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A randomized comparative clinical trial of recombinant

canine interferon- (KT-100) in atopic dogs using


antihistamine as control
Blackwell Publishing Ltd

Toshiroh Iwasaki* and Atsuhiko Hasegawa


*Department of Veterinary Internal Medicine, Tokyo University of
Agriculture and Technology, Saiwai 3-5-8, Fuchu, Tokyo 183-8509,
Japan
Department of Pathobiology School of Veterinary Medicine, Nihon
University, 1866, Kameino, Fujisawa, Kanagawa 252-8510, Japan
Conflict of interest and funding for the study:
This project was funded by Toray Industries, Inc. KT-100 was
approved in Japan for treatment of canine AD in June 2005.
We have been involved with the work, have approved the manuscript
and agreed to its submission.
Correspondence: Toshiroh Iwasaki, Department of Veterinary
Internal Medicine, Tokyo University of Agriculture and Technology,
Saiwai 3-5-8, Fuchu, Tokyo 183-8509, Japan.
E-mail: bpag2180@cc.tuat.ac.jp

Abstract
Recombinant canine interferon- (KT-100) or topical
antihistamine (diphenhydramine: DH) was administered
to dogs with atopic dermatitis (AD) for 4 weeks and
their efficacies were compared using pruritus, excoriation, erythema and alopecia as evaluation criteria.
Clinical studies on 92 atopic dogs (KT-100 group: 63,
DH group: 29) were conducted at 18 animal hospitals
in Japan. KT-100 was administered subcutaneously
once a day three times a week on alternating days for
4 weeks. DH was administered topically twice daily for
4 weeks. The efficacy rates of the KT-100 group on day
28 were 72.1% for pruritus, 73.8% for excoriation,
75.4% for erythema and 60.7% for alopecia, which
were significantly higher than those of the DH group
(20.7% for pruritus, 27.6% for excoriation, 24.1% for
erythema and 24.1% for alopecia).
Accepted 21 March 2006

Introduction
Interferon (IFN)- is known to exhibit both immunoenhancing and immunoregulatory effects on the immune
system, and to be effective in cases of human atopic
dermatitis (AD).14 Various drugs for the treatment of canine
AD have been investigated, including glucocorticoids,
calcineurin inhibitors, histamine-1 receptor antagonists,
phosphodiesterase inhibitors, leucotriene inhibitors, prostaglandin analogues and inhibitors, externally applied antipruritics, immunoregulatory antibiotics, Chinese herbs and
homeopathic drugs.5 However, problems associated with the
use of these drugs can include adverse effects or low efficacy.

It has been demonstrated that the pathogenesis of


canine AD involves an increase in Th2 cytokine expression
level as well as high IL-4 mRNA expression at lesion sites,68
and low IFN- mRNA expression in peripheral mononuclear
blood cells9 and skin lesions.8 Moreover, since the IFN-:IL-4
mRNA ratio was increased significantly following successful
allergen-specific immunotherapy in atopic dogs and this
therapy resulted in clinical improvement, the imbalance
between Th1 and Th2 cytokine expression level was shown
to be a significant contributor to the pathogenesis of canine
AD10. Our previous study of the efficacy of a canine IFN-
preparation (KT-100) in dogs revealed that (1) the IL-4:IFN mRNA ratio in peripheral mononuclear blood cells was
decreased following administration; (2) the serum total IgE
level was decreased significantly following administration;
and (3) the number of mast cells in the superficial dermal
layer was decreased,11 suggesting clinical efficacy of IFN-.
On the basis of these findings, the following study was
conducted in order to confirm the clinical effects of KT-100
on canine AD.

Materials and methods


Drugs
A freeze-dried preparation of KT-100 (Interdog, Toray Industries, Inc., Tokyo,
Japan), which contained 60 000 units of canine IFN- (recombinant)12
per vial, was used. KT-100 was dissolved in sterilized physiological
saline solution immediately before injection. A topical spray formulation
containing 1.0 g of diphenhydramine per 100 mL (DH) was used
as the control drug (Puredomin Riken, Rikenchikusan Chemical Co.,
Ltd, Saitama, Japan).

