Original Article

Submitted: 29.5.2015 DOI: 10.1111/ddg.12687

Accepted: 26.8.2015

Retrospective data collection of

psoriasis treatment with fumaric acid
esters in children and adolescents in
Germany (KIDS FUTURE study)

Kristian Reich1, Christoph Summary

Hartl2, Thilo Gambichler 3, Background: Given that there is no standard systemic treatment for children and
Ina Zschocke4 adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective
study collected data on the efficacy and safety of long-term treatment with fumaric
(1) Dermatologikum Hamburg, acid esters (FAEs) in this particular patient group.
­Germany Patients and methods: In patients younger than 18 years of age at the start of FAE
(2) Dermatology/Allergology Practice, treatment, data on efficacy and safety was retrospectively collected for at least 36
Eltville, Germany months.
(3) Department of Dermatology, Results: Data from 127 patients (aged 6–17 years) was collected for treatment dura-
­Venereology, and Allergology of the tions of up to 60 months. Physician’s Global Assessment, Psoriasis Area and Severity
Ruhr University, Bochum, Germany Index, and Body Surface Area showed marked improvement in the first six months.
(4) SCIderm GmbH Hamburg, Germany After 36 months, these parameters had, on average, improved by up to two-thirds of
baseline values. Thirty-seven patients experienced at least one adverse event (AE),
which was FAE-related in 36 individuals. Three AEs (proteinuria (one case), flushing
(two cases)) persisted during the observation period while on treatment. Fifteen AEs
led to the discontinuation of therapy; nearly all of these cases were related to gast-
rointestinal disorders.
Conclusions: The KIDS FUTURE study – for the first time – included a larger popula-
tion of children and adolescents with psoriasis who were treated with FAEs. The data
obtained suggests that long-term FAE therapy in this patient group may be effective
and safe. The results are currently being verified in an ongoing clinical study.

Introduction crucial in order to achieve optimal results [4]. Consistent and

Psoriasis is a common dermatological disorder in children
and adolescents, with a prevalence of 0.7 % in the under-18
age group. By contrast, the prevalence in the first 12 months
of life is only 0.1 % [1]. In most patients, however, the peak
incidence is in adulthood, between the age of 20 and 30. The
most common clinical form of psoriasis is chronic plaque pso-
riasis, both in adults (80 % of affected patients [2]) as well as
children (69 % of affected patients [3]). The increased amount
of time required for skin care and regular doctors’ visits is a
major burden. Nevertheless, for patients with a chronic disea-
se who are on long-term treatment, therapeutic adherence is
thorough patient follow-up is generally important in order to
be able to adjust the treatment if necessary [5]. Increasing si-
gnificance has been attached to the prompt identification and
treatment of psoriasis in childhood and adolescence, not least
following the establishment of national healthcare objectives
aimed at improving physical and mental symptoms and mini-
mizing potential negative long-term effects on future health
and psychosocial development [6–8]. The childhood preva-
lence of comorbidities such as obesity and diabetes is already
similar to that of adult patients with psoriasis [1, 9].
In general, there is no standard therapy for children
and adolescents with moderate to severe psoriasis requiring

