Diepgen_subbed.qxp 27/5/09 3:19 pm Page 38
Chronic Hand Eczema
Figure 4: Physician’s Global Assessment consistent with that observed during the first stage of the BACH
Responses at End of Re-treatment of Relapsed
study, and no late-arising toxicities were observed.
12
BACH Study Responders
As with all retinoid treatments, teratogenicity is an issue when
100
Clear
90
prescribing to female patients of child-bearing age. Strict adherence
Almost clear
80
80% to pregnancy prevention measures is necessary when receiving
70
alitretinoin before, during and after treatment.
)
%
60
50
48%
Guidelines for the Treatment of
P
atients ( 40 Chronic Hand Eczema
30
As mentioned above, the current treatment paradigm for CHE is
20
based on disease severity and follows a stepwise approach. However,
10
10% 8%
with alitretinoin entering the marketplace a revision of the current
0
Placebo Alitretinoin 10mg Placebo Alitretinoin 30mg
treatment algorithm is recommended to clearly define the place of
(n=10) (n=21) (n=24) (n=49)
alitretinoin as the only licensed systemic treatment for severe CHE in
Up to 80% of patients can be successfully re-treated by a second 12–24-week course of
the long-term management of CHE.
alitretinoin, as determined by the Physician’s Global Assessment (PGA) score.
New treatment guidelines for HE have been developed in Germany by
of the BACH trial and were treated for an additional 12–24 weeks the author of this article and colleagues in association with the German
with alitretinoin 30mg. Forty-seven per cent of those 248 patients Dermatology Association (DDG).
15
These guidelines recommend the use
achieved PGA scores of clear or almost clear at the end of of alitretinoin for persistent or chronic relapsing HE when topical
treatment. Moreover, the median mTLSS score at the end of therapies have failed. European Contact Dermatitis Society (ECSD)
treatment was reduced by 82% compared with baseline.
13
A total of guidelines are also in preparation. These guidelines will provide long-
117 patients who had responded to treatment in the BACH study
11
awaited systematic guidance for treating this multifaceted disease.
and relapsed on follow-up of up to six months were eligible to enrol
in an additional study to evaluate whether re-treatment with Conclusion
alitretinoin results in similar efficacy to the initial treatment. A total CHE is a highly visible disease that can be debilitating and has a
of 104 relapsed patients completed this additional study, having significant physical and emotional burden on patients, particularly for
been randomised to receive alitretinoin 30mg (n=21), alitretinoin those who are unresponsive to topical treatments. Given the
10mg (n=49) or placebo (n=34) once daily for 12–24 weeks. Patient limitations of current treatments, there is a clear unmet need for
response was again defined as the percentage of patients with a effective intermittent treatments in the long term for CHE that is
PGA score of clear or almost clear. Figure 4 shows that at the end unresponsive to potent topical corticosteroids that can improve the
of re-treatment, both alitretinoin groups had substantially higher prognosis of this chronic disease.
response rates compared with their respective placebo controls
(alitretinoin 10mg: 48 versus 10%; alitretinoin 30mg: 80 versus 8%). With the introduction of alitretinoin, physicians and patients with severe
These findings indicate that alitretinoin could be effective for the CHE have for the first time an efficacious licensed oral therapy for CHE.
long-term management of CHE.
12
The vitamin A derivative is currently the only evidence-based therapy
option for CHE. According to clinical data, a once-daily oral treatment
Clinical Safety Profile of Alitretinoin with alitretinoin 30mg leads to a clearing or almost clearing of the hands
Alitretinoin has been well tolerated in all clinical studies conducted to in every second patient and a median reduction of the symptoms by
date in severe CHE patients.
11–13
Adverse events were usually dose- 75%. Treatment with alitretinoin is generally well tolerated. Therefore,
related, manageable and typical of vitamin A derivatives.. Headache alitretinoin is a suitable intermittent treatment option for the long-term
was the most frequently reported side effect in patients treated with management of this chronic relapsing disease. ■
alitretinoin 30mg, which was generally well tolerated. In most cases
headache occurred early in treatment (within the first three to 10
Thomas L Diepgen is a Professor of Dermatology and
days) and could be managed with a standard analgesic (ibuprofen,
Allergology at the Ruprecht-Karls University in
paracetamol). Dry lips, cheilitis and dry skin – typical mucocutaneous Heidelberg and Past President of the European Society
side effects of retinoids were relatively rare – and similar to the rate
of Contact Dermatitis (ESCD). He is also Chairman of
the Department of Social Medicine Centre of
in the placebo group. The combined total rate of mucocutaneous side
Occupational and Environmental Dermatology of the
effects was 10%.
14
Other adverse events were typical for the retinoid University Hospital Heidelberg. Professor Diepgen is the
class, including changes in lipid levels.
author of more than 250 peer-reviewed publications
and book chapters. He is Editor in Chief of Occupational
and Environmental Dermatology, Section Editor for Contact Dermatitis and a Co-Editor
In the re-treatment study patients generally tolerated the second for the Cochrane Skin Group.
12–24-week course of alitretinoin well. The side effect profile was
1. Smit HA, et al., Int J Epidemiol, 1993;22:288–9. Dermatology: clinical and basic science series. 12. Ruzicka T, et al., EADV, 2008; abstract FC10.107.
2. Meding B, Järvholm B, J Invest Dermatol, 2002;118:719–23. 7. Meding B, et al., Br J Dermatol, 2005;152:975–80. 13. Diepgen T, et al., EADV, 2007; abstract 281.
3. Hogan DJ, et al., J Am Acad Dermatol, 1990;23:300–307. 8. Bollag W, Ott F, Dermatology, 1999;199:308–12. 14. Orfanos CE, Zouboulis CC, Dermatology, 1998;196(1):140–47.
4. Landow K, Postgrad Med, 1998;103:145–8. 9. Stephensen CB, et al., J Immunol, 2002;168:4495–4503. 15. Diepgen T, et al., J Dtsch Dermatol Ges, 2009;7(s£):s1–s16.
5. Diepgen T, et al., Contact Dermatitis, 2007;57(4):203–10. 10. Ruzicka T, et al., Arch Dermatol, 2004;140:1453–9.
6. Menne T, Maibach H, Hand eczema, 2nd edition, 11. Ruzicka T, et al., Br J Dermatol, 2008;158(4):808–17.
38 EUROPEAN DERMATOLOGY
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