How Is It Taken
Rituximab is given in hospital, through a drip into a vein. This is known as an intravenous infusion. This is done by a doctor or nurse, so they can check if you have any side effects while youre taking rituximab.
Usually, youll start treatment with two infusions of rituximab, given two weeks apart. Then your rituximab infusions will be repeated when it is starting to wear off or to prevent a flare-up of your arthritis. This can be anything from six months to a few years later.
The first infusion usually takes around six hours. Later infusions may take around four hours. But it can vary.
Many people need to have infusions at least once a year. If you have vasculitis, your treatment may be more frequent than this.
On the day of your rituximab infusion, you may be given steroids and paracetamol. You may also be given an antihistamine. Antihistamines are drugs used to ease symptoms of allergies or reactions.
Your doctor may recommend that you stop taking any drugs that lower blood pressure, known as antihypertensive drugs, for 12 hours before taking rituximab in case you have a drop in blood pressure during the infusion. Antihypertensive drugs include diuretics and vasodilators.
Between infusions, youll have blood tests. A specialist doctor or nurse will also check how youre getting on with the treatment.
How Long Does It Take To Work
Rituxan begins working after your first dose.
However, depending on what condition you have, you may not notice symptom relief for weeks afterward. For example, in the treatment of RA, many people see results within 8 weeks of taking Rituxan.
However, with other conditions, such as cancer, you may not notice a difference. This is because although the drug is reducing the number of cancer cells in your body, it may not get rid of them all.
Talk with your doctor about your condition and what to expect from taking Rituxan. Theyll be able to tell you how long it may be before your symptoms ease or your condition improves.
Fertility Pregnancy And Breastfeeding
If youre planning to try for a baby, if you become pregnant, or if youre thinking of breastfeeding, it’s a good idea to discuss your treatment with your doctor.
Because rituximab is a relatively new drug, we dont yet know how it might affect pregnancy or an unborn baby. So, youll usually be advised to stop rituximab six months before trying to have a baby. If youre a woman of childbearing age, its a good idea to use contraception while taking rituximab and for six months after you finish your treatment.
Tell your rheumatology team if you become pregnant whilst taking rituximab. If you accidentally take rituximab early in your first trimester, its unlikely to be harmful.
We dont yet know whether rituximab can pass into breastmilk, so current advice is not to breastfeed while taking this drug.
It is considered safe for men to continue taking rituximab while trying to father a baby.
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Additional Aspects To Be Considered And Research Agenda
It is evident from this document that several areas of future investigation and research are warranted. These are summarised in but are discussed in detail in the supplementary material, available online only. These relate particularly to mode of action, safety and efficacy issues with respect to the latter, questions such as optimal dose regimen, direct comparison with other biological agents and indicators for retreatment require appropriate answers.
Summary of additional clinical and research aspects for future consideration
What People On Rituximab Should Know About The Covid
Researchers and doctors may have reason to be cautious about recommending COVID-19 vaccination to people on rituximab without considering their dosing schedule, whereas those same hesitations do not apply to other kinds of biologics.
This doesnt mean that rituximab is less safe than other biologics, it just means that if you get a vaccine too close to your last infusion, there may be a chance the vaccine wont provide good protection.
We should consider medications that deplete B cells separately from other medications for the time being, says Alfred Kim, MD, PhD, Assistant Professor of Medicine, Pathology, and Immunology at Washington University in St. Louis, Missouri. He is currently overseeing a study to analyze the COVID-19 vaccines efficacy and safety in autoimmune patients on different kinds of immunosuppressant medications.
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How Is Rituxan Given
Like some other treatments for RA, Rituxan must be given directly into the bloodstream. So instead of being taken as a pill or an injection, it is given as an IV infusion. An IV infusion is a needle placed in a vein by a trained healthcare professional. When you receive your Rituxan infusion, it will be given to you in combination with another medication called methotrexate. Rituxan infusions will be administered 3-5 times a year at your doctorâs office, an infusion center, or a hospital. Each infusion typically lasts 4 to 6 hours, so itâs a good idea to plan accordingly.
