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Boehringer Ingelheim lança tratamento específico para controle da perda da função pulmonar para pacientes com esclerose sistêmica (ES)

O medicamento está aprovado no Brasil e oferece uma oportunidade de tratamento para os pacientes com a doença


News provided by

Boehringer Ingelheim

Feb 17, 2020, 10:42 ET

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SÃO PAULO, 17 de fevereiro de 2020 /PRNewswire/ -- Principal causa de morte em pacientes com esclerose sistêmica (ES), a doença pulmonar intersticial (DPI), que acomete 70% dos pacientes, até então não dispunha de um medicamento específico para tratamento no Brasil e no mundo1. Entretanto, com a aprovação da nova indicação terapêutica do nintedanibe pela Anvisa, o medicamento passa a ser o único no país para o tratamento (ou manejo) da doença pulmonar intersticial associada à esclerose sistêmica (DPI-ES)2.

A esclerose sistêmica é uma doença autoimune crônica inflamatória que acomete pequenos vasos sanguíneos, pele e articulações, podendo evoluir para fibrose e perda de função de órgãos internos3. Decorrente de uma maior concentração de colágeno nas camadas da pele, uma das principais características da doença é a pele espessada e endurecida3. "Os dois primeiros anos costumam apresentar uma piora e progressão mais acentuada da doença, que progride das extremidades, como mãos e pés, para os braços, pernas, face, tronco e abdome", afirma a médica reumatologista Dra. Cristiane Kayser, da Universidade Federal de São Paulo (Unifesp). Ela destaca ainda que a doença pode ocorrer em pessoas de qualquer idade, sexo e raça, mas a prevalência é de quatro a nove vezes maior em mulheres3.

O acometimento pulmonar acontece em 70% dos casos1. A DPI costuma aparecer nos cinco primeiros anos de diagnóstico da doença, por isso a médica ressalta a importância do acompanhamento clínico desde o início do diagnóstico da ES1. "Como a doença pulmonar intersticial pode não ser identificada somente no exame físico, é fundamental uma investigação pulmonar precoce com tomografia computadorizada de alta resolução, conhecida pela sigla TCAR", alerta a especialista.

A ES é classificada em duas formas: cutânea limitada (EScl) e cutânea difusa (EScd). O que difere as duas é a extensão do acometimento da pele. Na forma limitada, o espessamento da pele é restrito às mãos e antebraços, pernas e pés. Na difusa, mãos, antebraços, braços, pés, pernas, coxas e tronco são afetados3.

Pacientes com as duas formas da doença podem apresentar doença pulmonar intersticial associada. Em estudo europeu com mais de 3500 pacientes, 35% dos pacientes com EScl e 53% dos pacientes com EScd apresentaram fibrose pulmonar4. "Esse estudo mostra que independentemente de como a ES se manifesta nos pacientes, é comum o aparecimento da doença pulmonar, por isso é preciso investigar todos os pacientes com esclerose sistêmica", afirma a médica.

Responsável por cerca de 33% da mortalidade e considerada a causa mais frequente de óbito dos pacientes com ES5, a falta de tratamento específico para a DPI-ES sempre foi uma grande preocupação dos pacientes devido à gravidade da doença. "A aprovação da nova indicação do medicamento pela Anvisa oferece um controle efetivo e seguro da progressão da DPI-ES, o que deve aumentar em longo prazo a sobrevida dos pacientes", afirma Dra. Cristiane.

O medicamento já é aprovado no Brasil, e em mais de 70 países, para o tratamento da fibrose pulmonar idiopática (FPI) e câncer de pulmão não pequenas células (CPNPC)2. Com a nova indicação do medicamento, muitos dos pacientes com esclerose sistêmica no país terão a possibilidade de desacelerar a progressão da fibrose pulmonar, principal causa de morte da doença.

"O tratamento da DPI-ES é complexo, mas com a nova indicação do nintedanibe, os pacientes ganham uma esperança de ter um melhor controle do acometimento pulmonar", destaca a médica.

Para a identificação da esclerose sistêmica é preciso estar atento aos sinais da doença, como mudança de cor das extremidades, especialmente dos dedos das mãos e pés, associada ou não a dor, desencadeadas após exposição ou frio ou stress, inchaço, vermelhidão e calor das articulações das mãos e dos pés, diminuição da elasticidade da pele dos dedos e face e dificuldade de deglutição 3. Para quem já convive com a ES, é fundamental a investigação da doença pulmonar para que o médico possa avaliar as formas mais adequadas de tratamento.

Referências

1.

Kairalla Ronaldo Adib. Doença intersticial pulmonar na esclerodermia. J. bras. pneumol. [Internet].  005 Aug [cited 2020 Feb 07];31(4): i-iii.Available from: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1806-37132005000400001&lng=en.http://dx.doi.org/10.1590/S1806-37132005000400001

2.

Bula profissional de Ofev® (esilato de nintedanibe). Versão aprovada pela ANVISA em 17Dez2019.

3.

Sociedade Brasileira de Reumatologia. Esclerose Sistêmica. Cartilha para pacientes.

4.

Walker UA, Tyndall A, Czirják L, et al. Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR Scleroderma Trials And Research group database. Ann Rheum Dis. 2007;66(6):754-63.

5.

Sampaio-barros PD, Bortoluzzi AB, Marangoni RG, et al. Survival, causes of death, and prognostic factors in systemic sclerosis: analysis of 947 Brazilian patients. J Rheumatol. 2012;39(10):1971-8.

FONTE Boehringer Ingelheim

SOURCE Boehringer Ingelheim

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