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Effects of intravenous immunoglobulin therapy in Japanese patients with polymyositis and dermatomyositis resistant to corticosteroids: a randomized double-blind placebo-controlled trial.

Miyasaka N, Hara M, Koike T, Saito E, Yamada M, Tanaka Y, GB-0998 Study Gro - Mod Rheumatol (2011)

Bottom Line: High-dose intravenous immunoglobulin (IVIG) therapy has been effective in treating various autoimmune and systemic inflammatory diseases.However, significant improvements were also found in the placebo group, and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups.These results indicate that GB-0998 can be safely used with the same precautions as other current IVIG therapy.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Graduate School, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan. miya.rheu@tmd.ac.jp

ABSTRACT
High-dose intravenous immunoglobulin (IVIG) therapy has been effective in treating various autoimmune and systemic inflammatory diseases. Here, we assessed the efficacy and safety of IVIG therapy with polyethylene glycol-treated human IgG (drug code GB-0998) for patients with corticosteroid-refractory polymyositis (PM) and dermatomyositis (DM) by means of a randomized, double-blind, placebo-controlled study. We randomly assigned 26 subjects (16 PM and 10 DM) to receive either GB-0998 or placebo. Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint (manual muscle test score) and secondary endpoints (serum creatine kinase level and activities of daily living score). However, significant improvements were also found in the placebo group, and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups. We discuss possible reasons for the absence of a clear intergroup difference in efficacy. Nineteen adverse drug reactions were observed in 11 of 26 subjects (42.3%), of which 2 events (decreased muscle strength and increased serum creatine kinase) were assessed as serious; however, they are previously known events. These results indicate that GB-0998 can be safely used with the same precautions as other current IVIG therapy.

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Related in: MedlinePlus

Forest plots of before–after differences in ADL scores for the 8-week first period. Black circles and lines, respectively, represent point estimates and 95% confidence intervals of between-group differences (GB-0998 group versus placebo group) in the ADL scores for each activity
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Fig8: Forest plots of before–after differences in ADL scores for the 8-week first period. Black circles and lines, respectively, represent point estimates and 95% confidence intervals of between-group differences (GB-0998 group versus placebo group) in the ADL scores for each activity

Mentions: The intergroup differences in changes of ADL scores for the 15 actions evaluated in this study, during the first period, are shown in Fig. 8. The point-estimation values show that the changes were greater in the GB-0998 group than in the placebo group for 12 of the 15 actions, although the differences for individual actions were small. Among these actions, the difference (value 1.17) with respect to swallowing action at week 8 of the first period between an increase of 1.00 in the GB-0998 group and a decrease of −0.17 in the placebo group (the normal score is 3) was statistically significant (t test, p = 0.0222).Fig. 8


Effects of intravenous immunoglobulin therapy in Japanese patients with polymyositis and dermatomyositis resistant to corticosteroids: a randomized double-blind placebo-controlled trial.

Miyasaka N, Hara M, Koike T, Saito E, Yamada M, Tanaka Y, GB-0998 Study Gro - Mod Rheumatol (2011)

Forest plots of before–after differences in ADL scores for the 8-week first period. Black circles and lines, respectively, represent point estimates and 95% confidence intervals of between-group differences (GB-0998 group versus placebo group) in the ADL scores for each activity
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3375426&req=5

Fig8: Forest plots of before–after differences in ADL scores for the 8-week first period. Black circles and lines, respectively, represent point estimates and 95% confidence intervals of between-group differences (GB-0998 group versus placebo group) in the ADL scores for each activity
Mentions: The intergroup differences in changes of ADL scores for the 15 actions evaluated in this study, during the first period, are shown in Fig. 8. The point-estimation values show that the changes were greater in the GB-0998 group than in the placebo group for 12 of the 15 actions, although the differences for individual actions were small. Among these actions, the difference (value 1.17) with respect to swallowing action at week 8 of the first period between an increase of 1.00 in the GB-0998 group and a decrease of −0.17 in the placebo group (the normal score is 3) was statistically significant (t test, p = 0.0222).Fig. 8

Bottom Line: High-dose intravenous immunoglobulin (IVIG) therapy has been effective in treating various autoimmune and systemic inflammatory diseases.However, significant improvements were also found in the placebo group, and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups.These results indicate that GB-0998 can be safely used with the same precautions as other current IVIG therapy.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Graduate School, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan. miya.rheu@tmd.ac.jp

ABSTRACT
High-dose intravenous immunoglobulin (IVIG) therapy has been effective in treating various autoimmune and systemic inflammatory diseases. Here, we assessed the efficacy and safety of IVIG therapy with polyethylene glycol-treated human IgG (drug code GB-0998) for patients with corticosteroid-refractory polymyositis (PM) and dermatomyositis (DM) by means of a randomized, double-blind, placebo-controlled study. We randomly assigned 26 subjects (16 PM and 10 DM) to receive either GB-0998 or placebo. Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint (manual muscle test score) and secondary endpoints (serum creatine kinase level and activities of daily living score). However, significant improvements were also found in the placebo group, and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups. We discuss possible reasons for the absence of a clear intergroup difference in efficacy. Nineteen adverse drug reactions were observed in 11 of 26 subjects (42.3%), of which 2 events (decreased muscle strength and increased serum creatine kinase) were assessed as serious; however, they are previously known events. These results indicate that GB-0998 can be safely used with the same precautions as other current IVIG therapy.

Show MeSH
Related in: MedlinePlus