A pilot study to test the efficacy of oral administration of interferon-α lozenges to patients with Sjogren's syndrome

Background. Complications from Sjogren's syndrome-induced xerostomia may cause a significant disruption in daily routines such as speech and eating habits. In addition, the reduction in salivary output may lead to increased incidence of caries, oral ulcers, sialadenitis, periodontal problems, and Candida infections. Interferon-alpha. has been suggested as an effective drug therapy to increase salivary output. Objective. The objective was to test the efficacy of interferon-alpha lozenges in relieving the symptoms of dry mouth and dry eyes when administered orally to patients with Sjogren's syndrome in double-blind placebo-controlled and open-label trials. Study design. Twelve patients with a diagnosis of primary Sjogren's syndrome were provided an Institutional Review Board-approved, written informed-consent form. During the double-blind placebo-controlled study they were randomized to receive 150 IU of interferon-alpha (8 patients) or placebo (4 patients) for 24 weeks with 6-week reevaluations. Five patients who received interferon-alpha in the double-blind placebo-controlled trial were treated in an open-label study for another 24 weeks. Whole saliva was measured during each visit, and symptoms were assessed by questionnaires and visual analog scales. The Wilcoxon signed rank test was used to detect significant changes for each variable. Results. The results indicated that, by the end of 24 weeks, patients who received interferon-alpha had a statistically significant improvement in unstimulated salivary flow rate (P < .05), and statistically significant changes were observed in the median ocular dryness visual analog scale (P < .05) and oral dryness visual analog scale (P < .05). No significant changes were observed among the placebo patients. By the end of 48 weeks, medicated patients had better results than they had at the end of the double-blind placebo-controlled study and showed improvements in whole stimulated salivary flow rate, conditions of throat, and swallowing dry food. Conclusion. Oral administration of 150 IU interferon-alpha 3 times a day for the patients with primary Sjogren's syndrome improved saliva production, relieved symptoms of xerostomia and xerophthalmia, and was well tolerated by the patients.