Background Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrotic changes in skin and other organs involving excessive collagen deposition. Intravenous immunoglobulin (IVIG) suppressed collagen content and expression in a murine model. IVIG has been also reported to reduce skin stiffness in SSc patients in several open trials.
Objectives To examine the efficacy and safety of IVIG in treating diffuse cutaneous SSc in a multicenter, randomized, placebo-controlled, double-blind trial.
Methods It is first time trial in Japan, which was conducted in SSc at 17 sites. Patients with diffuse cutaneous SSc were recieved IVIG (400mg/kg/day for 5 consecutive days: a single course of therapy) or placebo intravenously. The primary outcome measure was the change of modified Rodnan’s total skin thickness score (MRSS) between before and 12 weeks after treatment.
Results The changes (mean±SD) of MRSS between before and 12 weeks after treatment were -3.3±4.2 (n=31) in the IVIG group versus -4.2±4.6 (n=31) in the placebo group. The difference between groups was not significant (p=0.3257). Histological evaluation revealed that the percent changes (mean±SD)of dermal fibrotic thickness were -2.23±34.48 (n=21) in the IVIG group versus 7.51±25.55 (n=22) in the placebo group. The change in the IVIG group was larger, but no difference between groups (p=0.0985). Adverse event rates of the IVIG group was higher than the placebo group (32.3% versus 12.5%), but absence of significant adverse events was observed. Retreated IVIG treatment for patients revealed the decrease of MRSS less than 5 points in this study showed the significant improvement of MRSS in a long-term observational study.
Conclusions A single course of IVIG treatment didn’t exhibit the improvement of MRSS in diffuse cutaneous SSc. However, MRSS decreased significantly by two courses of IVIG treatment. It is suggested that repeated IVIG treatment of more than two courses should be considered in some patients. Further trials are needed to evaluate the effect of IVIG when treated in different regimens.
Disclosure of Interest K. Takehara Consultant for: Benesis, H. Ihn: None Declared, S. Sato: None Declared
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