OBJECTIVES: To evaluate the efficacy and safety of
efalizumab in continuous or interrupted
therapy of adults with moderate-to-severe plaque
psoriasis who had failed to respond to or were intolerant of other systemic
therapies, including
methotrexate,
ciclosporin and
psoralen plus UVA
phototherapy, or for whom such
therapies were contraindicated. METHODS: Patients received a conditioning dose of
efalizumab 0.7 mg/kg followed by once-weekly open-label
efalizumab 1.0 mg/kg for 11 weeks. Responders (Physician Global Assessment [
PGA] score of "good" or better at Week 12) could continue
efalizumab for a further 8 weeks (continuous-treatment period). Nonresponders transitioned to alternative anti-
psoriasis medication or stopped treatment. Responders who discontinued
efalizumab could restart treatment if symptoms worsened.
PGA response was evaluated at Weeks 12 (primary endpoint) and 20, as were the proportions of patients achieving an improvement from baseline of >/=50%, >/=75% and >/=90% in
Psoriasis Area and Severity Index (PASI) (PASI 50, PASI 75 and PASI 90, respectively). RESULTS: A total of 1,255 patients were included in the intention-to-treat population. At Week 12, 68.0% of patients had a
PGA rating of "good" or better. Of 688 patients who entered the continuous-treatment period, 79.5% had a
PGA rating of "good" or better at Week 20. At Week 12, median improvement in PASI score was 68.4%. PASI 50/75/90 was achieved by 65.5%/35.9%/13.0% of patients at Week 12, and by 78.2%/52.9%/24.3% of responders at Week 20. Of the 127 responders at Week 12 who discontinued
efalizumab, 11% experienced rebound and 56.7% relapsed within 8 weeks after stopping
therapy.
Efalizumab was well tolerated during the study. CONCLUSIONS:
Efalizumab provided effective control of
psoriasis in the majority of patients during the initial treatment period. The high response rates were maintained in initial responders when treatment was continued beyond 12 weeks.