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

Authors

  • J.-H. Saurat,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • G. Stingl,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • L. Dubertret,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • K. Papp,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • R.G. Langley,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • J.-P. Ortonne,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • K. Unnebrink,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • M. Kaul,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • A. Camez,

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • for the CHAMPION Study Investigators

    1. Service de Dermatologie, Hôpital Cantonal Universitaire, 24 Rue Micheli-du-Crest, Geneva 1211, Switzerland
      *Universitätsklinik für Dermatologie, Vienna, Austria
      †Hôpital Saint Louis, Paris, France
      ‡Probity Medical Research, Waterloo, ON, Canada
      §Dalhousie University, Halifax, NS, Canada
      ¶Hôpital L’Archet 2, Nice, France
      **Abbott GmbH & Co. KG, Ludwigshafen, Germany
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  • Conflicts of interest
    J.-H.S., G.S., L.D., K.P. and J.-P.O. have served as consultants for Abbott Laboratories. In addition, they have participated in continuing medical education events supported by unrestricted educational grants from Abbott. R.G.L. reports receiving fees as a consultant or advisory board member for Abbott, Amgen, Astellas, Boehringer-Ingelheim, Barrier Therapeutics and Genentech; he has received lecture fees from Abbott, Amgen/Wyeth and Biogen-Idec, and has been the principal investigator and received grants from Abbott, Amgen, Astellas, Centocor, Galderma and Genentech. K.U., M.K. and A.C. are employees of Abbott.

  • CHAMPION Study Investigators are listed at the end of the report.

Jean-Hilaire Saurat.
E-mail: Jean.Saurat@medecine.unige.ch

Summary

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, = 108), methotrexate (7·5 mg orally, increased as needed and as tolerated to 25 mg weekly; = 110) or placebo (= 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 (< 0·001 vs. adalimumab) and 18·9% for placebo (< 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.

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