Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression ass...Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with ClinicalTrials.gov with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p< 0.0001; difference 42% , 95% CI 36- 48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5.0 vs 1.9; p< 0.0001, difference 3.0, 95% CI 1.6- 4.5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.展开更多
Background: Tumour necrosis factor α(TNFα) is thought to play a part in the pathogenesis of psoriasis. We assessed the efficacy and safety of continuous treatment with infliximab, a monoclonal antibody that binds to...Background: Tumour necrosis factor α(TNFα) is thought to play a part in the pathogenesis of psoriasis. We assessed the efficacy and safety of continuous treatment with infliximab, a monoclonal antibody that binds to and neutralises the activity of TNFα, in patients with psoriasis. Methods: In this phase III, multi centre, double-blind Rial , 378 patients with moderate-to-severe plaque psori asis were allocated in a 4:1 ratio to receive infusions of either infliximab 5 m g/kg or placebo at weeks 0, 2, and 6, then every 8 weeks to week 46. At week 24, placebo treated patients crossed over to infliximab treatment. Skin and nail signs of psoriasis were assessed using the psoriasis area and severity index (PASI ) and nail psoriasis severity index (NAPSI), respectively. The primary endpoint, analysed on an intention-to-treat-basis, was the proportion of patients achi eving at least a 75%improvement in PASI from baseline to week 10. Findings: At week 10, 80%(242/301) of patients treated with infliximab achieved at least a 7 5%improvement from their baseline PASI (PASI 75) and 57%(172/301) achieved at least a 90%improvement (PASI 90), compared with 3%and 1%in the placebo group, respectively (p< 00001). At week 24, PASI 75 (82%for infliximab vs 4%for pl acebo) and PASI 90 (58%vs 1%) were maintained (p< 00001). At week 50, 61%ac hieved PASI 75 and 45%achieved PASI 90 in the infliximab group. Infliximab was generally well tolerated in most patients. Interpretation: Infliximab is effecti ve in both an induction and maintenance regimen for the treatment of moderate-t o-severe psoriasis, with ahigh percentage of patients achieving sustained PASI 75 and PASI 90 improvement through 1 year.展开更多
Background: Use of current oral calcineurin inhibitors for the treatment of psoriasis is limited by toxicity. Objective: Evaluate the safety and efficacy of ISA247, a new oral calcineurin inhibitor, in plaque psoriasi...Background: Use of current oral calcineurin inhibitors for the treatment of psoriasis is limited by toxicity. Objective: Evaluate the safety and efficacy of ISA247, a new oral calcineurin inhibitor, in plaque psoriasis patients. Methods: This 12-week, randomized, double-blind, placebo-controlled, parallel-group study included 201 plaque psoriasis patients with ≥ 10% body surface area involvement. Patients were randomized to placebo, ISA247 0.5 mg/kg/d, and ISA247 1.5 mg/kg/d groups. End points included a 2-point reduction in the Static Global Assessment score and a 75% reduction in the Psoriasis Area and Severity Index. Results: A 2-point SGA reduction was achieved in 0% (placebo), 15.6% (0.5 mg/kg/d), and 45.1% (1.5 mg/kg/d) (P < .0001). A 75% reduction in the Psoriasis Area and Severity Index was achieved in 0% (placebo), 18.2% (0.5 mg/kg/d), and 66.7% (1.5 mg/kg/day) (P < .0001). While serum creatinine increased in patients treated with ISA247 1.5 mg/kg/d, it remained within the normal range. Limitations: Longer-term studies are needed to evaluate the effect of ISA247 on renal function. Conclusion: ISA247 appears safe and effective for treating moderate to severe psoriasis.展开更多
Background. This report investigates the effect of pimecrolimus cream 1%(Elid el., Novartis pharma AG, Basel, Switzerland), a nonsteroid, cell-selective, cyt okine inhibitor on the course of atopic dermatitis (AD), as...Background. This report investigates the effect of pimecrolimus cream 1%(Elid el., Novartis pharma AG, Basel, Switzerland), a nonsteroid, cell-selective, cyt okine inhibitor on the course of atopic dermatitis (AD), as assessed by changes in body surface involvement and pattern of drug use over time. Methods. Data fro m 961 patients in two 1-year double-blind, multicenter, pediatric studies of s imilar design were analyzed:250 infants (aged 3-23 months) were randomized 4: 1 and 711 children (aged 2-17 years) were randomized 2:1 to receive pimecrolim us cream 1%or vehicle, respectively. Emollients were used by all patients to al leviate dry skin and, at the first signs or symptoms of AD, pimecrolimus or vehi cle was applied twice daily to prevent progression to flares. If flares occurred in either group, moderately potent topical corticosteroids were mandated. Resul ts. Pimecrolimus was applied for 68.4%(infants) and 53.8%(children) of study d ays, and frequency of use of pimecrolimus decreased over time, reflecting improv ement in disease control. The mean total body surface area affected decreased co ntinuously over time. Significantly more patients in the pimecrolimus than contr ol groups were maintained without corticosteroid therapy (infants:63.7%vs. 34. 8%, P <.0.001; children:57.4%vs. 31.6%, P < 0.001, respectively). Conclusion . The need for pimecrolimus therapy decreases over time as the patients’disease improves. Hence, once long-term management of AD with pimecrolimus is establis hed, the burden of disease for both the patient and the caregiver decreases sign ificantly and disease-free periods become more frequent.展开更多
文摘Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with ClinicalTrials.gov with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p< 0.0001; difference 42% , 95% CI 36- 48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5.0 vs 1.9; p< 0.0001, difference 3.0, 95% CI 1.6- 4.5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.