Dogs
1) Inclusion criteria
Dogs were included if they fulfilled the Willemses criteria for AD.13
Adverse food reactions were excluded by feeding an elimination diet
for a minimum of 4 weeks and ectoparasites by trial therapy. If present,
secondary infections with Malassezia pachydermatis infection and
pyoderma were treated before the trial commenced. In addition, in order
to standardize the severity of AD in this study, only dogs for which the
severity of pruritus was evaluated to be moderate to severe and for
which the sum of the clinical scores for excoriation, erythema and
alopecia was 19 or higher at the initial examination were included in
the study (see succeeding text for scoring system). Dogs that had
received steroids (including oral and injectable), antihistamines, or
other immunotherapeutic drugs (including Chinese herbal medicine)
were required to undergo a withdrawal period of at least 2 weeks prior
to the study, and the concomitant use of these drugs was not permitted
during the study.

2) Exclusion criteria
Dogs were excluded from the study if they had mild AD, insufficient withdrawal periods of prohibited drugs, changes to the type or frequency

2006 The Authors. Journal compilation 2006 European Society of Veterinary Dermatology. 17; 195200

195

T. Iwasaki and A. Hasegawa

Table 1. Pruritus evaluation criteria


Score

Definition

0 No pruritus
1 Mild pruritus
2 Mild to moderate pruritus
3 Moderate pruritus
4 Moderate to severe pruritus
5 Severe pruritus

No pruritus observed
Occasional scratching or biting, almost no difference from normal dogs
Some scratching and biting, and slight restlessness
Frequent scratching and biting, and restlessness
Very frequent scratching and biting, and extreme restlessness
Continuous scratching and biting, and continuous restlessness causing the animal to wake his owner at night

Table 2. Clinical sign evaluation criteria


Clinical sign

Location

Score

Definition

Excoriation

Face, ear pinnae,


axilla, abdomen,
inguinal region,
extremities

0 No excoriation
1 Mild excoriation
2 Mild to moderate excoriation
3 Moderate excoriation
4 Moderate to severe excoriation
5 Severe excoriation
0 No erythema
1 Mild erythema
2 Mild to moderate erythema
3 Moderate erythema
4 Moderate to severe erythema
5 Severe erythema
0 No alopecia
1 Mild alopecia
2 Mild to moderate alopecia
3 Moderate alopecia

No excoriation observed
Shallow, inconspicuous wounds
Small number of wounds at lesion site
Large number of wounds at lesion site
Large number of wounds spreading over the entire area
Deep wounds with presence of blood over the entire area
No erythema observed
Some light pink zones
Sporadic light pink zones
Pink zones spreading over a moderate range
Deep pink zones spreading from the moderate range to the entire area
Red zones spreading over the entire area
No alopecia observed
Some zones of thinning hair
Zones of thinning hair spreading over a moderate range
Zones of thinning hair spreading over the entire area or zones of missing
hair spreading beyond the moderate range
Hardly any hair over the entire area or zones of missing hair over
nearly the entire area
Zones of missing hair spreading over the entire area

Erythema

Alopecia

4 Moderate to severe alopecia


5 Severe alopecia

of existing shampoo therapy, developed complications such as M.


pachydermatis infection or scabies during the trial, or were given
prohibited drugs during the trial.

Intervention
This study was conducted using Good Clinical Practice (GCP) standards
at 18 animal hospitals in Japan from August 2003 to January 2004.
The dogs were randomly assigned to the KT-100 and DH groups by a
third party to a ratio of 2: 1. The randomization table was prepared by
Toray Industries, Inc. after the veterinarians had verified that the dogs
met the inclusion criteria, and random assignment of the dogs to the
two groups was performed.
The dosage for the KT-100 group was based on the results of a
previous dose finding study (Hasegawa A., unpublished data). Dogs
of the KT-100 group were administered subcutaneously 10 000 units
of KT-100 per kilogram body weight once a day, three times a week,
on alternating days for 4 weeks. During the subsequent 4-week
follow-up period, the frequency of administration was adjusted at
the discretion of the veterinarian monitoring the dogs condition
while the amount administered was unchanged at 10 000 units kg1
body weight. Dogs in the DH group were sprayed twice daily for 8
weeks according to the manufacturers instructions.

