Abstract | BACKGROUND: METHODS: This study consisted of a randomized, double-bind, parallel, placebo-controlled, investigator-masked, multicenter trial lasting 3 months and an open-label study from month 3 to month 6. Adults with a clinical and histologic diagnosis of cutaneous sarcoidosis were included in nine hospital centers in France. Patients were randomized 1:1 to oral thalidomide (100 mg once daily) or to a matching oral placebo for 3 months. In the course of an open-label follow-up from month 3 to month 6, all patients received thalidomide, 100 mg to 200 mg daily. The proportions of patients with a partial or complete cutaneous response at month 3, based on at least a 50% improvement in three target lesions scored for area and infiltration, were compared across randomization groups. RESULTS: The intent-to-treat population included 39 patients. None of them had a complete cutaneous response. Four out of 20 patients in the thalidomide group (20%) vs four out of 19 patients in the placebo group (21%) had a partial cutaneous response at month 3 (difference in proportion of -1% [95% CI, -26% to +24%] for thalidomide vs placebo, P = 1.0). Eight patients with side effects were recorded in the thalidomide group vs three in the placebo group. We observed a large number of adverse event-related discontinuations in patients taking thalidomide in the first 3 months (four patients with thalidomide, zero with placebo) and in the 3 following months (five patients). CONCLUSIONS: At a dose of 100 mg daily for 3 months, our results do not encourage thalidomide use in cutaneous sarcoidosis. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT0030552; URL: www.clinicaltrials.gov.
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Authors | Catherine Droitcourt, Michel Rybojad, Raphaël Porcher, Caroline Juillard, Anne Cosnes, Pascal Joly, Jean-Philippe Lacour, Michel D'Incan, Nicolas Dupin, Bruno Sassolas, Laurent Misery, Jacqueline Chevrant-Breton, Bénédicte Lebrun-Vignes, Kristell Desseaux, Dominique Valeyre, Jean Revuz, Abdellatif Tazi, Olivier Chosidow, Alain Dupuy |
Journal | Chest
(Chest)
Vol. 146
Issue 4
Pg. 1046-1054
(Oct 2014)
ISSN: 1931-3543 [Electronic] United States |
PMID | 24945194
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Immunosuppressive Agents
- Thalidomide
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Topics |
- Adult
- Aged
- Double-Blind Method
- Female
- France
- Humans
- Immunosuppressive Agents
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Remission Induction
- Sarcoidosis
(drug therapy)
- Skin Diseases
(drug therapy)
- Thalidomide
(adverse effects, therapeutic use)
- Treatment Outcome
- Young Adult
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