Fumaric acid esters safe and beneficial for long‐term clinical use

[Fred]

This study looked at the long‐term safety and effectiveness of Fumaric acid esters (FAEs) as monotherapy and in combination with phototherapy or methotrexate in patients with psoriasis treated at a single centre in Germany.

Quote:

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Background:
Fumaric acid esters (FAEs) are an established systemic treatment for moderate‐to‐severe psoriasis. However, the long‐term clinical safety and effectiveness of continuous FAE monotherapy and combination therapy have not been established.

Objective:
To examine the long‐term safety and effectiveness of FAEs as monotherapy and in combination with phototherapy or methotrexate in patients with psoriasis treated at a single centre in Germany.

Methods:
This monocentric, retrospective observational study, with a follow‐up period of up to 32.5 years, included 859 patients: 626 received FAE monotherapy, 123 received FAEs with concomitant phototherapy and 110 received FAEs with methotrexate.

Results:
Approximately half of patients (49.0%) reported adverse events (566 total events), most of which involved the gastrointestinal tract. Serious adverse events were reported in 2.3% of patients, but none were deemed to have a causal relationship with any of the treatment regimens. Adverse events leading to treatment discontinuation were observed in 12.9% of patients. A median duration of 1 year was observed in all three treatment sub‐cohorts (P = 0.70) from initiation of FAE treatment to a 50% response rate, where response was defined as achieving a cumulative static Physician's Global Assessment (PGA) score of ‘light’ and at least a 2‐point reduction in baseline PGA. A 50% response rate for the cumulative Psoriasis Area and Severity Index 75 was achieved in the FAE monotherapy sub‐cohort after a median of 3 years of treatment, in the FAEs + phototherapy sub‐cohort after 6.7 years and in the FAEs + methotrexate sub‐cohort after 8.1 years (P = 0.001).

Conclusion:
According to our data, FAEs as monotherapy or in combination with phototherapy or methotrexate are safe and beneficial for long‐term clinical use. However, multicentre, randomised controlled trials are required to establish the clinical value of monotherapy versus combination therapy and the optimal treatment duration.

Source: onlinelibrary.wiley.com

Early view funding unknown.

[Caroline]

It's about what is known already in certain groups of doctors who already prescribe FAE's for years. But it is great to read that a good study, proves that this knowledge now also is supported by research.
I am really happy with this.

[jiml]

It's about what is known already in certain groups of doctors who already prescribe FAE's for years. But it is great to read that a good study, proves that this knowledge now also is supported by research.
I am really happy with this.

Yes I agree with you Caroline it proves what we already knew, but it’s good to read research confirming it
It’s worked for me for over 6 years and shows no sign of faltering

[Fred]

I was surprised to see "used in combination with Methotrexate" mentioned I would have thought one or the other, not both.

Taking one pill is bad enough for me let alone two to do the same job.

[jiml]

I was surprised to see "used in combination with Methotrexate" mentioned I would have thought one or the other, not both.

Taking one pill is bad enough for me let alone two to do the same job.

I noticed that as well, which is strange as when my rheumatologist suggested methotrexate for PSA she said I would need to give up Fumaderm .... that’s when I said no thanks and am back under the dermatologist now and Fumaderm is controlling both conditions ( without methotrexate )

[Caroline]

I was surprised to see "used in combination with Methotrexate" mentioned I would have thought one or the other, not both.

Taking one pill is bad enough for me let alone two to do the same job.

I noticed that as well, which is strange as when my rheumatologist suggested methotrexate for PSA  she said I would need to give up Fumaderm .... that’s when I said no thanks and am back under the dermatologist now and Fumaderm is controlling both conditions ( without methotrexate )

Don’t ever go to MTX Jim !
Yesterday in a patients meeting I spoke to a doctor and heard from him that MTX does not do much for PsA. So it is totally senseless to use it in combination with DMF. This doctor has about 15 to 20 years of experience in prescribing DMF for Psoriasis, he is also a very knowledged internist. I did not agree with him all the way, but that happens sometimes with me...

[jiml]

I was surprised to see "used in combination with Methotrexate" mentioned I would have thought one or the other, not both.

Taking one pill is bad enough for me let alone two to do the same job.

I noticed that as well, which is strange as when my rheumatologist suggested methotrexate for PSA  she said I would need to give up Fumaderm .... that’s when I said no thanks and am back under the dermatologist now and Fumaderm is controlling both conditions ( without methotrexate )

Don’t ever go to MTX  Jim !
Yesterday in a patients meeting I spoke to a doctor and heard from him that MTX does not do much for PsA. So it is totally senseless to use it in combination with DMF. This doctor has about 15 to 20 years of experience in prescribing DMF for Psoriasis, he is also a very knowledged internist. I did not agree with him all the way, but that happens sometimes with me...    

I wouldn’t go on to methotrexate again Caroline... it wasn’t my favourite, that’s why I stopped seeing the rheumatologist ... I always heed your advice

[Maryam]

I think a combination may be used cause of the different pathways. DMF cleared my scalp first before anything else, Stelara was very slow with scalp psoriasis, and very quick on my legs and stomach area.

Also; It might be possible to use a low dose of DMF combined with a low dose of MTX to avoid bad adverse events such as low lymphocytes or issues with the liver. I think it is a good thing there are different options cause bio's might not be an option for everyone (cancer survivors for example) and high doses of either med might lead to patients having to quit.

[mataribot]

Great, more hoops you got to jump through before a biologic.

[Maryam]

Great, more hoops you got to jump through before a biologic.

No, more “off-label” for people who can’t use a bio and experience to much side effects on higher (working) doses of either one of them.