Long-term efalizumab therapy for patients with moderate-to-severe, chronic plaque psoriasis: results from an Australian expanded access program.
BACKGROUND
Psoriasis is a chronic skin disease that can impact heavily on a patient's well-being. Efalizumab, a unique, targeted, biological therapy, has demonstrated efficacy in treating moderate-to-severe, chronic plaque psoriasis with <or=36 months of continuous therapy. The objective of this Extended Access Program (EAP) was to evaluate further the benefit of efalizumab as long-term therapy in a real-world clinical setting.


METHODS
After an initial conditioning dose of efalizumab (0.7 mg/kg subcutaneously), a weekly dose of efalizumab (1.0 mg/kg) was administered for <or=21 months. Patients with reduced Psoriasis Area and Severity Index (PASI) scores (>or=50%, or a score <or=8) at month 3 entered the long-term maintenance treatment period.


RESULTS
In total, 101 patients (>18 years) with severe plaque psoriasis enrolled on the EAP, of these 93 (92.1%) met all the inclusion criteria. After 3 months of treatment, 84/101 (83.2%) patients had evaluable data and entered the maintenance period. After 3 months, 57/84 (67.9%) patients had achieved PASI-50. Using an intent-to-treat analysis, after 21 months of treatment, PASI-75 and PASI-50 were achieved by 43/101 (42.6%) and 69/101 (68.3%) of patients, respectively. Efalizumab was generally well tolerated during the 21 months of continuous therapy.


CONCLUSIONS
Efalizumab, 1.0 mg/kg/week, is effective and well tolerated in a 'real world' clinical setting, providing enduring reduction of psoriasis symptoms for up to 21 months.
Foley
Peter
P
Department of Medicine (Dermatology), The University of Melbourne, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia. Peter.FOLEY@svhm.org.au
Freeman
Michael
M
Gebauer
Kurt
K
Murrell
Dedee
D
Shumack
Stephen
S
Tyson
Christopher
C
Varigos
George
G
D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens; D002908:Chronic Disease; D006801:Humans; D007279:Injections, Subcutaneous; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens; C472181:efalizumab