Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: updated results from an ongoing trial.
BACKGROUND
Efalizumab is a T cell-targeted therapy for psoriasis.


OBJECTIVE
We sought to evaluate the efficacy and safety of long-term, continuous efalizumab therapy.


METHODS
Of 339 patients enrolled in this ongoing, open-label, phase III study, after 3 months 290 qualified for and entered the maintenance treatment phase.


RESULTS
Results for the first 27 months of this 36-month continuous therapy trial are available. At month 3, 41% of patients achieved at least a 75% reduction in Psoriasis Area and Severity Index (PASI) score; at month 27, 47% achieved at least a 75% reduction in PASI score (intent to treat, n = 339). Among patients eligible for maintenance therapy (n = 290), 56% achieved at least a 75% reduction in PASI score at month 27. Moreover, the at least 90% reduction in PASI score rate increased through 18 months (33%). The safety profile with efalizumab was sustained throughout 27 months of continuous treatment with no new common events over time.


CONCLUSIONS
Because the extended treatment period was not a randomized clinical trial, no formal comparative analyses versus placebo were conducted. Three-month placebo data from randomized, parallel, placebo-controlled studies are briefly discussed.


CONCLUSIONS
These results suggest that efalizumab maintains, and in some patients continues to improve, efficacy during long-term therapy.
University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901-0019, USA. alice.gottlieb@umdnj.edu
Alice B
AB
Gottlieb
Tiffani
T
Hamilton
Ivor
I
Caro
Paul
P
Kwon
Peter G
PG
Compton
Craig L
CL
Leonardi
D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D003131:Combined Modality Therapy; D005446:Fluocinolone Acetonide / Q000627:therapeutic use; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010976:Platelet Count; D011565:Psoriasis / Q000188:drug therapy* / Q000628:therapy; D016896:Treatment Outcome; D014467:Ultraviolet Therapy
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D007155:Immunologic Factors; D005446:Fluocinolone Acetonide; C472181:efalizumab