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Improvement in psoriasis after intradermal administration of delipidated, deglycolipidated Mycobacterium vaccae (PVAC™): results of an open‐label trial
Author(s) -
Balagon M. V.,
Tan P. L.,
Prestidge R.,
Cellona R. V.,
Abalos R. M.,
Tan E. V.,
Walsh G. P.,
Watson J. D.,
Walsh D. S.
Publication year - 2001
Publication title -
clinical and experimental dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.587
H-Index - 78
eISSN - 1365-2230
pISSN - 0307-6938
DOI - 10.1046/j.1365-2230.2001.00804.x
Subject(s) - medicine , psoriasis , psoriasis area and severity index , lesion , randomized controlled trial , randomization , dermatology , surgery , gastroenterology
The aim of new treatments for psoriasis is to induce extended remissions with fewer side‐effects. Previous studies suggest that Mycobacterium vaccae , a harmless organism prepared as a heat‐killed suspension, may induce periods of remission in some psoriasis patients after intradermal administration. To assess a more potent derivative of M. vaccae , we conducted an open‐label study in which 20 patients with moderate to severe psoriasis (Psoriasis Area and Severity Index of 12–35) received two intradermal inoculations of heat‐killed, delipidated, deglycolipidated M. vaccae (DD‐MVAC or ‘PVAC’) in lesion‐free deltoid skin, separated by a period of 3 weeks. Twelve weeks after the injections, 13 out of 20 patients (65%) showed marked improvement in the PASI score (> 50% reduction), three were unchanged (< 25% reduction), three had worsened (> 5% increase), and one was withdrawn from the trial because of an exfoliative flare. At 24 weeks, 13 out of 19 patients continued to show > 50% improvement that, in some, lasted for 6 months or longer. Patients classified as good responders at 12 or 24 weeks were then offered additional PVAC injections after 24 weeks if the PASI reached 8 or higher. Intra‐dermal administration of PVAC was safe, well tolerated, and induced clinically significant improvement in many psoriasis patients. A randomized, double‐blind, controlled study is warranted.