Randomised comparison of thalidomide versus placebo in toxic epidermal necrolysis

Wolkenstein, Pierre; Latarjet, J; Roujeau, Jean‐Claude; Duguet, C.; Boudeau, S.; Vaillant, L; Maignan, M.; Schuhmacher, Marie-Hélène; Milpied, B.; Pilorget, A.; Bocquet, Hélène; Brun‐Buisson, Christian; Revuz, J.

doi:10.1016/s0140-6736(98)02197-7

Cited by 385 publications

(209 citation statements)

References 24 publications

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“…On the basis of this information, the potential for blockingTNF-a inTEN has attracted significant interest.Thalidomide has been reported to inhibit TNF-a in vitro and in vivo [46].In fact the only randomized controlled trial of therapy inTEN was a trial of thalidomide [47].The trial had to be stopped early because of an excess mortality in the treatment group. However, it should be noted that the authors concluded that their data suggested that thalidomide did not inhibit TNF-a in that study,and that the excess mortality may have been related to other effects of thalidomide.…”

Section: Intravenous Immunoglobulin (Ivig)mentioning

confidence: 99%

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Skin manifestations of drug allergy

Ardern‐Jones

Friedmann

2011

Brit J Clinical Pharma

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Cutaneous adverse drug reactions range from mild to severe and from those localized only to skin to those associated with systemic disease. It is important to distinguish features of cutaneous drug reactions which help classify the underlying mechanism and likely prognosis as both of these influence management decisions, some of which necessarily have to be taken rapidly. Severe cutaneous reactions are generally T cell-mediated, yet this immunological process is frequently poorly understood and principles for identification of the culprit drug are different to those of IgE mediated allergic reactions. Furthermore, intervention in severe skin manifestations of drug allergy is frequently necessary. However, a substantial literature reports on success or otherwise of glucocorticoids, cyclophsphamide, ciclosporin, intravenous immunoglobulin and anti-tumour necrosis factor therapy for the treatment of toxic epidermal necrolysis without clear consensus. As well as reviewing the recommended supportive measures and evidence base for interventions, this review aims to provide a mechanistic overview relating to a proposed clinical classification to assist the assessment and management of these complex patients.

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Section: Intravenous Immunoglobulin (Ivig)mentioning

confidence: 99%

“…Other treatment approaches including GM-CSF, insulin, zinc and N-acetylcysteine remain largely untested in significant numbers of patients [35,47].…”

Section: Intravenous Immunoglobulin (Ivig)mentioning

confidence: 99%

Skin manifestations of drug allergy

Ardern‐Jones

Friedmann

2011

Brit J Clinical Pharma

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“…Wolkenstein and associates started a placebo-controlled study of thalidomide with immunosuppressive and anti-angiogenic effects, mediated by reduced release of TNF-alpha from monocytes. However, the study was ended because higher mortality was recorded in the group of patients receiving thalidomide (43).…”

Section: Pharmacological Therapymentioning

confidence: 99%

An update on diagnosis and treatment of toxic epidermal necrolysis / Novine u dijagnostici i lečenju toksične epidermalne nekrolize

Kandolf-Sekulović¹

2011

Serbian Journal of Dermatology and Venerology

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Toxic epidermal necrolysis is an idiosyncratic drug reaction which manifests with extensive epidermal detachment due to the massive keratinocyte apoptosis, mucous membrane involvement, and potentially lethal outcome. It is caused by adverse reactions to drugs, mostly idiosyncratic, unpredictable and independent of the applied dose, which develops 7-21 days after initiation of the drug, and is most commonly caused by the following drugs: sulfonamides, allopurinol, carbamazepine, phenobarbitone, phenytoin and oxycam group of nonsteroidal anti-inflammatory drugs. The treatment outcome depends on several factors, while older age, multiple drug use, late exclusion of the drug inducing toxic epidermal necrolysis, raised serum levels of urea, creatinine and cytopenia are poor prognostic indicators which are rated in SCORTEN scoring which proved to be of great help in the assessment of disease outcome. The basic approach to the treatment is early diagnosis, immediate suspension of the probable inducing drug, and emergency transport to the closest burn center, since treatment in burn units is associated with a lower risk of infection and mortality of these patients. Exclusion of the drug that induced toxic epidermal necrolysis, and supportive therapy, is the first and only therapy for which there is a consensus in different centers. Various forms of adjuvant therapy are also applied: in France, supportive therapy is a standard of care, in Germany it is short-term use of high-dose corticosteroids, while in USA, in the last decade high-dose intravenous immunoglobulins are the most widely accepted treatment modalities. Case reports and small patients' series described therapeutic effects of plasmapheresis, cyclosporine and other immunosuppressants. In conclusion, elimination of the possible causal agent, rapid transport to the burn unit, and multidisciplinary approach to treatment are of utmost importance for favorable outcome of the disease with 20-30% mortality rate. An update on diagnosis and the treatment of toxic epidermal necrolysis is provided in this review.

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“…L'essai thalidomide-Lyell a été mené sur une population très particulière, représentant une maladie rare dans laquelle aucun essai randomisé n'avait été conduit jusque-là [4], et avec relativement peu de données épidémiologiques disponibles en termes de critères d'évaluation. La mortalité moyenne de ce syndrome est de l'ordre de 30%.…”

Section: Essai Thalidomide Dans Le Syndrome De Lyell Et Essai Cythalunclassified

“…L'essai avait pour critère de jugement principal l'étendue du décollement cutané et était planifié pour inclure 50malades. Rapidement, des investigateurs expérimen-tés appartenant au centre ayant le plus grand recrutement notèrent une mortalité inhabituellement élevée parmi les malades inclus [4]. Un comité fut réuni en urgence sur cette constatation.…”

Section: Essai Thalidomide Dans Le Syndrome De Lyell Et Essai Cythalunclassified

Randomised comparison of thalidomide versus placebo in toxic epidermal necrolysis

Cited by 385 publications

References 24 publications

Skin manifestations of drug allergy

Skin manifestations of drug allergy

An update on diagnosis and treatment of toxic epidermal necrolysis / Novine u dijagnostici i lečenju toksične epidermalne nekrolize

Les DSMB 2. De l’importance d’un DSMB efficace : exemples d’essais cliniques « à risque »

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