You may be given additional medicine before each infusion to reduce the risk of side effects . If you experience any discomfort during the infusion, seek immediate medical attention.
Infusion-related reactions are the most common side effect of Rituxan treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of Rituxan.
Rituxan For Rheumatoid Arthritis
Rituxan is approved to be used in adults with moderate to severely active rheumatoid arthritis. For this purpose, Rituxan is used with methotrexate .
Before taking Rituxan for your RA, you must have tried a type of drug known as a tumor necrosis factor antagonist. However, you werent able to tolerate the side effects of the TNF antagonist or the medication didnt relieve your symptoms. Examples of TNF antagonists include adalimumab , infliximab , and etanercept .
RA explained
RA is an autoimmune disease, which means it causes your immune system to mistakenly attack your own body. RA specifically damages joints, causing them to become painful and swollen. RA can attack any joints, but it often affects feet and hands.
Rituxan is for RA thats moderate to severely active. Moderate to severe means that the cartilage between your joints has become affected and may become damaged. When RA is active, youre currently having symptoms, such as painful or swollen joints.
Effectiveness for RA
Clinical trials used American College of Rheumatology criteria to determine how well People who had a score of ACR50 showed at least a 50% improvement in their RA symptoms. After 24 weeks, an ACR50 was reported in:
- 27% of people who took Rituxan and methotrexate
- 5% of people who took methotrexate and a placebo
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Immunogenicity Of Rituximab In Ra
As rituximab is a chimeric monoclonal antibody, the development of human anti-chimeric antibodies that lower the level of the drug and hence its clinical efficacy is a concern. In the first RCT conducted by Edwards et al,25 HACAs were reported in 4.3% of patients who received rituximab. However, no breakdown figures were available for the rituximab monotherapy group in comparison with the combination groups. Thus, whether combining rituximab with MTX or CYC might reduce the incidence of HACAs is unclear. In subsequent RCTs, rituximab was exclusively used in combination with MTX. The incidence of HACAs to rituximab ranged from 2.7% to 7.9%.2630 A pooled analysis on the long-term safety of rituximab in clinical trials revealed that HACAs were present in 11% of patients on at least one visit.62 There was no obvious relationship between the dose of rituximab used and the incidence of the HACA response. Interestingly, HACAs to rituximab were also detected in 3.6% of placebo-treated patients in the SERENE study.28 The presence of HACAs to rituximab does not appear to affect the efficacy of rituximab in depleting B cells, clinical efficacy at the study endpoints, and retreatment efficacy. There is also no obvious relationship between the HACA response and the occurrence of infusion reactions to rituximab.
Lower Doses Fewer Steroids
These finding suggest that high doses of steroids, which have many side effects when used long term, may not be needed in these patients.
Rheumatologist Simon Helfgott, MD, tells WebMD that this comes as no surprise. Helfgott treats rheumatoid arthritis patients at Brigham and Women’s Hospital in Boston he says about 40% of his patients are on biologics.
“Those of us who have been using this drug and following this understand that you don’t need to give the whopping doses of steroids that were used in the early trials,” he says.
He says Rituxan is emerging as a useful therapy for patients who fail treatment with the tumor necrosis factor -targeting biologics, such as Enbrel, Humira and Remicade.
“The difference in its mode of action is intriguing,” he says. “Some patients strike out on all of the anti-TNF agents. It will be interesting to see how they respond to this drug.”
Show Sources
SOURCES: Emery, P. Arthritis and Rheumatism, May 2006 vol 54: pp1390-1400. Roy Fleischmann, MD, clinical professor of medicine, University ofTexas Southwestern Medical Center, Dallas. Nermohamed et al., Drugs, 2005 vol65: pp 661-694. Simon Helfgott, MD, rheumatologist, Brigham and Women’sHospital, Boston associate professor of medicine, Harvard Medical School.