50 © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2016/1401
Original Article  Gene expression in pseudosyndactyly in RDEB
systemic treatment. Systemic therapeutic agents for children
and adolescents only include etanercept, which is approved
as a second-line agent in children ≥6 years with severe psoria-
sis, in whom conventional systemic therapies have failed. All
other systemic antipsoriatic agents therefore have to be used
off-label in children and adolescents [6, 10–12]. Thus, the
prescribing doctor is in a legal gray area, especially becau-
se there is only very limited safety data for long-term tre-
atment of psoriasis in this age group [13–16]. With respect
to children and adolescents, experience with conventional
systemic therapeutic agents also used in the treatment of pso-
riasis comes from other approved indications such as juveni-
le arthritis and Crohn’s disease, as well as following organ
transplants [17–21]. Thus, according to a German consensus
recommendation, children and adolescents with psoriasis
requiring systemic therapy should initially be treated with
methotrexate and cyclosporine, or alternatively fumaric acid
esters (FAEs) and retinoids [22]. The latter, however, should
only be used in adolescence because of their possible effects
on epiphyseal closure. Given the side effect profile and lack
of approval for this indication, there is still a need for a reim-
bursable, effective, and safe first-line therapy in children and
adolescents. In those cases in which FAEs were employed as
off-label therapy for moderate to severe psoriasis in child-
ren and adolescents, adult dose regimens were used [23]. The
maximum daily FAE dose was up to four tablets (containing
120 mg dimethyl fumarate [DMF], 87 mg ethyl hydrogen
fumarate [EHF] [calcium salt], 5 mg EHF [magnesium salt]
and 3 mg EHF [zinc salt]). The case reports [13–16] as well
as unpublished expert experience thus suggest that FAEs
may also be effective and well tolerated in children and ado-
lescents. In 1994, FAEs (Fumaderm initial® and Fumaderm®)
were licensed for the treatment of severe psoriasis in adults;
in 2008, this approval was extended to moderate psoriasis
[24–27]. Fumaric acid esters are suited and recommended
for systemic long-term treatment of adults with moderate to
severe psoriasis; in Germany, they currently rank among the
most frequently prescribed agents for systemic psoriasis the-
rapy [2]. This multicenter, retrospective study has – for the
first time – collected data on long-term efficacy and safety
as well as therapeutic concepts in the routine use of FAEs in
the treatment of children and adolescents using Fumaderm
initial® (30 mg DMF, 67 mg EHF [calcium salt], 5 mg EHF
[magnesium salt] and 3 mg EHF [zinc salt]) and Fumaderm®
(see above for concentrations of active ingredients).
Patients/material and methods
Methods
The present study is based on multicenter, retrospective,
non-interventional, investigator-initiated data collection, in
© 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2016/1401
which 292 questionnaires were sent to 78 specifically selec-
ted centers. The documentation was supposed to include chil-
dren and adolescents younger than 18 years of age at the start
of systemic psoriasis treatment with FAEs. The planned time
span of retrospective data collection per patient was at least
36 months or longer, if FAE therapy was continued that long.
As this was a retrospective data collection, the approval
of an ethics committee was not sought.
Parameters
Using a documentation form, the following data was recor-
ded prior to the initiation of therapy as well as after 1, 3, 6,
12, 24, 36 or more months of treatment: demographic details
(age, gender, height, weight), age at the time of the initial
diagnosis of psoriasis, previous psoriasis treatment, comor-
bidities and comedication, treatment with FAEs (duration,
interruption/discontinuation, dosing course), laboratory pa-
rameters (routine tests including CBC with differential, liver
function tests, renal function tests, urinalysis). The severity
was classified using the following five-point scale according to
the Physician’s Global Assessment (PGA): “asymptomatic”,
“mild psoriasis”, “moderate psoriasis”, “severe psoriasis”
and “very severe psoriasis”. The Psoriasis Area and Severity
Index (PASI) was used to determine the extent of erythema,
infiltration, and scaling of the affected body surface on the
head, trunk, arms, and legs, respectively. The percentage of
body surface area (BSA) affected was objectively assessed
using the BSA score.
Statistics
All parameters were analyzed purely descriptively using an
as-observed analysis. The following descriptive parame-
ters were determined for all constant variables: number (n),
mean, standard deviation, standard error, median, mini-
mum, and maximum. Absolute and relative frequencies were
determined for categorical variables. The relative frequencies
refer to the number of patients with available values. The
total number of patients with available values can vary for
different analyses and was therefore also shown. Analyses
were performed using SAS™ for Windows version 9.3 (SAS
Institute Inc., North Carolina).
Results
Study population characterization
Of the 292 questionnaires, 43.5 % were returned: 127 pati-
ents from 37 study centers were thus included. Regarding a
treatment duration of 12 months, data from 66.1 % (n = 84)
of patients was available. A treatment duration of 24 months
51
 Original Article  Fumaric acid esters in psoriasis in juvenile patients

Figure 1  Number of patients with do-

cumentation over the course of time.

Table 1  Study population characteristics (n = 127).

n Mean SD Median Min–max

Age at the time of initial diagnosis [years] 126 12.1 3.48 13.0 0.0–17.0
Age at the start of treatment [years] 119 14.8 2.28 15.0 6.0–17.0
Weight [kg] 90 66.6 15.09 68.0 18.0–100.0
Height [cm] 90 169.2 12.32 170.5 128.0–191.0
BMI [kg/m ] 2
89 22.9 3.48 22.6 11.0–32.9
PGA prior to the start of treatment 127 2.7 0.65 3.0 1.0–4.0
PASI prior to the start of treatment 59 17.3 8.57 15.5 2.3–48.6

