RAPTIVA for 200+ lb. Patients

Results with RAPTIVA

RAPTIVA is the only therapy that has demonstrated consistent efficacy in patients and long-term maintenance of response in patients 200 lbs & above.

  • Baseline

  • At 2 months on RAPTIVA

  • BSA Percent Over Time


Individual results may vary


CASE STUDY: Anthony S.*, a patient with persistent plaque psoriasis

  • Patient overview

    • 40-year-old male, 5'10", 210lbs/95 kg (BMI = 30)
    • 21-year history of plaque psoriasis of the back and trunk

    Prior treatments

    • Methotrexate, topical steroids, and ultraviolet B (UVB)
    • Topical treatment impractical for large body surface
    • UVB considered inconvenient and time consuming by patient

  • Clinical course on RAPTIVA

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

    • Baseline psoriasis BSA 60%
    • Visible improvement at 2 months
    • After 4 months, BSA 1%

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 Valentina Bradley, MD

Clinical Data

Weight & Psoriasis

In biologic clinical trials, appoximately half of patients with chronic moderate to severe plaque psoriasis weighed 200 lbs & above1,2,15

Not actual patients. Models serve as a visual reference of patients 200 lbs & above.


Consider weight-based therapies for patients with plaque psoriasis weighing 200 lbs & above.

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

Patients who weigh 200 lbs & above may not be achieving adequate control with fixed-dose therapy

  • Initial Clinical Response
  • Patients 200 lbs & above are less likely to achieve a PASI 75 response with a fixed-dose therapy relative to patients less than 200 lbs2,3
  • Long-term Response
  • Patients 200 lbs & above may have loss of efficacy over time with fixed-dose therapy relative to patients less than 200 lbs4

Response to fixed-dose therapies may not be optimal in patients with plaque psoriasis who weigh 200 lbs & above

  • Additional considerations when evaluating chronic plaque psoriasis patients weighing 200 lbs & above
  • Heavier patients are more likely to have severe psoriasis 4,14
  • Psoriasis may have a significant lifestyle impact that can exacerbate obesity and its related risk factors 4,13
  • Up to 71% of psoriasis patients in one study became overweight or obese after onset disease 4

Consistent Efficacy by Weight

In patients 200 lbs & above, RAPTIVA provides consistent efficacy beyond 12 weeks

PASI 75 at 12 and 24 weeks in plaque psoriasis patients taking RAPTIVA 1


Pooled phase III clinical trial data, 12-week placebo-controlled period in ACD 2058, 2059, 2390, and 2600; 24-weekextended treatment data from trials 2391, 2601, and 2243. Based on confidence intervals, none of the response rate data points are statistically different between patients weighing less than 200 lbs and patients 200 lbs & above.


  • 43% of patients 200 lbs & above achieved a PASI 75 at 24 weeks

PASI 75 results during 3-year study in plaque psoriasis patients taking RAPTIVA1 (ITT analysis)


This 3-year trial represents the longest continuous treatment trial in plaque psoriasis patients receiving a biologic agent

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. Based on confidence intervals, none of the response rate data points are statistically different between patients less than 200 lbs and patients 200 lbs & above.1,5


  • 46% of patients 200 lbs & above maintained a PASI 75 response for up to 36 months

This 3-year trial represents the longest continuous treatment trial in plaque psoriasis patients receiving a biologic agent5

With RAPTIVA, PASI 90 treatment responses were maintained over 3 years

PASI 90 results during 3-year study in plaque psoriasis patients taking RAPTIVA1 (ITT analysis)

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. Based on confidence intervals, none of the response rate data points are statistically different between patients less than 200 lbs and patients 200 lbs & above.1,5


  • The number of PASI 90 responders continued to increase over initial 18 months
  • 26% of patients 200 lbs & above maintained a PASI 90 response for up to 36 months
  • Treatment response with RAPTIVA is maintained over 3 years, regardless of weight
  • RAPTIVA is the only therapy that has demonstrated:
  • Consistent efficacy in patients 200 lbs & above
  • Long-term maintenance of response in patients 200 lbs & above

View Case Studies

Consistent Efficacy Across BMI

Patients with psoriasis are more likely than the general population to be overweight or obese (BMI greater than 25)

BMI ranges defined6

  • Study reveals that patients with psoriasis are almost twice as likely to be obese than the general Utah population (34% vs 18%; P<.001)4

Prevalence of obesity in psoriasis patients - Utah Psoriasis Institute (UPI)4

Patients 200 lbs & above are more likely to have a BMI greater than 256


  • RAPTIVA provides consistent response across BMI groups

PASI results by BMI ranges at 24 weeks1

Pooled phase III clinical trial data from 24-week follow-up period in ACD 2390/2391, 2600/2601, and 2243 g. All confidence intervals overlap. No statistical difference between middle groups and end groups.