sites, namely, the face, pinnae, axilla, abdomen, inguinal region and
extremities. Compared with the scores on the initial day, 75%
improvement of pruritus, excoriation, erythema or alopecia was
evaluated as excellent; 50% to < 75% improvement, as good; 0% to
< 50% improvement, as fair; no change in scores, as no effect; and
worsening of symptoms, as worsened. The efficacy rate for each
symptom was expressed as follows:
(no. of excellent cases + no. of good cases)/total no. of cases.
The same veterinarian performed the scoring of clinical signs on
days 0, 14, 21, 28 and 56.

Antigen-specific IgE test, blood count and serum


chemistry panel

Evaluation of efficacy

An antigen-specific IgE test was performed on the initial day of


examination using an enzyme-linked immunosorbent assay (Hitachi
Chemical Co., Ltd, Ibaragi, Japan) for 24 antigens (indoor: house dust
mite, storage mite, flea saliva, cockroach and dog and cat epithelia;
outdoor: Japanese cedar, white birch, grass mix and ragweed; food:
beef, chicken, pork, fish, egg, milk, rice, wheat, maize flour, soybean,
potato and lamb; fungus: Fusarium, Malassezia and fungus mix). In
addition, measurement of body temperature and body weight, a
complete blood count and serum chemistry panel were performed
on the initial day of examination (day 0) and on days 14, 28 and 56.
All adverse events were recorded by the veterinarian.

Pruritus, excoriation, erythema and alopecia were chosen as evaluation criteria by assigning a score of 05 using a simplified version of the
CADESI (canine atopic dermatitis extent and severity index) score.14
The severity of pruritus was scored as follows: 0 for no pruritus, 1 for
mild pruritus, 2 for mild to moderate pruritus, 3 for moderate pruritus,
4 for moderate to severe pruritus, and 5 for severe pruritus, as determined by the veterinarian through interviews with dog owners (Table 1).
Excoriation, erythema and alopecia were evaluated by the veterinarian
and scored as follows: 0 for no symptoms, 1 for mild symptoms, 2 for mild
to moderate symptoms, 3 for moderate symptoms, 4 for moderate to
severe symptoms, and 5 for severe symptoms (Table 2), at each of six

Statistical analysis was conducted using StatView 5.0 (SAS Institute


Inc., Cary, NC, USA), and two-sided P-values are shown. Statistical
significance was set at 5%. Differences in signalment and clinical data
were tested using the chi-square test and the Students t-test. Therapeutic efficacy was compared between groups using the chi-square
test, the Students t-test and the MannWhitney U-test. The Students
t-test was used to assess changes in scores between the two groups,
the MannWhitney U-test was used for 5-grade efficacy analysis
(excellent, good, fair, no effect and worse), and the chi-square test

196

Statistical analysis

2006 The Authors. Journal compilation 2006 European Society of Veterinary Dermatology.

Efficacy of KT-100 in canine atopic dermatitis

Table 3. Signalment and clinical data


Criterion
Number of subjects
Sex
Age

Breed

ELISA results
Duration of clinical signs in years

Body weight

Withdrawal period

Severity of clinical signs prior to


therapy (mean SD)

Level

Study group
KT-100

DH

Total

Male
Female
<1
1<3
3<5
5 < 10
10
Unknown
(mean SD)
Shih Tzu
Shiba Inu
West Highland white terrier
Golden retriever
Shetland sheepdog
Labrador retriever
Other
Positive
Negative
<1
1<3
3<6
6
Unknown
(mean SD)
<6
6 < 12
12
(mean SD)
2 weeks < 1 month
1 month <
Unknown
Pruritus
Excoriation
Erythema
Alopecia

63
32
31
2
15
18
24
3
1
5.08 2.77
21
10
3
4
3
1
21
40
23
13
14
20
7
9
3.13 2.41
23
24
16
10.10 7.14
14
43
6
3.58 0.66
14.98 6.04
15.86 5.43
12.37 6.23

