An independent prospective randomised controlled trial comparing the efficacy and cost effectiveness of infliximab and etanercept in 'high need' patients with moderate to severe chronic plaque type psoriasis

TNF antagonists such as etanercept and infliximab (biologics) have been
approved for the treatment of moderate to severe psoriasis patients. In the
Netherlands etanercept is the most frequently prescribed biological. In
comparison analysis it was suggested that infliximab is more effective than
etanercept. However, the use of infliximab has several specific limitations.
Costs associated with psoriasis care are considerable and are expected to
increase steeply due to the introduction of the biologics. Furthermore
psoriasis has an enormous impact on patients* health related quality of life
(HRQOL).
There are no direct comparative studies available of infliximab and etanercept
and existing studies did not include an economic evaluation of these expensive
agents.
That*s why we want to compare by an independent prospective RCT the efficacy
and cost effectiveness of infliximab and etanercept by these patients.

What is the incremental cost effectiveness ratio of the use of etanercept
versus infliximab?
Are there subgroups of which infliximab or etanercept is more or less
cost-effective in daily practice?

Primary objectives:
1. To compare clinical efficacy of etanercept and infliximab (ie, proportion of
patients achieving PASI75, I-GA almost clear, clear).
2. To compare patient reported outcomes such as HRQOL and treatment
satisfaction between etanercept and infliximab.
3. To compare from a societal perspective the incremental cost effectiveness
ratio of the use of etanercept versus infliximab

Secondary objectives:
1. In (good-)responders, to compare the duration of remission.
2. In non-responders, to investigate patients perspectives of the comparative
drug.
3. To compare the side-effects.
4. Subgroup analyses in relation to (cost-) effectiveness and safety, and
antibody formation
5. To compare the improvement of nailpsoriasis graded by the NAPSI.

This trial is a multi-centre, pharmaceutical independent, prospective
randomised controlled trial comparing head-to-head infliximab and etanercept.

Treatment will be given according to nowadays standard care with respect to
frequency of follow up and monitoring.
Etanercept will be self administered by subcutaneous injection between week 0
and 12 at a doses of 50 mg twice weekly (BIW). At week 12, patients with a
PASI50 or more ((good-)responders) will continue 50 mg BIW for another 12 weeks
up to week 24, non-responders (< PASI50) will switch to infliximab after a 4
week washout time.
Infliximab is an intravenous treatment with 5 mg/kg at 0, 2, and 6 weeks, then
every 8 weeks thereafter. At week 12, (good-) responders (PASI50 or more)
continue therapy with injections every other 8 weeks up to week 22,
non-responders (< PASI50) switch to etanercept 50 mg BIW for 12 weeks.

At week 24 study treatment will be stopped, although there is a possibility to
continue if the patient strongly insist of continuation, after informing them
about the possible infusion reaction of infliximab retreatment .
If there is a PASI <50 after therapy stopped, (re-)treatment can be initiated
at the outpatients'clinic. For infliximab retreatment this will be depending of
the therapy free interval. Despite of the therapy, study follow up visits will
be every two months up to one year.

A direct comparison of etanercept and infliximab is needed to answer which of
these therapies is preferred by patients and which is the most cost-effective
drug in this subpopulation of psoriasis patients. The results of the study
could help other psoriasis patients to get the best treatment of biologics.The
benefit for the patient could be an improvement of the psoriasis plaques.
The risks will be the same when prescribing biologics in regulary care, like
infusion vs. injection site reactions, infections, malignancies and adverse
events. These will be evaluated in the study. Recent developments suggests that
retreatment of infliximab, after a therapy free period of more than 20 weeks,
has a greater probability for infusion reactions.