Adalimumab-psoriasis and Small Bowel Lesions
Condition: Plaque Psoriasis; Crohn's Disease
MeSH terms: Crohn Disease; Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the prevalence of small bowel lesions suggestive of Crohn's disease
      (CD) in patients with moderate to severe plaque psoriasis using capsule endoscopy. The study
      also aims to determine if the treatment of psoriasis with adalimumab will have an effect on
      the healing of the small bowel for patients who have lesions suggestive of CD.

      Patients with psoriasis are at increased risk of developing Crohn's disease (CD), but the
      exact prevalence of CD in patients with psoriasis at this time is unknown as many patients
      probably have undiagnosed disease as the early signs will often cause no symptoms. CD is
      therefore receiving very little attention from dermatologists who are treating patients with
      psoriasis. For example, very few dermatologists will actively question patients with
      psoriasis about symptoms of CD. This lack of knowledge may induce delays in diagnosis. By the
      time the diagnosis is made and patients receive their first treatment, they may already have
      significant fibrosis and stenosis of the intestine. Current treatments, including adalimumab,
      cannot reverse small bowel anomalies to normal in the presence of fibrosis. Therefore, many
      patients with a late diagnosis will still have symptoms or will eventually require surgery
      despite good control of the inflammation. Treatment of CD should start as early as possible,
      as early treatment has been associated with an increased rate of complete healing. Complete
      control of the disease at its early stages may prevent complications.
    

Detailed description: 
      This open-label, phase IV, 24-week study will recruit a total of 100 patients with moderate
      to severe plaque psoriasis without a diagnosis of inflammatory bowel disease. All patients
      will undergo capsule endoscopy at the beginning of the study to detect the presence of small
      bowel lesions suggestive of CD such as erosions and ulcers. All patients will receive
      adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.
      Patients for whom no small bowel lesions suggestive of CD were detected will remain in the
      study and under adalimumab therapy until week 12. A second capsule endoscopy will be
      performed 24 weeks after initiation of adalimumab for patients who had small bowel lesions
      suggestive of CD to evaluate changes in bowel inflammation.
    

Intervention name(s): Adalimumab; Capsule endoscopy
Intervention type(s): Drug; Device
Intervention description(s): Adalimumab will be administered sub-cutaneously to all patients entering the study with a loading dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week. Patients who did not have small bowel lesions detected will be in the study and receive adalimumab until week 12. Patients who had small bowel lesions detected will be in the study and receive adalimumab until week 24.; All patients will undergo capsule endoscopy (EndoCapsule EC type 1; Olympus) to treatment initiation (adalimumab) in order to detect the presence of small bowel lesions suggestive of Crohn's disease. Twenty-four (24) weeks after treatment with adalimumab was initiated, patients for whom small bowel lesions were detected will undergo a second capsule endoscopy to evaluate changes in bowel inflammation.
Other intervention name(s): Humira; EndoCapsule EC-1; OLYMPUS EC TYPE 1
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: small bowel lesions; Crohn's Disease; Plaque psoriasis; adalimumab; capsule endoscopy