التفاصيل البيبلوغرافية
| العنوان: |
Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. |
| المؤلفون: |
Chaudhari U (AUTHOR), Romano P (AUTHOR), Mulcahy LD (AUTHOR), Dooley LT (AUTHOR), Baker DG (AUTHOR), Gottlieb AB (AUTHOR), Chaudhari, U1 (AUTHOR), Romano, P (AUTHOR), Mulcahy, L D (AUTHOR), Dooley, L T (AUTHOR), Baker, D G (AUTHOR), Gottlieb, A B (AUTHOR) |
| المصدر: |
Lancet. 6/9/2001, Vol. 357 Issue 9271, p1842-1847. 6p. |
| مستخلص: |
Background: Currently available treatments for moderate to severe psoriasis are either incompletely effective in some patients, or are associated with toxic effects. Since tumour necrosis factor alpha (TNF-alpha) is thought to have a role in the pathogenesis of psoriasis, we did a double-blind, randomised trial to assess the clinical benefit and safety of infliximab-a monoclonal antibody against TNF-alpha.Methods: 33 patients with moderate to severe plaque psoriasis were randomly assigned intravenous placebo (n=11), infliximab 5 mg/kg (n=11), or infliximab 10 mg/kg (n=11) at weeks 0, 2, and 6. Patients were assessed at week 10 for the primary endpoint (score on the physician's global assessment [PGA]). Analysis was by intention to treat.Findings: Of the 33 patients enrolled, three dropped out. Nine of 11 (82%) patients in the infliximab 5 mg/kg group were responders (good, excellent, or clear rating on PGA), compared with two of 11 (18%) in the placebo group (difference 64% [95% CI 20-89], p=0.0089), and ten of 11 (91%) patients in the infliximab 10 mg/kg group were responders (difference from placebo 73% [30-94], p=0.0019). The median time to response was 4 weeks for patients in both infliximab groups. There were no serious adverse events, and infliximab was well tolerated.Interpretation: In this controlled trial, patients receiving the anti-TNF-alpha agent infliximab as monotherapy experienced a high degree of clinical benefit and rapid time to response in the treatment of moderate to severe plaque psoriasis compared with patients who received placebo. These findings suggest that TNF-alpha has a pivotal role in the pathogenesis of psoriasis. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
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