In short
Fatty acids unsaturated is an investigational add-on treatment being studied in psoriatic arthritis. The main trial is a Phase 2 randomised, open-label, proof-of-concept study in 50 participants, testing whether adding 1000 mg of polyunsaturated fatty acid ethyl esters to TNF-alpha inhibitor therapy reduces pain and improves disease activity. The substance is given orally and contains EPA and DHA at a concentration of at least 85%.
Key points
- Phase 2 randomised, open-label, proof-of-concept trial in psoriatic arthritis.
- Planned enrolment: 50 participants.
- The trial tests add-on polyunsaturated fatty acid ethyl esters, 1000 mg orally, combined with TNF-alpha inhibitor therapy.
- Co-primary outcomes: pain intensity on a 0–10 cm visual analogue scale and minimal disease activity at Month 6.
- Status: Authorised.
- The fatty acid product contains EPA and DHA at a content of at least 85%.
What is fatty acids unsaturated?
Fatty acids unsaturated is an investigational substance being studied as an add-on treatment in psoriatic arthritis. In the trial record, the intervention is described as polyunsaturated fatty acid ethyl esters, 1000 mg, with an EPA and DHA content not lower than 85%. EPA stands for eicosapentaenoic acid and DHA for docosahexaenoic acid, two long-chain omega-3 fatty acids.
The substance is given by mouth and is being evaluated in combination with TNF-alpha inhibitor therapy. TNF-alpha inhibitors are medicines that block tumour necrosis factor alpha, a protein involved in inflammation. In this trial, the TNF-alpha inhibitors used are adalimumab, certolizumab pegol, golimumab, infliximab and etanercept.
How does fatty acids unsaturated work?
The trial is designed to test whether adding polyunsaturated fatty acid ethyl esters to TNF-alpha inhibitor therapy reduces pain and improves disease activity control compared with TNF-alpha inhibitor therapy alone. The fatty acid product used in the study contains EPA and DHA at a concentration of at least 85%. These long-chain omega-3 fatty acids are being investigated for their potential role in inflammatory conditions, but the trial record does not describe a specific molecular target or mechanism of action for this substance.
Which conditions is fatty acids unsaturated being studied for?
- Psoriatic arthritis — a chronic inflammatory condition that affects the joints and often occurs in people with the skin condition psoriasis. The trial is testing whether the add-on fatty acid treatment can reduce pain and help patients reach minimal disease activity.
How is fatty acids unsaturated given?
In the trial, fatty acids unsaturated is given as a 1000 mg dose by oral use. The TNF-alpha inhibitors in the study are given by subcutaneous use, which means they are injected under the skin.
What do the clinical trials show?
The clinical development programme for fatty acids unsaturated in psoriatic arthritis consists of one trial listed in the EU Clinical Trials Information System. It is a Phase 2 randomised, open-label, proof-of-concept study with a planned enrolment of 50 participants. The trial is currently authorised.
The study has two co-primary objectives. The first is to evaluate whether add-on polyunsaturated fatty acid ethyl esters, 1000 mg, combined with TNF-alpha inhibitor therapy, reduces pain intensity compared with TNF-alpha inhibitor therapy alone. Pain is measured as the change from baseline to Month 6 using a 0–10 cm visual analogue scale, where 0 means no pain and 10 means the worst possible pain. The second co-primary objective is to explore whether the add-on treatment improves disease activity control, measured as the difference between treatment arms in the proportion of patients achieving minimal disease activity at Month 6.
Because the trial is open-label, both participants and researchers know which treatment each participant is receiving. The study compares two approaches: TNF-alpha inhibitor therapy alone versus TNF-alpha inhibitor therapy plus the fatty acid add-on. The trial is randomised, meaning participants are assigned to one of the two treatment arms by chance.
What side effects are known?
The trial record does not report side effects for fatty acids unsaturated. No supplementary sources were provided for this substance, so no side effect information can be given here.