29
9
20
0
3
7
11
8
0
7.35 3.93
16
3
2
0
0
1
7
20
9
5
2
4
4
14
3.37 3.10
11
14
4
7.56 4.33
3
26
0
3.55 0.69
12.74 6.00
13.83 5.71
11.07 7.02

92
41
51
2
18
25
35
11
1
5.80 3.34
37
13
5
4
3
2
28
60
32
18
16
24
11
23
3.18 2.55
34
38
20
9.30 6.47
17
69
6
3.57 0.67
14.28 6.08
15.22 5.57
11.07 7.02

Significance
P = 0.0765*

P = 0.0216*

P = 0.3170*

P = 0.6086*
P = 0.4019*

P = 0.4191*

P = 0.1176*

P = 0.8543
P = 0.1007
P = 0.1050
P = 0.3752

*chi-square test, Students t-test.

was used for 2-grade evaluation (excellent + good and fair + no effect
+ worse). The outcome measures for efficacy analysis were assessed
per protocol. The clinical scores of all the dogs were included in the
statistical analyses, whether or not the dog had completed the study.
All missing clinical scores were replaced using the last value carry
forward rule.

Results
Subjects
One hundred and nine dogs (KT-100 group: 75, DH group:
34) were enrolled in the study. Seventeen dogs (KT-100
group: 12, DH group: 5) were excluded from the efficacy
analysis on day 14 and two dogs (KT-100 group) were
excluded from the efficacy analysis on day 28 because of
deviation from the study protocol. Of the excluded dogs,
three (KT-100 group: 2, DH group: 1) had heart disease;
one each (KT-100 group) had hypothyroidism, seborrhoeic
dermatitis and flea allergy dermatitis; three (KT-100 group:
1, DH group: 2) lacked clinical scores on the initial day and
two (KT-100 group) did not meet the required withdrawal
period. During the study, existing shampoo therapy was
changed or the frequency of bathing was increased in two
dogs (DH group), medication was discontinued on day 7 as

per owners request in one dog (KT-100 group), three dogs


(KT-100 group) showed relapse with secondary infection
(M. pachydermatis) on days 7, 9 and 14, respectively, and
two dogs (KT-100 group) were diagnosed with sarcoptic
mange on days 19 and 21, respectively. Therefore, 92 dogs
(KT-100 group: 63, DH group: 29) were evaluated from day
0 to day 14, and 90 dogs (KT-100 group: 61, DH group: 29)
completed the study. Data on adverse reactions were
recorded for all dogs.
Signalment and clinical data
The signalments and clinical data for each group are shown
in Table 3. There were no differences between the two
groups in all parameters except the age distribution. The mean
age of the dogs in the DH group was above 2.3 years.
Twenty-two breeds were enrolled: Shih Tzu (37), Siba Inu
(13), West Highland White terrier (5), Miniature dachshund
(5), golden retriever (4), Shetland sheepdog (3), Cavalier
King Charles spaniel (3), Labrador retriever (2), Yorkshire
terrier (2), Welsh corgi Pembroke (2), American cocker
spaniel (2), Great Pyrenees (1), dachshund (1), toy poodle
(1), Basset hound (1), Papillion (1), beagle (1), Maltese (1),
Miniature schnauzer (1), Wire fox terrier (1), Kishu inu (1)
and mongrel (4). Although the allergen-specific IgE test

2006 The Authors. Journal compilation 2006 European Society of Veterinary Dermatology.

197

T. Iwasaki and A. Hasegawa

Figure 1. Time course of each clinical scores of atopic dogs administered KT-100 or DH.
Significant differences in the scores of pruritus, excoriation and erythema were observed between the KT-100 group and the DH group on days
21, 28 and 56, while that of alopecia was observed on day 56 (Students t-test).

