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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

Time-courses of MMT scores of individual subjects for 8 weeks after initiation of first-period administration (a GB-0998 group, b placebo group). Broken lines indicate the time-courses after transfer to the second period in the cases of subjects who were transferred before the full 8 weeks in the first period
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Fig9: Time-courses of MMT scores of individual subjects for 8 weeks after initiation of first-period administration (a GB-0998 group, b placebo group). Broken lines indicate the time-courses after transfer to the second period in the cases of subjects who were transferred before the full 8 weeks in the first period

Mentions: The time-courses of MMT scores and serum CK levels in individual patients for 8 weeks after the initial administration are shown in Figs. 9, 10, respectively, for both the GB-0998 and placebo groups. The broken lines indicate the time-courses in patients after early transition to the second period.Fig. 9


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)

Time-courses of MMT scores of individual subjects for 8 weeks after initiation of first-period administration (a GB-0998 group, b placebo group). Broken lines indicate the time-courses after transfer to the second period in the cases of subjects who were transferred before the full 8 weeks in the first period
© Copyright Policy
Related In: Results  -  Collection

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

Fig9: Time-courses of MMT scores of individual subjects for 8 weeks after initiation of first-period administration (a GB-0998 group, b placebo group). Broken lines indicate the time-courses after transfer to the second period in the cases of subjects who were transferred before the full 8 weeks in the first period
Mentions: The time-courses of MMT scores and serum CK levels in individual patients for 8 weeks after the initial administration are shown in Figs. 9, 10, respectively, for both the GB-0998 and placebo groups. The broken lines indicate the time-courses in patients after early transition to the second period.Fig. 9

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