Abstract | BACKGROUND: OBJECTIVE: In this phase II study we investigated the safety, tolerability, and effectiveness of bexarotene in psoriasis at doses of 0.5 to 3.0 mg/kg/day. METHODS: Fifty patients with moderate to severe plaque-type psoriasis were treated with bexarotene in 4 sequential dose-defined panels of 12-13 patients at doses of 1.0, 2.0, 0.5, and 3.0 mg/kg/day for 12-24 weeks. Patients were monitored for safety and clinical efficacy. RESULTS: No serious adverse events related to the drug occurred. Bexarotene was well tolerated in most patients. Most frequently observed adverse events related to bexarotene were hypertriglyceridaemia (56%) and a decrease in free T4 serum levels (54%). Significant improvement of psoriasis after bexarotene at all doses was confirmed by a modified psoriasis area and severity index (mPASI), plaque elevation (PEL), and physician's global assessment ( PGA). Overall response rates (> or =50% improvement) for mPASI, PEL, and PGA were 22%, 52%, and 36%, respectively. No significant dose-response effect was established for these parameters. CONCLUSION: The present study indicates an anti-psoriatic effect of bexarotene. Further studies are necessary to assess the optimal dose and the potential for bexarotene as a new therapy for psoriasis.
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Authors | Jürgen V Smit, Manon E J Franssen, Elke M G J de Jong, Julien Lambert, Diane I Roseeuw, Jozef De Weert, Richard C Yocum, Victor J Stevens, P C M van De Kerkhof |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 51
Issue 2
Pg. 249-56
(Aug 2004)
ISSN: 1097-6787 [Electronic] United States |
PMID | 15280844
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- CD4 Antigens
- Tetrahydronaphthalenes
- Bexarotene
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Topics |
- Adult
- Bexarotene
- CD4 Antigens
(blood, drug effects)
- Female
- Humans
- Hypertriglyceridemia
(chemically induced)
- Male
- Psoriasis
(drug therapy)
- Quality of Life
- Secondary Prevention
- Tetrahydronaphthalenes
(administration & dosage, adverse effects)
- Treatment Outcome
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