Low-dose maintenance steroid treatment could reduce the relapse rate in patients with type 1 autoimmune pancreatitis: a long-term Japanese multicenter analysis of 510 patients

Kensuke Kubota, Terumi Kamisawa, Kazuichi Okazaki, Shigeyuki Kawa, Kenji Hirano, Yoshiki Hirooka, Kazushige Uchida, Hideyuki Shiomi, Hirotaka Ohara, Kyoko Shimizu, Norikazu Arakura, Atsushi Kanno, Junichi Sakagami, Takao Itoi, Tetsuhide Ito, Toshiharu Ueki, Takayoshi Nishino, Kazuo Inui, Nobumasa Mizuno, Hitoshi YoshidaMasanori Sugiyama, Eisuke Iwasaki, Atshishi Irisawa, Toru Shimosegawa, Yoshifumi Takeyama, Tsutomu Chiba

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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.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalJournal of Gastroenterology
DOIs
Publication statusAccepted/In press - 2017 Jan 6

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Pancreatitis
Steroids
Maintenance
Recurrence
Therapeutics
Group Psychotherapy
Consensus
Japan

Keywords

  • Autoimmune pancreatitis
  • Maintenance steroid treatment
  • Relapse rate
  • Steroid toxicity

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Low-dose maintenance steroid treatment could reduce the relapse rate in patients with type 1 autoimmune pancreatitis : a long-term Japanese multicenter analysis of 510 patients. / Kubota, Kensuke; Kamisawa, Terumi; Okazaki, Kazuichi; Kawa, Shigeyuki; Hirano, Kenji; Hirooka, Yoshiki; Uchida, Kazushige; Shiomi, Hideyuki; Ohara, Hirotaka; Shimizu, Kyoko; Arakura, Norikazu; Kanno, Atsushi; Sakagami, Junichi; Itoi, Takao; Ito, Tetsuhide; Ueki, Toshiharu; Nishino, Takayoshi; Inui, Kazuo; Mizuno, Nobumasa; Yoshida, Hitoshi; Sugiyama, Masanori; Iwasaki, Eisuke; Irisawa, Atshishi; Shimosegawa, Toru; Takeyama, Yoshifumi; Chiba, Tsutomu.

In: Journal of Gastroenterology, 06.01.2017, p. 1-10.

Research output: Contribution to journalArticle

Kubota, K, Kamisawa, T, Okazaki, K, Kawa, S, Hirano, K, Hirooka, Y, Uchida, K, Shiomi, H, Ohara, H, Shimizu, K, Arakura, N, Kanno, A, Sakagami, J, Itoi, T, Ito, T, Ueki, T, Nishino, T, Inui, K, Mizuno, N, Yoshida, H, Sugiyama, M, Iwasaki, E, Irisawa, A, Shimosegawa, T, Takeyama, Y & Chiba, T 2017, 'Low-dose maintenance steroid treatment could reduce the relapse rate in patients with type 1 autoimmune pancreatitis: a long-term Japanese multicenter analysis of 510 patients', Journal of Gastroenterology, pp. 1-10. https://doi.org/10.1007/s00535-016-1302-1
Kubota, Kensuke ; Kamisawa, Terumi ; Okazaki, Kazuichi ; Kawa, Shigeyuki ; Hirano, Kenji ; Hirooka, Yoshiki ; Uchida, Kazushige ; Shiomi, Hideyuki ; Ohara, Hirotaka ; Shimizu, Kyoko ; Arakura, Norikazu ; Kanno, Atsushi ; Sakagami, Junichi ; Itoi, Takao ; Ito, Tetsuhide ; Ueki, Toshiharu ; Nishino, Takayoshi ; Inui, Kazuo ; Mizuno, Nobumasa ; Yoshida, Hitoshi ; Sugiyama, Masanori ; Iwasaki, Eisuke ; Irisawa, Atshishi ; Shimosegawa, Toru ; Takeyama, Yoshifumi ; Chiba, Tsutomu. / Low-dose maintenance steroid treatment could reduce the relapse rate in patients with type 1 autoimmune pancreatitis : a long-term Japanese multicenter analysis of 510 patients. In: Journal of Gastroenterology. 2017 ; pp. 1-10.
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author = "Kensuke Kubota and Terumi Kamisawa and Kazuichi Okazaki and Shigeyuki Kawa and Kenji Hirano and Yoshiki Hirooka and Kazushige Uchida and Hideyuki Shiomi and Hirotaka Ohara and Kyoko Shimizu and Norikazu Arakura and Atsushi Kanno and Junichi Sakagami and Takao Itoi and Tetsuhide Ito and Toshiharu Ueki and Takayoshi Nishino and Kazuo Inui and Nobumasa Mizuno and Hitoshi Yoshida and Masanori Sugiyama and Eisuke Iwasaki and Atshishi Irisawa and Toru Shimosegawa and Yoshifumi Takeyama and Tsutomu Chiba",
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TY - JOUR

T1 - Low-dose maintenance steroid treatment could reduce the relapse rate in patients with type 1 autoimmune pancreatitis

T2 - a long-term Japanese multicenter analysis of 510 patients

AU - Kubota, Kensuke

AU - Kamisawa, Terumi

AU - Okazaki, Kazuichi

AU - Kawa, Shigeyuki

AU - Hirano, Kenji

AU - Hirooka, Yoshiki

AU - Uchida, Kazushige

AU - Shiomi, Hideyuki

AU - Ohara, Hirotaka

AU - Shimizu, Kyoko

AU - Arakura, Norikazu

AU - Kanno, Atsushi

AU - Sakagami, Junichi

AU - Itoi, Takao

AU - Ito, Tetsuhide

AU - Ueki, Toshiharu

AU - Nishino, Takayoshi

AU - Inui, Kazuo

AU - Mizuno, Nobumasa

AU - Yoshida, Hitoshi

AU - Sugiyama, Masanori

AU - Iwasaki, Eisuke

AU - Irisawa, Atshishi

AU - Shimosegawa, Toru

AU - Takeyama, Yoshifumi

AU - Chiba, Tsutomu

PY - 2017/1/6

Y1 - 2017/1/6

N2 - 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.

AB - 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.

KW - Autoimmune pancreatitis

KW - Maintenance steroid treatment

KW - Relapse rate

KW - Steroid toxicity

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