and 36 months was documented in 38.6 % (n = 49) and
23.6 % (n = 30) of patients, respectively (Figure 1). The lon-
gest documented period was 60 months (n = 2). Reasons for
the discontinuation of documentation or treatment were ge-
nerally not recorded.
The study population was made up of 51.2 % (n = 65)
men and 48.8 % (n = 62) women, with an average age of
14.8 ± 2.28 years at the start of treatment. Table 1 provides
an overview of patient demographics. The patients’ age dis-
tribution is summarized in Figure 2.
Classification and severity of psoriasis prior to
treatment
The most common diagnosis, plaque psoriasis was recorded
in 75.6 % (n = 96) of patients. Other documented clinical
manifestations included scalp psoriasis (36.2 %, n = 46), gut-
tate psoriasis (30.7 %, n = 39), nail psoriasis (11.0 %, n = 14),
inverse/intertriginous psoriasis (4.7 %, n = 6), psoriatic ar-
thritis (3.2 %, n = 4), and pustular psoriasis (2.4 %, n = 3).
The mean severity of psoriasis prior to treatment was 2.7
(n = 127) for PGA, ranging from 1–4 (mild to very severe),
and 17.3 (n = 59) for PASI, thus clinically moderate to severe
(Table 1).
Comorbidities and comedication prior to treatment
The majority of patients had no comorbidity (80 %, n = 96);
at least one comorbidity was recorded in 17.5 % (n = 21) of
individuals, and no information on comorbidities was availa-
ble for 2.5 % of patients (n = 3). Here, important comorbidi-
ties included obesity (n = 2), diabetes mellitus (n = 1), arterial
hypertension (n = 1), and bronchial asthma (n = 3).
During the documentation period, a comedication was
reported in 59.0 % of patients (n = 69); 39.3 % (n = 46)
did not receive any comedication, and no information was

52 © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2016/1401
Original Article  Gene expression in pseudosyndactyly in RDEB

Figure 2  Age distribution of patients.

Table 2  Details of FAE therapy – dose regimen (n = 127).

Dose regimen according to the Summary of Product Characteristics n %

Initial phase No 7 5.51
Yes 120 94.49
Updosing phase No 32 25.20
Yes 93 73.23
Unknown 2 1.57

available in 1.7 % of cases (n = 2). Most of the documented
comedications were skincare products and topical antipsori-
atic agents, predominantly including vitamin D analogues as
mono or combination preparations, topical class II–IV corti-
costeroids, and salicylic acid; rarely also coal tar products or
short-term UV therapy.
Practical therapeutic concepts using FAEs in
­children and adolescents
For most of the documented patients (81.9 %, n = 104), FAEs
were the first systemic therapy; second, for 13.4 % (n = 17);
and third for 4.7 % (n = 6).
In the initial phase (treatment weeks 1–3), 94.5 % of
patients took the FAEs according to the dose regimen recom-
mended in the Summary of Product Characteristics, increa-
sing the daily dose by one tablet (containing 30 mg DMF)
per week (Table 2). In the subsequent updosing phase (treat-
ment weeks 4–9), 73.2 % of patients were treated according
to the recommended dose regimen, increasing the daily dose
by one tablet (containing 120 mg DMF) per week (Table 2).
The mean daily dose of those patients (at least at one point
in time) who did not follow the recommended dose regimen
is given in Table 3.
Long-term efficacy of FAE treatment in children
and adolescents
Assessment of psoriatic skin lesions by PGA, PASI, and BSA
showed clear improvement in severity during FAE treatment.
After three months, 36.4 % of patients (n = 40) had a PGA
score ≤ 1; 50.0 % (n = 47), after 6 months. Compared to
the start of treatment (PGA 2.7; n = 127), the mean PGA
(1.3; n = 30) was reduced by about one-half after 36 months.
Figure 3 shows the course of mean and median PGA
values. The PASI improved by about one-half over the first
three months of treatment, from a mean score of 17.3 (n = 59)
to a mean score of 9.0 (n = 54). Continued improvement was
seen up to month 36, with a reduction of the mean PASI score
to 4.8 (n = 22) (Figure 4).