Table 4. Degree of improvement by symptom on final evaluation day


Symptom
Pruritus
Excoriation
Erythema
Alopecia

Study
group

Excellent

Good

Fair

No
effect

Worse

Total

KT-100
DH
KT-100
DH
KT-100
DH
KT-100
DH

19
1
36
2
37
4
29
2

25
5
9
6
9
3
8
5

12
12
10
11
9
13
13
14

5
10
0
0
0
2
5
2

0
1
6
10
6
7
6
6

61
29
61
29
61
29
61
29

used in this study evaluated the reactions to 24 allergens,


including environmental antigens, 32 of the 92 dogs (34.7%)
demonstrated a negative reaction to all the allergens.
Steroids had been given to 17 dogs (18.5%) prior to the
withdrawal period of 2 weeks to less than 1 month, and to
69 dogs (75%) prior to the withdrawal period of 1 month
or more. The history of steroid administration of six dogs
(6.5%) was unknown because they were new patients.
The route of administration of the steroid preparations to
the 17 dogs prior to the withdrawal period was as follows: oral
(prednisolone; 11), injection (prednisolone; 3, triamcinolone;
2), and topical (dolbalon; 1). The percentage reductions in
pruritus, excoriation, erythema and alopecia on day 28 were
not significantly different between groups with a withdrawal
period of 2 weeks to less than 1 month and groups with a
withdrawal period of 1 month or more (Students t-test,
pruritus: KT-100 group, P = 0.0813, DH group, P = 0.3397;
excoriation: KT-100 group, P = 0.3405, DH group, P =
0.9290; erythema: KT-100 group, P = 0.1036, DH group,
P = 0.9083; alopecia: KT-100 group, P = 0.4081, DH group,
P = 0.7217).
Efficacy
As shown in the results of the 5-grade efficacy analysis for
pruritus, excoriation, erythema and alopecia on day 28
(Table 4), the efficacy rates of the KT-100 group on day 28
were 72.1% for pruritus, 73.8% for excoriation, 75.4% for
erythema and 60.7% for alopecia, which were significantly
higher than those of the DH group (20.7% for pruritus,
27.6% for excoriation, 24.1% for erythema and 24.1%
for alopecia).
198

MannWhitneys
U-test
P < 0.0001
P < 0.0001
P < 0.0001
P = 0.0009

Efficacy rate
72.1%
20.7%
73.8%
27.6%
75.4%
24.1%
60.7%
24.1%

Chi-square
test
P < 0.0001
P < 0.0001
P < 0.0001
P = 0.0012

Changes in pruritus, excoriation, erythema and alopecia


scores of the two groups from the initial day of examination
to day 56 are shown in Fig. 1. Significant differences in
the scores of pruritus, excoriation and erythema were
observed between the KT-100 group and the DH group on
days 21, 28 and 56, while a significant difference in the
score of alopecia was observed on day 56.
There were 53 dogs of the KT-100 group and 26 dogs of
the DH group in the subsequent 4-week follow-up period
after the 4-week treatment. The trial was discontinued in
eight dogs of the KT-100 group because of lack of response
(3), remission (2), owners request (2) and change in bathing
frequency (1), and in three dogs of the DH group, because
of lack of response (1), exacerbation of clinical signs (1) and
owners request (1). The two dogs that went into remission
were maintained after the injections were stopped. The
frequency of administration of KT-100 from day 28 to day
56 was 03 in 14 dogs (26.4%), 4 in 32 dogs (60.4%), and
512 in seven dogs (13.2%), for an average of 3.7 administrations. The injections were thus given on average
approximately once weekly. Seven dogs (13.2%) were not
administered KT-100 during the entire 4-week follow-up
period. The efficacy rates of the KT-100 group on day
56 were 79.2% for pruritus, 79.2% for excoriation, 81.1%
for erythema and 73.6% for alopecia, and those of the
DH group were 34.6% for pruritus, 34.6% for excoriation,
38.5% for erythema and 23.1% for alopecia.
Adverse events
All dogs of the KT-100 and DH groups were evaluated for
adverse events during the 8-week trial period. Adverse

2006 The Authors. Journal compilation 2006 European Society of Veterinary Dermatology.

Efficacy of KT-100 in canine atopic dermatitis

events included pain at the time of injection (one dog) and


keratoconjunctivitis sicca (KCS) of the left eye (one dog) in
the KT-100 group. The former dog suffered pain at each
injection. KCS was observed in the latter dog on day 49;
however, because this dog had suffered from KCS in the
past, the veterinarian concluded that KT-100 was not the
cause of the KCS. Thus, of the two events, only the former
was judged to have a relationship with KT-100, and no
serious adverse events were observed other than pain.
There were no abnormal changes in laboratory data of the
two dog groups after completion of the study.

