Original Article

Submitted: 12.5.2015 DOI: 10.1111/ddg.12837

Accepted: 24.8.2015

Efficacy and safety of fumaric

acid esters in combination with
phototherapy in patients with
moderate-to-severe plaque psoriasis
(FAST)

Peter Weisenseel1, Kristian Summary

Reich1, Wiebke Griemberg2, Background: While treatment of patients with moderate-to-severe psoriasis using a
Katharina Merten3, Christine combination of fumaric acid esters (FAE, Fumaderm®) and phototherapy (UV) is com-
Gröschel3, Natalie Nunez mon practice, there have been hardly any studies investigating this regimen. Available
Gomez3, Kirsi Taipale3, information is limited to data from a small pilot study. The objective of the present
Beate Bräu4, Ina Zschocke2 study was to evaluate FAE/UV combination therapy in a larger patient cohort with
moderate-to-severe psoriasis.
(1) Dermatologikum Hamburg, Patients and methods: In this prospective noninterventional multicenter study, data
Germany from patients treated with FAE/UV combination therapy was assessed with regard to
(2) SCIderm GmbH, Hamburg, efficacy (PGA‚ PASI, DLQI, EQ-5D), safety, and dosage over a twelve-month period.
Germany The findings were subsequently compared to data from a previous retrospective
(3) Biogen Idec GmbH, Ismaning, study on FAE monotherapy.
Germany Results: Data from 363 patients was included in the analysis. Efficacy measures impro-
(4) Joint Dermatology Practice Dr. ved substantially on combination therapy. Compared to FAE monotherapy, FAE/UV
med. Beate Bräu und Dr. med. Antje therapy led to a faster clinical response, however, there was no difference in efficacy
Gross, Giessen, Germany after 12 months. Neither the duration nor the type of phototherapy had an impact on
efficacy. In general, combination therapy was well tolerated. Seven percent of pati-
ents experienced adverse events.
Conclusions: FAE/UV combination therapy is effective and well tolerated in patients
with moderate-to-severe psoriasis. Such treatment may induce a faster therapeutic re-
sponse, and appears to be useful, particularly in the first three months of FAE therapy.

Introduction treatment of adult patients with moderate-to-severe psoria-

With a prevalence of 2 % to 3 %, psoriasis is one of the most
common chronic inflammatory skin disease in industriali-
zed countries, affecting roughly 1.5 to 2 million individuals
in Germany [1, 2]. The most common clinical form is pla-
que psoriasis, seen in approximately 80 % of patients [2].
Around 50 % of patients treated by dermatologists have mo-
derate-to-severe psoriasis, which, according to S3 guidelines,
requires systemic treatment [3].
Based on their good efficacy and safety profi le, fumaric
acid esters (FAE) are recommended for long-term systemic
sis. They currently constitute the most commonly prescribed
systemic agent for psoriasis in Germany [4–6 ], where they
were approved for the treatment of severe adult psoriasis in
1994. In 2008, the approved indication was extended to pa-
tients with moderate psoriasis [4, 7 ]. In rare cases, FAE have
also been used off-label in children and adolescents with pso-
riasis [8]. Treatment usually involves a gradual dose increase
starting with one tablet of Fumaderm initial® per day, which
contains 30 mg of dimethyl fumarate (DMF), 67 mg ethyl
hydrogen fumarate (EHF) calcium salt, 5 mg EHF magne-
sium salt, and 3 mg EHF zinc salt [2, 7 ]. Subsequently, the

