Clinical trial NCT04190108: Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis.
Official title: Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis and Its Predictive Role for Inflammatory Bowel Disease Occurrence: a Prospective, Long-term, Controlled Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Inflammatory Bowel Diseases
Lead sponsor: Hospital of Prato
Sponsor class: OTHER
Collaborators: name: Giulia Franchi,Department of Rheumatology, Hospital of Prato
name: Maurizio Benucci,S.Giovanni di Dio Hospital
name: Raffaele Scarpa, Rheumatology Unit, University of Naples Federico II, Naples
name: Francesco Caso, Rheumatology Unit, University of Naples Federico II, Naples
name: Rosario Foti,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania
name: Antonio Carletto,Rheumatology Unit, AOUI, Verona.
name: Elisa Visalli,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania
name: Laura Niccoli,Department of Rheumatology, Hospital of Prato
First posted: 2019-12-09
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both cases and controls were abdominal symptom-free.

Brief summary: Background.Recent epidemiologic studies have shown an association between psoriasis, psoriatic arthritis (PsA) and inflammatory bowel diseases (IBD). Recently, measurement of fecal calprotectin (FC) demonstrated a good sensitivity and specificity for intestinal inflammation.

Primary objective of present study was to evaluate the presence of occult bowel inflammation in patients with PsA as expressed by elevated levels of FC. Secondary objectives were to investigate the correlation between the levels FC and clinical and laboratory features, and the outcome of CF-positive patients in terms of IBD development.

Detailed description: A number of studies evaluated the presence of occult intestinal inflammation by using FC assay in patients with axial SpA. In 2000, a study conducted in PsA patients without bowel symptoms showed at mucosa biopsies the presence of microscopic changes, increase in lamina propria cellularity, consisting of plasma cells and lymphocytes, and lymphoid aggregates.Present prospective case-control study was designed to investigate occult intestinal inflammation by using FC assay in consecutive patients with PsA at onset, and who had no abdominal symptoms. Five Italian Centers contributed to patients recruitment adopting the same inclusion and exclusion criteria over a 3 year period.

FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit. This automated method is a particle enhanced turbidimetric immunoassay employing polyclonal antibodies. The manufacturer cut-off for FC positivity was 50 μg/g, with a sensitivity of 100% and a specificity of 53.1%.

The number of patients developing IBD was evaluated at the end of follow-up. Clinical and laboratory data collection was centralized and two experts statisticians performed the data analysis.

Statistical analysis. All demographic, clinical, and laboratory data were collected and descriptive statistics, presented as mean value and standard deviation, were calculated using Microsoft ® Office Excel for Windows and ©2019 Minitabs, LLC for Windows. Chi-square test was used for categorical variables. FC test sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were calculated. Bayes's theorem was used to calculate the 95% confidence interval (95%CI). Correlations were calculated using Spearman's correlation (rs). P values ≤ 0.05 were accepted as statistically significant.

The median follow-up was 30 months.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* absence of any abdominal symptoms or diarrhoea
* non-steroidal anti-inflammatory drug (NSAIDs) interruption 10 days before enrollment
* Corticosteroids (CS) at stable low dose (prednisone 10 mg/day or equivalent) during the preceding 2 weeks were permitted in both groups.

Exclusion Criteria:

* age \< 18 years
* previous diagnosis of CD or UC or current diagnosis of infectious colitis
* previous therapy with traditional DMARDs or any biologic therapies
* CS at high doses.

Primary outcomes:
measure: The percentage of elevated FC levels in cases and controls
timeFrame: 3 YEARS
Secondary outcomes:
measure: Correlations of FC levels with laboratory data
timeFrame: 3 YEARS
measure: The percentage of patients developing IBD over the follow up
timeFrame: 3 YEARS
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Fabrizio Cantini
state: Tuscany
Study officials:
References:
citation: Fu Y, Lee CH, Chi CC. Association of Psoriasis With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018 Dec 1;154(12):1417-1423. doi: 10.1001/jamadermatol.2018.3631.
citation: Scher JU, Ubeda C, Artacho A, Attur M, Isaac S, Reddy SM, Marmon S, Neimann A, Brusca S, Patel T, Manasson J, Pamer EG, Littman DR, Abramson SB. Decreased bacterial diversity characterizes the altered gut microbiota in patients with psoriatic arthritis, resembling dysbiosis in inflammatory bowel disease. Arthritis Rheumatol. 2015 Jan;67(1):128-39. doi: 10.1002/art.38892.
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citation: Adarsh MB, Dogra S, Vaiphei K, Vaishnavi C, Sinha SK, Sharma A. Evaluation of subclinical gut inflammation using faecal calprotectin levels and colonic mucosal biopsy in patients with psoriasis and psoriatic arthritis. Br J Dermatol. 2019 Aug;181(2):401-402. doi: 10.1111/bjd.17745. Epub 2019 May 6. No abstract available.
citation: Scarpa R, Manguso F, D'Arienzo A, D'Armiento FP, Astarita C, Mazzacca G, Ayala F. Microscopic inflammatory changes in colon of patients with both active psoriasis and psoriatic arthritis without bowel symptoms. J Rheumatol. 2000 May;27(5):1241-6.