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
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.