180 © 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2017/1502
Original Article Fumaric acid esters in combination with phototherapy
dose can be upped (by one tablet) at weekly intervals, until
switching to Fumaderm® (120 mg DMF, 87 mg EHF calcium
salt, 5 mg EHF magnesium salt and 3 mg EHF zinc salt) is
possible. The maximum dose is six tablets of Fumaderm® per
day. However, only few patients require such a high dose.
Most patients do well on 3–4 tablets per day. For each pa-
tient, the dose should be adjusted in a way that combines
optimal efficacy with good tolerability.
In keeping with the updosing regimen, the initial (gra-
dual) onset of action on FAE monotherapy can be seen after
about four to six weeks. However, given that the effecti-
veness of the drug shows a signifi cant increase within the
fi rst 6–12 months, a conclusive assessment of the effi cacy
of monotherapy should not be done prior to the end of the
fi rst six months [5, 7, 9]. In order to speed up the onset of
action, there are approaches to initially combine FAE tre-
atment with phototherapy (UV). While such combination
therapy is widely used in daily practice, there have hardly
been any clinical studies investigating this regimen. The
only data available comes from a small open randomized
pilot study with 15 patients [5 ] that examined whether con-
current UVB phototherapy improved the effectiveness of
fumaric acid esters. Here, patients received FAE over six
months. In addition, one side of the body was treated with
narrowband UVB (311 nm) during the fi rst 4–6 weeks. At
week four, there was already a signifi cant reduction in the
modifi ed PASI score on the side that had been treated with
phototherapy compared to the non-UVB-exposed side.
After twelve weeks, however, the differences between the
two sides were no longer observable. These initial fi ndings
indicated that a combination with phototherapy at the be-
ginning of FAE treatment might be able to accelerate the
onset of action [5 ].
Current S3 guidelines also provide for the combination
of FAE and phototherapy during the fi rst three weeks of FAE
treatment [4].
The present noninterventional FAST study (FAST:
effi cacy, safety and dosage of fumaric acid esters in com-
bination with phototherapy in patients with moderate-to-
severe plaque psoriasis) was designed to investigate the
combination of FAE and initial phototherapy in a larger
patient collective. For this purpose, we collected data on
effi cacy and tolerability as well as information on the type
and duration of phototherapy. Effi cacy results obtained in
the FAST study were then compared to results from a pre-
vious retrospective study in psoriasis patients (FUTURE).
In the FUTURE study, approximately 1,000 patients were
treated with FAE monotherapy (without additional pho-
totherapy) over a period of at least 24 months [1]. Sixty-
seven percent of patients showed signifi cant improvement
or complete clearance after six months; 76 %, after twelve
months.
© 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2017/1502
Patients and methods
The present study is a prospective noninterventional mul-
ticenter study. Three hundred sixty-three adult patients trea-
ted with a combination of FAE and UV at 155 German study
centers (office-based dermatologists and hospital-affi liated
outpatient clinics) were included. The observation period was
twelve months. Overall, five visits per patient were scheduled
(baseline/week 1, week 6, month 3, 6 and 12).
Pursuant to Section 67, Clause 6 of the Medicinal Pro-
ducts Act (AMG), the study was reported to the National
Association of Statutory Health Insurance Physicians, the
competent federal authorities, and to the health insurance
associations. The study was conducted in accordance with
ethical principles based on the Declaration of Helsinki.
Observation parameters
Using questionnaires, information on demographics, age at
first diagnosis, and previous treatment for psoriasis were re-
trospectively gathered prior to treatment (baseline). At the
start (baseline) and over the course of the study – after 6 weeks,
3, 6, and 12 months – the following parameters were prospec-
tively documented: comorbidities and other medications, treat-
ment with FAE (number of tablets per dose, temporal course)
and phototherapy (type, duration, dosage). Disease severity
was assessed by Physician’s Global Assessment (PGA) and the
Psoriasis Area and Severity Index (PASI) [10, 11]. Disease-de-
pendent quality of life of the preceding seven days was deter-
mined using the Dermatology Life Quality Index (DLQI) [12].
Quality of life on the day of the visit was to be assessed with
the Euro Quality of Life (EQ-5D) [13]. In addition, adverse
events (AEs) and serious adverse events (SAEs) were documen-
ted. Moreover, the PASI and the FAE dose were compared to
data from the aforementioned FUTURE study [1].
Statistical analysis
Analysis of all parameters was exclusively descriptive using ob-
served case analysis. For all continuous variables, the following
descriptive parameters were determined: number (n), mean
value, standard deviation, standard error, median, minimum,
maximum. For categorical variables, absolute and relative fre-
quencies were determined. Relative frequencies are each based
on the number of patients with existing values. As the total
number of patients with existing values may vary for different
parameters, this was indicated accordingly. In addition, sub-
group analysis – “UV therapy < 3 months” and “UV therapy
≥ 3 months” – was carried out in order to ascertain whether
there is a difference in efficacy data between these two groups.
All analyses were done using the software SAS™ for Windows
version 9.3 (SAS Institute Inc., North Carolina, USA).
181
 Original Article Fumaric acid esters in combination with phototherapy