文摘Background: Tumour necrosis factor α(TNFα) is thought to play a part in the pathogenesis of psoriasis. We assessed the efficacy and safety of continuous treatment with infliximab, a monoclonal antibody that binds to and neutralises the activity of TNFα, in patients with psoriasis. Methods: In this phase III, multi centre, double-blind Rial , 378 patients with moderate-to-severe plaque psori asis were allocated in a 4:1 ratio to receive infusions of either infliximab 5 m g/kg or placebo at weeks 0, 2, and 6, then every 8 weeks to week 46. At week 24, placebo treated patients crossed over to infliximab treatment. Skin and nail signs of psoriasis were assessed using the psoriasis area and severity index (PASI ) and nail psoriasis severity index (NAPSI), respectively. The primary endpoint, analysed on an intention-to-treat-basis, was the proportion of patients achi eving at least a 75%improvement in PASI from baseline to week 10. Findings: At week 10, 80%(242/301) of patients treated with infliximab achieved at least a 7 5%improvement from their baseline PASI (PASI 75) and 57%(172/301) achieved at least a 90%improvement (PASI 90), compared with 3%and 1%in the placebo group, respectively (p< 00001). At week 24, PASI 75 (82%for infliximab vs 4%for pl acebo) and PASI 90 (58%vs 1%) were maintained (p< 00001). At week 50, 61%ac hieved PASI 75 and 45%achieved PASI 90 in the infliximab group. Infliximab was generally well tolerated in most patients. Interpretation: Infliximab is effecti ve in both an induction and maintenance regimen for the treatment of moderate-t o-severe psoriasis, with ahigh percentage of patients achieving sustained PASI 75 and PASI 90 improvement through 1 year.
文摘Background: Use of current oral calcineurin inhibitors for the treatment of psoriasis is limited by toxicity. Objective: Evaluate the safety and efficacy of ISA247, a new oral calcineurin inhibitor, in plaque psoriasis patients. Methods: This 12-week, randomized, double-blind, placebo-controlled, parallel-group study included 201 plaque psoriasis patients with ≥ 10% body surface area involvement. Patients were randomized to placebo, ISA247 0.5 mg/kg/d, and ISA247 1.5 mg/kg/d groups. End points included a 2-point reduction in the Static Global Assessment score and a 75% reduction in the Psoriasis Area and Severity Index. Results: A 2-point SGA reduction was achieved in 0% (placebo), 15.6% (0.5 mg/kg/d), and 45.1% (1.5 mg/kg/d) (P < .0001). A 75% reduction in the Psoriasis Area and Severity Index was achieved in 0% (placebo), 18.2% (0.5 mg/kg/d), and 66.7% (1.5 mg/kg/day) (P < .0001). While serum creatinine increased in patients treated with ISA247 1.5 mg/kg/d, it remained within the normal range. Limitations: Longer-term studies are needed to evaluate the effect of ISA247 on renal function. Conclusion: ISA247 appears safe and effective for treating moderate to severe psoriasis.
文摘Background. This report investigates the effect of pimecrolimus cream 1%(Elid el., Novartis pharma AG, Basel, Switzerland), a nonsteroid, cell-selective, cyt okine inhibitor on the course of atopic dermatitis (AD), as assessed by changes in body surface involvement and pattern of drug use over time. Methods. Data fro m 961 patients in two 1-year double-blind, multicenter, pediatric studies of s imilar design were analyzed:250 infants (aged 3-23 months) were randomized 4: 1 and 711 children (aged 2-17 years) were randomized 2:1 to receive pimecrolim us cream 1%or vehicle, respectively. Emollients were used by all patients to al leviate dry skin and, at the first signs or symptoms of AD, pimecrolimus or vehi cle was applied twice daily to prevent progression to flares. If flares occurred in either group, moderately potent topical corticosteroids were mandated. Resul ts. Pimecrolimus was applied for 68.4%(infants) and 53.8%(children) of study d ays, and frequency of use of pimecrolimus decreased over time, reflecting improv ement in disease control. The mean total body surface area affected decreased co ntinuously over time. Significantly more patients in the pimecrolimus than contr ol groups were maintained without corticosteroid therapy (infants:63.7%vs. 34. 8%, P <.0.001; children:57.4%vs. 31.6%, P < 0.001, respectively). Conclusion . The need for pimecrolimus therapy decreases over time as the patients’disease improves. Hence, once long-term management of AD with pimecrolimus is establis hed, the burden of disease for both the patient and the caregiver decreases sign ificantly and disease-free periods become more frequent.
