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• W2044191583 abstract "We read with interest the paper published in the February 2006 issue in which Hanauer et al1Hanauer S.B. Sandborn W.J. Rutgeerts P. Fedorak R.N. Lukas M. Macintosh D. Panaccione R. Wolf D. Pollack P. Human anti-tumor necrosis factor monoclonal antibody (Adalimumab) in Crohn’s disease the CLASSIC-I Trial.Gastroenterology. 2006; 130: 323-333Abstract Full Text Full Text PDF PubMed Scopus (1414) Google Scholar show that human anti-tumor necrosis factor monoclonal antibody (Adalimumab) is effective in inducing remission of moderate-severe Crohn’s disease (CD) in comparison with placebo (remission rate at week 4: 18% in 40/20 mg group, 24% in 80/40 mg group, 36% in 160/80 mg group, and 12% in the placebo group). We would like to raise ethical concern about this trial.In Table 1, the authors show the characteristics of the patients enrolled in the trial. In the placebo group, 34% of patients took any corticosteroid, 30% took any immunosuppressive agent, and 7% took antibiotics; therefore, there was a group of patients (29%) who were treated only with 5-ASA despite a moderate and severe disease. Our question is, if it is ethical to include these patients in such a trial? The use of placebo controls raises ethical concern when an evidence-based treatment is available. A fundamental principle of randomized control trials is that patients cannot be assigned only to placebo when standard alternative effective therapy exists.2Pocock S. Clinical trials. Wiley and Sons, New York1983Google Scholar In the case of Crohn’s disease3Winship D.H. Summers R.W. Singleton J.W. Best W.R. Becktel J.M. Lenk L.F. Kern Jr, F. National Cooperative Crohn’s Disease Study study design and conduct of the study.Gastroenterology. 1979; 77: 829-842PubMed Scopus (128) Google Scholar in 1979, it was clearly shown that steroids are the best effective treatment in the moderate-severe disease. As a consequence of this achievement, we believe that when it is necessary to evaluate a new treatment in CD patients, the comparison should be done with the best available treatment. In the case of the trial of Hanauer et al, we retain that 29% of patients taking placebo did not receive the best treatment, and therefore they couldn’t be included in this trial. After the evidence of the role of infliximab,4Targan S.R. Hanauer S.B. van Deventer S.J. Mayer L. Present D.H. Braakman T. DeWoody K.L. Schaible T.F. Rutgeerts P.J. Crohn’s Disease cA2 Study GroupA short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease.N Engl J Med. 1997; 337: 1029-1035Crossref PubMed Scopus (3048) Google Scholar, 5Hanauer S.B. Feagan B.G. Lichtenstein G.R. Mayer L.F. Schreiber S. Colombel J.F. Rachmilewitz D. Wolf D.C. Olson A. Bao W. Rutgeerts P. ACCENT I Study GroupMaintenance infliximab for Crohn’s disease the ACCENT I randomised trial.Lancet. 2002; 359: 1541-1549Abstract Full Text Full Text PDF PubMed Scopus (3580) Google Scholar another ethical concern deals with the problem of which drug should be used as comparison when evaluating a new biological therapy in the treatment of patients with moderate-severe CD taking steroids or any immunosuppressive therapy. Is it ethically correct to compare Adalimumab vs placebo in patients taking steroids or any immunosuppressive therapy? In fact, the main question for a clinician dealing with this group of patients is whether there is any drug more effective than infliximab, or as effective as infliximab, but with less side effects or lower costs. In conclusion, in our opinion, all the new trials evaluating biological therapies in moderate-severe CD should be carried out comparing the new drugs with steroids in naive patients and with infliximab in steroid resistant/dependent patients. We read with interest the paper published in the February 2006 issue in which Hanauer et al1Hanauer S.B. Sandborn W.J. Rutgeerts P. Fedorak R.N. Lukas M. Macintosh D. Panaccione R. Wolf D. Pollack P. Human anti-tumor necrosis factor monoclonal antibody (Adalimumab) in Crohn’s disease the CLASSIC-I Trial.Gastroenterology. 