Discontinuing long-term iloprost treatment for Raynaud's phenomenon and systemic sclerosis: a single-center, randomized, placebo-controlled, double-blind study

Background Iloprost has been reported to reduce Raynaud's phenomenon (RP) and to inhibit progression of systemic sclerosis (SSc). Objective The aim of our study was to compare monthly iloprost infusions with placebo in patients treated long-term. Methods Seventeen patients, six with RP and 11 with SSc on monthly treatment with iloprost, received either a 3-hour intravenous infusion of iloprost or an equal volume of placebo once per month for 4 months in a monocentric, randomized, placebo-controlled, double-blind study. Raynaud attacks as measured by diary entries, skin temperature, skin sclerosis, fist closure, mouth opening, and digital ulcers were recorded during the observation period. Results Whereas mouth opening improved significantly (p = 0.043) in the iloprost-treated group, RS improved in both patient groups. However, no significant differences were found in the outcome measures. Conclusion Although iloprost influences the inflammatory cascade in SSc, no statistical differences were seen in our study, indicating that treatment strategies with iloprost should be modified.