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Abstract Number: 749

High Clinical Remission Rate With Relatively High Incidence  Of Serious Infection In Newly-Onset ANCA-Associated Vasculitides In Japan – A Report From The Nationwide Prospective Cohort Study

Masayoshi Harigai1, Ken-ei Sada2, Takao Fujii3, Masahiro Yamamura4, Yoshihiro Arimura5 and Hirofumi Makino2, 1Dept of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan, 2Department of Medicine and Clinical Science, Okayama University, Okayama, Japan, 3Department of the Control for Rheumatic Diseases, Graduate School of Medicine, Kyoto University, Kyoto, Japan, 4Center for Rheumatology, Okayama Saiseikai Hospital, Okayama, Japan, 5First Department of Internal Medicine, Kyorin University School of Medicine, Tokyo, Japan

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ANCA, epidemiologic methods and vasculitis

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Session Information

Title: Vasculitis I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Clinical characteristics and antineutrophil cytoplasmic antibody (ANCA)-serology of ANCA-associated vasculitis (AAV) patients are substantially different between Western and Asian countries. We investigated effectiveness and safety of remission induction therapy currently performed for patients with AAV in Japan using data from a nationwide prospective inception cohort study (UMIN000001648)

Methods: A total of 156 Japanese patients with newly diagnosed AAV (safety population) were registered by 22 university hospitals and referring hospitals from 2009 until 2010, and 155 had follow-up data (effectiveness population). Patients were classified according to the European Medicines Agency (EMEA) algorithm. Patients were evaluated at Months 3, 6, 12, 18, and 24 and at relapse. Remission, survival and renal survival rates were compared among groups by disease classification, disease severity (localized, early systemic, generalized, severe), and concomitant use of cyclophosphamide (CY).

Results: Of 156 patients, 14 patients were classified as having eosinophilic granulomatosis with polyangiitis (EGPA), 33 patients were granulomatosis with polyangiitis (GPA), 78 patients were microscopic polyangiitis (MPA), 31 patients were unclassified (U). Baseline characteristics of 156 patients were as follows: mean age, 68 years old; female, 61%; P-ANCA positive, 83%; C-ANCA positive, 12%; mean serum creatinine, 1.75 mg/dl; mean Birmingham vasculitis activity score (BVAS), 17. As remission induction therapy, all patients started corticosteroid with mean prednisolone-equivalent dosage of 42 mg/day, and 62 (40%) and 54 (35%) were given methylprednisolone pulse therapy and cyclophosphamide, respectively. Of the effectiveness population, 141 (91%) achieved remission by Month 18. The time to remission differ significantly by disease classification (P=0.0004, U0.8mg/kg/day (PSL-equivalent) (HR 2.7, p=0.002) were identified as predictors for SIs.

Conclusion: More than 90% of newly onset AAV patients achieved BVAS remission in clinical practice in Japan with relatively high incidence of serious infection. Investigation to establish treatment strategy with better benefit-risk balance is warranted.


Disclosure:

M. Harigai,

Abbott Japan Co., Ltd., Astellas Pharma Inc., Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Santen Pharmaceutical Co., Ltd, Takeda Pharmaceutical Co., Ltd., Teijin Pharma, Ltd.Mitsubishi Tanabe ,

2,

Janssen Pharmaceutical K.K., Chugai Pharmaceutical Co., Teijin Pharma, Ltd.,

5;

K. E. Sada,
None;

T. Fujii,

Abbott Japan Co., Ltd., Astellas Pharma Inc., Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo Pharmaceutical Co. Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co, Takeda Pharmaceutical Co., Ltd., and Pfizer Japan Inc.,

2;

M. Yamamura,
None;

Y. Arimura,
None;

H. Makino,
None.

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