Kensuke Kubota1, Terumi Kamisawa2, Kazuichi Okazaki3, Shigeyuki Kawa4, Kenji Hirano5, Yoshiki Hirooka6, Kazushige Uchida3, Hideyuki Shiomi7, Hirotaka Ohara8, Kyoko Shimizu9, Norikazu Arakura10, Atsushi Kanno11, Junichi Sakagami12, Takao Itoi13, Tetsuhide Ito14, Toshiharu Ueki15, Takayoshi Nishino16, Kazuo Inui17, Nobumasa Mizuno18, Hitoshi Yoshida19, Masanori Sugiyama20, Eisuke Iwasaki21, Atshishi Irisawa22, Toru Shimosegawa11, Yoshifumi Takeyama23, Tsutomu Chiba24. 1. Department of Endoscopy, Yokohama City University Hospital, Yokohama, Japan. 2. Department of Internal Medicine, Tokyo Komagome Metropolitan Hospital, Tokyo, Japan. kamisawa@cick.jp. 3. Department of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan. 4. Center for Health, Safety and Environmental Management, Shinshu University, Matsumoto, Japan. 5. Department of Gastroenterology, Graduate School of Medicine, Tokyo University, Tokyo, Japan. 6. Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan. 7. Department of Gastroenterology, Graduate School of Medicine, Kobe University, Kobe, Japan. 8. Department of Community-Based Medical Education, Graduate School of Medicine, Nagoya City University, Nagoya, Japan. 9. Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan. 10. Department of Gastroenterology, Graduate School of Medicine, Shinshu University, Matsumoto, Japan. 11. Department of Gastroenterology, Graduate School of Medicine, Tohoku University, Sendai, Japan. 12. Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan. 13. Department of Gastroenterology, Tokyo Medical University, Tokyo, Japan. 14. Department of Medicine and Bioregulatory Science, Graduate School of Medicine, Kyushu University, Fukuoka, Japan. 15. Department of Gastroenterology, Chikushi Hospital, Fukuoka University, Fukuoka, Japan. 16. Department of Gastroenterology, Yachiyo Hospital, Tokyo Women's Medical University, Tokyo, Japan. 17. Department of Gastroenterology, Second Teaching Hospital, Fujita Health University, Toyoake, Japan. 18. Department of Gastroenterology, Aichi Cancer Center, Nagoya, Japan. 19. Department of Gastroenterology, School of Medicine, Showa University, Tokyo, Japan. 20. Department of Surgery, School of Medicine, Kyorin University, Tokyo, Japan. 21. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University, Tokyo, Japan. 22. Department of Gastroenterology, Aizu Medical Center, Fukushima Medical University, Fukushima, Japan. 23. Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kinki University Faculty of Medicine, Osaka, Japan. 24. Gastroenterology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Abstract
BACKGROUND: The effect of maintenance steroid treatment (MST) in reducing the risk of relapse in patients with autoimmune pancreatitis (AIP) remains under debate. The aim of this study was to validate the effect of MST on AIP administered in accordance with the 2010 Japanese consensus guidelines. METHODS: The clinical data of patients with (n = 510) from 22 high-volume centers in Japan were studied. The primary endpoints were the relapse rates (RRs) in patients administered MST versus those not administered MST. The secondary endpoints were the optimal dose and duration of MST in terms of steroid toxicity and the predictors of relapse. RESULTS: The RRs were 10.0% within 1 year, 25.8% within 3 years and 35.1% within 5 years. The RR in the steroid therapy group reached a plateau at 42.7% at 7 years. In terms of the optimal dosage, the overall RR in the MST 5 mg/day group was 26.1%, which was significantly lower than that in the group which had discontinued steroid therapy (45.2%; p = 0.023) or was receiving MST at 2.5 mg/day (43.4%, p = 0.001). The RRs in the group receiving MST at ≥5 mg/day versus the patient group receiving MST at <5 mg/day were 10.6 vs. 10.3% within 1 year, 23.5 vs. 32.9% within 3 years and 32.2 vs. 41.3% within 5 years, respectively (log-rank, p = 0.028). The best cutoff value of the total steroid dose for serious steroid toxicity was 6405 mg, with a moderate accuracy of 0.717 determined using the area under the curve. Presence of diffuse pancreatic swelling [odds ratio OR) 1.745; p = 0.008) and MST at >5 mg/day were identified as predictors of relapse (OR 0.483; p = 0.001). CONCLUSIONS: The RR could continue to increase for 7 years even under MST. Based on our analysis of the side effects of steroid therapy, MST at 5 mg/day for 2 (total 4625 mg) to 3 (total 6425 mg) years might be a rational and safe therapeutic strategy in terms of keeping the RR to <30% while avoiding potential steroid toxicity.
BACKGROUND: The effect of maintenance steroid treatment (MST) in reducing the risk of relapse in patients with autoimmune pancreatitis (AIP) remains under debate. The aim of this study was to validate the effect of MST on AIP administered in accordance with the 2010 Japanese consensus guidelines. METHODS: The clinical data of patients with (n = 510) from 22 high-volume centers in Japan were studied. The primary endpoints were the relapse rates (RRs) in patients administered MST versus those not administered MST. The secondary endpoints were the optimal dose and duration of MST in terms of steroidtoxicity and the predictors of relapse. RESULTS: The RRs were 10.0% within 1 year, 25.8% within 3 years and 35.1% within 5 years. The RR in the steroid therapy group reached a plateau at 42.7% at 7 years. In terms of the optimal dosage, the overall RR in the MST 5 mg/day group was 26.1%, which was significantly lower than that in the group which had discontinued steroid therapy (45.2%; p = 0.023) or was receiving MST at 2.5 mg/day (43.4%, p = 0.001). The RRs in the group receiving MST at ≥5 mg/day versus the patient group receiving MST at <5 mg/day were 10.6 vs. 10.3% within 1 year, 23.5 vs. 32.9% within 3 years and 32.2 vs. 41.3% within 5 years, respectively (log-rank, p = 0.028). The best cutoff value of the total steroid dose for serious steroidtoxicity was 6405 mg, with a moderate accuracy of 0.717 determined using the area under the curve. Presence of diffuse pancreatic swelling [odds ratio OR) 1.745; p = 0.008) and MST at >5 mg/day were identified as predictors of relapse (OR 0.483; p = 0.001). CONCLUSIONS: The RR could continue to increase for 7 years even under MST. Based on our analysis of the side effects of steroid therapy, MST at 5 mg/day for 2 (total 4625 mg) to 3 (total 6425 mg) years might be a rational and safe therapeutic strategy in terms of keeping the RR to <30% while avoiding potential steroidtoxicity.
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