It is sometimes necessary for people with lupus to receive medicine in the form of infusion therapy, which involves the delivery of these medications intravenously (through the veins). Different medicines may be used, such as Cytoxan and, more recently, Rituxan.
In this presentation, Ms. Leff describes the different indications for various medicines delivered via infusion therapy. She also explains what patients should be prepared for, how the process works, and what’s involved in the follow-up.
Most importantly, however, she sheds some light on various upcoming therapies, including those currently undergoing clinical trials as well as several biologic agents on the horizon that may be aimed at slowing or stopping specific disease processes.
In order to control flares of joint pain, fatigue, or even organ involvement, your doctor may choose to administer doses of intravenous steroids, chemotherapeutic agents, or newer disease-modifying drugs. The following are some examples of these kinds of medications:
While corticosteroids are produced naturally by the adrenal glands, this man-made version is specifically helpful in blocking and suppressing inflammatory reactions.
Given in large doses (500mg to 1 gram) using a small IV catheter, the medication is administered intravenously using an infusion pump. The administration process takes between one and two hours, with vital signs continually being monitored by the attending nurse. This medicine is typically given 1-3 days each month, or as needed.
Considered to be a “cornerstone treatment” in treating lupus, methylprednisolone is usually a fast-acting treatment with noticeable results within a very short time. It can, however, produce side effects ranging from high blood pressure and an increase in blood sugar (sometimes resulting in steroid induced diabetes) to sleep difficulties and mood swings. Some patients experience headaches, which can be medicated (with your doctor’s permission) with Tylenol PM or a similar drug.
Considering the risks involving increases in blood sugar and blood pressure, it’s important to resist the probable craving for sweets and salt known to be associated with this steroid pulse.
This medication is a chemotherapy medication administered by IV for about an hour, with a few hours of hydration (drinking water) included before and after the process. This medication, like all chemotherapeutic agents, suppresses the immune system by decreasing the amount of white blood cells in the body.
The entire process takes about five hours, but the lengthy process involved with the infusion is necessary to keep the body hydrated – an important factor in avoiding a condition called hemorrhagic cystitis, in which the urinary bladder becomes inflamed, causing pain and blood in the urine. Patients are urged to continue hydrating after returning home from therapy.
Lupus nephritis patients typically receive this treatment once a month for six months, then every three months for two years.
Possible side effects include nausea and vomiting (Ms. Leff says there are great anti-nausea drugs on the market and nausea isn’t as much of a concern as it used to be with cyclophosphamide), some hair loss (but not as much as that found in the oncology [cancer care] population when undergoing chemotherapy), fatigue, increased risk of infection (as chemotherapy suppresses the immune system), anemia, fertility problems (Ms. Leff urges patients to try not to get pregnant while on cyclophosphamide), cystitis, and an increased risk of cancer.
Ms. Leff noted that 10-14 days after administration of cyclophosphamide, patients will be at their lowest white blood cell count, so it’s important to watch out for neighbors and children with colds at this point. You don’t want to get sick when your body isn’t at full strength.
Rituximab - a biologic agent that targets the specific causes of certain diseases - has recently been adapted from the oncology population for use in other areas. The FDA approved rituximab for use in lymphomas in 1996 and for rheumatoid arthritis in 2006, but recent clinical trials have focused on its uses in lupus patients, specifically for its ability to deplete B cells, which play an important role in the pathogenesis (disease progress) of lupus.
While rituximab is labeled for use in patients with lymphomas and rheumatoid arthritis, the drug has extensively been used “off-label” in lupus patients. For more information, read a recent HSS article entitled Progressive Multifocal Leukoencephalopathy (PML) in Two Lupus Patients Treated with Rituximab (Rituxan): An HSS Rheumatology Perspective.
There are currently two clinical trials focusing on rituximab for SLE at HSS:
EXPLORER: Led by HSS rheumatologist Michael D. Lockshin, MD, this drug trial, for patients with moderate to severe SLE, compares rituximab to a placebo over the course of 18 months.
LUNAR: Dr. Lockshin also heads this study, focusing on the comparison of rituximab to a placebo in lupus nephritis patients over an 18 month period.
The medication is infused in two all-day sessions, two weeks apart. The first infusion is given over 5 ½ hours, while the second is administered over a slightly shorter period of 4 ½ hours. One gram of rituximab is given during each session.
While cyclophosphamide is a chemotherapeutic drug that reduces B cell counts generally, rituximab attacks the B cells specifically, avoiding many of the side effects commonly attributed to chemotherapeutic agents. B cells are necessary in normal immune function; in lupus, these cells can trigger immune responses that can cause inflammation and disease.
Although the side effects are limited in comparison to cyclophosphamide, possible side effects of rituximab include infusion reactions (such as hives, headaches, and skin rashes) and an increased risk of infection. To combat these effects, patients will typically receive an antihistamine (such as Benadryl), acetaminophen (such as Tylenol), and 100 mg of methylprednisolone, a form of steroid. Rituximab was also reported to have induced progressive multifocal leukoencephalopathy, or PML, in two lupus patients. HSS weighed in on these findings in a related article.
One support group member said that when she went to the Internet and saw dire warnings about the risk of tumor lysis syndrome after rituximab therapy, it scared her away from considering the treatment. Ms. Leff explained that the tumor lysis syndrome is specific to patients being treated for lymphoma with rituximab, so that this type of infusion reaction won’t occur in lupus patients. Infusion reactions, even severe ones, could still occur in lupus patients, however, for reasons other than tumor lysis.
Rituximab is presently FDA-approved for use in rheumatoid arthritis, and severe infusion reactions to Rituxan have been rare in rheumatoid arthritis patients. Lupus patients would be expected to react more like the rheumatoid arthritis patients than the lymphoma patients in this regard, and thus are likely to have few severe infusion reactions to Rituxan.
One support group member with RA and lupus mentioned that her physician decided against administering Rituxan in her case because she was not on methotrexate, which is an immunosuppressant in the form of a light chemotherapy agent. Ms. Leff then explained that while clinical trials have used this combination in their studies, and the FDA approval for rituximab is for its use combined with methotrexate, each doctor can decide whether or not this is an essential component of the treatment.
Another member who had received this treatment described her own experience with the medication, commenting that it “works great” and that she’d suffered no infusion reactions up to that point. She was pleased to report that her condition had definitely improved after two treatments with rituximab.
Ms. Leff stressed that anyone considering this treatment (or any other treatment for lupus) should speak to their doctor to manage their expectations. Going into treatment with realistic expectations is essential in keeping your morale high. Keeping that in mind, she noted, an administration of rituximab may take several weeks or more to make a patient feel better, so patience is important.
Learn more about the HSS SLE Workshop, a free support and education group held monthly for people with lupus and their families and friends.
Summary by Mike Elvin