Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence

Phase 4

Completed

Interventions: Drug: Cyclosporins
Drug: Retinoids
Drug: Systemic corticosteroids
Drug: Methotrexate
Drug: Systemic corticosteroids/methotrexate

Brief Summary: This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.

Recruitment & Eligibility

Inclusion Criteria

Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study IMP24011.
Inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and inflammatory in nature.
Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care.
Female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either:
- Being post-menopausal or surgically sterile, or
- Using an accepted form of contraception.
Confirmation that the subject was not pregnant had to be established by a negative urinary hCG test at SD1. A pregnancy test was not required if the subject was post-menopausal or surgically sterile.
Outpatient status at the time of enrolment.

Exclusion Criteria

Disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.

Arm && Interventions

Group	Intervention	Description
Cyclosporin	Cyclosporins	Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
Retinoids	Retinoids	Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
Systemic corticosteroids	Systemic corticosteroids	Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
Methotrexate	Methotrexate	Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
Systemic corticosteroids/methotrexate	Systemic corticosteroids/methotrexate	Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.

Primary Outcome Measures

Name	Time	Method
Physician's Global Assessment (PGA) of Change Over Time (Good or Better)	12 weeks	The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline: Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%

Secondary Outcome Measures

Name	Time	Method
Patient's Global Psoriasis Assessment (PGPA)	12 weeks	The PGPA consisted of a single self-explanatory item: On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now. Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis).