DMF (dimethylfumarate) quality of life study

[Fred]

This study looked at quality of life outcomes in adults with moderate‐to‐severe plaque psoriasis treated with dimethylfumarate (DMF)

Quote:

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Background:
Psoriasis is a chronic inflammatory skin disease associated with quality of life (QoL) impairment. BRIDGE was a randomised, double‐blind, phase III study comparing the efficacy and safety of dimethylfumarate (DMF) with a fixed combination of fumaric acid esters (FAE) or placebo for the treatment of moderate‐to‐severe psoriasis.

Objectives:
This post‐hoc analysis investigated treatment effect on QoL overall and by patient sub‐groups categorised by disease severity. Week 8 efficacy responses were also investigated as possible predictors of Week 16 Dermatology Life Quality Index (DLQI) outcomes.

Methods:
Patients were randomised to receive a maximum daily dose of 720 mg of DMF, FAE (gradual up‐titration) or placebo for 16 weeks. Psoriasis Area Severity Index, Body Surface Area, Physician's Global Assessment and DLQI were assessed at baseline, Week 8 and 16. DLQI 0–1 indicated ‘no effect on patient life’. Associations between baseline severity,

Week 16 DLQI and Week 8 efficacy (as observed cases) were also examined.

Results:

At baseline, 671 patients were included in the full analysis set (267 randomised to DMF, 273 to FAE and 131 to placebo). DMF was superior to placebo (P < 0.001) and not significantly different to FAE regarding Week 16 DLQI outcomes (P > 0.05). Baseline disease severity did not impact DLQI outcomes at Week 16. In DMF‐ and FAE‐treated patients, Week 8 PASI 50/75 responders reported better DLQI responses at Week 16 vs non‐responders (P < 0.05). Week 8 PASI ≤3 and/or PGA 0–1 responders were also more likely to report DLQI 0–1 at Week 16 vs non‐responders (P < 0.05).

Conclusion:
DMF significantly improved DLQI outcomes versus placebo and was not affected by baseline disease severity. Efficacy responses (PASI 50/75, PASI ≤3 and PGA 0–1) as early as Week 8 were predictive of QoL outcomes at Week 16 in DMF‐ and FAE‐treated patients.

Source: onlinelibrary.wiley.com

*Early view funding unknown

[Caroline]

Thanks for showing this to us Fred.

A few remarks.

1. 8 weeks is far too less to measure full DMF capacity, that may take at least twice as long. 
   
2. Why the max of 720 mg? There is no reason for that, other than an imaginary reason caused by Fumaderm. In the Netherlands doctors experience shows that doses up to 1200 mg may be necessary to start up the working of the DMF, often afterwards this can be reduced again. 
   
3. What are the other FAE’s? Probably a combination of MEF and DMF, as in Fumaderm, as there are not much more possibilities, no one as far as I know. In 2004 a study of Nicole Litjens already showed that MEF is useless. Result, as in no difference concerning both medications was to be expected. Still only DMF is to be preferred. The addition of MEF has no value and makes the product toxic. 
   
4. They should have incorporated a controlled (slow) release version as that makes difference for half of the patients. 
   

I would not be surprised as the funding would have been given by Almirall

[jiml]

I thought it an interesting study and a positive result let's hope it encourages dermatologists to prescribe it more often instead of the other cheap medications