Results cumentation on the duration was available for 88 patients).

Characterization of the study population
Data from 363 patients who had received FAE/UV combina-
tion therapy was included in the analysis; data for the entire
study period of twelve months was available for 237 patients
(65.3 %).
The study population consisted of 203 (55.9 %) male
and 158 (43.5 %) female patients; for two patients (0.6 %),
no gender information was provided. Mean age at baseline
was 46.4 ± 14.8 years. For 287 patients (79.1 %), fumaric
acid esters constituted the fi rst systemic treatment; 12.9 %
of patients received FAE as follow-up therapy after they had
discontinued prior systemic treatment due to lack of efficacy
or AEs. At baseline, 38.8 % of patients had already been
started on FAE, whereas 60.3 % of patients were FAE-nai-
ve. Mean duration of prior FAE therapy was 371.5 days (do-
Other demographic data such as comorbidities and other
medications at baseline are summarized in Table 1 below.
Subgroup analysis based on the duration of UV therapy
included 212 patients with UV therapy < 3 months and 151
patients with UV therapy ≥ 3 months.
Phototherapy
The type of phototherapy was documented for 357 patients. Of
these, 96.1 % (n = 343) received monotherapy and 3.9 % (n =
14) combination therapy consisting of two different photothe-
rapies. In this context, broadband UVB therapy was the most
commonly used modality (42.3 % of patients). Table 2 shows
the various phototherapies employed and their frequencies.
For broadband UVB, the mean number of treatment
sessions was 15.4, with a median dose of 1 J/cm 2; for narrow-
band UVB (311 nm), 19.0 sessions, with a median dose of

Table 1 Characteristics of the study population (n = 363).

Parameter n Mean SD Median Min–Max

Age at baseline [years] 361 46.4 14.79 47.0 18–81
Weight [kg] 360 80.06 15.503 80.00 50.2–150.0
Height [cm] 361 173.3 8.61 174.0 150–195
BMI [kg/m2] 360 26.6 4.80 26.0 17–53
Duration [days] of prior FAE treatment 88 371.5 587.59 107.0 1–2,734
n %
Skin type I 24 6.6
II 213 58.7
III 97 26.7
IV 4 1.1
FAE-naive 219 60.3
Previous therapies
− fumaric acid esters 141 38.8

− other systemic therapies 47 12.9

At least 1 co-medication 167 46.0
At least 1 comorbidity 114 31.4
Vascular disorders 62 17.1
Metabolic and nutritional disorders 34 9.4
Musculoskeletal, connective tissue, and bone disorders 22 6.1
Cardiac disease 16 4.4
Disorders of the respiratory tract, thorax, and mediastinum 12 3.3
Psychiatric disorders 11 3.0
Endocrine disorders 8 2.2
Nervous system disorders 6 1.7
Others 26 7.2

