The purpose of this study is to determine if calcipotriene/bethamethasone can safely and
effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving
efalizumab (Raptiva) for moderate to severe plaque psoriasis.
It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB
and thus allow patients to continue efalizumab without interruption.
LMB (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in
efalizumab treated patients. It is generally papular in nature and does not involve existing
lesions. Clinical experience suggests that LMB may not have a clinical impact in patients
responding to efalizumab and therefore may be treated without interrupting efalizumab
therapy. To relieve discomfort topical therapy may be indicated until the symptoms are
This is a single arm, open label study. Fifteen patients who are receiving efalizumab before
entrance into this study and who develop LMB wil be enrolled. Topical
calcipotriene/betamethasone (Taclonex) will be applied to the areas (except face, axillae or
groin) once a day for two weeks. The PI may choose to continue two more weeks if needed for
a total of four weeks of therapy. All patients will continue with efalizumab without dose
modification for the duration of the study. Patients will return for follow up visits at
weeks 2, 4 and 6. Topical desonide may be used for LMB involvement of the face, groin or
- Ability to provide written, informed consent and comply with study assessments for
the full duration of the study.
- Age 18 years or older.
- Moderate to severe plaque psoriasis being treated with efalizumab.
- Develop LMB during efalizumab treatment.
- PGA of LMB at least mild (2) excluding face, axillae and groin.
- Patients with known hypersensitivity to efalizumab, calcipotriene/betamethasone or
any of its components.
- Pregnant or lactating women.
- Known or suspected disorders of calcium metabolism.
- Erythrodermic, exfoliative and/or pustular psoriasis.
- Concomitant use of topical thaerapy, phototherapy or immunosuppressive agents.
- LMB (in areas other than face, axillae or groin) constitutes more than 30% of total
body surface area.
- Patients with generalized inflammatory flare which is defined as widespread worsening
of psoriasis characterized by erythematous and and edematous lesions within exisiting
- Any other condition the investigator believes would pose a significant hazard to the
subject if the investigational therapy were initiated.