Rituximab prescription for chronic conditions is not a recent phenomenon, as can be noted with the FDA’s approval since 2006. It has been influential in the treatment of rheumatoid arthritis (RA), cancers, and other diseases.
However, research hasn’t established the optimal dosage and appropriate retreatment schedule for RA Consequently, some doubt Rituximab’s effectiveness for RA. Some even claim that the drug may be dangerous to the user.
The following contains essential information about this drug, including the appropriate conditions to utilize, what the researchers say, and possible aftereffects.
- What Is Rituximab?
- Who Is the Appropriate Patient for this Treatment?
- What Do the Clinical Trials Say?
- How Does Rituximab Work for Rheumatoid Arthritis?
- Are There Side Effects?
- In Conclusion
What Is Rituximab?
Rituximab is the generic name for Rituxan, an FDA-approved biologic drug for the treatment of rheumatoid arthritis.
Rituxan is administered by infusion. The colorless liquid is a genetically modified antibody that centers on the CD20 molecules of the B cells involved in rheumatoid arthritis. Rituxan also has FDA approval to treat granulomatosis with polyangiitis, chronic lymphocytic leukemia, and non-Hodgkin’s lymphoma.
Health experts recommend using Rituximab alongside methotrexate, an immune-system inhibitor, a combination initially to combat cancers.
Who Is the Appropriate Patient for this Treatment?
Typically, drugs work differently in different people, Rituxan inclusive. Therefore, the medication may not improve RA in some patients, while it does to varying extents in others. The FDA endorsed Rituximab and methotrexate as a treatment for people who:
- Suffer moderate to chronic rheumatoid arthritis.
- Have failed to respond favorably to generic antirheumatic medications, including the blocking agents for tumor necrosis factor.
There are concerns about using the drug on children, pregnant women, and nursing mothers, as safety isn’t assured. The FDA approves Rituxan use for pregnant women ONLY if the likely benefits significantly outweigh the potential harm.
Some might find this assurance offensive, as it may be impossible to perfectly measure the potential benefits and risks of Rituxan to a pregnant user.
That point aside, the FDA discourages the use of Rituximab for patients who haven’t used one or two TNF blocking agents. In other words, it is best to use TNF blocking agents before opting for Rituximab as a RA drug.
Lastly, the FDA disapproves of using Rituxan for people treated with Hepatitis B or who still carry the virus. The drug may reactivate Hepatitis B.
What Do the Clinical Trials Say?
In 1998, the medical field recorded the first successful use of Rituxan as an antirheumatic. Other credible studies have since followed.
The FDA approved Rituximab as an RA treatment following three trials where both the researchers and the participants weren’t aware that they were experimenting with the drug. They focused on measuring the effects of Rituxan and methotrexate with the results of placebo and methotrexate. While this double-blind approach has its critics, the results are hardly biased and dependable.
As such, the FDA could be 100% sure of the results they recorded. One such study was named the “Randomized Evaluation of Long‐Term Efficacy of Rituximab in RA (REFLEX)”.
Also, StuffThatWorks, an AI-assisted platform and app that assesses the various treatment types available for chronic conditions, suggests that Rituximab might be a grossly underrated treatment for RA. As it ranks as the number 1 most effective treatment for RA, the data indicates that less than 1% of the members living with RA have tried Rituxan, making it the 28th most tried treatment.
An Overview of REFLEX
REFLEX was a randomized study spread over two years to assess Rituximab’s use in RA. The study measured effectiveness by noting improvements in joint swelling and tenderness — much like the American College of Rheumatology (ACR) assessment model.
The patients received the infusion only twice in two years, a fortnight apart. After six months, REFLEX discovered that:
- Fifty-one percent of the participants experienced significant ACR20 improvements than the eighteen percent recorded for placebo-treated persons.
- Twenty-seven percent of the participants experienced significant ACR50 improvements, compared to the five percent recorded for placebo-treated persons.
- Twelve percent of the participants experienced significant ACR270 improvements, compared to the one percent recorded for placebo-treated persons.
Overall, the patients treated with Rituximab experienced improved health. They enjoyed a higher quality of life compared to their counterparts. X-ray scans also revealed a reduction in the possibility of joint damage over time.
It is noteworthy that certain participants showed side effects, but they were mostly mild to moderate. Plus, the eventual result mattered more.
How Does Rituximab Work for Rheumatoid Arthritis?
Research hasn’t yet unraveled or completely understood the mechanism that makes Rituxan a potent antirheumatic. However, the more popular consensus is that the antibodies in the drug target the CD20, a molecule found on the surface of B cells involved in rheumatoid arthritis. This may be because these B cells are considered the culprit in RA and other inflammatory conditions.
Scientists have observed and reported that Rituximab temporarily but thoroughly depletes the B cells in the patient’s blood, the bone marrow and tissues, although to partial regard. However, these cells regenerate within six to nine months, suggesting that Rituxan infusion has to be a continuous process.
As things stand, more research is ongoing to find out a compelling explanation for Rituximab’s usefulness in rheumatoid arthritis treatment.
What Should I Expect During Rituximab Infusion?
Rituxan infusion is painless when an expert handles the process. Patients receive Rituximab through intravenous transfusion (IV) in two 1,000 milligram dosages within the space of two weeks. Patients may develop allergic reactions, which explains why a doctor has to conduct a checkup before infusion starts.
Besides the checkup, there are other preps a doctor has to do, including a 100-milligram infusion dosage of methylprednisolone or a similar steroid thirty minutes before the operation, plus an antihistamine dose. Such steroids help reduce potential allergic reactions to the infusion.
Typically, the first infusion starts at a slow rate of 50 milligrams per hour—with the doctor on hand to keep track of vitals and react proactively to potential adverse reactions. The first phase takes an average of 4 hours and 30 minutes, out of which the doctor dedicates 15 minutes to flush the bag with a solution to ensure the patient gets the total dose.
After the first phase, patients may rest up before the second and final phase. This part lasts about one hour only.
Are There Side Effects?
Very few (only 18%) of patients displayed negative aftereffects of the Rituxan RA treatment. However, when these side effects occur, most patients experience mild symptoms like nausea and rash. At the same time, few face the most severe instances, such as reactivation of Hepatitis B cells and the development of progressive multifocal leukoencephalopathy.
It is necessary to note that these symptoms vary in persons; therefore, let us look at the most common ones below.
- Flu-related symptoms
- Mild throat tightness
- Upset stomach
- Muscle stiffness
- Respiratory infections
Most people do not develop these reactions in most cases, due to the antihistamine and steroid shot before the process.
However, if you experience these symptoms and they persist, you must contact your doctor immediately.
Rituxan has been a medically certified drug for rheumatoid arthritis since 2006. Over the years, it has provided an alternative for patients who failed to respond favorably to the more common RA treatments. Over 100,000 RA patients had received Rituximab infusion by 2011.
However, there are likely side effects, although they happen very rarely. This should be taken into consideration. Therefore, it is in your best interest to weigh both the potential benefits and risks of Rituxan as an antirheumatic before deciding.