In a study with a fixed dose biologic, patients with a BMI 25 or greater were more likely to achieve a suboptimal response compared to patients with a BMI less than 257


Weight-based Dosing

RAPTIVA works differently

RAPTIVA has a unique mechanism of action that targets T-cells. RAPTIVA blocks T-cell activation, reactivation, and trafficking8

Weight may be a consideration in treatment selection1

  • Weight-based dosing with RAPTIVA has been established and clinically proven10,11
  • Efficacy of RAPTIVA was found to be consistent across weight groups4
  • Weight was found to be a significant factor in the observed serum concentrations (exposure) of RAPTIVA
  • In patients receiving weekly subcutaneous doses of 1 mg/kg, RAPTIVA exposure was consistent across body weight quartiles
  • Together, these results support the body weight-adjusted dosing regimen for RAPTIVA,providing consistent exposure across a range of patient body weights

RAPTIVA is the only therapy that has demonstrated both:

  • Consistent efficacy in patients 200 lbs & above
  • Long-term maintenance of response in patients 200 lbs & above

RAPTIVA provides sustained efficacy with a proven safety profile

In phase III clinical trials

Low incidence of serious infections and malignancies


  • Incidence of serious infections in patients treated with RAPTIVA was low and similar to placebo
    • Serious infections requiring hospitalization occurred in 0.3% of patients treated with RAPTIVA11
  • Incidence of malignancies was low (1.8per 100patient-years of RAPTIVA-treated patients vs 1.6 per 100 patient-years for placebo-treated patients)11
  • In RAPTIVA Phase III clinical trials, there were:
    • NO signals for multiple sclerosis1
    • NO signals for exacerbated or new-onset congestive heart failure attributed to RAPTIVA observed
    • NO signals for end-organ toxicities observed*
    • NO pancytopenia or aplastic anemia observed
    • LOW incidence of granulomatous infections (such as tuberculosis, histoplasmosis, or listeria) observed

*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.

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 important infections. 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 for 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. A cellular, 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).

Read More: Case Studies in patients 200lbs and above

References:

  1. Data on file,Genentech,Inc.
  2. Gordon K ,Korman N, Frankel E, et al. Efficacy of etanercept in an integrated multistudy database of patients with psoriasis. JAm Acad Dermatol.2006;54:S101-S111.
  3. Dermatologic and Ophthalmic Drugs Advisory Committee. Questions to the Committee. Available at:http://www.fda.gov/ohrms/dockets/ac/02/questions/ 3865Q1_FINAL.pdf.Accessed February 28,2007.
  4. Herron MD, Hinckley M, Hoffman MS, et al. Impact of obesity and smoking on psoriasis presentation and management. Arch Dermatol.2005;141:1527-1534.
  5. Gottlieb AB, Gordon KB, Hamilton TK, Leonardi C. Maintenance of efficacy and safety with continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: final phase lllb study results. Poster presented at: Annual Meeting of the American Academy of Dermatology; February 18-22,2005;New Orleans,La.
  6. National Institutes of Health; National Heart, Lung, and Blood Institute. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed February 27,2007.
  7. Strober B, Gottlieb AB, Leonardi C, et al. Levels of response of psoriasis patients with different baseline characteristics treated with etanercept. Poster presented at: Annual Meeting of the American Academy of Dermatology; March 3-7,2006;San Francisco,Ca.
  8. Leonardi CL. Efalizumab in the treatment of psoriasis. Dermatol Ther.2004;17:393-400.
  9. Buxton ILO. Pharmacokinetics and pharmacodynamics: the dynamics of drug absorption, distribution, action, and elimination. In: Brunton LL, ed-in-chief. Goodman & Gilman's the Pharmacological Basis of Therapeutics[online version].11th ed.New York,NY:McGraw-Hill;2007.Available at: http://www.accessmedicine.com/resourceTOC.aspx?resourceID=28.Accessed March 20,2007.
  10. Sun Y-N, Lu J-F, Joshi A, Compton P, Kwon P, Bruno RA. Population pharmacokinetics of efalizumab (humanized monoclonal anti-CD11a antibody) following long-term subcutaneous weekly dosing in psoriasis subjects. JClin Pharmacol.2005;45:468-476.
  11. RAPTIVA [package insert].South San Francisco, CA: Genentech,Inc.; June 2005.
  12. Buxton ILO. Pharmacokinetics and pharmacodynamics: the dynamics of drug absorption, distribution, action, and elimination. In:Brunton LL, ed-in-chief.Goodman & Gilman's the Pharmacological Basis of Therapeutics[online version]. 11th ed. New York, NY:McGraw-Hill; 2007. Available at: http://www.accessmedicine.com/resourceTOC.aspx?resourceID=28.Accessed March 20,2007.
  13. The Centers for Disease Control and Prevention. Overweight and obesity. Available at: http://www.cdc.gov/nccdphp/dnpa/obesity/index.htm. Accessed August 23, 2007
  14. Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol. 2006;55:829-835.
  15. Reich K, Gottlieb AB, Kimball A, Li S. Consistency of infliximab response across subgroups of patients with psoriasis: integrated results from randomized controlled clinical trials. Poster presented at: Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, Ca.


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