182 © 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2017/1502
Original Article Fumaric acid esters in combination with phototherapy
Table 2 Overview of the various phototherapies employed
(n = 357).
Type of phototherapy
UVA
Broadband UV
Narrowband UVB (311 nm)
Whole-body bath PUVA
Bath PUVA (foot)
Cream PUVA (hand)
Cream PUVA (foot)
Others
Abbr.: UV, ultraviolet; PUVA, psoralen plus UVA.
5.4 J/cm 2; for whole-body bath PUVA (psoralen plus UVA),
19.9 sessions, with a median dose of 30.9 J/cm 2; and for
UVA, 16.5 sessions, with a median dose of 39.8 J/cm 2 . The
majority of patients (63.7 %) received fewer than 20 treat-
ments. Mean treatment duration was 116 days; most patients
(58.4 %) underwent phototherapy for less than three months.
FAE dosage
The mean daily FAE dose during treatment weeks 1–3 (n = 281)
was 2.1 tablets (30 mg DMF, 75 mg EHF). The maintenance
dose was 2.6 tablets (120 mg DMF, 95 mg EHF) per day.
Clinical data with regard to FAE in combination
with phototherapy
Compared to baseline, the combination of FAE with photo-
therapy showed significant improvement in all efficacy mea-
sures over the course of the twelve-month treatment period.
No significant differences between the various photothera-
pies were observed.
The mean PGA score continuously improved during the
study, from 2.5 at baseline to 1.1 after 12 months (Figure 1).
Fifty-five percent of patients achieved a PGA score ≤ 1 after
3 months; 72 %, after 6 months; and 78 %, after 12 months
(Figure 2). At baseline, only eight patients (2.2 %) showed a
PGA score ≤ 1.
Comparing patients with UV therapy < 3 months versus
≥ 3 months revealed no difference in the improvement of the
PGA score over the course of the study. However, the propor-
tion of patients with a PGA score ≤ 1 was somewhat higher in
patients with UV therapy < 3 months (Figure 2).
Furthermore, the proportion of patients who achieved a
PGA ≤ 1 was higher in FAE-naive patients after 3, 6, and 12
months than in those with prior FAE treatment (Figure 2),
regardless of how long they had been received phototherapy.
© 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2017/1502
n (%)
58 (16.2)
151 (42.3)
85 (23.8)
61 (17.1)
1 (0.3)
2 (0.6)
1 (0.3)
12 (3.4)
Figure 1 Efficacy of FAE in combination with phototherapy
according to PGA.
Over the course of the study, the mean PASI score impro-
ved from 18.5 at baseline to 8.7 after 3 months and 5.1 after
12 months (Figure 3a), an improvement of 53 %, respectively
72.4 %. Based on the percentage difference at the patient
level, the calculated mean PASI reduction was 46 % after 3
months and 72 % at month 12. After 12 months of FAE/UV
combination therapy, 87.5 % of patients achieved a PASI 50
response (signifying a PASI improvement of 50 %); 54.7 %, a
PASI 75 response; and 23.4 %, a PASI 90 response.
Comparing the PASI scores of FAE-pretreated and
FAE-naïve patients showed no difference (Figure 3b). With
regard to the duration of UV therapy, there were no rele-
vant differences between individuals treated for less than 3
months and those treated for 3 months or more.
The mean DLQI improved from 12.0 at baseline to 3.4
after 12 months (Figure 4a), corresponding to an improvement
of 72 %. The average percentage reduction amounted to
66 %. After twelve months of treatment, 73.3 % of patients
showed a DLQI improvement by at least 5 points.
Figure 2 Efficacy of FAE in combination with phototherapy.
Proportion of patients with a PGA score ≤ 1. Further subdivision
by duration of phototherapy (< 3 months, ≥ 3 months) and FAE
pretreatment (FAE-naive/pretreated).
183
 Original Article Fumaric acid esters in combination with phototherapy
Figure 3 Efficacy of FAE in combination with phototherapy
according to PASI (a). Mean PASI in the subgroups of FAE-
naive and FAE-pretreated patients (b).
The reduction in DLQI scores was somewhat more pro-
nounced in FAE-naive patients than in patients with prior FAE
treatment (Figure 4b). This is also reflected in the percentage
of patients showing significant improvement of the DLQI by
at least 5 points: 45.8 % of FAE-naive patients and 26.3 %
of FAE-pretreated patients achieved this goal after 12 months.
The overall score of the EQ-5D improved from 6.7 (n
= 362) at baseline to 5.6 (n = 236) after 12 months. Assess-
ment of the personal well-being on the day of the visit using
a visual analog scale (VAS) improved from 53.0 (n = 359) at
baseline to 80.1 (n = 234) after 12 months. In the subgroups
“FAE-naïve” and “FAE-pretreated”, mean EQ-5D scores
and the results of the VAS corresponded to those of the over-
all population.
Safety of FAE in combination with phototherapy
During FAE/UV therapy, a total of 50 AEs were reported by
27 patients (7.4 %) In 23 patients (6.3 %), 37 gastrointestinal
disturbances were documented. Other AEs are listed in
Table 3. In 21 patients (5.8 %) at least one AE was related to
FAE therapy. Three patients (0.8 %), experienced SAEs with
no apparent causal relation to FAE therapy.
For 237 patients, there was complete documentation of
visits 1 through 5. Of these, 101 (27.8 %) patients dropped
184 © 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2017/1502
Figure 4 Quality of life during FAE in combination with pho-
totherapy according to DLQI (a). Mean DLQI in the subgroups
of FAE-naive and FAE-pretreated patients (b).
out prematurely. Reasons for dropping out included AEs
in 32 patients (8.8 %), lack of efficacy in twelve patients
(3.3 %), and a contraindication for treatment in one patient
(0.3 %). For 54 patients (14.9 %), other reasons such as “lost
to follow-up” were documented.
Comparison with FAE monotherapy
The results of the present study (FAST) were compared to
efficacy data from the retrospective FAE monotherapy (FU-
TURE) study (Figure 5a, b).
While the PASI reduction was comparable in both stu-
dies, the decrease in PASI in the FAST study was more pro-
nounced, particularly in the fi rst three months: In the FAST
study, the mean PASI score decreased from 18.5 to 8.7 during
this period; this corresponds to an improvement of the mean
PASI of 53 % and a mean percentage reduction of 45,5 %.
In the FUTURE study, the mean PASI decreased from 22.7
to 13.9 in the fi rst three months, a reduction of 39 %. These
differences, however, had resolved by the end of the treat-
ment period. In the FAST study, the mean PASI decreased
by 72.4 % from baseline to month 12 (from PASI 18.5 to
5.1), with a mean percentage reduction by 71,6 %. In the
FUTURE study, the mean PASI dropped by 71.8 % during
this period (from PASI 22.7 to PASI 6.4).
Original Article Fumaric acid esters in combination with phototherapy

