Exploring the use of adalimumab for patients with moderate Crohn's disease: Subanalyses from induction and maintenance trials

Sandborn, William J.; Colombel, Jean–Frédéric; Panés, Julián; Castillo, Majin; Robinson, Anne; Zhou, Qian; Yang, Mei; Thakkar, Roopal

doi:10.1016/j.crohns.2013.02.016

Cited by 11 publications

(6 citation statements)

References 33 publications

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“…64 Patients with moderate Crohn’s disease and high C-reactive protein receiving placebo had disease activity and number of hospitalizations similar to patients with severe Crohn’s disease receiving placebo 60. This study suggests that there may be a role for obtaining C-reactive protein levels in patients with moderate Crohn’s disease because this patient population has the highest benefit from treatment with adalimumab and are at great risk for disease progression 60…”

Section: Resultsmentioning

confidence: 76%

Adalimumab treatment in Crohn's disease: an overview of long-term efficacy and safety in light of the EXTEND trial

Asgharpour¹,

Cheng²,

Bickston

2013

CEG

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The advent of anti-tumor necrosis factor (TNF) therapies revolutionized the treatment of inflammatory bowel disease. Adalimumab is a subcutaneous anti-TNF agent indicated for use in patients with moderate-to-severe Crohn’s disease and those with moderate-to-severe ulcerative colitis. In both diseases, it can be used for both induction of remission and for maintenance of remission. This review focuses on its use in Crohn’s disease as described in the EXTEND (Extend the Safety and Efficacy of Adalimumab through Endoscopic Healing) trial. Several clinical trials using traditional instruments to measure clinical response have had endoscopic substudies looking for endoscopic healing. The EXTEND trial is the first to use mucosal healing on endoscopy as a primary endpoint for patients with moderate-to-severe Crohn’s disease and baseline ulcerative disease treated with continuous adalimumab. In this well designed trial, the primary endpoint was narrowly missed, but the secondary endpoints further the notion that mucosal healing should be a more mainstream measure of drug efficacy. How this will translate from clinical trials to the clinic is not yet clear, but identifying noninvasive markers for mucosal healing, and understanding the implications of mucosal healing for safety, resource utilization, and quality of life are all worthy targets for further study. The aim of this review is to understand the role of mucosal healing, safety profile, and efficacy in patients treated with anti-TNF therapy, with particular attention to adalimumab and the EXTEND trial.

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Section: Resultsmentioning

confidence: 76%

Adalimumab treatment in Crohn's disease: an overview of long-term efficacy and safety in light of the EXTEND trial

Asgharpour¹,

Cheng²,

Bickston

2013

CEG

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“…Subgroup analyses from prospective, randomised, controlled trials in patients with active CD indicate that various patient disease characteristics and demographics can affect clinical outcomes . In particular, patients with a shorter duration of CD achieve greater clinical benefit compared with patients with longer disease duration, and treatment with biologics and/or immunosuppressive drugs early in duration of CD leads to higher steroid‐free clinical remission rates .…”

Section: Introductionmentioning

confidence: 99%

“…In particular, patients with a shorter duration of CD achieve greater clinical benefit compared with patients with longer disease duration, and treatment with biologics and/or immunosuppressive drugs early in duration of CD leads to higher steroid‐free clinical remission rates . Similarly, greater CD activity at baseline may negatively influence the efficacy of established therapy …”

Section: Introductionmentioning

confidence: 99%

Impact of patient characteristics on the clinical efficacy of mongersen (GED‐0301), an oral Smad7 antisense oligonucleotide, in active Crohn's disease

