor necrosis factor-alpha (anti-TNF-α) agents have received increasing attention. In this study, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of anti-TNF-αagents for patients with intestinal BD. Materials and Methods: We searched PubMed, Embase, and Cochrane Library databases up to July 1, 2021 and articles that metthe eligibility criteria were further assessed. Pooled rates were synthesized by a randomized effects model using Stata software. Results: Eleven clinical trials covering 671 patients with intestinal BD were included. According to compositive data, the pooledrate for remission was 39% [95% confidence interval (CI) 26–52] in patients receiving anti-TNF-α agents. Intestinal symptomswere cured in 70% (95% CI 53–84) of the patients, and the rate for endoscopic healing was 65% (95% CI 52–78). Corticosteroid discontinuationwas achieved in 43% (95% CI 28–58) of the patients, and the dose reduction of corticosteroid was 20.43 mg (95% CI13.4–27.46). There were 239 adverse events and 80 serious adverse events during follow-up. Conclusion: Our study indicated that anti-TNF-α agents may serve as an effective treatment with acceptable safety for patientswith intestinal BD. However, more robust evidence from randomized controlled trials is urgently needed to assess the long-termefficacy and safety of anti-TNF-α agents for those patients.
Abstract
Purpose: Intestinal Behcet’s disease (BD) is a systemic autoimmune disease for which treatment options are limited. As a prospectivetherapeutic strategy for intestinal BD, anti-tumor necrosis factor-alpha (anti-TNF-α) agents have received increasing attention. In this study, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of anti-TNF-αagents for patients with intestinal BD. Materials and Methods: We searched PubMed, Embase, and Cochrane Library databases up to July 1, 2021 and articles that metthe eligibility criteria were further assessed. Pooled rates were synthesized by a randomized effects model using Stata software. Results: Eleven clinical trials covering 671 patients with intestinal BD were included. According to compositive data, the pooledrate for remission was 39% [95% confidence interval (CI) 26–52] in patients receiving anti-TNF-α agents. Intestinal symptomswere cured in 70% (95% CI 53–84) of the patients, and the rate for endoscopic healing was 65% (95% CI 52–78). Corticosteroid discontinuationwas achieved in 43% (95% CI 28–58) of the patients, and the dose reduction of corticosteroid was 20.43 mg (95% CI13.4–27.46). There were 239 adverse events and 80 serious adverse events during follow-up. Conclusion: Our study indicated that anti-TNF-α agents may serve as an effective treatment with acceptable safety for patientswith intestinal BD. However, more robust evidence from randomized controlled trials is urgently needed to assess the long-termefficacy and safety of anti-TNF-α agents for those patients.
참고문헌 (38)
- Cheon JH, "An update on the diagnosis, treatment, and prognosis of intestinal Behçet’s disease", Curr Opin Rheumatol, 27, pp.24~31 (2015)
- Sakane T, "Behçet’s disease", N Engl J Med, 341, pp.1284~1291 (1999)
- 조성빈, "New Insights in the Clinical Understanding of Behçet’s Disease", Yonsei Medical Journal, 53(1), pp.35~42 (2012), 연세대학교의과대학
- 이현정, "Optimal diagnosis and disease activity monitoring of intestinal Behçet’s disease", Intestinal research, 15(3), pp.311~317 (2017), 대한장연구학회
- Hassard PV, "Anti-tumor necrosis factor monoclonal antibody therapy for gastrointestinal Behçet’s disease : a case report", Gastroenterology, 120, pp.995~999 (2001)
- Lee JH, "Efficacy of infliximab in intestinal Behçet’s disease : a Korean multicenter retrospective study", Inflamm Bowel Dis, 19, pp.1833~1838 (2013)
- Yazici Y, "Behçet’s syndrome", Curr Rheumatol Rep, 12, pp.429~435 (2010)
- Lee CR, "Colonoscopic findings in intestinal Behçet’s disease", Inflamm Bowel Dis, 7, pp.243~249 (2001)
- Hisamatsu T, "Diagnosis and management of intestinal Behçet’s disease", Clin J Gastroenterol, 7, pp.205~212 (2014)
- Hatemi I, "Characteristics, treatment, and long-term outcome of gastrointestinal involvement in Behcet’s syndrome : a strobe-compliant observational study from a dedicated multidisciplinary center", Medicine(Baltimore), 95, pp.e3348~ (2016)
- Yong Eun Park, "Updated treatment strategies for intestinal Behçet’s disease", The Korean Journal of Internal Medicine, 33(1), pp.1~19 (2018), 대한내과학회[DOI]