© 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2016/1401
53
 Original Article  Fumaric acid esters in psoriasis in juvenile patients

Table 3  Daily dose (tablets per day) for patients not receiving FAEs according to the Summary of Product Characteristics.

n Mean SD Median Min–max

Week 1 6 1.2 0.41 1.0 1.0–2.0
Week 2 7 2.6 0.98 2.0 2.0–4.0
Week 3 7 3,9 2.19 3.0 2.0–7.0
Week 4 24 1.4 0.77 1.0 1.0–3.0
Week 5 25 1.9 0.87 2.0 1.0–4.0
Week 6 26 2.4 1.11 2.0 1.0–5.0
Week 7 25 2.7 1.35 3.0 1.0–6.0
Week 8 25 2.8 1.38 3.0 1.0–6.0
Week 9 24 2.8 1.44 2.6 1.0–6.0

Figure 3  Mean and median PGA values

over the course of time.

Figure 4  Mean and median PASI

­values over the course of time.

54 © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2016/1401
Original Article  Gene expression in pseudosyndactyly in RDEB
Table 4  Adverse events (AEs) according to MedDRA System Organ Class (SOC), version 14.1 (n = 127) (more than one AE per
patient possible).
Gastrointestinal disorders
Infections and infestations
Musculoskeletal and connective tissue disorders
Renal and urinary tract disorders
Skin and subcutaneous tissue disorders
Vascular disorders (flushing)
Moreover, the frequency of PASI responders was deter-
mined, i.e. patients showing an improvement in the PASI sco-
re by 50, 75, or 90 % after three (n = 53) and six (n = 46)
months of treatment. A PASI 50 was achieved by 37.7 %
(n = 20) after three months and by 63.0 % (n = 29) after six
months; 18.9 % (n = 10) had a PASI 75 after three months and
30.4 % (n = 14) after six months; 7.6 % (n = 4) achieved PASI
90 after three months and 10.9 % (n = 5) after six months.
Compared to the start of treatment (mean BSA 18.2; n = 40),
the mean BSA was reduced by one-half after three months of
FAE therapy (mean BSA 9.1; n = 38) and by approximately
two-thirds after 36 months (mean BSA 6.6; n = 19). Figure 5
shows the course of mean and median BSA values.
Long-term safety of FAEs in the treatment
of children and adolescents
Side effects during FAE treatment in the form of one or more
adverse events (AEs) were recorded in 29.1 % (n = 37) of
© 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2016/1401
Figure 5  Mean and median BSA values
over the course of time.
n %
33 25.43
4 2.97
2 1.58
2 1.58
1 0.79
10 7.87
patients. In 28.4 % (n = 36) of individuals, at least one AE
was associated with FAE therapy. During the observation pe-
riod, AEs persisted in three patients (proteinuria (one case)
and flushing (two cases)). Overall, three AEs were conside-
red severe, all of which were gastrointestinal disorders. In
general, gastrointestinal complaints and flushing were most
frequently reported (Table 4). Fifteen patients (11.8 %) had
to discontinue treatment due to an AE, in nearly all cases
caused by gastrointestinal problems (including diarrhea, vo-
miting, tenesmus, abdominal cramps). One patient exhibited
both gastrointestinal symptoms as well as flushing. In ano-
ther patient, proteinuria led to discontinuation of therapy.
There was no serious AE.
Compared to the start of treatment, there were slight
changes in lab tests over the course of long-term FAE therapy.
These included leukocytes, lymphocytes, and gamma-glutamyl
transpeptidase (GGT). While there was a slight increase in the
mean leukocyte count until month 3, it subsequently dropped
to slightly below baseline levels until month 24. The mean
55
 Original Article  Fumaric acid esters in psoriasis in juvenile patients
lymphocyte count decreased slightly until month 3, almost
reaching baseline levels again by month 24. Compared to the
start of treatment, mean GGT levels increased slightly until
month 24. The assessment of these lab changes is limited due
to the decreasing number of patients with adequate docu-
mentation of lab results over the course of the study. Possible
measures in response to the lab parameter changes were not
documented/recorded.
Discussion
Given that only isolated case reports have been published to
date [13–16] and that the prescription of FAEs in children and
adolescents currently constitutes off-label use due to lack of
official approval (etanercept is the only approved [since 2008]
systemic second-line drug for children ≥ 6 years with severe
psoriasis), there is great demand for more information about
the efficacy and safety of systemic long-term therapy with
FAEs in this patient group. This multicenter, retrospective stu-
dy has – for the first time – collected data on the use of FAEs
(as Fumaderm initial®: 30 mg DMF, 67 mg EHF [calcium salt],
5 mg EHF [magnesium salt] and 3 mg EHF [zinc salt] and
Fumaderm®: 120 mg DMF, 87 mg EHF [calcium salt], 5 mg
EHF [magnesium salt] und 3 mg EHF [zinc salt]) in children
and adolescents with respect to long-term efficacy and safety.
The results show that there was a clear improvement in
the severity of psoriatic skin lesions over the course of the
treatment, with marked improvement after just three to six
