Please review the Data Sheet before prescribing.
MabThera is an anti-CD20 therapy for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).1
MabThera is a Prescription Medicine, available as 100 mg/10 mL and 500 mg/50 mL vials for intravenous (IV) infusion.
For information on dosage and administration of MabThera, please refer to the Data Sheet on the Medsafe website here.
MabThera’s auto-immune indications registered by Medsafe are:
- MabThera, in combination with methotrexate, is indicated for the treatment of patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying agents.1
- MabThera, in combination with glucocorticoids, is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (GPA, also known as Wegener’s granulomatosis) and microscopic polyangiitis (MPA).1
MabThera’s Mechanism of Action
MabThera is a chimeric mouse/human monoclonal antibody that binds specifically to the trans-membrane antigen CD20. This antigen is located on pre-B- and mature B-lymphocytes, but not on haemopoietic stem cells, pro–B-cells, normal plasma cells or other normal tissue.1
MabThera binds to the CD20 antigen on B-lymphocytes and initiates immunologic reactions that mediate B-cell lysis. Possible mechanisms of cell lysis include complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and induction of apoptosis.1
For a short video explaining MabThera’s mode of action, click the image below.
MabThera’s Funding Status
MabThera is listed on the Hospital Medicines List, within the Pharmaceutical Schedule, for the treatment of RA, GPA and MPA.2 Click here to see the full funding criteria.
MabThera for RA: Anti-TNF inadequate-responders
SWITCH-RA is a prospective, global, observational study, conducted in real life practical conditions. The primary objective was to compare the effectiveness of MabThera with an alternative anti-TNF for patients with an inadequate response to one previous anti-TNF.1
The sub-group analysis conducted on rheumatoid factor status was a pre-planned statistical analysis.1
The REFLEX study evaluated the safety and efficacy of MabThera-plus-methotrexate versus placebo-plus-methotrexate for patients with active RA who had an inadequate response to, or intolerance of, anti-TNF therapy.2
MabThera for RA: Methotrexate inadequate-responders
The SERENE study investigated the efficacy and safety of MabThera in combination with MTX, in patients with active RA who had an inadequate response to MTX and in whom no prior biological treatment for RA had been administered.3
MabThera for MPA and GPA
The RAVE study compared MabThera with standard cytotoxic therapy for patients with severe ANCA-associated vasculitis.4,5
Key Safety Information
For the full safety information for MabThera, please refer to the Data Sheet available here.6
Long-term safety data for MabThera have been pooled from the global clinical trial programme. In 2015, data were published evaluating 3,595 patients who received up to 20 courses of MabThera over 11 years, providing 14,816 patient-years of observation.7
The key findings were:7
- No new safety signals with increased duration of exposure (over 11 years)
- Infusion-related reactions are the most common event, predominantly occurring with the first infusion of the first course in 22% of patients and are rarely serious.
- Overall adverse events (AEs) and serious AEs (SAEs) are comparable to the pooled placebo population.
- SAEs in >1% of patients were exacerbations of RA, pneumonia, osteoarthritis and falls (all 2%)
- Serious and non-serious infection rates do not increase over time
- Serious and non-serious infection rates were comparable to the pooled placebo population
- The most frequently reported serious infections were lower respiratory tract infections (predominantly pneumonia)
- Switching to subsequent biologics was not associated with an increased serious infection rate.
Warnings and Precautions (RA, GPA and MPA):6
- Mostly mild-moderate and more common with first infusion. Serious and severe IRRs, some with a fatal outcome, have been reported.
- Premedicate with analgesic/anti-pyretic, anti-histamine and glucocorticoid prior to each infusion.
- Monitor for infusion-related reactions (IRRs) and hypersensitivity.
- Administer in an environment with full resuscitation facilities.
- For IRRs, reduce rate, interrupt treatment and administer appropriate medicines if required. If IRRs resolved, resume at 50% reduction in rate. Temporary or permanent discontinuation may also be required, depending on IRR severity and treatment interventions required.
- Medicines to treat hypersensitivity reactions should be available for immediate use.
- Angina pectoris, arrhythmias, heart failure and MI have occurred in patients treated with MabThera.
