RAPTIVA and Plaque Psoriasis

RAPTIVA is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The information in this section is intended to provide a general overview of RAPTIVA.

• Mechanism of Action
• Clinical Experience
• Efficacy Information
• Dosing & Administration
• Safety Information
• Distribution & Support for Patients

Mechanism of Action

RAPTIVA has a unique, targeted mechanism of action

• RAPTIVA works differently:
• RAPTIVA [efalizumab] has a different mechanism of action that targets T-cells. RAPTIVA blocks T-cell activation, reactivation, and trafficking
• Binds to CD11a sites
• Modulates T-cell behavior, interrupting key steps in the inflammatory cascade
• Is the only biologic that is a targeted, reversible T-cell modulator
• Considered a reversible therapy because, following plasma clearance of RAPTIVA, T-cell function recovers rapidly^1,2

• RAPTIVA does not:
• Bind tumor necrosis factor (TNF)
• Induce T-cell apoptosis (cell death)

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Efficacy Information

RAPTIVA gives patients significant improvement, sustained over time.

PASI response at 3 and 6 months

• In phase III clinical trials
• 27% of patients achieved PASI 75 at 3 months1; 44% at 6 months^4,5
• 59% of patients achieved PASI 50 at 3 months1; 66% at 6 months^4,5

A randomized, double-blind, parallel-group, placebo-controlled, multi-center study in which patients received 1 mg/kg/wk RAPTIVA (n = 369) or placebo (n = 187) for 3 months. Patients on RAPTIVA who completed the initial treatment were allowed to enter an open-label extension trial at the same dose for an additional 3 months.

RAPTIVA is the only biologic with demonstrated experience in psoriasis for over 3 years.

Efficacy in open-label study over 36 months (ITT)

• Improvement in PASI response over 36 months (ITT)⁶
• 41% of patients reached PASI 75 by 3 months; 45% by 36 months
• 13% of patients reached PASI 90 at 3 months; 25% at 36 months

Efficacy in open-label study over 36 months (AT)^5,6

• Improvement in PASI response over 36 months (AT)⁶
• 41% of patients reached PASI 75 by 3 months; 73% by 36 months
• 13% of patients reached PASI 90 at 3 months; 40% at 36 months

A long-term, 36-month, open-label clinical trial in which patients who achieved ≥ PASI 50 or a static Physician's Global Assessment (sPGA) rating of clear, minimal, or mild after an initial 3 months of treatment could enter the maintenance treatment period. Intent-to-treat (ITT) group consisted of all 339 patients who enrolled in the study, even if they did not meet the criteria to enter into the maintenance treatment period. As-treated (AT) group included only those patients who remained in the study to initiate a treatment segment. During the maintenance treatment period, concomitant topical psoriasis therapies or UVB were permitted.

* During the initial 3-month treatment period, enrolled patients received SC efalizumab 2 mg/kg/week. After this 3-month period, patients who achieved at least a 50% improvement in baseline PASI or sPGA grading of clear, minimal, or mild were eligible to enter the maintenance portion of the study. + Patients were transitioning out of the study during the last 3 months.

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Safety Information

The most serious adverse reactions observed during treatment with RAPTIVA were serious infections, malignancies, immune-mediated thrombocytopenia, immune-mediated hemolytic anemia, arthritis events, and psoriasis worsening and variants. Serious infections and immune-mediated thrombocytopenia have been reported during post-marketing surveillance. Physicians should follow patients for signs and symptoms of thrombocytopenia; platelet monitoring is recommended. Acellular, live, and live-attenuated vaccines should not be administered during RAPTIVA treatment.

The most common adverse reactions associated with RAPTIVA were a symptom complex that included headache, chills, fever, nausea and myalgia within 48 hours following the first two injections. These events were largely mild-to-moderate when a conditioning dose of 0.7 mg/kg was given, and by the third dose acute adverse affects were no different than placebo. Less than 1% of patients discontinued RAPTIVA treatment because of these adverse events.

* 4% of patients treated with RAPTIVA experienced a shift to above-normal values of alkaline phosphatase compared with 0.6% of placebo-treated patients. The clinical significance of this change is unknown.

For Important Safety Information click here.

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References:

1. Cather JC, Menter A. Modulating T cell responses for the treatment of psoriasis: a focus on efalizumab. Expert Opin Biol Ther. 2003; 3: 361-370.
2. Leonardi CL. Efalizumab: an overview. J Am Acad Dermatol. 2003; 49:S98-S104.
3. Data on file,Genentech,Inc.
4. Menter A, Gordon K, Carey W, et al. Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol. 2005;141:31-38.
5. Prescribing Information for RAPTIVA. June 2005.
6. Gottlieb AB, Gordon KB, Hamilton TK, et al. Maintenance of efficacy and safety with continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: final phase IIIb study results. Presented at 2005 AAD; February 18-23, 2005.

To find out more, see Results with RAPTIVA.