A phase II multicenter clinical trial of systemic bexarotene in psoriasis - 24/08/11
Nijmegen, The Netherlands; Antwerp, Brussels, and Ghent, Belgium; and San Diego, California
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 (≥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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 | Funding sources: Supported by Ligand Pharmaceuticals Incorporated, San Diego, California. Conflicts of interest: None identified. Presented in part as a plenary paper at the SID congress in Chicago in May 2000. Reprints not available from authors. |
Vol 51 - N° 2
P. 249-256 - août 2004 Retour au numéro
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- E-mail TOC box p 248
- Systemic treatment of psoriatic patients with bexarotene decreases epidermal proliferation and parameters for inflammation, and improves differentiation in lesional skin
- Jürgen V Smit, Elke M.G.J de Jong, Candida A.E.M van Hooijdonk, Marisol E Otero, Jan B.M Boezeman, Peter C.M van de Kerkhof
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