Monteleone

Sabatino

Ardizzone

et al. 2016

Aliment Pharmacol Ther

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SummaryBackgroundIn a phase 2 study, mongersen, an oral antisense oligonucleotide targeting Smad7, was effective in inducing clinical remission in approximately 60% of patients with active Crohn's disease (CD).AimIn a post hoc analysis to evaluate those patient disease characteristics that may have influenced the efficacy and safety of mongersen therapy.MethodsPatients with steroid‐dependent/resistant, active CD were randomised to mongersen 10, 40 or 160 mg/day or placebo for 2 weeks; patients were followed for 10 weeks. Clinical remission [Crohn's Disease Activity Index (CDAI) score <150] and clinical response (CDAI score reduction ≥100 points) were assessed at weeks 2, 4 and 12 for these subgroups: disease duration <5/≥5 years, human serum C‐reactive protein (hsCRP) <3/≥3 mg/L, and CDAI at baseline ≤260/>260. Additional patient baseline and disease characteristics were explored.ResultsClinical remission and response rates were significantly higher in patients receiving mongersen 40 and 160 mg/day but not 10 mg/day vs. placebo and independent of disease duration and hsCRP. Patients with baseline CDAI ≤260 had significantly higher remission rates with 40 and 160 mg/day. In patients with baseline CDAI >260, remission rates were statistically greater with 160 mg/day and numerically better with 40 mg/day vs. placebo. Adverse event rates were similar across treatment groups. Mongersen was safe and well tolerated.ConclusionsPatients with higher CDAI scores achieved clinical remission most frequently with the highest mongersen dose. Disease duration and baseline human serum C‐reactive protein did not appear to significantly impact efficacy of mongersen in this study (EudraCT Number: 2011‐002640‐27.)

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“…This has been observed to occur with prevalence rates between 6.4% and 16% in inflammatory bowel disease (IBD) patients [ 5 , 12 , 31 , 82 ] although the rates have not been ascertained in uveitis patients. Antibodies to TNFi have also been observed following treatment with humanised agents, adalimumab (3.8% of treated patients) and certolizumab pegol (12% of treated patients) in IBD and rheumatoid arthritis [ 83 , 84 ]. Significant adverse events may also necessitate discontinuation of treatment, such as drug-induced lupus-like reaction with infliximab [ 22 , 89 ] or reactivation of latent tuberculosis (TB) [ 47 ].…”

Section: Beyond Anti-tnfα Agentsmentioning

confidence: 99%

A Review of the Landscape of Targeted Immunomodulatory Therapies for Non-Infectious Uveitis

Sharma

2017

Ophthalmol Ther

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Systemic immunomodulatory therapies are the principal means of managing non-infectious uveitis. This review aims to explore the current landscape of systemic uveitis treatments, including biologic therapies and the advent of biosimilar therapies.Electronic supplementary materialThe online version of this article (10.1007/s40123-017-0115-5) contains supplementary material, which is available to authorized users.

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Exploring the use of adalimumab for patients with moderate Crohn's disease: Subanalyses from induction and maintenance trials

Abstract: This analysis suggests that moderate CD patients can be treated effectively with adalimumab, and supports using CRP to identify moderate CD patients at greatest risk of disease progression.

Cited by 11 publications

References 33 publications

Adalimumab treatment in Crohn's disease: an overview of long-term efficacy and safety in light of the EXTEND trial

Adalimumab treatment in Crohn's disease: an overview of long-term efficacy and safety in light of the EXTEND trial

Impact of patient characteristics on the clinical efficacy of mongersen (GED‐0301), an oral Smad7 antisense oligonucleotide, in active Crohn's disease

A Review of the Landscape of Targeted Immunomodulatory Therapies for Non-Infectious Uveitis

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Exploring the use of adalimumab for patients with moderate Crohn's disease: Subanalyses from induction and maintenance trials

Abstract: This analysis suggests that moderate CD patients can be treated effectively with adalimumab, and supports using CRP to identify moderate CD patients at greatest risk of disease progression.

Cited by 11 publications

References 33 publications

Adalimumab treatment in Crohn&#39;s disease: an overview of long-term efficacy and safety in light of the EXTEND trial

Adalimumab treatment in Crohn&#39;s disease: an overview of long-term efficacy and safety in light of the EXTEND trial

Impact of patient characteristics on the clinical efficacy of mongersen (GED‐0301), an oral Smad7 antisense oligonucleotide, in active Crohn's disease

A Review of the Landscape of Targeted Immunomodulatory Therapies for Non-Infectious Uveitis

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Adalimumab treatment in Crohn's disease: an overview of long-term efficacy and safety in light of the EXTEND trial

Adalimumab treatment in Crohn's disease: an overview of long-term efficacy and safety in light of the EXTEND trial