Systematic review and meta-analysis for 2017 clinical practice guidelines of the Japan research committee of the ministry of health, labour, and welfare for intractable vasculitis for the management of ANCA-associated vasculitis

Abstract

Objectives: To provide evidence for the revision of clinical practice guideline (CPG) for the management of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) by the Japan Research Committee for Intractable Vasculitis.

Methods: PubMed, CENTRAL, and the Japan Medical Abstracts Society were searched for articles published between January 1994 and January 2015 to conduct systematic review (SR), and the quality of evidence was assessed with GRADE approach.

Results: Nine randomized controlled trials (RCTs) and two non-RCTs were adopted for remission induction therapy, three RCTs and two non-RCTs for plasma exchange, and five RCTs and one non-RCT for remission maintenance therapy. A significant difference was found in efficacy and safety for the following comparisons. In the non-RCT adopted for remission induction therapy, glucocorticoid (GC) + cyclophosphamide (CY) was significantly superior to GC monotherapy regarding remission. GC + intravenous CY for remission induction therapy was superior to GC + oral CY regarding death at one year, serious adverse events, and serious infection. Concomitant use of plasma exchange for remission induction therapy of AAV with severe renal dysfunction reduced risk of end-stage renal disease versus non-users at month 3.

Conclusion: This SR provided necessary evidence for developing CPG for the management of ANCA-associated vasculitis.

Keywords:

• ANCA-associated vasculitis
• GRADE system
• granulomatosis with polyangiitis
• microscopic polyangiitis
• systematic review

Acknowledgements

JPVAS appreciate Tomoko Morimasa and Naoko Suwabe from Japan Library Association who carried out the literature search for SR.

Conflict of interest

To maintain strictness and transparency of developing GPG, the management of COI of all healthcare professionals is necessary. The organizing committee discussed about economic COI disclosure form and its management and decided to ask Japan College of Rheumatology for the management. Members of the organizing committee, CPG panel, SR team, and secretariat submitted the COI disclosure form to Japan College of Rheumatology. To minimize academic COI, the organizing committee convened physicians with diverse specialties as members of the CPG panel and SR team and made the best effort to exclude preferences of each member and scientific organization they belong to and possible effects of competition among healthcare professionals and/or organizations. Academic COI of the organizing committee, the CPG panel, and SR team are described in Supplementary Table.

MH received research grants and lecture fee from Teijin Pharma Ltd., Chugai Pharmaceutical Co., Ltd. and Mitsubishi Tanabe Pharma Corporation and served as an adviser for Kissei Pharmaceutical Co., Ltd. and Zenyaku Kogyo. K.S has received lecture fee from Chugai Pharmaceutical Co., Ltd.

Additional information

Funding

Research grants of JPVAS from the Ministry of Health, Labour, and Welfare of Japan (H26-nanchi-nanchitou (nan)-ippan-044) and Department of Pharmacovigilance, Tokyo Medical and Dental University, were used for the payment for venues, traveling and correspondence expenses, and meals. No compensation was made to the members involved in the development of the CPG.