A phase II multicenter clinical trial of systemic bexarotene in psoriasis.

Abstract

BACKGROUND:

Bexarotene, a novel and unique synthetic P, RXR-selective retinoid, is available as a treatment for cutaneous T-cell lymphoma. In psoriasis, a common retinoid-sensitive disease, no data are available on bexarotene treatment.

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.

• 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)

Chemical References

• CD4 Antigens
• Tetrahydronaphthalenes
• Bexarotene

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