Il Comitato per i Prodotti Medicinali per Uso Umano (CHMP) dell'Agenzia Europea dei Medicinali (EMEA) ha analizzato le informazioni disponibili sulla sicurezza di Raptiva (efalizumab) ed ha concluso che allo stato attuale delle conoscenze i benefici di Raptiva non superano più i rischi. L'EMEA ha quindi raccomandato la sospensione dell'autorizzazione alla commercializzazione del prodotto.
I pazienti che attualmente stanno assumendo Raptiva non devono interrompere il trattamento drasticamente, ma devono consultare il proprio medico per concordare la terapia sostitutiva più adatta.
I medici non devono effettuare alcuna nuova prescrizione per Raptiva e devono rivedere il trattamento dei pazienti che attualmente stanno assumendo il farmaco in maniera da stabilire le alternative più appropriate in vista di una interruzione del trattamento con Raptiva.
I medici inoltre non devono interrompere il trattamento in maniera repentina per evitare una recidiva della malattia o una sua esacerbazione e devono accertarsi che i pazienti che hanno assunto Raptiva siano attentamente esaminati per sintomi neurologici e di infezione.
Raptiva è stato autorizzato nell'Unione Europea per il trattamento di pazienti adulti affetti da psoriasi cronica a placche da moderata a severa che non rispondono, hanno una controindicazione, o non possono assumere altre terapie sistemiche per la psoriasi quali ciclosporina, metotressato e PUVA (psoralene + raggi UVA).
Per permettere il graduale passaggio dei pazienti in terapia con Raptiva ad altre terapie, il farmaco in Italia rimane per ora in commercio fino all'emissione del provvedimento di sospensione definitivo da parte dell'Emea.

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Fonte: AIFA. 23 febbraio 2009
Si rendono disponibili importanti informazioni di sicurezza relative alla specialità medicinale Raptiva (efalizumab), di cui il 19 febbraio scorso l'Agenzia Europea dei Medicinali (EMEA) ha raccomandato la sospensione dell'autorizzazione all'immissione in commercio.
Il Comitato per i Prodotti Medicinali per Uso Umano (CHMP)dell'EMEA ha ritenuto, infatti, che il rapporto beneficio/rischio nelle indicazioni approvate di Raptiva sia divenuto sfavorevole, a seguito dell'insorgenza di alcuni casi di Leucoencefalopatia Multifocale Progressiva (PML) e ad altri eventi avversi gravi, quali la sindrome di Guillan-Barré e la sindrome di Miller-Fisher, encefaliti, encefalopatia, meningite, sepsi ed infezioni opportunistiche (infezioni ricorrenti in pazienti con sistema immunitario compromesso) in pazienti affetti da psoriasi cronica a placche in trattamento continuo con Raptiva.
Rapiva è un anticorpo monoclonale umanizzato ad azione immunosoppressiva approvato in Europa nel 2004 per il trattamento di pazienti adulti affetti da psoriasi cronica a placche da moderata a severa, che non rispondono, o per i quali vi è una controindicazione, e o che sono intolleranti ad altre terapie sistemiche che includono ciclosporina, metotressato e PUVA.


EFALIZUMAB (RAPTIVA): RECOMMENDATION TO SUSPEND MARKETING AUTHORISATION AS RISKS OUTWEIGH BENEFITS
Fonte: EMEA. 19 febbraio 2009
The European Medicines Agency has completed a review of efalizumab (Raptiva) after concerns about its safety. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of efalizumab do not outweigh its risks, and that the Marketing Authorisation should be suspended across the EU.
Efalizumab is used to treat adults with moderate to severe chronic plaque psoriasis (a disease that causes red, scaly patches on the skin) who have not responded to, or who are unable to take, other treatments for psoriasis (including ciclosporin, methotrexate, and PUVA).
This medicine was reviewed after reports of serious side effects, including three confirmed cases of progressive multifocal leukoencephalopathy (PML, a rare but serious disorder of the central nervous system) in patients who had received efalizumab for more than 3 years; two of these patients died.
Although psoriasis is a disabling condition that can cause social and psychological problems for patients, it is very rarely life-threatening. The Committee concluded that the risk of PML is unacceptable for patients taking efalizumab. They recommended that the Marketing Authorisation should be suspended until there is adequate new evidence to identify a group of patients in which the benefits of efalizumab outweigh its risks.
Advice for patients:
" Patients who are currently taking efalizumab (Raptiva) should make an appointment with the doctor who prescribed it
" Patients should not stop treatment with efalizumab abruptly because it could cause psoriasis to return or worsen. Your doctor will discuss with you the most appropriate replacement treatment
" Patients who have taken efalizumab in the past and who have any questions or concerns should speak to their doctor or pharmacist.
Advice for healthcare professionals:
" Prescribers should not issue any prescriptions for efalizumab to patients who are not already taking it
" Prescribers should review the treatment of all patients who are currently taking efalizumab, with a view to stopping treatment
" Treatment with efalizumab should not stop abruptly (which could cause psoriasis to return or worsen). Prescribers should consider alternative treatments and continue to monitor the patient's psoriasis
" Efalizumab's effects on the immune system last for about 8-12 weeks. Healthcare professionals should closely monitor patients for infections and neurological symptoms after stopping treatment.


FDA ADVISES PUBLIC OF SERIOUS ADVERSE EVENT WITH PSORIASIS DRUG RAPTIVA
Fonte: FDA. 19 febbraio 2009
The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.
The FDA is reviewing this latest information. The agency will take appropriate steps to:
- ensure that the risks of Raptiva do not outweigh its benefits;
- that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
- that health care professionals carefully monitor patients for the possible development of PML.
PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.
Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies.
In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug's risks.
The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.
Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient's susceptibility to infections.


SUSPENSION OF MARKETING OF RAPTIVA (EFALIZUMAB) IN CANADA
Fonte: Health Canada. 20 febbraio 2009
Health Canada is providing for your convenience the links to the new postings entitled:
Suspension of marketing of Raptiva (efalizumab) in Canada - EMD Serono Canada Inc. At the recommendation of Health Canada, EMD Serono Canada Inc. has suspended the marketing of RAPTIVA in Canada due to safety concerns, including progressive multifocal leukoencephalopathy.

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