Clinical efficacy of efalizumab in patients with chronic plaque psoriasis: results from three randomized placebo-controlled Phase III trials: part I.
BACKGROUND
Effective psoriasis therapies are needed for long-term symptom control.


OBJECTIVE
Assess efalizumab (Raptiva) efficacy in a large cohort of psoriasis patients.


METHODS
Data from three Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter studies were pooled. Patients (n = 1,651) with moderate to severe plaque psoriasis received 12 weeks of subcutaneous efalizumab 1 or 2 mg/kg/wk or placebo.


RESULTS
All efficacy measures reached statistical significance within each of the individual studies (p < 0.001) and overall. More efalizumab-treated patients achieved > or = 75% and > or = 50% Psoriasis Area and Severity Index (PASI) improvement at week 12 than did placebo-treated patients (27.8% vs 3.8% [p < 0.001] and 56.1% vs 14.6% [p < 0.001], respectively). Significant PASI improvements occurred as early as week 2 (12.5% vs 7.9%, p =0.0001). Adverse events were generally mild to moderate.


CONCLUSIONS
Efalizumab resulted in early and significant improvement for all efficacy endpoints and was well tolerated in patients with moderate to severe chronic plaque psoriasis.
Pariser
David M
DM
Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA. dpariser@pariserderm.com
Gordon
Kenneth B
KB
Papp
Kim A
KA
Leonardi
Craig L
CL
Kwon
Paul
P
Compton
Peter G
PG
Rundle
Amy Chen
AC
Walicke
Patricia A
PA
Lebwohl
Mark
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015992:Body Mass Index; D002908:Chronic Disease; D017326:Clinical Trials, Phase III as Topic; D015331:Cohort Studies; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; C472181:efalizumab