Incidence of inflammatory bowel disease among ixekizumab-treated patients with moderate-to-severe plaque psoriasis and psoriatic arthritis: Data from 8 clinical trials

ObjectivesHere, we present the reported incidence rates of inflammatory bowel disease (IBD) in patients receiving treatment with secukinumab for psoriasis (PsO), psoriatic arthritis (PsA) or ankylosing spondylitis (AS), in a pooled analysis of 21 clinical trials.MethodsData from all patients who had received at least one dose of secukinumab were included. Safety analyses were conducted to evaluate cumulative IBD rates as well as per-year rates, by indication. Crohn’s disease (CD), ulcerative colitis (UC) and IBD unclassified (IBDU) events were analysed using exposure-adjusted incidence rates (patient incidence rates per 100 patient-years (PY)).ResultsA total of 7355 patients with a cumulative exposure of 16 226.9 PY were included in the pooled analysis. Among 5181 patients with PsO, there were 14 cases of UC, 5 cases of CD and 1 case of IBDU, with exposure adjusted incidence rates (EAIRs) of 0.13, 0.05 and 0.01, respectively. Of these 20 cases, 14 were new-onset. In 1380 patients with PsA, there were 3 cases of UC, 3 cases of CD and 2 cases of IBDU (EAIRs 0.08, 0.08 and 0.05); 7 of these represented new-onset cases. Among 794 patients with AS, there were 4 cases of UC, 8 cases of CD and 1 case of IBDU (EAIRs 0.2, 0.4 and 0.1); 9 were new-onset cases. In the per year analysis, the EAIRs for each indication did not increase over time with secukinumab treatment.ConclusionsIn this pooled secukinumab safety analysis of 7355 patients across 21 clinical trials, cases of IBD events (including CD, UC and IBDU) were uncommon.

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Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents

BioDrugs ◽

10.1007/s40259-019-00394-x ◽

2019 ◽

Vol 34 (1) ◽

pp. 27-37 ◽

Cited By ~ 9

Author(s):

Vibeke Strand ◽

Joao Gonçalves ◽

Timothy P. Hickling ◽

Heather E. Jones ◽

Lisa Marshall ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Rheumatic Diseases ◽

Plaque Psoriasis ◽

Bowel Disease ◽

Regulatory Documents ◽

Inflammatory Bowel

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Correction to: Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents

BioDrugs ◽

10.1007/s40259-020-00410-5 ◽

2020 ◽

Vol 34 (2) ◽

pp. 253-253

Author(s):

Vibeke Strand ◽

Joao Gonçalves ◽

Timothy P. Hickling ◽

Heather E. Jones ◽

Lisa Marshall ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Rheumatic Diseases ◽

Plaque Psoriasis ◽

Bowel Disease ◽

Regulatory Documents ◽

Inflammatory Bowel

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Secukinumab-Induced Inflammatory Bowel Disease in a Patient Treated for Chronic Plaque Psoriasis and Psoriatic Arthritis: A Case Report and Review of the Role of Novel Biologic Agents Targeting the p19 Subunit of IL-23

Case Reports in Medicine ◽

10.1155/2020/9404505 ◽

2020 ◽

Vol 2020 ◽

pp. 1-6

Author(s):

K. M. Darch ◽

T. L. Holland ◽

L. J. Spelman

Keyword(s):

Inflammatory Bowel Disease ◽

Psoriatic Arthritis ◽

Plaque Psoriasis ◽

Bowel Disease ◽

Human Monoclonal Antibody ◽

Biologic Agents ◽

Chronic Plaque Psoriasis ◽

Inflammatory Conditions ◽

Inflammatory Bowel

Chronic plaque psoriasis and psoriatic arthritis are common autoimmune inflammatory conditions, often existing as comorbidities that have a significant impact on a patient’s quality of life. The availability of a range of novel, targeted therapies for their treatment, most notably the availability of biologic agents, has revolutionised management of these conditions and allowed for significant improvements in patient outcomes. Secukinumab (Cosentyx), a fully-human monoclonal antibody that acts by selectively binding to and neutralising the proinflammatory cytokine IL-17A, is used widely for the treatment of both chronic plaque psoriasis and psoriatic arthritis. In this report, we discuss the case of a 54-year-old female with chronic plaque psoriasis and psoriatic arthritis, who experienced the onset of symptoms and was subsequently diagnosed with Crohn’s disease during treatment with secukinumab. It was determined by the gastroenterologist that this may represent secukinumab-induced inflammatory bowel disease. We will review the current understanding of the role of IL-17 in inflammatory bowel disease and the important role of novel agents that target the p19 subunit of IL-23 which have shown significant promise in the management of not only chronic plaque psoriasis and psoriatic arthritis, but also inflammatory bowel disease itself.

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Prebiotics and Probiotics in Inflammatory Bowel Disease: Where are we now and where are we going?

Current Clinical Pharmacology ◽

10.2174/1574884715666200312100237 ◽

2020 ◽

Vol 15 (3) ◽

pp. 216-233 ◽

Cited By ~ 1

Author(s):

Maliha Naseer ◽

Shiva Poola ◽

Syed Ali ◽

Sami Samiullah ◽

Veysel Tahan

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Clinical Trials ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Adverse Effects ◽

Bowel Disease ◽

Relapse Prevention ◽

Remission Induction ◽

Inflammatory Bowel

The incidence, prevalence, and cost of care associated with diagnosis and management of inflammatory bowel disease are on the rise. The role of gut microbiota in the causation of Crohn's disease and ulcerative colitis has not been established yet. Nevertheless, several animal models and human studies point towards the association. Targeting intestinal dysbiosis for remission induction, maintenance, and relapse prevention is an attractive treatment approach with minimal adverse effects. However, the data is still conflicting. The purpose of this article is to provide the most comprehensive and updated review on the utility of prebiotics and probiotics in the management of active Crohn’s disease and ulcerative colitis/pouchitis and their role in the remission induction, maintenance, and relapse prevention. A thorough literature review was performed on PubMed, Ovid Medline, and EMBASE using the terms “prebiotics AND ulcerative colitis”, “probiotics AND ulcerative colitis”, “prebiotics AND Crohn's disease”, “probiotics AND Crohn's disease”, “probiotics AND acute pouchitis”, “probiotics AND chronic pouchitis” and “prebiotics AND pouchitis”. Observational studies and clinical trials conducted on humans and published in the English language were included. A total of 71 clinical trials evaluating the utility of prebiotics and probiotics in the management of inflammatory bowel disease were reviewed and the findings were summarized. Most of these studies on probiotics evaluated lactobacillus, De Simone Formulation or Escherichia coli Nissle 1917 and there is some evidence supporting these agents for induction and maintenance of remission in ulcerative colitis and prevention of pouchitis relapse with minimal adverse effects. The efficacy of prebiotics such as fructooligosaccharides and Plantago ovata seeds in ulcerative colitis are inconclusive and the data regarding the utility of prebiotics in pouchitis is limited. The results of the clinical trials for remission induction and maintenance in active Crohn's disease or post-operative relapse with probiotics and prebiotics are inadequate and not very convincing. Prebiotics and probiotics are safe, effective and have great therapeutic potential. However, better designed clinical trials in the multicenter setting with a large sample and long duration of intervention are needed to identify the specific strain or combination of probiotics and prebiotics which will be more beneficial and effective in patients with inflammatory bowel disease.

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