- Consider withholding antihypertensives 12 hours prior to and during infusion.
- Closely monitor patients with a history of cardiac disease or prior cardiopulmonary AEs.
- Do not treat severely immunocompromised patients or those with active infection.
- Caution in patients with history of recurring or chronic infections or predisposing conditions.
- Prior to treatment, screen all patients for HBV.
- Monitor all patients for infection including reactivation of HBV and PML. Promptly evaluate and treat patients who develop infections.
Progressive Multifocal Leukoencephalopathy (PML)
- If PML is suspected suspend treatment until PML diagnosis has been excluded; permanently discontinue treatment if PML is confirmed.
- SJS and TEN, some with fatal outcome, have been reported.
- Discontinue if severe skin reactions occur.
- Complete vaccinations at least 4 weeks prior to treatment.
- Live virus vaccines not recommended during treatment.
Not recommended in MTX-naïve patients.
Pregnancy and lactation:
- Women of childbearing age must use effective contraceptive methods during and for 12 months after treatment with Mabthera.
- Should not be administered to nursing mothers.
Adverse Effects (Very common and common only; See Data Sheet for full list)6
- Infections/Infestations: URTI, UTI, bronchitis, sinusitis, gastroenteritis, tinea pedis.
- Immune system/administration site conditions: IRRs (see Data Sheet for details).
- Metabolism/nutrition: hypercholesterolemia.
- Nervous system: headache, paraesthesia; migraine; dizziness; sciatica.
- Skin/SC: alopecia.
- Psychiatric: depression; anxiety.
- GI: dyspepsia; diarrhoea; GORD; mouth ulceration; abdominal pain.
- Musculoskeletal/CT: arthralgia; osteoarthritis; bursitis.
GPA/MPA (>5%): In addition to IRRs (see Data Sheet for details)
- Blood/lymphatic: thrombocytopenia.
- GI: diarrhoea, dyspepsia, constipation.
- General disorders: peripheral oedema.
- Infections: UTI, bronchitis, herpes zoster, nasopharyngitis.
- Investigations: decreased haemoglobin.
- Metabolism/nutrition: hypokalaemia.
- Nervous system: dizziness, tremor,
- Psychiatric: insomnia.
- Respiratory/thoracic: cough, dyspnoea, epistaxis, nasal congestion.
- Skin/SC: acne.
- Vascular: hypertension, flushing.
Musculoskeletal/CT: muscle spasm/weakness, arthralgia, musculoskeletal pain, back pain, pain in extremities.
Please contact the Roche team for further information on the efficacy and/or safety of our products.
- Emery P, Gottenberg JE, Rubbert-Roth A, et al. Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study. Ann Rheum Dis 2014;74:979-84
- Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthr & Rheum 2006;54(9):2793-2806
- Emery P, Deodhar A, Rigby WF, et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab’s Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis 2010;69:1629–1635
- Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med 2010;363:221-32
- Specks U, Merkel PA, Seo P, et al. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med 2013;369:417-27
- MabThera® (rituximab) Data Sheet. Available here.
- Van Vollenhoven RF, Fleischmann RM, Furst DE, et al. Longterm safety of rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 years. J Rheumatol 2015;42:1761-6
MabThera Funding Criteria
Click the image to download a two-page summary of the Hospital Medicines List funding criteria for the use of MabThera in rheumatoid arthritis (RA).
Click the image to download a two-page summary of the Hospital Medicines List funding criteria for the use of MabThera in granulomatosis with polyangitis (GPA) or microscopic polyangitis (MPA)
Click the image to download a 14-page instruction booklet on how to infuse MabThera for the treatment of RA, GPA and MPA.
MabThera Dosing and Administration Summary
Click the image for a one-page summary of the dosing and administration guidelines for the infusion of MabThera for the treatment of RA, GPA and MPA.
MabThera Patient Booklet
Click the image for an 18-page booklet for RA patients who have been prescribed MabThera.
This booklet has been created to be a helpful source of information to support patients throughout their treatment. It is not meant to substitute any guidance, advice or help provided by their doctor, nurse or pharmacist.
More patient information on MabThera can be found in the Consumer Medicine Information (CMI) leaflet, available here.