RAPTIVA for hand & foot plaque psoriasis

Results with RAPTIVA

Clinical study confirms safety and efficacy of RAPTIVA in chronic moderate to severe plaque psoriasis involving the hands and feet.

  • Baseline

  • After 3 months on RAPTIVA

  • BSA Percent Over Time


Individual results may vary


CASE STUDY: Allen K.*, significant improvement of psoriasis in a patient with comorbid congestive heart failure (CHF)

  • Patient overview

    • 64-year-old male, 5'10", 195 lbs/88.6 kg (BMI = 28)
    • 8-month history of moderate to severe plaque psoriasis of the arms, legs, trunk, and feet
    • Comorbidities included alcohol abuse and CHF

    Prior treatments

    • Inadequate response to clobetasol, calcipotriene ointment, and ketoconazole cream

  • Clinical course on RAPTIVA

    (RAPTIVA 1 mg/kg SC weekly, after initial 0.7 mg/kg conditioning dose)

    • Baseline psoriasis BSA 20%
    • Visible improvement after 1 month
    • At 3 months, BSA improved to 5%
      • Feet: resolution of pain and fissuring, plaques thinner and less lichenified
      • Body: only post inflammatory changes and residual hyperpigmentation

This case study shows one patient's response to treatment with RAPTIVA for a given period of time. *Name has been changed to protect patient's privacy. Patient case information provided by Deborah Englert, MD

Clinical Data

Efficacy Data

In the only randomized, placebo-controlled clinical trial of a biologic for chronic plaque psoriasis involving the hands and feet:

46.2% of patients with chronic moderate to severe plaque psoriasis involving the Hands and Feet achieved a PGA score of Clear, Almost clear, or Mild by 12 weeks (P=0.015 vs placebo)1

In the only hand and foot clinical trial of a biologic for patients with moderate to sever plaque psoriasis, RAPTIVA delivered Clear and Almost Clear results

One third of patients (32.7%) achieved a PGA score of Clear or Almost clear by 12 weeks, compared with 7.1%of patients treated with placebo (P=0.013)


This phase IV, randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of RAPTIVA in adult patients with chronic moderate to sever plaque psoriasis involving hand and feet, with or without additional body involvement. Patients (N=80) with no previous exposure to RAPTIVA were randomized in a 2:1 ration to receive 12 weeks of either 1.0 mg/kg/week of SC RAPTIVA (n-52) or SC placebo equivalent (n=28). Patients received a conditioning dose of 0.7 mg/kg of SC RAPTIVA or placebo equivalent on Day0. Conditioning dose was followed by 11 weekly doses of 1.0 mg/kg of SC RAPTIVA or placebo equivalent.

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Challenge and Prevalence

  • Psoriasis involving the hands and feet poses unique challenges

    • Plaque Psoriasis of the hands or feet is:
    • Difficult to treat2
    • Often chronic and recurrent2
    • Responsible for added disability and physical stress above and beyond psoriasis anywhere else on the body3
  • Up to 25% of psoriasis patients suffer from chronic plaque psoriasis involving the hands or feet

  • Identifying patients with chronic plaque psoriasis of the hands and feet with or without body involvement

    • When examining patients consider:
    • Where on the body is the psoriasis?
    • Does it involve their hands and/or feet? (It is important to thoroughly examine patients' Hands and Feet because they may not self-report involvement of both)
    • Is the psoriasis adversely affecting daily activities?
    • Patient Testimony
    • "I had psoriasis on my body from head to toe. I'm a sign language interpreter for the deaf. And my hands are always in use, and when it started to develop onmy hands, I really knew. It started to interfere with my professional life; I had to do something about it."
    • Tim S., RAPTIVA patient, 7 months

Trial Design

Randomized, placebo-controlled study in adult patients with chronic moderate to severe plaque psoriasis involving the Hands and Feet1

  • Study Objective:
  • To evaluate the efficacy of a 12-week course of 1.0 mg/kg/week of subcutaneous (SC) RAPTIVA compared with placebo in adults (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the Hands and Feet
  • Study Design:
  • Phase IV, randomized, double-blind, placebo-controlled study
  • Designed to evaluate the safety and efficacy of RAPTIVA in adult patients with chronic moderate to severe plaque psoriasis involving the Hands and Feet
  • Patients (N = 80) with no previous exposure to RAPTIVA were randomized in a 2:1 ratio to receive 12 weeks of either 1.0mg/kg/week of SC RAPTIVA (n = 52) or SC placebo equivalent (n = 28)
  • Patients received a conditioning dose of 0.7mg/kg of SC RAPTIVA or placebo equivalenton Day 0
  • Conditioning dose was followed by 11 weekly doses of 1.0mg/kg of SC RAPTIVA or placebo equivalent 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.
  • Primary Outcome Measure:
  • Proportion of patients who achieved a Physician's Global Assessment (PGA) score of Clear (0), Almost clear (1), or Mild (2) at Day 84