- Miyagawa I, "Comparative study of corticosteroid monotherapy, and TNF inhibitors with or without corticosteroid in patients with refractory entero-Behcet’s disease", Arthritis Res Ther, 21, pp.151~ (2019)
- Jung YS, "Prognostic factors and long-term clinical outcomes for surgical patients with intestinal Behcet’s disease", Inflamm Bowel Dis, 17, pp.1594~1602 (2011)
- 박재준, "Outcome Predictors for Intestinal Behçet’s Disease", Yonsei Medical Journal, 54(5), pp.1084~1090 (2013), 연세대학교의과대학[DOI]
- Park J, "Risk factors and outcomes of acute lower gastrointestinal bleeding in intestinal Behçet’s disease", Int J Colorectal Dis, 32, pp.745~751 (2017)
- Hisamatsu T, "The 2nd edition of consensus statements for the diagnosis and management of intestinal Behçet’s disease : indication of anti-TNFα monoclonal antibodies", J Gastroenterol, 49, pp.156~162 (2014)
- Shamseer L, "Preferred reporting items for systematic review and metaanalysis protocols(PRISMA-P)2015 : elaboration and explanation", BMJ, 350, pp.g7647~ (2015)
- Freeman MF, "Transformations related to the angular and the square root", Ann Math Stat, 21, pp.607~611 (1950)
- DerSimonian R, "Meta-analysis in clinical trials", Control Clin Trials, 7, pp.177~188 (1986)
- Egger M, "Bias in metaanalysis detected by a simple, graphical test", BMJ, 315, pp.629~634 (1997)
- Zou J, "Long-term outcomes and predictors of sustained response in patients with intestinal Behcet’s disease treated with infliximab", Dig Dis Sci, 62, pp.441~447 (2017)
- Tanida S, "Long-term efficacy of adalimumab in patients with intestinal Behcet’s disease : eight consecutive cases", J Clin Med Res, 8, pp.334~337 (2016)
- Tanida S, "Adalimumab for the treatment of Japanese patients with intestinal Behçet’s disease", Clin Gastroenterol Hepatol, 13, pp.940~948.e3 (2015)
- Yasuo Suzuki, "Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study", Intestinal research, 19(3), pp.301~312 (2021), 대한장연구학회[DOI]
- Sugimura N, "Real-world efficacy of adalimumab and infliximab for refractory intestinal Behçet’s disease", Dig Liver Dis, 51, pp.967~971 (2019)
- Ma D, "Etanercept in the treatment of intestinal Behcet’s disease", Cell Biochem Biophys, 69, pp.735~739 (2014)
- Kinoshita H, "Efficacy of infliximab in patients with intestinal Behçet’s disease refractory to conventional medication", Intern Med, 52, pp.1855~1862 (2013)
- Iwata S, "Efficacy of combination therapy of anti-TNF-α antibody infliximab and methotrexate in refractory entero-Behçet’s disease", Mod Rheumatol, 21, pp.184~191 (2011)
- Hibi T, "Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease : efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study", Medicine(Baltimore), 95, pp.e3863~ (2016)
- Ferraz MB, "Sensitivity and specificity of different diagnostic criteria for Behçet’s disease according to the latent class approach", Br J Rheumatol, 34, pp.932~935 (1995)
- Ozguler Y, "Management of major organ involvement of Behçet’s syndrome:a systematic review for update of the EULAR recommendations", Rheumatology (Oxford), 57, pp.2200~2212 (2018)
- Naganuma M, "Efficacy of infliximab for induction and maintenance of remission in intestinal Behçet's disease", Inflamm Bowel Dis, 14, pp.1259~1264 (2008)
- Hatemi I, "TNF-alpha antagonists and thalidomide for the management of gastrointestinal Behçet’s syndrome refractory to the conventional treatment modalities : a case series and review of the literature", Clin Exp Rheumatol, 33, pp.S129~ (2015)[DOI]
- Watanabe K, "Evidence-based diagnosis and clinical practice guidelines for intestinal Behçet’s disease 2020 edited by Intractable Diseases, the Health and Labour Sciences Research Grants", J Gastroenterol, 55, pp.679~700 (2020)
- Arida A, "Anti-TNF agents for Behçet’s disease : analysis of published data on 369 patients", Semin Arthritis Rheum, 41, pp.61~70 (2011)
- Melikoglu M, "Short-term trial of etanercept in Behçet’s disease : a double blind, placebo controlled study", J Rheumatol, 32, pp.98~105 (2005)
- Park Y, "Update on the treatment of Behcet’s disease of the small bowel with biologic agents", Curr Gastroenterol Rep, 22, pp.24~ (2020)
- Lv R, "Tumor necrosis factor alpha blocking agents as treatment for ulcerative colitis intolerant or refractory to conventional medical therapy : a metaanalysis", PLoS One, 9, pp.e86692~ (2014)
