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 Qu ality Index (DLQI) and adverse events. Results: Most patients who were treated w ith alefacept in the phase III programme were not candidates for ≥1 of the abov e-mentioned therapies, and 41 and 21%were not candidates for ≥2 and ≥3, resp ectively. A reduction in PASI of ≥75%was achieved by 27, 23 and 26%of aleface pt-treated patients who were not candidates for ≥1, ≥2 and ≥3 conventional s ystemic psoriasis therapies or phototherapy, respectively (all p ≤0.001 vs. pla cebo). The corresponding results for PASI 50 were 53, 52 and 50%(all p ≤0.001 vs. placebo). At 2 weeks after the last dose of alefacept, mean DLQI overall sco res were reduced by-4.2,-3.9 and-5.2, respectively (all p ≤0.001 vs. placebo ). The incidence of adverse events was similar in the alefacept and placebo grou ps. Conclusions: The efficacy, quality of life effects and safety of alefacept i n patients who were not candidates for conventional systemic psoriasis therapies or phototherapy were similar to those reported previously for the overall alefa cept-treated population in the phase III studies.
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