Table 3 Adverse events by MedDRA System Organ Class (SOC), version 14.1 (n = 363) (multiple AEs possible per patient).

n %
Number of patients with one or more AEs 27 7.4
Total number of AEs 50
Gastrointestinal disorders 37 9.9*
Abnormal lab values 4 1.1
Hematological and lymphatic disorders 2 0.6
General disorders and symptoms at the administration site 1 0.3
Diseases of the skin and subcutaneous tissue 1 0.3
Nervous system disorders 1 0.3
Vascular disorders 1 0.3
Metabolic and nutritional disorders 1 0.3
Injury, poisoning, and procedural complications 2 0.6
*In one patient, diarrhea occurred twice. For the purpose of frequency calculation, this AE was counted as one single event.

Comparison of the Fumaderm® maintenance dose in both Discussion

studies revealed it to be slightly lower in the FAST study (2.6 ta-
blets per day) than in the FUTURE study (2.9 tablets per day).
Figure 5 Comparison FAST versus FUTURE: Efficacy according
to PASI.
The present prospective noninterventional multicenter study
is the fi rst to provide data on FAE/UV combination therapy
in a larger patient collective.
Our fi ndings demonstrate that the combination of FAE
and phototherapy in patients with moderate-to-severe pso-
riasis is effective and well tolerated. The PGA, PASI, DLQI,
and EQ-5D scores improved significantly during the twel-
ve-month combination therapy. The type of phototherapy
employed in conjunction with FAE played had no significant
impact on clinical efficacy or tolerability.
Previous results from personal reports as well as a pi-
lot study suggested that combining FAE with phototherapy
might result in a faster onset of action [5 ]. With regard to
improving the mean PASI, this observation was confi rmed
in the present study. Comparing the mean percentage of
PASI reduction in the FAST and the FUTURE study sho-
wed that FAE/UV combination therapy resulted in greater
improvement after three months than monotherapy. After
twelve months, the clinical response was comparable [1]
in both studies. Given the difference in PGA scales used –
dynamic PGA in the FUTURE study and static PGA in the
present FAST study – a comparison of effi cacy based on
PGA was not feasible. Comparison of the average main-
tenance dose in the FAST and the FUTURE study might
indicate a dose-reducing effect of FAE/UV combination
therapy.
A major difference between the two studies was that
patients who stopped taking FAE within the fi rst two years
due to lack of efficacy or insufficient tolerability were not
included in the FUTURE study. It is safe to assume that the
differences in terms of onset of action and efficacy in the fi rst
six months would be even more clearly in favor of FAE/UV