Discussion
Canine AD is a chronic disease that requires lifelong
control. Although systematic reviews of drugs for treating
canine AD have been conducted in recent years, high efficacy was noted only for glucocorticoids and cyclosporin.5
However, glucocorticoids are frequently associated with
such adverse effects as polydipsia and polyuria, although
they are commonly prescribed for symptomatic treatment
in Japan. Although mild cases can be controlled to a certain
extent with medicated shampoos, antihistamines and
Chinese herbal medicine, thereby reducing dependency on
steroids, moderate and severe cases often require steroids
at an appropriate dosage and frequency to achieve high
efficacy. Cyclosporine has been associated with vomiting
(incidence: 14 42%), diarrhoea (incidence: 1618%) and
skin infection (incidence: 29%).5 Although hyposensitization
therapy has been employed, it is not widely used in Japan
when compared with the USA or EU, because it requires
long-term and frequent injection of allergens, and because it
can induce side-effects such as systemic allergic reactions.
In this study, we showed that KT-100 is significantly
more effective for the treatment of canine AD than DH, an
antihistamine preparation currently used for the treatment
of allergic dermatitis in Japan. Compared with DH
administration, KT-100 administration for 4 weeks resulted
in significant improvement of all clinical signs assessed in
this study, including pruritus, excoriation, erythema and
alopecia. Compared with the DH group, we noted significant
reductions in the scores of pruritus, excoriation and erythema in the KT-100 group from day 21, and a significant
reduction in the score of alopecia on day 56. Obviously,
alopecia takes longer to resolve than the inflammatory
changes due to the time taken for hair regrowth. In many
clinical studies to assess the efficacy of drugs on canine
AD, the observation period is usually set between 3 and
8 weeks.1518 In our study, the administration period was
set at 4 weeks, followed by a 4-week follow-up period.
Therefore, the 4-week clinical study period for canine AD
may be sufficient. The results of the follow-up period
suggested that the effect of KT-100 might persist over the
course of 4 weeks even when the frequency of administration was reduced to once a week or less.
In this study, we used DH as the control because it is the
only drug authorized for treating canine allergic dermatitis
and pruritic dermatitis by the Japanese government. In
this regard, a blinded study is difficult due to the difference
in the route of administration, namely, injection and topical,
and therefore, a randomized trial that involved comparison
with a control drug was performed.

In 18.5% of our cases, the steroid withdrawal period


prior to the study was between 2 weeks and 1 month, and
82.3% of these dog patients had been using prednisolone
(oral: 64.7%, injection: 17.6%). As most of the clinical
trials for canine AD have a withdrawal period of more than
1 month, the optimum withdrawal period for prednisolone
is controversial. Our results showed no significant difference
between the < 2 weeks to 1 month withdrawal period
group and > 1 month withdrawal period group; therefore,
the steroid withdrawal period of at least 2 weeks had no
effects on the results.
In canine AD, allergen-specific IgE antibody levels tend to
increase; however, 34.8% of the dogs enrolled in this study
did not show any positive reaction to common allergens.
In general, serum testing is considered to be no more
reliable than intradermal skin testing for the identification
of causative allergens in atopic patients19 and the results
of ELISA vary depending on the assay used, the antibody
measured and the allergens tested. Mueller et al. demonstrated that 27.4% of atopic dogs showed negative
serological testing for IgE, compared with the results of
intradermal skin testing.20
Several reports have indicated improvement in human
AD following administration of IFN-.14 In this study, we
showed that KT-100, a canine IFN-, was effective for the
treatment of canine AD. Moreover, the administration of
KT-100 for 2 months produced no serious adverse events.
However, its safety in the case of administration for more
than 2 months is unknown, and thus additional studies
are required in the future. Since AD is a chronic disease
that requires lifelong control, a safe form of treatment is
required. Through future research, it is hoped that KT-100
will become one of the mainstay treatment modalities for
canine AD.

