Protopic®
Active ingredient: Tacrolimus
Marketing authorisation holder: Astellas Pharma Europe B.V.
Availability: National Health Service and Private Sector
Variations:
A seven month, double blind, randomised parallel group study was carried out on paediatric
population (2-11 years) suffering from moderate to severe atopic dermatitis. In one study group, the patients
were using Protopic® 0.03% ointment (n=121) twice daily for 3 weeks followed by once daily regimen until
disappearance. In the other group, patients received 1% hydrocortisone acetate ointment for head and neck and
0.1% hydrocortisone butyrate ointment for trunk and limbs (n=111) twice daily for 2 weeks followed by
hydrocortisone acetate twice daily to all afflicted areas. All participants (n=44) were administered a primary
immunisation and a rechallenge with a protein-conjugate vaccine against Neisseria meningitides serogroup C.
The main end-point of this study was the response rate to vaccination, that is, the percentage of patients with a
serum bactericidal antibody titre ≥8 after 5 weeks. It was similarly high in the study group of hydrocortisone
ointment 98.3%, tacrolimus ointment 95.4% and 98% in the control group. It showed that primary response to
vaccination was not affected by the use of tacrolimus but induction of a T-cell dependent response and
immunological memory was present. There is no proof of systemic immunosuppression in view of efficacy and
safety findings which are coherent with other studies carried out beforehand. Hence no new clinical findings
were established that could alter the benefit-risk assessment of Protopic®.
The ATC code on the SmPC was changed to be concordant with WHO amendments.
Reference: European Medicines Agency. Protopic. [online]. 2011August 16 [cited 2011 July 30]; Available from: URL:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000374/human_med_001000.jsp&murl=menus/medicine
s/medicines.jsp&mid=WC0b01ac058001d124