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Efficacy between high and medium doses of glucocorticoid therapy in remission induction of IgG4‐related diseases: a preliminary randomized controlled trial
Author(s) -
Wu Qingjun,
Chang Jie,
Chen Hua,
Chen Yu,
Yang Hongxian,
Fei Yunyun,
Zhang Panpan,
Zeng Xiaofeng,
Zhang Fengchun,
Zhang Wen
Publication year - 2017
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.13088
Subject(s) - medicine , prednisone , glucocorticoid , adverse effect , dose , gastroenterology , randomized controlled trial , igg4 related disease , complete remission , clinical endpoint , antibody , immunology , chemotherapy , disease
Aim In order to evaluate the efficacy and safety of high versus medium doses of glucocorticoid therapy in remission induction of immunoglobulin G4‐related disease (IgG4‐ RD ), we set up a randomized controlled study. Method Newly diagnosed IgG4‐ RD patients were randomly assigned to two groups: high doses of prednisone (0.8–1.0 mg/kg/day) and medium doses (0.5–0.6 mg/kg/day). Patients were assessed at weeks 0, 4, 12 and 24. The primary outcome was the remission rate at week 24. The secondary endpoints included IgG4‐ RD responder index (IgG4‐ RD RI ), IgG and IgG4 levels. Results Twenty cases in each group finished the study. At week 24, the total response rates were 95% and 80% in high and medium dose groups, respectively. There was no significant difference between the two groups. IgG4‐ RD RI reduced from 14.9 to 3.0 in the high dose group, while in the medium dose group it was from 13.1 to 3.2. At week 24, the average level of IgG4 reduced from 1576 to 324 mg/dL and from 1445 to 684 mg/dL in the two groups, respectively. Relapsed patients had higher baseline IgG4‐ RD RI . There was no severe adverse effect shown in both groups. Conclusion The effect of remission induction was similar in high and medium glucocorticoid groups. However, patients with more organs involved and higher IgG4‐ RD RI score at baseline might get more benefit with high dose glucocorticoid for remission induction.