Acknowledgements
The authors would like to thank the following veterinarians
who collaborated in the clinical study: Drs Riko Itoh, Takuya
Kubo, Ikuo Konishi, Satoshi Saitoh, Toru Takahashi, Shingo
Torigoe, Kazutaka Takehara, Michio Yamaguchi, Kenichi
Mizoguchi, Tomiya Uchino, Satoru Yonezawa, Hirohide
Kamimura, Koji Nishida, Tetsuya Shimoda, Fumio Shibasaki,
Kaoru Kato, Masahiko Takenaka and Teruaki Amimoto. We
are grateful to Ms Toshiko Sakamoto (Toray Industries Inc.)
for her excellent help in preparing the manuscript.

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Rsum Un interfron - (KT-100) recombinant de chien et un antihistamine topique (la diphnhydramine:


DH) ont t administrs des chiens souffrant de dermatite atopique (AD) pendant 4 semaines pour
comparer leurs efficacits relatives au niveau du prurit, des excoriations, de lrythme et de lalopcie.
Ltude a enrl 92 chiens atopiques (KT-100: 63 chiens, DH: 29 chiens) recruts dans 18 cliniques
vtrinaires au Japon. Le KT-100 a t administr par voie sous cutane une fois par jour, trois fois par
semaine, tous les deux jours, pendant 4 semaines. DH a t administre par voie topique deux fois par jour
pendant 4 semaines. Lefficacit pour le groupe KT-100 J28 tait de 72.1% pour le prurit, 73.8% pour les
excoriations, 75.4% pour lrythme et 60.7% pour lalopcie, rsultats significativement plus levs que
ceux observs dans le groupe DH (20.7% pour le prurit, 27.6% pour les excoriations, 24.1% pour lrythme
et 24.1% pour lalopcie).
Resumen Se compar la eficacia del Interfern- (KT-100) frente a un antihistamnico tpico (difenhidramina:
DH) en perros con dermatitis atpica. El tratamiento se realiz durante cuatro semanas y se valoraron prurito,
excoriacin, eritema y alopecia como criterios de evaluacin. Los estudios clnicos en 92 perros con atopia
(grupo KT-100: 63; grupo DH: 29) se condujeron en 18 hospitales veterinarios en Japn. KT-100 se administr
por va subcutnea una vez al da y tres veces por semana en das alternos, durante un total de cuatro
semanas. DH se administr por va tpica dos veces al da durante cuatro semanas. El porcentage de eficacia
en el grupo KT-100 en el da 28 fue de un 72.1% para el prurito, 73.8% para la excoriacin, 75.4% para el
eritema y 60.7% para la alopecia, porcentages que fueron significativamente mayores que los obtenidos
en el grupo DH (20.7% para el prurito, 27.6% para la excoriacin, 24.1% para la alopecia).
Zusammenfassung Rekombinantes canines Interferon- (KT-100) oder topisches Antihistamin (Diphenhydramin: DH) wurde Hunden mit atopischer Dermatitis (AD) vier Wochen lang verabreicht. Ihre Wirksamkeit
wurde verglichen, wobei Juckreiz, Exkoriation, Erythem und Alopezie als Evaluationskriterien verwendet
wurden. Klinische Studien mit 92 atopischen Hunden (KT-100 Gruppe: 63, DH Gruppe: 29) wurden in 18
Tierkliniken in Japan durchgefhrt. KT-100 wurde vier Wochen lang einmal tglich, dreimal pro Woche an
alternierenden Tagen subkutan verabreicht. DH wurde zweimal tglich vier Wochen lang topisch verwendet.
Die Wirksamkeitsraten der KT-100 Gruppe am Tag 28 waren 72.1% fr Juckreiz, 73.8% fr Exkoriation,
75.4% fr Erythem und 60.7% fr Alopezie. Diese Werte waren signifikant hher als die in der DH Gruppe
(20.7% fr Juckreiz, 27.6% fr Exkoriation, 24.1% fr Erythem und 24.1% fr Alopezie).

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2006 The Authors. Journal compilation 2006 European Society of Veterinary Dermatology.

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