Human Anti–Tumor Necrosis Factor Monoclonal Antibody (Adalimumab) in Crohn’s Disease: the CLASSIC-I Trial

Hanauer, Stephen B.; Sandborn, William J.; Rutgeerts, Paul; Fedorak, Richard N.; Lukáš, Milan; MacIntosh, Donald; Panaccione, Remo; Wolf, Douglas C.; Pollack, Paul

doi:10.1053/j.gastro.2005.11.030

Cited by 1,492 publications

(1,077 citation statements)

References 29 publications

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“…ADA consists of human-derived heavy and light chain variable regions and a human IgG1 constant region: it binds specifically to TNF␣ and blocks its interaction with the p55 and p75 cell surface TNF receptors [11]. ADA has been shown to be effective and safe for inducing and maintaining remission in patients with moderate to severe Crohn's disease (CD), either naïve to anti-TNF␣ or with previous loss of response or intolerance to infliximab [9,[12][13][14][15]. Open-label and retrospective studies have shown that ADA can be an effective therapeutic option for inducing and maintaining remission in patients with active UC refractory or who are intolerant to standard therapy [16][17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

Adalimumab in active ulcerative colitis: A “real-life” observational study

Armuzzi¹,

Biancone²,

Daperno³

et al. 2013

Digestive and Liver Disease

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a b s t r a c tBackground and aims: The effectiveness of adalimumab in the treatment of ulcerative colitis is under debate. Although controlled trials have shown that adalimumab is significantly better than placebo, the absolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort of ulcerative colitis patients treated in 22 Italian centres. Methods: All patients with active disease treated with adalimumab were retrospectively reviewed. Coprimary endpoints were clinical remission at weeks 4, 12, 24 and 54. Secondary endpoints were sustained clinical remission, steroid discontinuation, endoscopic remission and need for colectomy. Results: Eighty-eight patients were included. Most patients had received previous infliximab treatment. Clinical remission rates were 17%, 28.4%, 36.4% and 43.2% at 4, 12, 24 and 54 weeks respectively. Twentytwo patients required colectomy. Clinical remission and low C-reactive protein at week 12 predicted clinical remission at week 54 (OR 4.17, 95% CI 2.36-19.44; OR 2.63, 95% CI 2.32-14.94, respectively). Previous immunosuppressant use was associated with a lower probability of clinical remission at week 54 (OR 0.67, and with a higher rate of colectomy (HR 9.7, 95% CI 1.46-9.07). Conclusion: In this large "real-life" experience adalimumab appears effective in patients with otherwise medically refractory ulcerative colitis. Patients achieving early remission can expect a better long-term outcome.

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Section: Introductionmentioning

confidence: 99%

Adalimumab in active ulcerative colitis: A “real-life” observational study

Armuzzi¹,

Biancone²,

Daperno³

et al. 2013

Digestive and Liver Disease

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“…Since the first double-blind, placebo-controlled trial with Infliximab (IFX) 2 numerous pivotal trials on the efficacy of IFX, Adalimumab (ADA) and Certzolizumab pegol (CTZ) in inducing and maintaining clinical response and remission and achieving mucosal healing have been published [2][3][4][5][6][7] .…”

Section: Introductionmentioning

confidence: 99%

Addressing current treatment challenges in Crohn's disease in real life: A physician's survey

Vavricka

Radivojevic²,

Manser³

et al. 2014

Digestive and Liver Disease

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BACKGROUND: In recent years several trials have addressed treatment challenges in Crohn's disease. Clinical trials however, represent a very special situation. AIMS: To perform a cross-sectional survey among gastroenterologists on the current clinical real life therapeutic approach focussing on the use of biologics. METHODS: A survey including six main questions on clinical management of loss of response, diagnostic evaluation prior to major treatment changes, preference for anti-tumour necrosis factor (TNF) agent, (de-)escalation strategies as well as a basic section regarding personal information was sent by mail to all gastroenterologists in Switzerland (n=318). RESULTS: In total, 120 questionnaires were analysed (response rate 37.7%). 90% of gastroenterologists in Switzerland use a thiopurine as the first step-up strategy (anti-TNF alone 7.5%, combination 2.5%). To address loss of response, most physicians prefer shortening the interval of anti-TNF administration followed by dose increase, switching the biologic and adding a thiopurine. In case of prolonged remission on combination therapy, the thiopurine is stopped first (52.6%) after a mean treatment duration of 15.7 months (biologic first in 41.4%). CONCLUSIONS: Everyday clinical practice in Crohn's disease patients appears to be incongruent with clinical data derived from major trials. Studies investigating reasons underlying these discrepancies are of need to optimize and harmonize treatment.

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“…These rates are higher than those in randomized, double-blind placebo-controlled studies. Within 4 weeks, the remission rates in the CLASSIC I and GAIN trials for ADA-treated patients at a dose of 160/80 mg were 36% and 21%, respectively (10,21) . In the CHARM trial, which lasted 1 year, remission occurred in 36% of the sample (5) .…”

Section: Discussionmentioning

confidence: 99%

“…It is a recombinant monoclonal human antibody of immunoglobulin G1 that is subcutaneously administered with high affinity and specificity to TNF-α (5) . The clinical efficacy and safety of ADA in CD have been demonstrated in various clinical multi-center, randomized, double-blind, placebo-controlled trials, with distinction to CLASSIC I and II, CHARM and GAIN (5,10,20,21) , as well as in real life case series (24) .…”

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confidence: 99%

ADALIMUMAB FOR MAINTENANCE THERAPY FOR ONE YEAR IN CROHN’S DISEASE: results of a Latin American single-center observational study

Kotze¹,

Abou-Rejaile²,

Uiema³

et al. 2014

Arq. Gastroenterol.

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Context Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohn’s disease patients are scarce. Objectives The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn’s disease patients. Methods Retrospective, single-center, observational study of a Brazilian case series of Crohn’s disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (P<0.05). Results Fifty patients, with median age of 35 years at therapy initiation, were included. Remission rates after 12 months of therapy were 54% under non-responder-imputation and 88% under last-observation-carried-forward analysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033). Conclusions Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.

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Human Anti–Tumor Necrosis Factor Monoclonal Antibody (Adalimumab) in Crohn’s Disease: the CLASSIC-I Trial

Cited by 1,492 publications

References 29 publications

Adalimumab in active ulcerative colitis: A “real-life” observational study

Adalimumab in active ulcerative colitis: A “real-life” observational study

Addressing current treatment challenges in Crohn's disease in real life: A physician's survey

ADALIMUMAB FOR MAINTENANCE THERAPY FOR ONE YEAR IN CROHN’S DISEASE: results of a Latin American single-center observational study

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