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Whos A Good Candidate For This Treatment
The FDA has approved treatment with Rituxan and methotrexate:
- if you have moderate to severe RA
- if you havent responded positively to treatment with blocking agents for tumor necrosis factor
The FDA advises that Rituxan should be used during pregnancy only when the potential benefit to the mother outweighs any potential risk to the unborn child. The safety of Rituxan use with children or nursing mothers isnt yet established.
The FDA recommends against the use of Rituxan for people with RA who havent been treated with one or more blocking agents for TNF.
Rituxan is also not recommended for people who have had hepatitis B or carry the virus, because Rituxan could reactivate hepatitis B.
Who Can I Call About My Financial Support Options
Our patient resource center is dedicated to getting patients and caregivers to the right resources. Call 1-877-GENENTECH Monday-Friday, 6 AM – 5 PM PT with questions.
Find more answers to your questions about Rituxan in our patient brochure
*Rituxan Immunology Access Solutions cannot complete or submit an appeal for you.
IMPORTANT SIDE EFFECT INFORMATION
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Rituximab For Rheumatoid Arthritis
We examined research published up to January 2014 on the effect of rituximab for people with rheumatoid arthritis. From eight studies evaluating 2720 people with rheumatoid arthritis, we found that rituximab probably:
– improved pain, function and other symptoms
– reduced disease activity
– reduced joint damage as seen on the x-ray.
We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Possible side effects are infusion reactions, vascular disorders, and infections.
What is rheumatoid arthritis and what is rituximab?When you have rheumatoid arthritis, your immune system, which normally fights infection, attacks the lining of your joints. This makes your joints swollen, stiff, and painful. There is no cure for rheumatoid arthritis at present, so the treatments aim to relieve pain and improve your ability to move.
Rituximab works by depleting the levels of B-cells, a type of immune cell in the body that causes swelling and joint damage in people who have rheumatoid arthritis. Rituximab is given intravenously. Rituximab is of great interest to rheumatoid arthritis patients based on improvements in symptoms and radiographic progression, and the low rate of short-term side effects.
What happens to people with rheumatoid arthritis who are given rituximab plus methotrexate?
Quality of life – physical component
Quality of life – mental component
*1% unit difference due to rounding.
Predictive Factors Of Good Response To Rituximab
We analysed the clinical factors associated with achieving biologic-free remission after the first cycle of rituximab and found that only the previous use of two or more anti-TNF agents was significant. Disease activities, comorbidities, type or number of concomitant csDMARDs, and the corticosteroid dose did not significantly affect the achievement of biologic-free remission. Multivariable linear regression analysis of the factors that extend the time interval between the retreatment courses showed that prior or concomitant use of two or more csDMARDs and concomitant use of corticosteroids were significant factors .
Table 3. Clinical characteristics of patients who achieved and did not achieved biologic-free remission after first cycle.
Table 4. Factors related to extending the time intervals between rituximab treatment.
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Retreatment Schedule With Rituximab
The optimal timing for rituximab retreatment remains a research question. Options include treatment on flare, regular retreatment , treatment with any deterioration, or treatment-to-target.44 Retrospective data supported a treatment-to-target strategy,45 whereas regular retreatment regardless of the disease activity might risk overtreatment in some patients that may lead to an increased rate of infective complications.44
In clinical studies, rituximab was given per protocol at baseline and then every 6 months.27,28,30 Clinical response is typically observed 34 months after the first course of rituximab. However, the durability of the clinical response is variable and often unpredictable in different patients. A prospective study showed that the mean time for rituximab retreatment since baseline was around 8.5 months in anti-TNF failure RA patients.34 The rituximab insert package in the US states that retreatment can be given every 6 months according to clinical evaluation, but not sooner than every 4 months.5 The latest European consensus statements on use of rituximab in RA suggested that retreatment of rituximab might be considered after at least 24 weeks in patients who did not achieve clinical remission or at least low disease activity state as evidenced by any disease activity index.44 Otherwise, retreatment should be delayed until disease activity returned.
