Safety and Efficacy of Injectable Pentigetide: Double-Blind, Placebo-Controlled Study in Patients with Allergic Rhinitis

Abstract

Pentigetide is a synthetic pentapeptide derived from the Fc region of human IgE reported to inhibit IgE-mediated allergic responses. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of subcutaneously administered pentigetide in the treatment of allergic rhinitis. After a 3-day baseline period, 55 patients received 5 injections of either 20 mg of pentigetide for injection (n = 31) or placebo solution (n = 24), one injection every 3 to 4 days for 14 days. Physician assessment of frequency and severity of sneezing, rhinorrhea, congestion, nasal itching, and 3 non-nasal symptoms obtained at baseline, after 1 week, and study completion were compared between pentigetide and placebo treatment groups. The physician's assessment of therapeutic response made at study completion showed that 71% of patients receiving pentigetide were improved, whereas 37% of patients receiving placebo had improved, a difference which was statistically (chi square, p = 0.013) as well as clinically significant. Mean symptom scores indicated that the frequency and severity of sneezing, rhinorrhea, and nasal itching decreased after 1 week of pentigetide treatment and remained decreased until study completion, whereas congestion was unchanged or slightly increased. In contrast, the frequency and severity of sneezing, rhinorrhea, and nasal itching increased after placebo treatment, with congestion essentially unchanged. No clinical or statistical differences in safety parameters between pentigetide and placebo treatments were observed. The results of this pilot trial suggested that subcutaneous pentigetide is safe and effective in the treatment of allergic rhinitis and justified expanded safety and efficacy studies in a greater number of patients treated for a longer period of time.