2006; 130: 323-333Abstract Full Text Full Text PDF PubMed Scopus (1414) Google Scholar show that human anti-tumor necrosis factor monoclonal antibody (Adalimumab) is effective in inducing remission of moderate-severe Crohn’s disease (CD) in comparison with placebo (remission rate at week 4: 18% in 40/20 mg group, 24% in 80/40 mg group, 36% in 160/80 mg group, and 12% in the placebo group). We would like to raise ethical concern about this trial. In Table 1, the authors show the characteristics of the patients enrolled in the trial. In the placebo group, 34% of patients took any corticosteroid, 30% took any immunosuppressive agent, and 7% took antibiotics; therefore, there was a group of patients (29%) who were treated only with 5-ASA despite a moderate and severe disease. Our question is, if it is ethical to include these patients in such a trial? The use of placebo controls raises ethical concern when an evidence-based treatment is available. A fundamental principle of randomized control trials is that patients cannot be assigned only to placebo when standard alternative effective therapy exists.2Pocock S. Clinical trials. Wiley and Sons, New York1983Google Scholar In the case of Crohn’s disease3Winship D.H. Summers R.W. Singleton J.W. Best W.R. Becktel J.M. Lenk L.F. Kern Jr, F. National Cooperative Crohn’s Disease Study study design and conduct of the study.Gastroenterology. 1979; 77: 829-842PubMed Scopus (128) Google Scholar in 1979, it was clearly shown that steroids are the best effective treatment in the moderate-severe disease. As a consequence of this achievement, we believe that when it is necessary to evaluate a new treatment in CD patients, the comparison should be done with the best available treatment. In the case of the trial of Hanauer et al, we retain that 29% of patients taking placebo did not receive the best treatment, and therefore they couldn’t be included in this trial. After the evidence of the role of infliximab,4Targan S.R. Hanauer S.B. van Deventer S.J. Mayer L. Present D.H. Braakman T. DeWoody K.L. Schaible T.F. Rutgeerts P.J. Crohn’s Disease cA2 Study GroupA short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease.N Engl J Med. 1997; 337: 1029-1035Crossref PubMed Scopus (3048) Google Scholar, 5Hanauer S.B. Feagan B.G. Lichtenstein G.R. Mayer L.F. Schreiber S. Colombel J.F. Rachmilewitz D. Wolf D.C. Olson A. Bao W. Rutgeerts P. ACCENT I Study GroupMaintenance infliximab for Crohn’s disease the ACCENT I randomised trial.Lancet. 2002; 359: 1541-1549Abstract Full Text Full Text PDF PubMed Scopus (3580) Google Scholar another ethical concern deals with the problem of which drug should be used as comparison when evaluating a new biological therapy in the treatment of patients with moderate-severe CD taking steroids or any immunosuppressive therapy. Is it ethically correct to compare Adalimumab vs placebo in patients taking steroids or any immunosuppressive therapy? In fact, the main question for a clinician dealing with this group of patients is whether there is any drug more effective than infliximab, or as effective as infliximab, but with less side effects or lower costs. In conclusion, in our opinion, all the new trials evaluating biological therapies in moderate-severe CD should be carried out comparing the new drugs with steroids in naive patients and with infliximab in steroid resistant/dependent patients. Human Anti–Tumor Necrosis Factor Monoclonal Antibody (Adalimumab) in Crohn’s Disease: the CLASSIC-I TrialGastroenterologyVol. 130Issue 2PreviewBackground & Aims: Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn’s disease (CD). Adalimumab is a human immunoglobulin G1 (IgG1) monoclonal antibody targeting tumor necrosis factor (TNF). A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of adalimumab induction therapy in patients with CD. Methods: A total of 299 patients with moderate to severe CD naive to anti–TNF therapy were randomized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg or placebo. Full-Text PDF" @default.
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