Improvement in psoriasis after intradermal administration of heat-killed Mycobacterium vaccae.
BACKGROUND
New treatments for psoriasis are being developed, but many are associated with limited efficacy, side-effects, or rapid recurrence after discontinuation. Thus, the aim of new agents is to induce longer term remissions with fewer side-effects. Preliminary studies have shown that Mycobacterium vaccae, a nonpathogenic organism prepared as a heat-killed suspension, may induce periods of remission in some psoriasis patients when administered intradermally.


METHODS
To further assess the efficacy and tolerability of M. vaccae in patients with moderate to severe psoriasis (psoriasis area and severity index (PASI) of 12-35), we conducted an open label study whereby 24 patients received two intradermal inoculations of M. vaccae in lesion-free deltoid skin, separated by a period of 3 weeks.


RESULTS
Twelve weeks after starting treatment, 14 of 24 patients (58%) showed marked improvement in the PASI score (greater than 50% reduction), two had moderate improvement (25-50% reduction), six were unchanged (< 25% reduction), and two had worsened (> 5% increase). By 24 weeks, 11 of 22 patients continued to show greater than 50% improvement. Five patients had complete clearance of skin lesions that lasted for at least 6 months.


CONCLUSIONS
Intradermal administration of heat-killed M. vaccae suspension was well tolerated and induced clinically significant improvement in a majority of psoriasis patients in this cohort. Placebo-controlled testing to further define the efficacy of this treatment is warranted.
Balagon
M V
MV
Leonard Wood Memorial Center for Leprosy Research (American Leprosy Foundation), Cebu City, Philippines.
Walsh
D S
DS
Tan
P L
PL
Cellona
R V
RV
Abalos
R M
RM
Tan
E V
EV
Fajardo
T T
TT
Watson
J D
JD
Walsh
G P
GP
D000293:Adolescent; D000328:Adult; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007167:Immunotherapy; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000276:immunology*; D011565:Psoriasis / Q000473:pathology / Q000628:therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000627:therapeutic use
D001428:Bacterial Vaccines; D015164:Vaccines, Inactivated