Treatment of primary Sjogren's syndrome with low-dose natural human interferon-alpha administered by the oral mucosal route: A phase II clinical trial

The purpose of this investigation was to examine the safety and efficacy of four dosages of natural human interferon-alpha (nHuIFN-alpha) delivered ov er a 12-week period orally in lozenges (150 IU and 450 IU, once [QD] or thr ee times [TID] daily) compared to placebo in subjects with primary Sjogren' s syndrome. This randomized, double-blinded clinical trial demonstrated tha t nHuIFN-alpha at a dose of 150 IU administered TLD by oral lozenge signifi cantly improved stimulated whole saliva output compared to placebo after 12 weeks of treatment. The 150 IU TID dose also was suggestive of benefit for 5 of 7 subjective measures of oral and ocular comfort. IFN lozenges demons trated a good safety profile, with no serious adverse events found in any t reatment group. There were no significant differences between the placebo a nd the four doses of IFN for adverse events by total number, organ system, severity, dropouts, and number judged to be related to treatment. In conclu sion, these results demonstrated that the use of 150 IU IFN lozenges TID fo r 12 weeks in subjects with primary Sjogren's syndrome improved salivary ou tput and decreased complaints of xerostomia without causing significant adv erse medical events.