Infections Of Special Attention
In the long-term rituximab in RA safety report,66 serious opportunistic infections were rarely reported , corresponding to a rate of 0.06/100 patient-years. Two cases of pulmonary TB were reported, but no cases of extra-pulmonary TB, atypical mycobacterial infection, or multidrug-resistant TB were observed. Moreover, no patients had hepatitis B reactivation, but there was one case of de novo hepatitis B infection. In the all exposure population, 108 cases of herpes zoster were reported in 100 patients, giving a rate of 9.0/1,000 patient-years, which was similar to that of the MTX plus placebo group and the general RA populations .
Only several isolated cases of reactivation of hepatitis B were reported in RA patients receiving rituximab in the literature.7072 None of these cases came from high prevalence areas like Asian countries.
There is no evidence to suggest that reactivation of TB occurs more frequently in RA patients receiving rituximab.21,66 In fact, a recent study of 56 RA patients from Taiwan did not report any cases of TB reactivation after rituximab treatment for 1 year.73 Also, no significant change in released interferon gamma levels on a QuantiFERON-TB-Gold assay was observed in patients with latent TB infection or in those with previous TB infection related to anti-TNF agents after rituximab therapy. It was suggested that rituximab might be an alternative agent for patients with high risk of TB reactivation.
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Data Collection And Assessment Of Disease Activity
Medical information was collected through data uploaded to the KOBIO web server . At the time of registration, individual investigators at each centre obtained information through structured interviews or using medical chart records including clinical information, laboratory tests, and radiologic imaging. Data for each patient were updated annually using a standardised case report form, and all data are transferred to the web server. Clinical information, such as age, sex, body mass index, alcohol consumption, smoking habits, extra-articular manifestations, previous or current medications, and concomitant diseases, was collected primarily from health questionnaires and interviews. Laboratory tests included rheumatoid factor , anti-citrullinated protein antibody , erythrocyte sedimentation rate , and C-reactive protein . All radiographs were evaluated by radiologists, and bone erosion was defined as the presence of erosion of at least one proximal interphalangeal joint, metacarpophalangeal joint, wrist, and metatarsophalangeal joint on plain radiographs of the hand and foot. Disease activity was evaluated according to the number of tender and swollen joints, visual analogue scales for pain, patient’s and physician’s global assessment, and Disease Activity Score in 28 joints -ESR and DAS28-CRP.
Optimal Dosing Regimen Of Rituximab
The optimal dosing regimen of rituximab in RA has not been established. In two RCTs, DANCER26 and SERENE,28 no significant differences in the clinical response of the two doses of rituximab could be demonstrated in MTX inadequate responders. In the MIRROR study,27 however, the higher rituximab dose group was associated with a better and sustained clinical response at week 48. In MTX naïve early RA patients , MTX in combination with rituximab was not significantly more effective than a lower rituximab dose at week 52 in terms of ACR and EULAR responses.31 A recent meta-analysis on the above four RCTs did not demonstrate a significant difference in the clinical responses between the high- and low-dose rituximab regimens.42
In early RA patients, a higher dose of rituximab in combination with MTX showed a better efficacy in halting radiological progression than a lower dose of rituximab when compared to MTX alone, although a lower dose of rituximab itself was associated with a significant difference in progression of radiological damage compared with placebo.31,36 As erosion occurs early in the course of the disease,43 prevention of radiological progression with the use of a higher dose of rituximab seems to be logical in patients with early RA. In patients who are refractory to the anti-TNF biologics, a lower dose of rituximab has not been tested for radiological progression, whereas efficacy in slowing radiological damage has been shown with the higher dosing regimen .33
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