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Rheumatology Advance Access originally published online on August 28, 2009
Rheumatology 2009 48(11):1388-1391; doi:10.1093/rheumatology/kep237
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Low-dose natural human interferon-{alpha} lozenges in the treatment of Behçet's syndrome

Hasan Kiliç1, Hasan E. Zeytin2, Cengiz Korkmaz3, Cem Mat4, Ahmet Gül5, Fulya Cosan5, Ayhan Dinç6, Ismail Simsek6, Necdet Süt7 and Hasan Yazici1

1Division of Rheumatology, Cerrahpasa Medical Faculty, University of Istanbul, 2Nobel Ilaç San. ve Tic A.S., Istanbul, 3Department of Internal Medicine, Division of Rheumatology, Eskisehir Osmangazi University, Eskisehir, 4Department of Dermatology, Cerrahpasa Medical Faculty, Istanbul University, 5Department of Internal Medicine, Division of Rheumatology, Istanbul Faculty of Medicine, Istanbul, 6Department of Medicine, Division of Rheumatology, Gulhane Military School of Medicine, Ankara and 7Department of Biostatistics, Trakya University Medical Faculty, Edirne, Turkey.

Correspondence to: Hasan E. Zeytin, Nobel Ilaç San. ve Tic A.S., Istanbul, Turkey. E-mail: hasan.zeytin{at}nobel.com.tr


  Abstract

Objectives. There had been evidence that low-dose local IFN could be beneficial in the management of recurrent oral ulcers (OUs). We investigated the efficacy and collected initial data on the safety of low-dose natural human IFN-{alpha} administered by the oral mucosal route in Behçet's syndrome (BS) in a placebo controlled, double blind study.

Methods. Eighty-four (59 males and 25 females) patients with BS with mainly skin mucosa disease and a history of recurrent OU for >=1 year were studied. When they had at least two OUs with a total diameter of >=4 mm, they were randomly allocated to (i) 2000 IFN-{alpha} IU/day, (ii) 1000 IFN-{alpha} IU/day and (iii) placebo groups. Subjects were monitored weekly over an initial 4 weeks and bi-weekly for an additional 8 weeks of treatment. OU were counted and measured at each study visit. The primary efficacy end point was the difference in the total ulcer burden at Week 0 compared with that at Week 12.

Results. Out of the 84 patients enrolled, 72 completed the trial. There were no statistically significant differences between the treatment arms in terms of the primary endpoint.

Conclusions. Low-dose natural human IFN-{alpha} did not have beneficial effects on reducing the total ulcer burden among BS patients from Turkey. The study also showed that counting the number of ulcers rather than measuring the size would be adequate in future studies.

Trial registration. ClinicalTrials.gov, NCT00483184 [ClinicalTrials.gov] , http://www.clinicaltrials.gov/ct2/results?term=NCT00483184

KEY WORDS: Behçet's syndrome, Oral ulcers, Low-dose oral interferon-{alpha}

Submitted 24 April 2009; revised version accepted 7 July 2009.
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