months. After 36 months of FAE treatment, the following
parameters had, on average, improved by up to two-thirds of
baseline values: PGA from 2.7 to 1.3, PASI from 17.3 to 4.8,
and BSA from 18.2 to 6.6. However, compared to month 3
and 6, the only score that showed subsequent improvement
until month 36 was the PASI, albeit to a lesser degree. By
contrast, the PGA and BSA values displayed no further im-
provement after month 6. This essentially corresponds to the
12 to 24 weeks recommended (by the FUTURE study) as
optimal point in time for assessing therapeutic success, with
final assessment of the therapeutic efficacy of FAEs no sooner
than after six months of treatment [25, 26, 28].
Moreover, the results obtained suggest that the dosage re-
commended for adults in the Summary of Product Characte-
ristics is essentially also effective for children and adolescents
and similarly well tolerated. The majority of children and
adolescents were successfully treated both in the initial phase
(weeks 1–3) and in the updosing phase (weeks 4–9) according
to the dose regimen recommended for adults (95 % and 79 %).
The required maximum daily dose should be determined in-
dividually. A large percentage (59 %) of patients additionally
received comedication over the course of the documentation
period, in most cases as supportive psoriasis treatment in the
form of topical therapy and/or medicinal skin care products.
56 © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2016/1401
Compared with adult patients, who often receive comedicati-
on for their comorbidities, the prevalence of documented co-
morbidities was – as expected and according to age – rather
low (18 %) [25, 29]. Because of their unique metabolism, the-
re are no known interactions between FAEs and other drugs
[23]. With increasing patient age and a greater number of
systemic comedications, this positive aspect therefore plays a
more important role than in children and adolescents.
The percentage of patients in whom an AE led to discon-
tinuation of therapy was relatively high (11.8 %) compared
to the FUTURE study (1.8 %). It must be borne in mind,
though, that patients who stopped FAE therapy within the
first two years because of lack of efficacy or insufficient to-
lerability were not recorded in the FUTURE study. In nearly
all cases, the AEs leading to discontinuation of therapy in-
cluded gastrointestinal disorders, well known side effects of
FAEs.
The present study is limited by its retrospective design, in
which the quality of the physician’s documentation regarding
patient and treatment data plays a pivotal role. Moreover,
the as-observed analysis is based on available datasets. Apart
from the documented AE-related treatment discontinuations,
there is no information on patients who discontinued FAE
therapy early because of a lack of efficacy and poor tolerabi-
lity. Since data was available for only 66 % of patients after
12 months, 38.6 % after two years, and 23.6 % after three
years, the results obtained regarding efficacy in this non-in-
terventional study (NIS) cannot be generalized. In this study,
a small percentage of patients received FAEs for more than
12 months. This may also be explained by the as yet insuffi-
ciently studied natural course of psoriasis in childhood and
adolescence, with possible prolonged periods of remission. In
addition, parents also frequently request that systemic thera-
pies only be used as long as absolutely necessary.
In summary, the present, retrospective data collection
study shows that, in daily practice, FAEs are often success-
fully used as off-label therapy in children and adolescents.
Moreover, long-term FAE therapy may be effective and safe
in the treatment of children and adolescent patients with pso-
riasis. The efficacy and safety of FAEs in juvenile patients (10
to 17 years) are currently being investigated in a prospective
clinical study.
Conflict of interest
Data collection was financially supported by Biogen Idec
GmbH, Germany. K. Reich has received fees and/or travel
expenses for consultancy and/or lecturing activities from the
following companies that market products for the treatment
of psoriasis and/or has been involved in clinical studies of
the following companies: Abbott, AbbVie, Amgen, Basilea,
Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma,
GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac,
Original Article  Gene expression in pseudosyndactyly in RDEB
MSD (Essex Pharma, Schering-Plough), Novartis, Ocean
Pharma, Pfizer (Wyeth) and UCB. C. Hartl reports no con-
flicts of interest. T. Gambichler has received fees from Biogen
for consultancy and/or lecturing activities. I. Zschocke re-
ports no conflicts of interest.
Correspondence to
Prof. Dr. med. Kristian Reich
Dermatologikum Hamburg
Stephansplatz 5
20354 Hamburg
Germany
E-mail: kreich@dermatologikum.de
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