Psoriasis - Patient's guide

Efalizumab (RAPTIVA®)

RAPTIVA® is a recombinant humanized monoclonal antibody that binds specifically to the CD11a subunit of LFA-1 (lymphocyte function-associated antigen-1), a leukocyte cell surface protein. By this mechanism, efalizumab:

• inhibits the primary T lymphocyte activation in lymph nodes (including T lymphocyte proliferation, interleukin-2 (IL-2) receptor expression, CD11a expression, and cytokine release);
• inhibits T lymphocyte binding to endothelial cells and trafficking to psoriatic lesions;
• inhibits T lymphocyte reactivation in dermis/epidermis and interaction with keratinocytes.

RAPTIVA® is indicated for the treatment of patients with moderate-to-severe chronic plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy. It has also been studied in refractory patients who were not controlled by, contraindicated to, or intolerant to two or more systemic therapies (CLEAR study).

Clinical trial data

The efficacy of RAPTIVA® is largely based on 7 key studies that included more than 3,200 patients: 5 placebo controlled studies, plus two extension studies ranging from 12 weeks to 1 year and a long term open label trial for treatment up to 27 months. Patients randomized to the RAPTIVA® dose group achieved statistically significantly better responses than placebo on the primary endpoint, i.e., achieving a greater or equal to 75% improvement in PASI score compared to baseline in all studies. For example, in one study of 339 patients, 41% achieved PASI-75 and 82% achieved PASI-50 at week-12.

The improvement in PASI score in the RAPTIVA® arm relative to the placebo arm was seen as early as Week 2 of treatment and increased over time.

Dosing

RAPTIVA® is intended for use under the guidance and supervision of a health care professional. RAPTIVA® is administered as a subcutaneous injection and patients may self-inject following proper training in measurement of the correct dose and injection technique. Injection sites should be rotated. RAPTIVA® should be administered as an initial single 0.7 mg/kg body weight dose followed by weekly injections of 1.0 mg/kg body weight. The maximum single dose should not exceed a total of 200 mg.

Safety

The most common adverse drug reactions observed during RAPTIVA® therapy were mild to moderate dose-related acute flu-like symptoms including headache, fever, chills, nausea and myalgia. In large placebo-controlled clinical studies, these reactions were observed in approximately 17% of subjects in excess of placebo-treated patients over 12 weeks of treatment. Headache was the most prevalent type of flu-like symptoms. These reactions were greatest with the first dose administration, decreasing with the second and subsequent doses. Severe acute events of headache, chills, fever and myalgia were reported only in the RAPTIVA®-treated subjects affecting 3.6% of subjects.

Duration of Response

RAPTIVA® is best used as a continuous therapy. The median time to relapse among PASI responders who discontinued treatment after 12 weeks is approximately 67 days (time to relapse [= 50% loss of improvement] was evaluated in patients who were classified as responders [= 75% improved on PASI] after 12 weeks of treatment.). The majority of responding patients who were responders at the end of 12 weeks and continued RAPTIVA® treatment, maintained this response at 24 weeks. Extended treatment showed additional benefit for subjects who, at the end of the initial 12-week treatment, were either non-responders (subjects who did not achieve a PASI 50 response) or partial responders (subjects who achieved a PASI 50 but not a PASI 75 response). RAPTIVA® re-treatment was effective in subjects whose psoriasis recurred after RAPTIVA® withdrawal.

Drug Interactions

There have been no formal drug interaction studies conducted with RAPTIVA®. No data are available on the effects of vaccination or on the secondary transmission of infection by live vaccines in patients receiving RAPTIVA®. Patients should not receive acellular, live and live-attenuated vaccines during RAPTIVA® treatment.

The interaction of RAPTIVA® with other systemic antipsoriatic therapies, such as cyclosporin, methotrexate or oral retinoids, has not been formally studied. Limited data from clinical studies has been accumulated on concomitant use of RAPTIVA® and methotrexate, oral retinoids, UVB phototherapy, non steroidal anti inflammatory drugs (NSAIDs) and topical antipsoriastic agents. RAPTIVA® should be administered with caution in combination with these medications.

Given the mechanism of action of RAPTIVA® it is not recommended to use RAPTIVA® in combination with other immunosuppressive drugs.

Dovobet®

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• INTRODUCTION
  Dovobet (50 micrograms/gram calcipotriol and 0.5 milligrams/gram betamethasone dipropionate) is a topical ointment approved for use in Canada to treat plaque psoriasis. Dovobet has become the topical therapy of choice for many patients with plaque type psoriasis not involving the face or skin folds...   |   Read more ...



• CLININCAL EXPERIENCE
  More than six international studies involving over 6,000 patients have shown reductions in the PASI (Psoriasis Area and Severity Index) of approximately 40% after one week of treatment and 70% after four weeks...   |   Read more ...



• INDICATIONS
  Used to treat chronic plaque psoriasis that covers less than 30% of the body surface (see following slides for clarification). Dovobet is not often used to treat the scalp because the sticky base does not allow for easy application or removal...   |   Read more ...



• PATIENT PROFILE
  Patients with chronic plaque psoriasis that covers less than 30% of the body surface. In some cases, a patient could use it on a greater BSA if he/she wanted to as long as the use/week is 100 g per week or less...   |   Read more ...



• DOSING
  Dovobet should be applied to the affected area once daily for four weeks. Several studies have shown that there are no statistically significant differences between applying the ointment once daily or twice daily...   |   Read more ...



• EFFICACY
  Six international studies involving more than 6,000 patients using Dovobet to treat psoriasis have shown PASI reductions of approximately 40% after one week of treatment and 70% after four weeks. Additional studies have shown that Dovobet has superior...   |   Read more ...



• COMPLIANCE
  Compliance is aided by the convenience of the once daily dosing of Dovobet. Compliance is also less of a problem than with most products due to the rapid onset of action. Significant improvement is usually seen within the first week...   |   Read more ...



• SIDE EFFECTS, SAFETY AND RISKS
  Because Dovobet is a combination drug, the frequency of side effects reported is less than would be expected if using each compound on its own: for example, the anti-inflammatory action of the corticosteroid (betamethasone dipropionate) minimizes the irritation often reported when using calcipotriol alone...   |   Read more ...



• COST OF TREATMENT
  It is probably the single most effective topical therapy available for psoriasis, so patients are generally prepared to pay for this. It is somewhat more expensive than the equivalent potent topical steroid, but the rapid and significant improvement in quality of life...   |   Read more ...

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