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

Jonathan A. Ship, Philip C. Fox, Joel E. Michalek, Martin J. Cummins, Alan B. Richards, Ibtisam Al-Hashimi, Ava Wu, Gary M. Kammer, Edward V. Lally, Francis G. LeVeque, Peter B. Lockhart, Michael T. Montgomery, Mahvash Navazesh, Nelson L. Rhodus, Beatrice Gandara, Charles F. Streckfus

Research output: Contribution to journalArticle

99 Citations (Scopus)

Abstract

The purpose of this investigation was to examine the safety and efficacy of four dosages of natural human interferon-α (nHuIFN-α) delivered over a 12-week period orally in lozenges (150 IU and 450 IU, once [QD] or three times [TID] daily) compared to placebo in subjects with primary Sjogren's syndrome. This randomized, double-blinded clinical trial demonstrated that nHuIFN-α at a dose of 150 IU administered TID by oral lozenge significantly 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 demonstrated a good safety profile, with no serious adverse events found in any treatment group. There were no significant differences between the placebo and the four doses of IFN for adverse events by total number, organ system, severity, dropouts, and number judged to be related to treatment. In conclusion, these results demonstrated that the use of 150 IU IFN lozenges TID for 12 weeks in subjects with primary Sjogren's syndrome improved salivary output and decreased complaints of xerostomia without causing significant adverse medical events.

Original languageEnglish (US)
Pages (from-to)943-951
Number of pages9
JournalJournal of Interferon and Cytokine Research
Volume19
Issue number8
DOIs
StatePublished - Sep 6 1999

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Phase II Clinical Trials
Sjogren's Syndrome
Interferons
Placebos
Safety
Xerostomia
Saliva
Therapeutics
Clinical Trials

ASJC Scopus subject areas

  • Immunology
  • Cell Biology
  • Virology

Cite this

Treatment of primary Sjogren's syndrome with low-dose natural human interferon-α administered by the oral mucosal route : A phase II clinical trial. / Ship, Jonathan A.; Fox, Philip C.; Michalek, Joel E.; Cummins, Martin J.; Richards, Alan B.; Al-Hashimi, Ibtisam; Wu, Ava; Kammer, Gary M.; Lally, Edward V.; LeVeque, Francis G.; Lockhart, Peter B.; Montgomery, Michael T.; Navazesh, Mahvash; Rhodus, Nelson L.; Gandara, Beatrice; Streckfus, Charles F.

In: Journal of Interferon and Cytokine Research, Vol. 19, No. 8, 06.09.1999, p. 943-951.

Research output: Contribution to journalArticle

Ship, JA, Fox, PC, Michalek, JE, Cummins, MJ, Richards, AB, Al-Hashimi, I, Wu, A, Kammer, GM, Lally, EV, LeVeque, FG, Lockhart, PB, Montgomery, MT, Navazesh, M, Rhodus, NL, Gandara, B & Streckfus, CF 1999, 'Treatment of primary Sjogren's syndrome with low-dose natural human interferon-α administered by the oral mucosal route: A phase II clinical trial', Journal of Interferon and Cytokine Research, vol. 19, no. 8, pp. 943-951. https://doi.org/10.1089/107999099313497
Ship, Jonathan A. ; Fox, Philip C. ; Michalek, Joel E. ; Cummins, Martin J. ; Richards, Alan B. ; Al-Hashimi, Ibtisam ; Wu, Ava ; Kammer, Gary M. ; Lally, Edward V. ; LeVeque, Francis G. ; Lockhart, Peter B. ; Montgomery, Michael T. ; Navazesh, Mahvash ; Rhodus, Nelson L. ; Gandara, Beatrice ; Streckfus, Charles F. / Treatment of primary Sjogren's syndrome with low-dose natural human interferon-α administered by the oral mucosal route : A phase II clinical trial. In: Journal of Interferon and Cytokine Research. 1999 ; Vol. 19, No. 8. pp. 943-951.
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