Treatment-related damage in elderly-onset ANCA-associated vasculitis: safety outcome analysis of two nationwide prospective cohort studies
Authors: Sada Ken-Ei , Ohashi Keiji , Asano Yosuke , Hayashi Keigo , Morishita Michiko , Watanabe Haruki , Matsumoto Yoshinori , Fujimoto Shouichi , Takasaki Yoshinari , Yamagata Kunihiro , Banno Shogo , Dobashi Hiroaki , Amano Koichi , Harigai Masayoshi , Arimura Yoshihiro , Makino Hirofumi ,   the Japan Research Committee of the Ministry of Health, Labour, and Welfare for Intractable Vasculitis (JPVAS) and the Research Committee of Intractable Renal Disease of the Ministry of Health, Labour, and Welfare of Japan, Usui Joichi , Atsumi Tatsuya , Sugihara Takahiko , Matsuo Seiichi , Sugiyama Hitoshi , Ishizu Akihiro , Fujii Takao , Okada Yasunori , Homma Sakae , Tsuboi Naotake , Kumagai Shunichi , Muso Eri , Murakawa Yohko , Banno Shogo , Hasegawa Hitoshi , Yumura Wako , Matsubara Hiroaki , Yoshida Masaharu , Katsuoka Kensei , Ogawa Noriyoshi , Komatsuda Atsushi , Ito Satoshi , Kawakami Atsushi , Nakaya Izaya , Saito Takao , Ito Takafumi , Hirawa Nobuhito , Yamamura Masahiro , Nakano Masaaki , Nitta Kosaku , Ogura Makoto , Naniwa Taio , Ozaki Shoichi , Hirahashi Junichi , Hosoya Tatsuo , Wada Takashi , Horikoshi Satoshi , Kawaguchi Yasushi , Hayashi Taichi , Watanabe Tsuyoshi , Inaguma Daijo , Tsuruya Kazuhiko , Homma Noriyuki , Takeuchi Tsutomu , Nakagawa Naoki , Takeda Shinichi , Katafuchi Ritsuko , Iwano Masayuki , Kobayashi Masaki 
Published: October 2020

Abstract
Background
It is not elucidated that there is treatment-related damage in elderly patients with antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis (AAV).

Methods
Elderly (≥ 75 years of age) patients were enrolled from two nationwide prospective inception cohort studies. The primary outcome was 12-month treatment-related Vasculitis Damage Index (VDI) score. Secondary outcomes included serious infections within 6 months, total VDI score, remission, and relapse. Patient characteristics and outcomes were compared across three different initial glucocorticoid (GC) dose groups: high-dose, prednisolone (PSL) ≥ 0.8 mg/kg/day; medium-dose, 0.6 ≤ PSL < 0.8 mg/kg/day; and low-dose, PSL < 0.6 mg/kg/day.

Results
Of the 179 eligible patients, the mean age was 80.0 years; 111 (62%) were female. The mean Birmingham Vasculitis Activity Score was 16.1. Myeloperoxidase-ANCA findings were positive in 168 (94%) patients, while proteinase 3-ANCA findings were positive in 11 (6%). The low-dose group was older and had higher serum creatinine levels than the other groups. There were no statistically significant intergroup differences in remission or relapse, whereas serious infection developed more frequently in the high-dose (29 patients [43%]) than the low-dose (13 patients [22%]) or medium-dose (10 patients [19%]) groups (p = 0.0007). Frequent VDI items at 12 months included hypertension (19%), diabetes (13%), atrophy and weakness (13%), osteoporosis (8%), and cataracts (8%). Logistic regression analysis revealed that GC dose at 12 months (odds ratio, 1.14; 95% confidence interval, 1.00–1.35) was a predictor for diabetes.

Conclusion
A reduced initial GC dose with rapid reduction might be required to ensure the safe treatment of elderly AAV patients.