Report of a preliminary discontinued double-blind, randomized, placebo-controlled trial of the anti-TNF-α chimeric monoclonal antibody infliximab in complex regional pain syndrome.

Objective: Inflammation appears to play a role in CRPS as, for example, cytokines (like TNF-α) are involved in the affected limb. The ongoing inflammation is probably responsible for the central sensitization that sometimes occurs in CRPS. Thus, early start of a TNF-α antagonist may counteract inflammation, thereby preventing rest damage and leading to recovery of the disease.

Design: Patients (n = 13) were randomly assigned to infliximab 5 mg/kg or placebo, both administered at week 0, 2, and 6.

Outcome Measures: The aim was to confirm a reduction in clinical signs of regional inflammation (based on total impairment level sumscore: ISS) after systemic administration of infliximab. Also, levels of mediators in the fluid of induced blisters were examined in relation to normalization and improvement in quality of life.

Results: Six patients received infliximab and 7, placebo. There was no significant change in total ISS score between the two groups. Similarly, no significant difference in change in cytokine levels was found between infliximab compared with placebo. However, there was a trend toward a greater reduction of TNF-α in the intervention group compared with the placebo group. A subscale of the EuroQol (ie EuroQol VAS) revealed significant decrease in health status in the intervention group compared with the placebo group.

Conclusions: This study was terminated before the required number of participants had been reached for sufficient statistical power. Nevertheless, a trend was found toward an effect of infliximab on the initially high TNF-α concentration.