Important Safety Information

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 most serious adverse reactions observed during treatment with RAPTIVA® [efalizumab] were serious infections, malignancies, thrombocytopenia, hemolytic anemia, arthritis events, and psoriasis worsening and variants.
  • RAPTIVA is an immunosuppressive agent. Many immunosuppressive agents have the potential to increase the risk of infection, reactivate latent, chronic infections, or increase the risk of malignancy. Patients receiving other immunosuppressive agents should not receive concurrent therapy with RAPTIVA.
  • Serious infections requiring hospitalization occurred in 0.3% of RAPTIVA patients during clinical trials, and additional serious infections have been reported during postmarketing surveillance. RAPTIVA should not be administered to patients with clinically importantinfections. If a patient develops a serious infection, RAPTIVA should be discontinued.
  • The role of RAPTIVA in the development of malignancy is not known. In clinical trials, the overall incidence of malignancies was 1.8 per 100 patient-years for RAPTIVA-treated patients vs 1.6 per 100 patient-years for placebo-treated patients. Caution should be exercised when considering the use of RAPTIVA in patients at high risk of malignancy. If a patient develops a malignancy, RAPTIVA should be discontinued.
  • Infrequent cases (0.3%) of immune-mediated thrombocytopenia were observed during clinical trials and reports of severe thrombocytopenia have been received postmarketing; therefore, platelet monitoring is recommended. Physicians should follow patients for signs and symptoms of thrombocytopenia,and RAPTIVA should be discontinued if thrombocytopenia develops.
  • Reports of immune-mediated hemolytic anemia, some serious, diagnosed 4-6 months after the start of RAPTIVA treatment have been received. RAPTIVA should be discontinued if hemolytic anemia occurs.
  • Worsening of psoriasis can occur during or after treatment with RAPTIVA. During clinical studies, 19 of 2589 (0.7%) RAPTIVA-treated patients had serious worsening of psoriasis during treatment (n = 5,0.2%) or after discontinuation of RAPTIVA (n = 14,0.5%). Some patients required hospitalization (n = 17,0.7%). Patients, including those not responding to RAPTIVA treatment, should be closely observed following discontinuation of RAPTIVA and appropriate psoriasis treatment instituted as necessary.
  • Infrequent new onset or recurrent severe arthritis events, including psoriatic arthritis events, have been reported in clinical trials and postmarketing. These arthritis events began while on treatment or following discontinuation of RAPTIVA and were uncommonly associated with flare of psoriasis. Patients improved after discontinuation of RAPTIVA with or without anti-arthritis therapy.
  • The safety and efficacy of vaccines administered to patients being treated with RAPTIVA have not been studied. 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 2 injections. These events were largely mild to moderate when a first dose of 0.7 mg/kg was given. Less than 1% of patients discontinued RAPTIVA treatment because of these adverse events.
  • Female patients should also be advised to notify their physicians if they become pregnant while taking RAPTIVA (or within 6 weeks of discontinuing RAPTIVA) and be advised of the existence of and encouraged to enroll in the RAPTIVA Pregnancy Registry by calling 1-877-RAPTIVA (1-877-727-8482).

Please see full Prescribing Information

References:

  1. Data on File,Genentech,Inc.
  2. Spuls PI,Hadi S,Rivera L,Lebwohl M.Retrospective analysis of the treatment of psoriasis of the palms and soles.JDermatol Treat.2003;14(suppl 2):21-25.
  3. Pettey AA,Balkrishnan R,Rapp SR,Fleischer AB,Feldman SR.Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis:implications for clinical practice.JAm Acad Dermatol.2003;49:271-275.
  4. Callen JP,Krueger GG,Lebwohl M,et al.AAD consensus statement on psoriasis therapies.JAm Acad Dermatol.2003;49:897-899.
  5. Farber EM,Jacobs PH,Nall ML.Relationship of mild to severe psoriasis.Cutis.1974;13:774-777.
  6. Farber EM,Nall L.Nonpustular palmoplantar psoriasis.Cutis.1992;50:407-410.
  7. 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:Annual Meeting of the American Academy of Dermatology;February 18-23,2005;New Orleans,La.
  8. Leonardi, C, Sofen H, Krell J, Caro I, Compton P, Sobell JM. Phase IV study to evaluate the safety and efficacy of efalizumab for treatment of hand and foot plaque psoriasis. Poster presented at: Annual Meeting of the American Academy of Dermatology; February 2-6,2007; Washington, DC


RAPTIVA (efalizumab)

Starting Patients on RAPTIVA Therapy

Additional Resources