Benefit-risk analysis of adalimumab versus methotrexate and placebo in the treatment of moderate to severe psoriasis: Comparison of adverse event-free response days in the CHAMPION trial

Journal of the American Academy of Dermatology

Volumn 63, Issue 6, 2010, Pages 1011-1018

  Reich, Kristian ^a   Signorovitch, James ^b   Ramakrishnan, Karthik ^b   Yu, Andrew P ^b   Wu, Eric Q ^b   Gupta, Shiraz R ^c   Bao, Yanjun ^c   Mulani, Parvez M ^c  

^a DERMATOLOGIKUM HAMBURG   (Germany)

^b ANALYSIS GROUP   (United States)

^c ABBOTT LABORATORIES   (United States)

Author keywords

Adalimumab; Adverse events; Benefit risk analysis; Global benefit risk; Health related quality of life; Methotrexate; Psoriasis

Indexed keywords

ADALIMUMAB; FOLIC ACID; METHOTREXATE; PLACEBO;

ADULT; ARTICLE; BODY SURFACE; CLINICAL ASSESSMENT; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; EVENT FREE SURVIVAL; FEMALE; FOLLOW UP; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; IMMUNOTHERAPY; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PSORIASIS; PSORIASIS SEVERITY INDEX; RACE; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; TREATMENT DURATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ADULT; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; METHOTREXATE; MIDDLE AGED; PLACEBOS; PSORIASIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 78650266922     PISSN: 01909622     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jaad.2009.12.029     Document Type: Article

References (22)

1. L. Naldi, and C.E. Griffiths Traditional therapies in the management of moderate-to-severe chronic plaque psoriasis: an assessment of the benefits and risks Br J Dermatol 152 2005 597 615
2. K.B. Gordon, R.G. Langley, C. Leonardi, D. Toth, M.A. Menter, and S. Kang Clinical response to adalimumab treatment in patients with moderate-to-severe psoriasis: double-blind, randomized controlled trial and open-label extension study J Am Acad Dermatol 55 2006 598 606
3. National Psoriasis Foundation. Statistics. Available from: URL: http://www.psoriasis.org/about/stats/. Accessed June 9, 2009.
4. M.J. Bhosle, S.R. Feldman, F.T. Camacho, J. Timothy Whitmire, M.C. Nahata, and R. Balkrishnan Medication adherence and health care costs associated with biologics in Medicaid-enrolled patients with psoriasis J Dermatolog Treat 17 2006 294 301
5. D. Revicki, M.K. Willian, J.H. Saurat, K.A. Papp, J.P. Ortonne, and C. Sexton Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate-to-severe plaque psoriasis Br J Dermatol 158 2008 549 557
6. S.R. Rapp, S.R. Feldman, M.L. Exum, A.B. Fleischer Jr., and D.M. Reboussin Psoriasis causes as much disability as other major medical diseases J Am Acad Dermatol 41 1999 401 407
7. A.B. Kimball, C. Jacobson, S. Weiss, M.G. Vreeland, and Y. Wu The psychosocial burden of psoriasis Am J Clin Dermatol 6 2005 383 392
8. M.A. Lebwohl clinician's paradigm in the treatment of psoriasis J Am Acad Dermatol 53 Suppl 2005 S59 S69
9. D. Thai Long-term data in the treatment of psoriasis Br J Dermatol 159 2008 18 24
10. S.L. McClure, J. Valentine, and K.B. Gordon Comparative tolerability of systemic treatments for plaque-type psoriasis Drug Saf 25 2002 913 927
11. R. Saini, W.D. Tutrone, and J.M. Weinberg Advances in therapy for psoriasis: an overview of infliximab, etanercept, efalizumab, alefacept, adalimumab, tazarotene, and pimecrolimus Curr Pharm Des 11 2005 273 280
12. J.H. Saurat, G. Stingl, L. Dubertret, K. Papp, R.G. Langley, and J.P. Ortonne CHAMPION Study Investigators. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs methotrexate vs placebo in patients with psoriasis (CHAMPION) Br J Dermatol 158 2008 558 566
13. Humira [package insert] 2008 Abbott Laboratories Chicago, IL
14. K.A. Papp, and E. Henninger Safe psoriasis control: a new outcome measure for the composite assessment of the efficacy and safety of psoriasis treatment J Cutan Med Surg 9 2005 276 283
15. M. Schulzer, and G.B.J. Mancini 'Unqualified success' and 'unmitigated failure': number-needed-to-treat-related concepts for assessing treatment efficacy in the presence of treatment-induced adverse events Int J Epidemiol 25 1996 704 712
16. P.S. Yamauchi, D. Rizk, and T. Kormeili Current systemic therapies for psoriasis: where are we now? J Am Acad Dermatol 49 Suppl 2003 S66 S77
17. Y.L. Pritchett, and R. Tamura Global benefit-risk assessment in designing clinical trials and some statistical considerations of the method Pharm Stat 7 2008 170 178
18. R. Entsuah, and J.M. Gorman Global benefit-risk assessment of antidepressants: venlafaxine XR and fluoxetine J Psychiatr Res 36 2002 111 118
19. M. Osiri, M.E. Saurez-Almazor, G.A. Wells, V. Robinson, and P. Tugwell Number needed to treat (NNT): implication in rheumatology clinical practice Ann Rheum Dis 62 2003 316 321
20. V.M. Heydendael, P.I. Spuls, B.C. Opmeer, C.A. de Borgie, J.B. Reitsma, and W.F. Goldschmidt Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis N Engl J Med 349 2003 658 665
21. J.P. Vandenbroucke, and B.M. Psaty Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects JAMA 300 2008 2417 2419
22. National Psoriasis Foundation. Methotrexate. Available from: URL: http://www.psoriasis.org/treatment/psoriasis/systemics/methotrexate.php. Accessed June 9, 2009.