A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4-related disease

Yasufumi Masaki, Shoko Matsui, Takako Saeki, Hiroto Tsuboi, Shintaro Hirata, Yasumori Izumi, Taiichiro Miyashita, Keita Fujikawa, Hiroaki Dobashi, Kentaro Susaki, Hisanori Morimoto, Kazutaka Takagi, Mitsuhiro Kawano, Tomoki Origuchi, Yoko Wada, Naoki Takahashi, Masanobu Horikoshi, Hiroshi Ogishima, Yasunori Suzuki, Takafumi KawanamiHaruka Kawanami Iwao, Tomoyuki Sakai, Yoshimasa Fujita, Toshihiro Fukushima, Masatoshi Saito, Ritsuro Suzuki, Yuko Morikawa, Tadashi Yoshino, Shigeo Nakamura, Masaru Kojima, Nozomu Kurose, Yasuharu Sato, Yoshiya Tanaka, Susumu Sugai, Takayuki Sumida

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Objective: Although glucocorticoids are effective for patients with IgG4-related disease, the treatment has not yet been standardized. Therefore, the treatment strategy should be established. Patients and methods: Patients who fulfilled the comprehensive diagnostic criteria for definite IgG4-related disease were started on prednisolone (0.6 mg/kg body weight) with the dose reduced every two weeks. The subsequent maintenance dose and need for prednisolone were determined for individual patients. The primary endpoint was the complete remission (CR) rate at one year. Secondary endpoints included overall response rate (ORR), the maintenance dose, the relapse rate, and adverse events. Results: This study enrolled 61 patients. After clinicopathological review, three patients were excluded, and one, 13, and 44 patients were diagnosed with probable, possible, and definite IgG4-related disease, respectively. Of the 44 patients with definite IgG4-RD, 29 (65.9%) achieved CR, and the ORR was 93.2%. No patient was refractory to primary treatment. The most frequent adverse events were glucose intolerance. Six patients relapsed. Conclusions: Glucocorticoid treatment is usually effective for patients with IgG4-RD, and we should examine the possibility of other disorders when a patient is glucocorticoid refractory. Some patients are misdiagnosed, making central clinicopathological review of diagnosis very important in conducting clinical studies.

Original languageEnglish
Pages (from-to)1-6
Number of pages6
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - Dec 8 2016

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Phase II Clinical Trials
Glucocorticoids
Immunoglobulin G
Prednisolone
Glucose Intolerance
Therapeutics
Diagnostic Errors

Keywords

  • 18FDG-PET
  • Glucocorticoid
  • Lymphoma
  • Multicentric Castleman's disease
  • Prospective trial

ASJC Scopus subject areas

  • Rheumatology

Cite this

A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4-related disease. / Masaki, Yasufumi; Matsui, Shoko; Saeki, Takako; Tsuboi, Hiroto; Hirata, Shintaro; Izumi, Yasumori; Miyashita, Taiichiro; Fujikawa, Keita; Dobashi, Hiroaki; Susaki, Kentaro; Morimoto, Hisanori; Takagi, Kazutaka; Kawano, Mitsuhiro; Origuchi, Tomoki; Wada, Yoko; Takahashi, Naoki; Horikoshi, Masanobu; Ogishima, Hiroshi; Suzuki, Yasunori; Kawanami, Takafumi; Kawanami Iwao, Haruka; Sakai, Tomoyuki; Fujita, Yoshimasa; Fukushima, Toshihiro; Saito, Masatoshi; Suzuki, Ritsuro; Morikawa, Yuko; Yoshino, Tadashi; Nakamura, Shigeo; Kojima, Masaru; Kurose, Nozomu; Sato, Yasuharu; Tanaka, Yoshiya; Sugai, Susumu; Sumida, Takayuki.

In: Modern Rheumatology, 08.12.2016, p. 1-6.

Research output: Contribution to journalArticle

Masaki, Y, Matsui, S, Saeki, T, Tsuboi, H, Hirata, S, Izumi, Y, Miyashita, T, Fujikawa, K, Dobashi, H, Susaki, K, Morimoto, H, Takagi, K, Kawano, M, Origuchi, T, Wada, Y, Takahashi, N, Horikoshi, M, Ogishima, H, Suzuki, Y, Kawanami, T, Kawanami Iwao, H, Sakai, T, Fujita, Y, Fukushima, T, Saito, M, Suzuki, R, Morikawa, Y, Yoshino, T, Nakamura, S, Kojima, M, Kurose, N, Sato, Y, Tanaka, Y, Sugai, S & Sumida, T 2016, 'A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4-related disease', Modern Rheumatology, pp. 1-6. https://doi.org/10.1080/14397595.2016.1259602
Masaki, Yasufumi ; Matsui, Shoko ; Saeki, Takako ; Tsuboi, Hiroto ; Hirata, Shintaro ; Izumi, Yasumori ; Miyashita, Taiichiro ; Fujikawa, Keita ; Dobashi, Hiroaki ; Susaki, Kentaro ; Morimoto, Hisanori ; Takagi, Kazutaka ; Kawano, Mitsuhiro ; Origuchi, Tomoki ; Wada, Yoko ; Takahashi, Naoki ; Horikoshi, Masanobu ; Ogishima, Hiroshi ; Suzuki, Yasunori ; Kawanami, Takafumi ; Kawanami Iwao, Haruka ; Sakai, Tomoyuki ; Fujita, Yoshimasa ; Fukushima, Toshihiro ; Saito, Masatoshi ; Suzuki, Ritsuro ; Morikawa, Yuko ; Yoshino, Tadashi ; Nakamura, Shigeo ; Kojima, Masaru ; Kurose, Nozomu ; Sato, Yasuharu ; Tanaka, Yoshiya ; Sugai, Susumu ; Sumida, Takayuki. / A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4-related disease. In: Modern Rheumatology. 2016 ; pp. 1-6.
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abstract = "Objective: Although glucocorticoids are effective for patients with IgG4-related disease, the treatment has not yet been standardized. Therefore, the treatment strategy should be established. Patients and methods: Patients who fulfilled the comprehensive diagnostic criteria for definite IgG4-related disease were started on prednisolone (0.6 mg/kg body weight) with the dose reduced every two weeks. The subsequent maintenance dose and need for prednisolone were determined for individual patients. The primary endpoint was the complete remission (CR) rate at one year. Secondary endpoints included overall response rate (ORR), the maintenance dose, the relapse rate, and adverse events. Results: This study enrolled 61 patients. After clinicopathological review, three patients were excluded, and one, 13, and 44 patients were diagnosed with probable, possible, and definite IgG4-related disease, respectively. Of the 44 patients with definite IgG4-RD, 29 (65.9{\%}) achieved CR, and the ORR was 93.2{\%}. No patient was refractory to primary treatment. The most frequent adverse events were glucose intolerance. Six patients relapsed. Conclusions: Glucocorticoid treatment is usually effective for patients with IgG4-RD, and we should examine the possibility of other disorders when a patient is glucocorticoid refractory. Some patients are misdiagnosed, making central clinicopathological review of diagnosis very important in conducting clinical studies.",
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T1 - A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4-related disease

