Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION) - PubMed (original) (raw)
Randomized Controlled Trial
. 2008 Mar;158(3):558-66.
doi: 10.1111/j.1365-2133.2007.08315.x. Epub 2007 Nov 28.
Collaborators, Affiliations
- PMID: 18047523
- DOI: 10.1111/j.1365-2133.2007.08315.x
Randomized Controlled Trial
Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION)
J-H Saurat et al. Br J Dermatol. 2008 Mar.
Abstract
Background: Biologic therapies such as adalimumab, a tumour necrosis factor antagonist, are safe and effective in the treatment of moderate to severe chronic plaque psoriasis.
Objectives: To compare a biologic agent with methotrexate, a traditional systemic agent, to define clearly the role of biologics in psoriasis.
Methods: Patients with moderate to severe plaque psoriasis were randomized to adalimumab (80 mg subcutaneously at week 0, then 40 mg every other week, n=108), methotrexate (7.5 mg orally, increased as needed and as tolerated to 25 mg weekly; n=110) or placebo (n=53) for 16 weeks. The primary efficacy endpoint was the proportion of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) after 16 weeks. Safety was assessed at all visits through week 16.
Results: After 16 weeks, 79.6% of adalimumab-treated patients achieved PASI 75, compared with 35.5% for methotrexate (P<0.001 vs. adalimumab) and 18.9% for placebo (P<0.001 vs. adalimumab). Statistically significantly more adalimumab-treated patients (16.7%) than methotrexate-treated patients (7.3%) or placebo-treated patients (1.9%) achieved complete clearance of disease. The response to adalimumab was rapid, with a 57% improvement in mean PASI observed at week 4. Adverse events were similar across treatment groups. Adverse events leading to study discontinuation were greatest in the methotrexate group, primarily because of hepatic-related adverse events.
Conclusions: After 16 weeks, adalimumab demonstrated significantly superior efficacy and more rapid improvements in psoriasis compared with either methotrexate or placebo.
Comment in
- Adalimumab: a new alternative biologic agent for chronic plaque psoriasis.
Ormerod AD. Ormerod AD. Br J Dermatol. 2008 Mar;158(3):435-6. doi: 10.1111/j.1365-2133.2008.08440.x. Br J Dermatol. 2008. PMID: 18275521 No abstract available. - Adalimumab vs methotrexate for the treatment of chronic plaque psoriasis.
Batchelor JM, Ingram JR, Williams H. Batchelor JM, et al. Arch Dermatol. 2009 Jun;145(6):704-6; discussion 706. doi: 10.1001/archdermatol.2009.104. Arch Dermatol. 2009. PMID: 19528428 No abstract available.
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