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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

Kaplan–Meier curve of patients for whom the MMT scores increased by 5 points or more in the first period. Event occurrence was defined as the time point when MMT scores initially increased by 5 points or more, and subsequently remained at the higher level, during the period from before drug administration until transfer to the second period. When the score was increased by less than 5 points upon transfer to the second period, the test was discontinued on day 56
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Fig3: Kaplan–Meier curve of patients for whom the MMT scores increased by 5 points or more in the first period. Event occurrence was defined as the time point when MMT scores initially increased by 5 points or more, and subsequently remained at the higher level, during the period from before drug administration until transfer to the second period. When the score was increased by less than 5 points upon transfer to the second period, the test was discontinued on day 56

Mentions: The Kaplan–Meier survival curves for the time until improvement are shown in Fig. 3. The median times until improvement were 16.5 days in the GB-0998 group, and 29.0 days in the placebo group, but the difference between the two groups was not statistically significant (log-rank test, p = 0.1154).Fig. 3


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)

Kaplan–Meier curve of patients for whom the MMT scores increased by 5 points or more in the first period. Event occurrence was defined as the time point when MMT scores initially increased by 5 points or more, and subsequently remained at the higher level, during the period from before drug administration until transfer to the second period. When the score was increased by less than 5 points upon transfer to the second period, the test was discontinued on day 56
© Copyright Policy
Related In: Results  -  Collection

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

Fig3: Kaplan–Meier curve of patients for whom the MMT scores increased by 5 points or more in the first period. Event occurrence was defined as the time point when MMT scores initially increased by 5 points or more, and subsequently remained at the higher level, during the period from before drug administration until transfer to the second period. When the score was increased by less than 5 points upon transfer to the second period, the test was discontinued on day 56
Mentions: The Kaplan–Meier survival curves for the time until improvement are shown in Fig. 3. The median times until improvement were 16.5 days in the GB-0998 group, and 29.0 days in the placebo group, but the difference between the two groups was not statistically significant (log-rank test, p = 0.1154).Fig. 3

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