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Severity-based treatment for Japanese patients with MPO-ANCA-associated vasculitis: the JMAAV study.

Ozaki S, Atsumi T, Hayashi T, Ishizu A, Kobayashi S, Kumagai S, Kurihara Y, Kurokawa MS, Makino H, Nagafuchi H, Nakabayashi K, Nishimoto N, Suka M, Tomino Y, Yamada H, Yamagata K, Yoshida M, Yumura W, Amano K, Arimura Y, Hatta K, Ito S, Kikuchi H, Muso E, Nakashima H, Ohsone Y, Suzuki Y, Hashimoto H, Koyama A, Matsuo S, Kato H - Mod Rheumatol (2011)

Bottom Line: The primary end points were the induction of remission, death, and end-stage renal disease (ESRD).Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD.Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan. ozk@marianna-u.ac.jp

ABSTRACT
We (JMAAV [Japanese patients with MPO-ANCA-associated vasculitis] Study Group) performed a prospective, open-label, multi-center trial to evaluate the usefulness of severity-based treatment in Japanese patients with myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA)-associated vasculitis. Patients with MPO-ANCA-associated vasculitis received a severity-based regimen according to the appropriate protocol: low-dose corticosteroid and, if necessary, cyclophosphamide or azathioprine in patients with mild form; high-dose corticosteroid and cyclophosphamide in those with severe form; and the severe-form regimen plus plasmapheresis in those with the most severe form. We followed up the patients for 18 months. The primary end points were the induction of remission, death, and end-stage renal disease (ESRD). Fifty-two patients were registered, and 48 patients were enrolled in this study (mild form, n = 23; severe form, n = 23; most severe form, n = 2). Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD. Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period. The JMAAV trial is the first prospective trial for MPO-ANCA-associated vasculitis to be performed in Japan. The remission and death rates were comparable to those in several previous clinical trials performed in western counties. The regimen employed in this trial was tailor-made based on patients' disease severity and disease type, and it seems that standardization can be consistent with treatment choices made according to severity.

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Time courses of changes in the Birmingham vasculitis activity score (BVAS), myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA) titer, and serum creatinine. The mean values of a BVAS, b ANCA titers, and c serum creatinine in each group stratified according to severity are plotted at 6 weeks, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months. Open squares/solid lines and closed circles/dotted lines indicate severe- and mild-form groups, respectively. The data for the most severe-form group were omitted from the figure as this group included only a single patient
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Fig2: Time courses of changes in the Birmingham vasculitis activity score (BVAS), myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA) titer, and serum creatinine. The mean values of a BVAS, b ANCA titers, and c serum creatinine in each group stratified according to severity are plotted at 6 weeks, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months. Open squares/solid lines and closed circles/dotted lines indicate severe- and mild-form groups, respectively. The data for the most severe-form group were omitted from the figure as this group included only a single patient

Mentions: Figure 2a shows the time courses of changes in BVAS in the severe- and mild-form groups in the present study population. The scores declined rapidly during the first 6 weeks. However, even at 6 weeks, the mean BVAS in the severe-form group was significantly higher than that in the mild-form group (P < 0.05). The scores in the severe- and mild-form groups were increased at 6 months and thereafter, reflecting the 8 patients showing relapse described above. On the other hand, there were no significant differences in BVAS scores for persistent disease between the baseline and any other examination time points (data not shown). Among the forms, however, the BVAS persistent scores in the severe-form group were significantly higher than those in the mild-form group at all examination time points (data not shown).Fig. 2


Severity-based treatment for Japanese patients with MPO-ANCA-associated vasculitis: the JMAAV study.

Ozaki S, Atsumi T, Hayashi T, Ishizu A, Kobayashi S, Kumagai S, Kurihara Y, Kurokawa MS, Makino H, Nagafuchi H, Nakabayashi K, Nishimoto N, Suka M, Tomino Y, Yamada H, Yamagata K, Yoshida M, Yumura W, Amano K, Arimura Y, Hatta K, Ito S, Kikuchi H, Muso E, Nakashima H, Ohsone Y, Suzuki Y, Hashimoto H, Koyama A, Matsuo S, Kato H - Mod Rheumatol (2011)

Time courses of changes in the Birmingham vasculitis activity score (BVAS), myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA) titer, and serum creatinine. The mean values of a BVAS, b ANCA titers, and c serum creatinine in each group stratified according to severity are plotted at 6 weeks, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months. Open squares/solid lines and closed circles/dotted lines indicate severe- and mild-form groups, respectively. The data for the most severe-form group were omitted from the figure as this group included only a single patient
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3375427&req=5

Fig2: Time courses of changes in the Birmingham vasculitis activity score (BVAS), myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA) titer, and serum creatinine. The mean values of a BVAS, b ANCA titers, and c serum creatinine in each group stratified according to severity are plotted at 6 weeks, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months. Open squares/solid lines and closed circles/dotted lines indicate severe- and mild-form groups, respectively. The data for the most severe-form group were omitted from the figure as this group included only a single patient
Mentions: Figure 2a shows the time courses of changes in BVAS in the severe- and mild-form groups in the present study population. The scores declined rapidly during the first 6 weeks. However, even at 6 weeks, the mean BVAS in the severe-form group was significantly higher than that in the mild-form group (P < 0.05). The scores in the severe- and mild-form groups were increased at 6 months and thereafter, reflecting the 8 patients showing relapse described above. On the other hand, there were no significant differences in BVAS scores for persistent disease between the baseline and any other examination time points (data not shown). Among the forms, however, the BVAS persistent scores in the severe-form group were significantly higher than those in the mild-form group at all examination time points (data not shown).Fig. 2

Bottom Line: The primary end points were the induction of remission, death, and end-stage renal disease (ESRD).Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD.Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan. ozk@marianna-u.ac.jp

ABSTRACT
We (JMAAV [Japanese patients with MPO-ANCA-associated vasculitis] Study Group) performed a prospective, open-label, multi-center trial to evaluate the usefulness of severity-based treatment in Japanese patients with myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA)-associated vasculitis. Patients with MPO-ANCA-associated vasculitis received a severity-based regimen according to the appropriate protocol: low-dose corticosteroid and, if necessary, cyclophosphamide or azathioprine in patients with mild form; high-dose corticosteroid and cyclophosphamide in those with severe form; and the severe-form regimen plus plasmapheresis in those with the most severe form. We followed up the patients for 18 months. The primary end points were the induction of remission, death, and end-stage renal disease (ESRD). Fifty-two patients were registered, and 48 patients were enrolled in this study (mild form, n = 23; severe form, n = 23; most severe form, n = 2). Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD. Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period. The JMAAV trial is the first prospective trial for MPO-ANCA-associated vasculitis to be performed in Japan. The remission and death rates were comparable to those in several previous clinical trials performed in western counties. The regimen employed in this trial was tailor-made based on patients' disease severity and disease type, and it seems that standardization can be consistent with treatment choices made according to severity.

Show MeSH
Related in: MedlinePlus