© 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2017/1502
185
 Original Article Fumaric acid esters in combination with phototherapy
combination therapy, if they were compared to a less selected
patient collective than that of the FUTURE study.
The results of the subgroup analysis of patients who
received UV therapy for less than three months, compared
to those treated for three months or longer, suggest three
months to be a sufficiently long period for additional photo-
therapy. A longer duration of phototherapy in combination
with FAE treatment revealed no further improvement in effi-
cacy or quality of life.
Compared to patients previously treated with FAE, a gre-
ater number of FAE-naive patients achieved a PGA score ≤ 1.
This might possibly indicate that additional phototherapy is
more effective at the beginning than during the later course of
FAE therapy. However, the group of patients previously trea-
ted with FAE is likely to be subject to negative selection, the
reason being that especially those patients are introduced to
FAE/UV combination therapy who do not insufficiently res-
pond to FAE monotherapy or suffer a temporary disease flare.
The tolerability and safety of the combination of FAE
with various phototherapies proved to be good. The AEs ob-
served were within the spectrum of known FAE side effects.
The present study is neither randomized nor controlled,
and the statements and comparisons made with respect to the
study data and subgroups are purely descriptive. Clear eviden-
ce on the clinical value of combination therapy compared to
monotherapy, as well as on the optimal duration of photothe-
rapy will require prospective randomized comparative trials.
In summary, it appears useful to combine FAE treat-
ment with phototherapy, especially in the fi rst three months.
Beyond a period of three months, the present study revealed
no additional value. Thus, a longer duration of phototherapy
does not appear to be advisable, not least because of its onco-
genic potential. Long-term data on the tolerability and safety
of FAE/UV combination therapy are not yet available.
Conflict of interest
Data collection was funded by Biogen Idec LLC, Germany.
P. Weisenseel has occasionally received fees and/or tra-
vel expenses for advisory and/or lecturing activities from the
following companies and/or participated in clinical trials
commissioned by the following companies: Abbott/AbbVie,
Biogen Idec, Dexcel, Galderma, Janssen-Cilag, Leo Phar-
ma, Medac, MSD (formerly Essex), Pfi zer (formerly Wyeth),
Novartis.
K. Reich has marketed drugs for the treatment of pso-
riasis by the following companies, received honoraria and/or
travel expenses for advisory and/or lecturing activities and/
or participated in clinical studies commissioned by the fol-
lowing companies: Abbott, Biogen Idec, Celgene, Centocor,
Janssen-Cilag, Leo Pharma, Medac, Merck Serono, MSD
(formerly Essex, Schering-Plough), Novartis, Pfi zer (formerly
Wyeth).
186 © 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd. | JDDG | 1610-0379/2017/1502
K. Merten, C. Gröschel, N. Nunez Gomez and K. Taipa-
le are employees of Biogen Idec LLC, the manufacturer of
Fumaderm®/Fumaderm® initial.
W. Griem Berg, B. Brau and I. Zschocke declare no con-
fl icts of interest.
Correspondence to
Dr. med. Peter Weisenseel
Dermatologikum Hamburg
Stephansplatz 5
20354 Hamburg, Germany
E-mail: p.weisenseel@dermatologikum.de
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