AU - Masaki, Yasufumi

AU - Matsui, Shoko

AU - Saeki, Takako

AU - Tsuboi, Hiroto

AU - Hirata, Shintaro

AU - Izumi, Yasumori

AU - Miyashita, Taiichiro

AU - Fujikawa, Keita

AU - Dobashi, Hiroaki

AU - Susaki, Kentaro

AU - Morimoto, Hisanori

AU - Takagi, Kazutaka

AU - Kawano, Mitsuhiro

AU - Origuchi, Tomoki

AU - Wada, Yoko

AU - Takahashi, Naoki

AU - Horikoshi, Masanobu

AU - Ogishima, Hiroshi

AU - Suzuki, Yasunori

AU - Kawanami, Takafumi

AU - Kawanami Iwao, Haruka

AU - Sakai, Tomoyuki

AU - Fujita, Yoshimasa

AU - Fukushima, Toshihiro

AU - Saito, Masatoshi

AU - Suzuki, Ritsuro

AU - Morikawa, Yuko

AU - Yoshino, Tadashi

AU - Nakamura, Shigeo

AU - Kojima, Masaru

AU - Kurose, Nozomu

AU - Sato, Yasuharu

AU - Tanaka, Yoshiya

AU - Sugai, Susumu

AU - Sumida, Takayuki

PY - 2016/12/8

Y1 - 2016/12/8

N2 - Objective: Although glucocorticoids are effective for patients with IgG4-related disease, the treatment has not yet been standardized. Therefore, the treatment strategy should be established. Patients and methods: Patients who fulfilled the comprehensive diagnostic criteria for definite IgG4-related disease were started on prednisolone (0.6 mg/kg body weight) with the dose reduced every two weeks. The subsequent maintenance dose and need for prednisolone were determined for individual patients. The primary endpoint was the complete remission (CR) rate at one year. Secondary endpoints included overall response rate (ORR), the maintenance dose, the relapse rate, and adverse events. Results: This study enrolled 61 patients. After clinicopathological review, three patients were excluded, and one, 13, and 44 patients were diagnosed with probable, possible, and definite IgG4-related disease, respectively. Of the 44 patients with definite IgG4-RD, 29 (65.9%) achieved CR, and the ORR was 93.2%. No patient was refractory to primary treatment. The most frequent adverse events were glucose intolerance. Six patients relapsed. Conclusions: Glucocorticoid treatment is usually effective for patients with IgG4-RD, and we should examine the possibility of other disorders when a patient is glucocorticoid refractory. Some patients are misdiagnosed, making central clinicopathological review of diagnosis very important in conducting clinical studies.

AB - Objective: Although glucocorticoids are effective for patients with IgG4-related disease, the treatment has not yet been standardized. Therefore, the treatment strategy should be established. Patients and methods: Patients who fulfilled the comprehensive diagnostic criteria for definite IgG4-related disease were started on prednisolone (0.6 mg/kg body weight) with the dose reduced every two weeks. The subsequent maintenance dose and need for prednisolone were determined for individual patients. The primary endpoint was the complete remission (CR) rate at one year. Secondary endpoints included overall response rate (ORR), the maintenance dose, the relapse rate, and adverse events. Results: This study enrolled 61 patients. After clinicopathological review, three patients were excluded, and one, 13, and 44 patients were diagnosed with probable, possible, and definite IgG4-related disease, respectively. Of the 44 patients with definite IgG4-RD, 29 (65.9%) achieved CR, and the ORR was 93.2%. No patient was refractory to primary treatment. The most frequent adverse events were glucose intolerance. Six patients relapsed. Conclusions: Glucocorticoid treatment is usually effective for patients with IgG4-RD, and we should examine the possibility of other disorders when a patient is glucocorticoid refractory. Some patients are misdiagnosed, making central clinicopathological review of diagnosis very important in conducting clinical studies.

KW - 18FDG-PET

KW - Glucocorticoid

KW - Lymphoma

KW - Multicentric Castleman's disease

KW - Prospective trial

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