We would like to know to what extent psoriasis patients develop antibodies against biologics and what the clinical consequences of these antibodies are in routine practice.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The serum level of antibodies against the concerning biologic.
Secondary outcome
The disease severity objectivated by the PASI in patients with antibodies to
biologics compared to patients without antibodies to biologics at several
timepoints.
Background summary
Biologics are nowadays used in routine therapy for patients with moderate to
severe chronic plaque type psoriasis. Registered (till 2009) are etanercept,
infliximab, adalimumab and recently also ustekinumab. Except for ustekinumab,
these biologics are also used in non-dermatological patients.
Experience with these patients showed that antibodies can be formed against the
biologics. Antibody formation against the monoclonal antibodies infliximab and
adalimumab has been shown to negatively influence the response to treatment in
patients with ankylosing spondylitis, rheumatoid arthritis and Crohn*s disease.
Also to the fusion protein etanercept antibodies are formed, although they do
not seem to have a direct effect on the efficacy.
Since biologics have proven to be a valuable suppletion to the traditional
therapeutic range for psoriasis, it is important to retain their efficacy.
Study objective
We would like to know to what extent psoriasis patients develop antibodies
against biologics and what the clinical consequences of these antibodies are in
routine practice.
Study design
This is a prospective observational cohort study.
The serum levels of the biologic and the serum levels of antibodies against the
biologic concerned are measured at specific time points: week 0, week 12, week
24 and week 52. At the same time points disease severity is measured using the
Psoriasis Area and Severity Index (PASI) and adverse events are evaluated.
Study burden and risks
At the timepoints week 12, week 24 and week 52 the routine blood drawing will
have to be done at the moment the blood contains the lowest levels of the
biologic and as a result the best measurable level of antibodies. For some
patients this means they will have to postpone the administration of their drug
for several hours, one day or several days until after the blood drawing. This
depends on the frequence of administration, their usual moment for
administration and the moment they visit the clinic. A patient can also choose
to pay the hospital an extra visit for blood drawing just before they will
administer the biologic. In that case they do not change their moment of
administration and dose interval
Meibergdreef 9
1105 AZ
Nederland
Meibergdreef 9
1105 AZ
Nederland
Listed location countries
Age
Inclusion criteria
- Written informed consent
- Patients diagnosed with chronic plaque type psoriasis
- Treatment with a biologic (etanercept, adalimumab, infliximab or efalizumab) for chronic moderate to severe plaque psoriasis started not longer than 52 weeks before.
- Consecutive patients starting treatment with a biologic (etanercept, adalimumab, infliximab or efalizumab) for chronic plaque psoriasis.
Exclusion criteria
- Previous treatment with the same biologic.
- Patients unable to comply with the requirements of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23022.018.08 |