Topical immunomodulation under systemic immunosuppression: results of a multicentre, randomized, placebo-controlled safety and efficacy study of imiquimod 5% cream for the treatment of actinic keratoses in kidney, heart, and liver transplant patients.
OBJECTIVE
In this study the safety and efficacy of imiquimod 5% cream for the treatments of actinic keratoses in kidney, heart and liver transplant recipients is evaluated.


BACKGROUND
Growing populations of organ transplant recipients face increased risk of developing actinic keratosis (AK) and skin cancer secondary to continuous systemic immunosuppressive therapy. Imiquimod 5% cream is an effective option for the treatment of AK, but the safety of topical immune stimulation in immunocompromised patients has not been widely evaluated.


METHODS
A total of 43 patients in six European transplant centres applied two sachets of topical imiquimod or vehicle cream three times per week to a 100 cm(2) field. Dosing continued for 16 weeks regardless of lesion clearance. Patients were assessed for safety variables that included adverse events, local skin reactions, laboratory results, vital signs, dosage of immunosuppressive medication and indication of graft rejection. A blinded independent expert committee was responsible for safety monitoring and final safety assessment.


RESULTS
No graft rejections or trends for a deterioration of graft function were detected. No meaningful trends were observed in laboratory results. Among patients randomized to imiquimod, the complete clearance rate was 62.1% (18/29); for vehicle patients, the complete clearance rate was 0% (0/14). Clinical clearance was confirmed histologically in all cases.


CONCLUSIONS
Imiquimod appears to be a safe alternative for the treatment of multiple actinic keratoses in patients with solid organ transplants. Efficacy was within the range previously observed in nontransplanted populations.
Ulrich
C
C
Clinic for Dermatology of the Charité, Charité Hospital, Campus Mitte, Charité-Platz 1, 10117-Berlin, Germany. claas.ulrich@charite.de
Bichel
J
J
Euvrard
S
S
Guidi
B
B
Proby
C M
CM
van de Kerkhof
P C M
PC
Amerio
P
P
Rønnevig
J
J
Slade
H B
HB
Stockfleth
E
E
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000009:adverse effects* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000276:immunology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077271:Imiquimod; D016867:Immunocompromised Host; D007642:Keratosis / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009381:Neoplasms, Radiation-Induced / Q000188:drug therapy / Q000276:immunology; D016377:Organ Transplantation; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod