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Adalimumab for the treatment of Crohn's disease.

Cassinotti A, Ardizzone S, Porro GB - Biologics (2008)

Bottom Line: Adalimumab (ADA) is a subcutaneously administered, recombinant, fully human, IgG1 monoclonal antibody that binds with high affinity and specificity to human TNF-alpha, thus modulating its biologic functions and its proinflammatory effects.To review the available data on ADA in CD for biological properties, efficacy, and safety.ADA appears to be effective in inducing and maintain clinical remission in CD, including patients not manageable with IFX.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Sciences, Chair of Gastroenterology, "Luigi Sacco" University Hospital, Milan, Italy.

ABSTRACT

Introduction: Crohn's disease (CD) is a chronic inflammatory bowel disease characterized by a relapsing-remitting course with trans-mural inflammation of potentially any section of the digestive tract. Adalimumab (ADA) is a subcutaneously administered, recombinant, fully human, IgG1 monoclonal antibody that binds with high affinity and specificity to human TNF-alpha, thus modulating its biologic functions and its proinflammatory effects.

Aims: To review the available data on ADA in CD for biological properties, efficacy, and safety.

Methods: Electronic searches were conducted using the Pubmed and SCOPUS databases from the earliest records to April 2008. The search terms used were "adalimumab", "anti-TNF", "TNF-alpha", "biologicals", "inflammatory bowel disease", and "Crohn's disease". Reference lists of all relevant articles were searched for further studies.

Results: Available studies suggest that ADA has the potential to induce and maintain clinical response and remission in moderate-severe CD, both in anti-TNF-naïve patients and in subjects who lost their response and/or became intolerant to infliximab (IFX). ADA seems also effective in maintaining corticosteroid-free remission and obtaining complete fistula closure (although no specific randomized trials are available). No concomitant immunosuppressors seem to be necessary. Side effects appear similar to IFX, while site-injection reactions are frequent and specific. Data on immunogenicity and its clinical impact are uncertain.

Conclusions: ADA appears to be effective in inducing and maintain clinical remission in CD, including patients not manageable with IFX. Successive clinical practice and further on going trials will confirm a positive role for ADA as a new anti-TNF treatment in CD. The impact on clinical management or on resources should be more studied.

No MeSH data available.


Related in: MedlinePlus

Efficacy of adalimumab (ADA) as a maintenance therapy for Crohn’s disease in the CHARM trial. Derived from Colombel et al (2007). p ≤ 0.001 for pairwise comparisons of each active treatment group vs placebo at all end points.
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f2-btt-2-763: Efficacy of adalimumab (ADA) as a maintenance therapy for Crohn’s disease in the CHARM trial. Derived from Colombel et al (2007). p ≤ 0.001 for pairwise comparisons of each active treatment group vs placebo at all end points.

Mentions: Results at weeks 26 and 56 for randomized responders showed significantly greater remission rates at both time points for patients who received maintenance therapy with ADA 40 mg every other week (40% at week 26; 36% at week 56) or ADA 40 mg weekly (47% at week 26; 41% at week 56) than for patients who received placebo (17% at week 26; 12% at week 56) (p < 0.001 among the 3 groups) (Figure 2). Statistically significant (p < 0.05) differences in remission rates between the ADA and placebo treatment arms were observed by week 6 and were sustained through week 56.


Adalimumab for the treatment of Crohn's disease.

Cassinotti A, Ardizzone S, Porro GB - Biologics (2008)

Efficacy of adalimumab (ADA) as a maintenance therapy for Crohn’s disease in the CHARM trial. Derived from Colombel et al (2007). p ≤ 0.001 for pairwise comparisons of each active treatment group vs placebo at all end points.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2727899&req=5

f2-btt-2-763: Efficacy of adalimumab (ADA) as a maintenance therapy for Crohn’s disease in the CHARM trial. Derived from Colombel et al (2007). p ≤ 0.001 for pairwise comparisons of each active treatment group vs placebo at all end points.
Mentions: Results at weeks 26 and 56 for randomized responders showed significantly greater remission rates at both time points for patients who received maintenance therapy with ADA 40 mg every other week (40% at week 26; 36% at week 56) or ADA 40 mg weekly (47% at week 26; 41% at week 56) than for patients who received placebo (17% at week 26; 12% at week 56) (p < 0.001 among the 3 groups) (Figure 2). Statistically significant (p < 0.05) differences in remission rates between the ADA and placebo treatment arms were observed by week 6 and were sustained through week 56.

Bottom Line: Adalimumab (ADA) is a subcutaneously administered, recombinant, fully human, IgG1 monoclonal antibody that binds with high affinity and specificity to human TNF-alpha, thus modulating its biologic functions and its proinflammatory effects.To review the available data on ADA in CD for biological properties, efficacy, and safety.ADA appears to be effective in inducing and maintain clinical remission in CD, including patients not manageable with IFX.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Sciences, Chair of Gastroenterology, "Luigi Sacco" University Hospital, Milan, Italy.

ABSTRACT

Introduction: Crohn's disease (CD) is a chronic inflammatory bowel disease characterized by a relapsing-remitting course with trans-mural inflammation of potentially any section of the digestive tract. Adalimumab (ADA) is a subcutaneously administered, recombinant, fully human, IgG1 monoclonal antibody that binds with high affinity and specificity to human TNF-alpha, thus modulating its biologic functions and its proinflammatory effects.

Aims: To review the available data on ADA in CD for biological properties, efficacy, and safety.

Methods: Electronic searches were conducted using the Pubmed and SCOPUS databases from the earliest records to April 2008. The search terms used were "adalimumab", "anti-TNF", "TNF-alpha", "biologicals", "inflammatory bowel disease", and "Crohn's disease". Reference lists of all relevant articles were searched for further studies.

Results: Available studies suggest that ADA has the potential to induce and maintain clinical response and remission in moderate-severe CD, both in anti-TNF-naïve patients and in subjects who lost their response and/or became intolerant to infliximab (IFX). ADA seems also effective in maintaining corticosteroid-free remission and obtaining complete fistula closure (although no specific randomized trials are available). No concomitant immunosuppressors seem to be necessary. Side effects appear similar to IFX, while site-injection reactions are frequent and specific. Data on immunogenicity and its clinical impact are uncertain.

Conclusions: ADA appears to be effective in inducing and maintain clinical remission in CD, including patients not manageable with IFX. Successive clinical practice and further on going trials will confirm a positive role for ADA as a new anti-TNF treatment in CD. The impact on clinical management or on resources should be more studied.

No MeSH data available.


Related in: MedlinePlus