Kara Moskalyk: "BENLYSTA™ - A New Option for Lupus, Who Should Consider It?"
Presented at the Spring 2012 Lupus SK Symposium.
Research on BENELYSTA™ (belimumab) initially began in 1996 by HGS with the discovery of the BLyS protein. After 10 years of research, HGS joined with GSK to co-develop and study belimumab in human trials. Finally, in July 2011 Health Canada approved BENLYSTA™, and now there are 45 patients in Canada receiving BENLYSTA™ infusions.
How does BENLYSTA™ work? In people with lupus certain white blood cells called autoreactive B cells - cells that react against the body - stay in the body longer than they should. These cells produce the autoantibodies that can attack your own body. One of the important proteins for the growth of these B cells is called BLyS. BENELYSTA™ binds to BLyS and prevents it from stimulating the autoreactive B-cells, leading to less attack on the body, and reduced inflammation.
Three large clinical trials have been conducted on BENLYSTA™. In total these trials involved 2,133 patients. All patients in the trials had active disease and were stable on one or more of the following standard therapies: corticosteroids, antimalarials, NSAIDS, and immunosuppressives. A total of 93% of the participants were female with ages ranging from 18 - 73 years old and were of Caucasian, Asian, African American, Hispanic and American Indian decent.
Those patients that were excluded from the study included patients with severe active lupus nephritis and severe active CNS lupus. Others excluded were those positive for HIV or Hepatitis B or C, patients who had tried an investigational drug within the past year, anyone under the age of 18 and pregnant or breastfeeding women.
The method used for the clinical trials was as follows: Patients were randomized to placebo or treatment groups. The treatment group got a dose of either 1mg/kg or 10mg/kg. Treatment was given once every 2 weeks for the first three doses, and then once every 4 weeks for 48 weeks.
The results in 52 weeks showed that patients given the BENLYSTA™ 10mg/kg dose responded better than those in the placebo group. No significant difference was seen in the lower dose 1mg/kg group. African American patients did not appear to respond to treatment, which may have been due to the small sample size, and further study is needed in this population group to determine efficacy.
Therefore, the patients who may benefit from BENLYSTA™ must meet the following criteria: adults over 18 years of age; active disease; currently receiving standard therapy; autoantibody positive. BENLYSTA™ should not be used by patients with severe lupus nephritis or CNS lupus, pregnant or nursing women, patients under 18, African American patients and anyone with active/chronic infections.
What is the dose?
• 10 mg/kg dose
How often will I get treatment?
• First three doses - at 2 week intervals, then given every 4 weeks
Where do I get my infusions?
• Given at an infusion center where you will be closely monitored
• Infusion centers in Saskatchewan:
- Saskatoon - Dr. Olsynski’s Office - Midtown Medical Center (23rd St.)
- Regina - Stapleford Clinic (376 McCarthy Blvd)
How long is my infusion?
• One hour infusion
Can I receive vaccinations during my therapy?
• Avoid live vaccinations
What are the potential reactions during the IV infusions?
• Serious reactions reported during IV infusions:
- Slowed heart rate
- Decreased blood pressure
- Swelling of the face
- Difficulty breathing
• Less serious infusion related reactions:
- Mild changes in blood pressure
- Joint Pain
What are the side effects of the treatment?
• Most common reported in trials:
- Pain in extremities
- Infections such as bronchitis, pharyngitis, urinary tract infections
What are the benefits of the treatment?
• May further reduce lupus disease activity in people already taking standard therapy
• May allow dose decreases of other medication- however more research is needed to confirm this
• Greatest benefit seen in those with greater disease activity, those requiring steroids
• Results will not be immediate-likely a minimum of 6 months to start seeing benefits
What is the cost of therapy?
• The cost of medication is $23,000 per year
• Saskatchewan Health coverage is still under review
• There are 80 private insurance plans offering coverage (Note: coverage is highly variable based on individual plans)
In conclusion, there are many things to consider when deciding if you should try a new medication like BENLYSTA™. The decision should be based on factors such as: your response to standard therapy, potential risks vs benefits as well as the cost.