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PrintCase Study #1


Patient Case Studies* involve real patients with RA who have had success with RITUXAN. These actual patient profiles are designed to illustrate a range of anti-TNF inadequate responders who are appropriate candidates for treatment with RITUXAN.

*Content is based on real patient profile. For illustrative purposes only. Individual results may vary.

Angie's Life With RA Before Rituxan1

A self-described workaholic, Angie has a brace for almost every part of her body—these braces allowed her to keep working long hours at the hospital, even when her RA would flare up. When home, Angie cares for abused animals. Her RA left her unable to hold a leash, so she couldn’t walk or even groom the dogs.

Angie's Life With RA After Rituxan1

While she hasn't disposed of her many braces, they are no longer a requirement for her to function. She can now bike to work and is once again able to care for the dogs, cats, and birds she takes into her home.

ANGIE,*1 AN RA CLINICAL TRIAL PATIENT, FLORIDA, AGE 43

ANGIE'S MEDICAL HISTORY1,2
  • Diagnosed with RA June 2002
  • Previous therapies (taken individually or concurrently):
    • DMARDs: methotrexate. NSAIDs: valdecoxib.
      Corticosteroids: prednisone.
  • Previous anti-TNF:
    • Etanercept
      • Reason for discontinuation of therapy: Angie had only 1 injection, which gave her severe nausea and headache
    • Infliximab
      • Reason for discontinuation of therapy: Inadequate response despite incremental dose increases over the course of 1 year. Headaches, nausea, and rashes were also factors
ANGIE'S SIGNS AND SYMPTOMS BEFORE RITUXAN*1,2
  • Early manifestation in the shoulders with painful swelling in multiple joints from jaw to toes
  • Morning stiffness that prevented her from getting out of bed unassisted
  • Swelling in her knees and feet, which often necessitated the use of crutches
  • Daily fatigue
  • No visible nodules, with several palpable nodules in the hands
ANGIE'S STATUS AFTER RITUXAN1,2
  • Angie's status as of April 2006:
    • Has taken 1 full course of RITUXAN therapy (for a total of 2 infusions) administered at her doctor's office
    • Is no longer taking prednisone
    • Joint swelling virtually disappeared
    • Experiences some mild morning stiffness

CHANGES IN SIGNS AND SYMPTOMS IN RA3
ACR Components: Before and After RITUXAN (Rituximab)
PATIENT SAFETY EXPERIENCE
  • Has not experienced any infusion reactions or other AEs with RITUXAN

DR YVONNE SHERRER — ANGIE'S RHEUMATOLOGIST — IN PRACTICE SINCE 1988

PHYSICIAN’S ASSESSMENT OF ANGIE'S RA2

  • Angie is a younger patient with moderately severe RA
  • Despite some improvement after trying 2 anti-TNF therapies, Angie still experienced:
    • Continued, active disease
    • Persistent and significant inflammation in multiple, alternating joints
    • Significantly diminished functioning

PHYSICIAN'S RATIONALE FOR CHOOSING RITUXAN2
With Angie, the standard therapies (methotrexate and two anti-TNF therapies) had already been used without adequate effect.

PHYSICIAN'S ASSESSMENT OF ANGIE'S RESULTS2
Dr Sherrer is very pleased with Angie's results. She had no swollen joints and all visible signs and symptoms of RA seemed to disappear. Angie maintained response and her blood test measures had all improved as well.

 

Next Subsequent Courses of Treatment


Boxed WARNINGS

Fatal Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion.

Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) patients with RITUXAN.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions, can occur in patients receiving RITUXAN.

Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients treated with Rituxan.

The most common adverse events* with greater incidence in the group receiving RITUXAN (n=540) vs the placebo group (n=398) were hypertension (8% vs 5%), nausea (8% vs 5%), upper respiratory tract infection (7% vs 6%), arthralgia (6% vs 4%), pyrexia (5% vs 2%), and pruritus (5% vs 1%)6

  • Based on 938 patients in phase II and III studies of RITUXAN (2 x 1000 mg) or placebo administered in combination with methotrexate (MTX)
*Coded using MedDRA.

Please see full prescribing information, including Boxed WARNINGS.

REFERENCES

  1. Data on file, Genentech/Biogen Idec. Interview With Patient, Thursday, April 20, 2006.
  2. Data on file, Genentech/Biogen Idec. Interview With Dr Yvonne Sherrer, Friday, May 5, 2006.
  3. Data on file, Genentech/Biogen Idec. Patient Medical Records