What is Leflunomide Winthrop?
Leflunomide Winthrop is a medicine that contains leflunomide as the active substance and is available as tablets (round white 10 and 100 mg; triangular yellow 20 mg).
The medicine is identical to Arava, which is already authorized for marketing in the European Union (EU). The company that makes Arava considered that the scientific data on it could also be used for Leflunomide Winthrop (“informed consent”).
What is Leflunomide Winthrop used for?
Leflunomide Winthrop is used to treat adults with active rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints) or active psoriatic arthritis (a disease that causes red, scaly patches on the skin and inflammation of the joints).
The medicine can only be obtained with a prescription.
How is Leflunomide Winthrop used?
Leflunomide Winthrop therapy should be initiated and supervised by a specialist experienced in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should perform blood tests to check the patient's liver, white blood cell and platelet counts before prescribing Leflunomide Winthrop, and regularly during treatment.
Leflunomide Winthrop treatment should be started with a 'loading dose' of 100 mg once daily for three days, followed by a maintenance dose. The recommended maintenance dose is 10-20 mg once daily in rheumatoid arthritis patients and 20 mg once daily in psoriatic arthritis patients. The medicine usually starts to work after four to six weeks. The effect can further improve for up to six months.
How does Leflunomide Winthrop work?
The active substance in Leflunomide Winthrop, leflunomide, is an immunosuppressant. This substance reduces inflammation by reducing the production of immune cells called 'lymphocytes', which are responsible for inflammation. Leflunomide does this by blocking an enzyme called 'dihydroorotate dehydrogenase', which is necessary for lymphocytes to multiply. With fewer lymphocytes, inflammation is reduced and helps control arthritis symptoms.
How has Leflunomide Winthrop been studied?
For rheumatoid arthritis Leflunomide Winthrop has been studied in four main studies involving over 2,000 patients in which it was compared with placebo (a dummy treatment), or with methotrexate or sulfasalazine (other medicines used to treat rheumatoid arthritis). ). Two of the studies lasted six months and two lasted a year. The two longer studies were subsequently extended and patients continued taking the medicines for at least another year.
Leflunomide Winthrop was compared with placebo for over six months in 186 patients with psoriatic arthritis.
In all studies, the main measure of effectiveness was the number of patients who responded to treatment, identified by disease-specific criteria (American College of Rheumatology response rates for rheumatoid arthritis and treatment response criteria for l "psoriatic arthritis).
What benefit has Leflunomide Winthrop shown during the studies?
In "rheumatoid arthritis, Leflunomide Winthrop demonstrated" efficacy superior to that of placebo and equivalent to that of sulfasalazine. Between 49 and 55% of patients taking Leflunomide Winthrop responded to treatment compared with 26-28% of those taking placebo and 54% of those taking sulfasalazine. These results were maintained in the extension studies. During the first year of therapy, Leflunomide Winthrop showed "equivalent efficacy to that of methotrexate, but only when taken with folate (a type of B vitamin). In the extension study, Leflunomide Winthrop did not show" equivalent efficacy. to that of methotrexate.
In psoriatic arthritis, Leflunomide Winthrop was more effective than placebo, with a treatment response rate of 59% of patients taking Leflunomide Winthrop compared with 30% of those taking placebo.
What are the risks associated with Leflunomide Winthrop?
The most common side effects with Leflunomide Winthrop (seen in between 1 and 10 patients in 100) are leukopenia (low white blood cell count), mild allergic reactions, increased levels of creatine phosphokinase (a marker of muscle injury), paraesthesia (sensory disturbances such as tingling and pricking), headache, dizziness, slight increase in blood pressure, diarrhea, nausea, vomiting, inflammation of the mouth (e.g. mouth ulcers), abdominal pain (stomach pain), increased liver enzyme levels, hair loss, eczema, rash, itching, dry skin, tenosynovitis (inflammation of the sheath that lines the tendons), loss of appetite, weight loss and asthenia (weakness). For the full list of side effects reported with Leflunomide Winthrop, see the package leaflet.
Leflunomide Winthrop should not be used in people who may be hypersensitive (allergic) to leflunomide or any of the other substances. Leflunomide Winthrop should not be used in patients with:
• liver disease;
• severe immunodeficiency states, eg. acquired immunodeficiency syndrome (AIDS);
• poor bone marrow function or low level of blood cells (red blood cells, white blood cells or platelets) due to diseases other than rheumatoid or psoriatic arthritis;
• severe infections;
• moderate to severe kidney disease;
• severe hypoproteinaemia (low levels of protein in the blood).
Leflunomide Winthrop should not be used in pregnant women, women of childbearing potential or breastfeeding.
Physicians prescribing Leflunomide Winthrop should be aware of the risk of liver problems associated with the medicine. Particular caution should also be exercised when switching a patient to Leflunomide Winthrop or when switching a patient taking Leflunomide Winthrop to another treatment.
Why has Leflunomide Winthrop been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Leflunomide Winthrop's benefits are greater than its risks for the treatment of adult patients with active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD ) and active psoriatic arthritis and recommended the granting of a marketing authorization for Leflunomide Winthrop.
Other information about Leflunomide Winthrop
The European Commission granted Sanofi-Aventis Deutschland GmbH a marketing authorization valid throughout the European Union for Leflunomide Winthrop on 8 January 2010. This authorization is valid for five years and is renewable.
For the full version of Leflunomide Winthrop EPAR, click here.
Last update of this summary: 11-2009.
The information on Leflunomide Winthrop published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
