Background: Many patients with moderate to severe chronic plaque psoriasis fail to respond to or are not appropriate candidates for conventional systemic therapies and/or phototherapy.
Objectives: To assess the efficacy, quality of life and safety of alefacept among the proportion of patients who participated in the phase III studies and who were not suitable candidates for conventional systemic psoriasis therapies or phototherapy.
Methods: The patient's historical responses at the baseline visit during the phase III studies of alefacept were used to identify a subpopulation in whom the use of methotrexate, ciclosporin, retinoids, ultraviolet B or psoralen plus ultraviolet A was ineffective or inappropriate. Endpoints included Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI) and adverse events.
Results: Most patients (69%) who were treated with alefacept in the phase III programme were not candidates for > or =1 of the above-mentioned therapies, and 41 and 21% were not candidates for > or =2 and > or =3, respectively. A reduction in PASI of > or =75% was achieved by 27, 23 and 26% of alefacept-treated patients who were not candidates for > or =1, > or =2 and > or =3 conventional systemic psoriasis therapies or phototherapy, respectively (all p < or = 0.001 vs. placebo). The corresponding results for PASI 50 were 53, 52 and 50% (all p < or = 0.001 vs. placebo). At 2 weeks after the last dose of alefacept, mean DLQI overall scores were reduced by -4.2, -3.9 and -5.2, respectively (all p < or = 0.001 vs. placebo). The incidence of adverse events was similar in the alefacept and placebo groups.
Conclusions: The efficacy, quality of life effects and safety of alefacept in patients who were not candidates for conventional systemic psoriasis therapies or phototherapy were similar to those reported previously for the overall alefacept-treated population in the phase III studies.
Copyright 2005 S. Karger AG, Basel.