A novel therapeutic approach to psoriasis with combination calcipotriol ointment and very low-dose cyclosporine: results of a multicenter placebo-controlled study.
BACKGROUND
Recent advances in the treatment of psoriasis include both the topical vitamin D analogue calcipotriol and cyclosporine. Combined treatments have been sought to decrease the incidence of side effects while maintaining efficacy in the treatment of severe chronic plaque psoriasis.


OBJECTIVE
The objective of this study was to evaluate the efficacy and safety of the combination of 2 mg/kg/day of cyclosporine with calcipotriol ointment (50 micrograms/gm) in the treatment of severe plaque psoriasis.


METHODS
Sixty-nine patients were randomly selected for this double-blind, multicenter study to receive cyclosporine (2 mg/kg/day) combined with calcipotriol ointment (50 micrograms/gm) or cyclosporine (2 mg/kg/day) combined with placebo ointment (vehicle of calcipotriol) for a 6-week period.


RESULTS
Complete clearing or 90% improvement in Psoriasis Area and Severity Index score occurred in 50.0% of patients in the calcipotriol/cyclosporine group in comparison with 11.8% of patients treated with placebo/cyclosporine (p = 0.0019). The confidence interval for the difference ranged from 17.8% to 58.7%. No difference was found between the two groups with respect to side effects.


CONCLUSIONS
The calcipotriol/cyclosporine combination was more effective than placebo/cyclosporine. Further studies are needed to establish the long-term efficacy and safety profile of this combination therapy.
Hôpital Saint-Louis, Paris, France.
R M
RM
Grossman
J
J
Thivolet
A
A
Claudy
P
P
Souteyrand
J J
JJ
Guilhou
P
P
Thomas
P
P
Amblard
S
S
Belaich
C
C
de Belilovsky
M
M
de la Brassinne
D000328:Adult; D000368:Aged; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy*
D003879:Dermatologic Agents; D009824:Ointments; C055085:calcipotriene; D016572:Cyclosporine; D002117:Calcitriol