Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION)

Saurat, Jean-Hilaire; Stingl, G.; Dubertret, L.; Papp, K.; Langley, R G.; Ortonne, J-P.; Unnebrink, K.; Kaul, M.; Camez, A.

doi:10.1111/j.1365-2133.2007.08315.x

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Title		Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION)
Authors		Saurat, Jean-Hilaire Stingl, G. Dubertret, L. Papp, K. Langley, R G. Ortonne, J-P. Unnebrink, K. Kaul, M. Camez, A. show all authors [1 - 9]
Published in		British journal of dermatology. 2008, vol. 158, no. 3, p. 558-66
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.
Keywords		Adult — Anti-Inflammatory Agents/administration & dosage/adverse effects — Antibodies Monoclonal — Antirheumatic Agents/administration & dosage/adverse effects — Dose-Response Relationship Drug — Double-Blind Method — Female — Humans — Male — Methotrexate/administration & dosage/adverse effects — Psoriasis/drug therapy — Quality of Life/psychology — Treatment Outcome
Identifiers		DOI: 10.1111/j.1365-2133.2007.08315.x PMID: 18047523
Full text		Article (Accepted version) (277 Kb) - Limited access to UNIGE
Structures		Faculté de médecine / Section de médecine clinique / Département des neurosciences cliniques
Research groups		CHAMPION Study Investigators La recherche en biochimie dermatologique (652) Rôle du CD44 (809)
Citation (ISO format)		SAURAT, Jean-Hilaire et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). In: British journal of dermatology, 2008, vol. 158, n° 3, p. 558-66. doi: 10.1111/j.1365-2133.2007.08315.x https://archive-ouverte.unige.ch/unige:680