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 effica...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.展开更多
Background: Conventional systemic therapies and phototherapy for psoriasis are limited by safety concerns that may preclude long-term treatment with these agents. Objectives: To estimate the unmet need for safe and ef...Background: Conventional systemic therapies and phototherapy for psoriasis are limited by safety concerns that may preclude long-term treatment with these agents. Objectives: To estimate the unmet need for safe and effective treatments for psoriasis. Methods: A survey was conducted at three psoriasis outpatient clinics in Europe. Male and female patients of any age with psoriasis requiring more than topical treatment were eligible to participate in the survey. Patient data were obtained from patients’answers to a questionnaire as well as by a chart review of each participating patient. The survey questionnaire addressed various aspects of psoriasis, including demographics and disease characteristics, treatment history, pre-existing medical conditions, and patient satisfaction with treatments received. Results: A total of 301 patients participated in the survey, with approximately 100 patients from each centre. Nearly 90%of patients had received at least one systemic therapy or phototherapy for psoriasis, with 39%of patients receiving three or more. Ultraviolet B (UVB), methotrexate, psoralen plus ultraviolet A (PUVA), retinoids and cyclosporin were the most commonly used agents. Inadequate response, reported by patients as no change or worsening of disease with treatment, ranged from 10%to 50%. Contraindications to conventional systemic therapies were reported by 9-22%of patients. A substantial number of patients (42%) were not satisfied with these therapies. Conclusions: This survey highlights the unmet need for safe and effective therapies for moderate to severe psoriasis.展开更多
文摘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.
文摘Background: Conventional systemic therapies and phototherapy for psoriasis are limited by safety concerns that may preclude long-term treatment with these agents. Objectives: To estimate the unmet need for safe and effective treatments for psoriasis. Methods: A survey was conducted at three psoriasis outpatient clinics in Europe. Male and female patients of any age with psoriasis requiring more than topical treatment were eligible to participate in the survey. Patient data were obtained from patients’answers to a questionnaire as well as by a chart review of each participating patient. The survey questionnaire addressed various aspects of psoriasis, including demographics and disease characteristics, treatment history, pre-existing medical conditions, and patient satisfaction with treatments received. Results: A total of 301 patients participated in the survey, with approximately 100 patients from each centre. Nearly 90%of patients had received at least one systemic therapy or phototherapy for psoriasis, with 39%of patients receiving three or more. Ultraviolet B (UVB), methotrexate, psoralen plus ultraviolet A (PUVA), retinoids and cyclosporin were the most commonly used agents. Inadequate response, reported by patients as no change or worsening of disease with treatment, ranged from 10%to 50%. Contraindications to conventional systemic therapies were reported by 9-22%of patients. A substantial number of patients (42%) were not satisfied with these therapies. Conclusions: This survey highlights the unmet need for safe and effective therapies for moderate to severe psoriasis.
