Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study

What Was Tested

This registered phase 2 trial tested Liraglutide for psoriasis and psoriatic arthritis.

Exploratory, double-blind randomized, placebo-controlled, Phase II study to evaluate the effect(s) of short-term administration of liraglutide, a GLP-1R (glucagon-like peptide-1 receptor) agonist on joint and skin inflammation in patients with active Psoriatic Arthritis.

It had two arms (groups): Interventional arm (experimental) and Placebo arm (placebo comparator).

Placebo sc daily for 12 weeks, volume titration at week 2 to mirror liraglutide arm.

The registry classes the interventions as drug and other.

More on the Plan

In addition to classical effects on glycemic-lowering, GLP-1R agonists are anti-diabetes agents which also have anti-inflammatory properties that may be clinically useful for patients with inflammatory diseases, particularly those with co-morbid metabolic disease.

Design: Double-blind, randomized, placebo-controlled trial, Phase II.

Patient population: 34 patients between with active Psoriatic Arthritis meeting CASPAR (ClASsification criteria for Psoriatic ARthritis).

Who Took Part

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with active psoriatic arthritis (3 tender and swollen joints) meeting CASPAR study group criteria.

The full record lists 1 inclusion and 14 exclusion criteria; among the exclusions: BMI \> 35 kg/m2; current biological treatment for any inflammatory disorder within the past three months; hepatic dysfunction (ast (aspartate aminotransferase), alt (alanine aminotransferase), total bilirubin \> 3 times upper limit of normal).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The psoriasis and psoriatic arthritis participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2015-05 with completion listed for 2016-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in people with psoriasis and psoriatic arthritis.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Psoriasis and psoriatic arthritis research.