Clinical trial NCT02174367: An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis
Official title: An Observational Cohort Study to Evaluate Factors Affecting Prevalence of Fatty Liver Disease and Fibrosis and Factors Affecting Response to Treatment in Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis Chronic
Liver Fibrosis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Keywords: Chronic plaque psoriasis
Liver fibrosis
Fatty liver disease
Non-alcoholic fatty liver disease
Transient elastography
Fibroscan
Procollagen-3 N-Terminal peptide
Alanine aminotransferase
Liver function tests
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-06-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital outpatient clinic

Brief summary: • Main objectives and outcome measures.

1. Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis.

   Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).
2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.
3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis.

Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI).

* Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study.
* Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith
* Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust


Eligibility criteria: Inclusion Criteria:

* Patients who have given written informed consent
* Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
* 18 yrs. of age

Exclusion Criteria:

* Patients who have not given written informed consent
* Patients under 18 yrs. of age
* Patients with a PASI less than 10.
* Pregnant women

Primary outcomes:
measure: Number of participants with liver fibrosis.
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Number of participants with fatty liver disease diagnosed by ultrasound
timeFrame: Within 12 months of enrollment
Other outcomes:
measure: Sensitivity, specificity, and likelihood ratios of noninvasive tests of liver fibrosis
timeFrame: Within 12 months of enrollment
measure: Response to treatment measured by PASI and PGA scores
timeFrame: 12-24 months following enrollment
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation trust and King's College London
Study officials:
affiliation: King's College London
name: Jonathan N Barker, BSC MD FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Guys and St Thomas' Hospitals Foundation Trust and King's College London
name: Catherine H Smith, MD FRCP
role: STUDY_DIRECTOR
References:
citation: Maybury CM, Jabbar-Lopez ZK, Wong T, Dhillon AP, Barker JN, Smith CH. Methotrexate and liver fibrosis in people with psoriasis: a systematic review of observational studies. Br J Dermatol. 2014 Jul;171(1):17-29. doi: 10.1111/bjd.12941. Epub 2014 Jul 15.
citation: Maybury CM, Samarasekera E, Douiri A, Barker JN, Smith CH. Diagnostic accuracy of noninvasive markers of liver fibrosis in patients with psoriasis taking methotrexate: a systematic review and meta-analysis. Br J Dermatol. 2014 Jun;170(6):1237-47. doi: 10.1111/bjd.12905.
citation: Samarasekera EJ, Smith CH; National Institute of Health and Care Excellence; Royal College of Physicians. Psoriasis: guidance on assessment and referral. Clin Med (Lond). 2014 Apr;14(2):178-82. doi: 10.7861/clinmedicine.14-2-178.
citation: Smith CH, Barker JN. Psoriasis and its management. BMJ. 2006 Aug 19;333(7564):380-4. doi: 10.1136/bmj.333.7564.380. No abstract available.
citation: Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
citation: Boehncke WH, Boehncke S, Schon MP. Managing comorbid disease in patients with psoriasis. BMJ. 2010 Jan 15;340:b5666. doi: 10.1136/bmj.b5666. No abstract available.
citation: Fonia A, Jackson K, Lereun C, Grant DM, Barker JN, Smith CH. A retrospective cohort study of the impact of biologic therapy initiation on medical resource use and costs in patients with moderate to severe psoriasis. Br J Dermatol. 2010 Oct;163(4):807-16. doi: 10.1111/j.1365-2133.2010.09944.x.
citation: Maybury CM, Porter HF, Kloczko E, Duckworth M, Cotton A, Thornberry K, Dew T, Crook M, Natas S, Miquel R, Lewis CM, Wong T, Smith CH, Barker JN. Prevalence of Advanced Liver Fibrosis in Patients With Severe Psoriasis. JAMA Dermatol. 2019 Sep 1;155(9):1028-1032. doi: 10.1001/jamadermatol.2019.0721.