8/8/11 People who take Orencia, or abatacept, to treat rheumatoid arthritis will soon have the option of self-injecting the drug instead of going to the doctor for an infusion.
The FDA on July 29 approved Orencia SC, a subcutaneous formulation, joining the intravenous Orencia IV as a treatment option for moderate to severe rheumatoid arthritis, or RA. This is the first biologic treatment for RA to be available in both formulations. Either can be used alone or with other drugs commonly used to treat RA, such as methotrexate. Neither should be used in conjunction with other biologic treatments, including anti-TNF drugs.
“This new formation allows patients to have more significant autonomy in their own care. Instead of being dependent on infusions every four weeks, they can now self-inject the medication at home,” says Mark Genovese, MD, professor of medicine and co-chief of the division of immunology and rheumatology at Stanford University Medical Center, in Palo Alto, Calif.
“The ability to self-inject saves time and effort for the patient, and may have a cost-effect benefit to the health care industry,” because insurers or patients on the SC formulation will no longer have to pay for the infusion administration of the IV formulation, says Dr. Genovese, who was lead author of the phase III study leading to FDA approval of Orencia SC. “Certainly the efficacy and safety of the two formulations are comparable,” he adds.
Abatacept works by blocking the activity of T-cells, a type of immune cell that is thought to be responsible for the pain and swelling in joints of people with RA.
If patients have an inadequate response to methotrexate, a first-line treatment, they are usually treated with one of the five anti-TNF biologic drugs available. If they don’t respond well to that treatment, then they go on to another biologic therapy.
The third-line is where the new formulation of abatacept would fit in, notes Arthur Kavanaugh, MD, professor of medicine at University of California San Diego. Dr. Kavanaugh was not involved in the phase III study.
There are several other third-line biologics in addition to abatacept, including anakinra, sold as Kineret SC, rituximab, or Rituxan and tocilizumab, or Actemra. “I educate patients about these drugs and they have the choice,” Dr. Kavanaugh says.
FDA approval of Orencia SC was based on the Phase III trial of 1,457 patients, which showed that Orencia SC plus methotrexate was as effective as Orencia IV plus methotrexate. According to American College of Rheumatology response criteria, it was effective in alleviating the signs and symptoms of RA, inducing a major clinical response, inhibiting the progression of joint damage and improving physical function in adults with RA. Outcomes for pain, physical function, and global assessment of disease activity were similar between the two formulations at the six-month mark. As with Orencia IV, injection-site reactions to the new formulation were mild and moderate, and none of these reactions required discontinuation of the drug.
The most common side effects reported by more than 5 percent of patients treated with either formulation included headache, inflammation of the nose and pharynx, upper respiratory tract infection, diarrhea and nausea. Serious adverse events were reported in 4.2 percent of the SC group and 4.9 percent of the IV group; serious infections were reported in 0.7 percent and 1.4 percent, respectively.
Orencia SC will be available in September. As yet, Orencia maker Bristol-Myers Squibb has not set a price for the SC formulation.
But...I have a strange pain afterwards in my thigh and lower leg that lasts for a couple of days..plus..I get a rapid heart rate within a day of injecting Orencia. Has anyone experienced this? Just curious...
I was diagnosed with Rheumatoid Arthritis at 32.10 years ago! I tried Methotrexate, Enbrel a combo of enbrel/ metho and Orencia infusion and now Orencia self injecting with the Metho.
I had to stop using Enbrel when I developed a fungal infection in the Sphenoid Sinus near the back of the sinus near the brain. It took almost 2 years to get rid of. I finally went on the Orencia and have felt much better till recently when I started the self injecting. I went to an ENT and he tested me for allergies to see if I could be allergic to something that could be a trigger... Turns out I am allergic to Wheat, Soy, Corn, peanuts and shellfish. Since I have changed my diet. I do feel better. But the once a week injection still has me feeling lousy for the first 3 days. I'd rather be out 3 days once a month than 3 days out of the week! Going to see if I can go back to the infusions! If your young and are being newly diagnosed with RA before you go on a high power med like this. Get a food allergy test. Had I had it done, and changed my diet early on... I don't think I would be this severe now! Food Allergies to Glue-ton and modified grains are the biggest reason RA is happening more!
I don't like taking drugs therefore the only other drug I take is a Thyroid mdication.
- you all will know about the pain with R.A. disease -
but I must say I'm pain free, my energy levels are great now and I can do things without the intervention of Cronic Faigue anemia and lots of other symptoms we all suffer with this disease. If Arava agrees with you amazing results will please you.
Off to Cleveland Clinic I go to see a Rheumatologist and an Oncologist to see what RA drug I can take take won't make my Marginal Zone Lymphoma agressive....In the process I saw a Dermatologist who pretty much diangnosed me with PA (Psoriatic Arithis) which explained the nails, as Psoriatic Arthiritis of the nail, not a fungus....So now I am trying to decide what avenue I want to proceed...Do I take Orencia, (I would prefer the shots) or as the RHeumy there suggested, both Arava with Orencia? Anyone out there on these together? My research shows that the side effects for Liver Problems in the first 6 months of using Arava are very high.
I appreciate hearing everyone's stories and can empathize with all of you...I encourage you all to be your own advocate and become as well informed as you can, because from my experience Dr.'s can make mistakes.. You have to draw them a road map of your life with this desease ....
orencia has worked better for me that Enbrel, Humira, kineret...been on them all!
be scared is normal.
i was diagnosed the past year (1yr 4m), j have psoriatic arthritis
my liver enzymes are high & down; but it´s all about dosis control
now, im with my second reumatologist for almost a year
at begginnig i was so scared for the liver enzymes, & still worries me, but i just let me go for my doctor
(sorry if i said terrible things, english it´s not my mother tongue)
just trust your doctor, read abour medicines & treatments, finally you decide, but doctors know what they do
i´m a generalist; i had my period for search scientific articles, that worried me more...
i thing, that after been diagnosed you go through a period, i some way you lost something...so, you´ll be sometimes angry, others sad or truly deppresed, it will be a time for acceptance, then you´ll do a real change of life of 360º... & all the time, you´ll be scared, more or less
but, just breath, ask your doctors, make togheter a decision but don`t stop medications by your own, trust your doctors
if you have more than a doctor, one of them should be the lider...i think shuold be the reumatologist, & have communication not only with you, with the others doctors too
that´s all i can said...
Kind regards
And Orencia is the first & only biologic to be available in both self injectable & infusion forms. So no, Remicade isn't injectable at home yet. But maybe this will pave the way for more biologics to formulate subQ versions of their medications!
1: Will patients self-inject once every 4 weeks or inject a smaller dosage more often (on a daily or weekly basis)?
2: As the most common infusion medication for patients with RA, has a subcutaneous formulation of Remicade been developed?
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