Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis.
ABSTRACT To assess the efficacy and safety of a 24-week course of efalizumab.
Phase 3, randomized, double-blind, parallel-group, placebo-controlled 12-week study followed by a 12-week open-label study.
Outpatient dermatology clinics. Patients A total of 556 patients with moderate to severe chronic plaque psoriasis who were seeing an outpatient dermatologist were included in the study. Intervention For weeks 1 to 12, the 556 patients were randomized to receive 1 mg/kg of efalizumab weekly or placebo subcutaneously. For weeks 13 to 24, 516 of these patients received 1 mg/kg of efalizumab weekly.
Proportion of patients with a 75% or greater improvement in Psoriasis Area and Severity Index (PASI-75), a 50% or greater improvement in PASI (PASI-50), static Physician's Global Assessment (sPGA) rating of minimal or clear, and improvements in Dermatology Life Quality Index (DLQI), itching scale, and Psoriasis Symptom Assessment (PSA) frequency and severity scores at weeks 12 and 24. Safety was evaluated by reviewing adverse events, laboratory parameters, vital signs, and anti-efalizumab antibodies.
At week 12, 26.6% of efalizumab-treated patients achieved PASI-75 and 58.5% achieved PASI-50. After 24 weeks of continuous efalizumab therapy, PASI responses increased: 43.8% of patients achieved PASI-75 and 66.6% achieved PASI-50. The percentage of patients who achieved an sPGA rating of minimal or clear increased from 25.7% to 35.9%. The mean percentage of improvement in all patient-reported outcomes (DLQI, itching scale, and PSA frequency and severity scores) at week 12 was maintained at week 24 (DLQI, 49.2%; itching scale, 42.2%; PSA frequency, 47.6%; PSA severity, 47.3%). There was a decline in overall reported adverse events from weeks 1 to 12 (80.4%) to weeks 13 to 24 (63.2%) without evidence of cumulative toxic effects. Conclusion Extending efalizumab treatment from 12 to 24 weeks leads to improved efficacy and maintenance of quality of life with no evidence of cumulative toxic effects noted in patients with moderate to severe chronic plaque psoriasis.
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ABSTRACT: Psoriasis vulgaris is the most prevalent T-cell-mediated inflammatory disease in humans. The pathogenesis of psoriasis is linked to activation of several types of leukocytes that control cellular immunity and to a T-cell-dependent inflammatory process in skin that accelerates the growth of epidermal and vascular cells in psoriasis lesions. Critical steps in immunologic activation include Langerhans cell maturation (activation), T-cell activation, differentiation and expansion of type 1 T cells, selective trafficking of activated T cells to skin, and induction of an inflammatory cytokine and chemokine cascade in skin lesions. In turn, each of these steps offers an opportunity for intervention with engineered biologic therapeutics.Journal of the American Academy of Dermatology 02/2002; 46(1):1-23; quiz 23-6. · 4.91 Impact Factor
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ABSTRACT: The aim of this survey was to quantify the level of handicap experienced by patients with severe psoriasis, and to assess the value that patients place on their disease using various questionnaire techniques. Dermatologists throughout the U.K. each gave a questionnaire to up to five psoriasis patients, who were either being admitted for in-patient care or were starting systemic therapy. Three hundred and sixty-nine questionnaires were completed. Of the 150 patients currently working, 59.3% had lost a mean of 26 days (SD 21.9) from work during the preceding year because of their psoriasis, and of the 180 not working 33.9% attributed not working to their psoriasis. The mean Psoriasis Disability Index (PDI) score was 38.2% (SD 23.3, n = 248), with the mean sub-scores of the 'daily activities' and 'treatment' sections being greater than those of the other three sections. Despite having severe psoriasis, the majority of patients felt that it would be worse to have diabetes, asthma or bronchitis than to have psoriasis. Forty-six, 42 and 32% considered it would be either 'better' or 'the same' to have diabetes, asthma or bronchitis, respectively. However, in those patients who also had the comparative disease, 87, 80 and 77% considered it would be 'better', or 'the same' to have the comparative disease. Forty-nine per cent of patients (n = 362) stated they would be prepared to spend 2 or 3 h each day on treatment if this might result in normal skin for the rest of the day.(ABSTRACT TRUNCATED AT 250 WORDS)British Journal of Dermatology 03/1995; 132(2):236-44. · 3.76 Impact Factor
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ABSTRACT: The purpose of this study was: (i) to examine the impact of the clinical severity, anatomical location and treatment of psoriasis on patients' quality of life, and (ii) to investigate the effects of perceptions of psoriasis-related stress on patients' physical and mental health and on areas of disability in everyday life. All patients (n = 204) attending a psoriasis specialty clinic were invited to complete a multidimensional quality of life assessment comprising the Psoriasis Disability Index (PDI), the SF-36 Health Survey and the Psoriasis Life Stress Inventory (PLSI). Results (n = 150) indicated that overall clinical severity of psoriasis as assessed by the Psoriasis Area and Severity Index, and duration of psoriasis, were unrelated to impairment in any areas of quality of life. Anatomical location (social visibility) of psoriasis was associated with self-report of poor physical health (P = 0.01), and there was a modest association with patients' mental health (P = 0.04); however, anatomical location of psoriasis was not significantly associated with self-reported disability in everyday life, or stress scores. Patients who were classified as more reactive to the stress associated with psoriasis (78% of the sample) were functioning less well in terms of their mental health (P = 0.001) and also experienced significantly more disability in all areas of everyday life (P = 0.001). Differences in method of treatment for psoriasis did not significantly affect scores on the psoriasis-specific (PDI; PLSI) or generic (SF-36) quality of life measures. A multiple regression analysis demonstrated that stress resulting from anticipating other people's reactions to their psoriasis contributed more to the variance in patients' disability in everyday life than any other medical or health status variable. The results support the importance of assessing the effects of stress in patients' adjustment to their condition and may indicate a role for adjunctive psychological stress management training for a significant number of patients with psoriasis.British Journal of Dermatology 12/1997; 137(5):755-60. · 3.76 Impact Factor