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Long-Term Data on Efficacy and Safety of Selexipag for Digital Systemic Sclerosis Vasculopathy.
Di Battista, Marco; Della Rossa, Alessandra; Mosca, Marta.
Afiliación
  • Di Battista M; M. Di Battista, MD, Rheumatology Unit, University of Pisa, Pisa, and Department of Medical Biotechnologies, University of Siena, Siena; dibattista.marco91@gmail.com.
  • Della Rossa A; A. Della Rossa, MD, PhD, M. Mosca, MD, PhD, Rheumatology Unit, University of Pisa, Pisa, Italy.
  • Mosca M; A. Della Rossa, MD, PhD, M. Mosca, MD, PhD, Rheumatology Unit, University of Pisa, Pisa, Italy.
J Rheumatol ; 51(9): 899-903, 2024 Sep 01.
Article en En | MEDLINE | ID: mdl-38879188
ABSTRACT

OBJECTIVE:

Raynaud phenomenon (RP) and digital ulcers (DUs) are the main signs of digital vasculopathy in systemic sclerosis (SSc). Selexipag is an oral prostacyclin agonist approved for SSc-related pulmonary arterial hypertension. Following our previous preliminary short-course report, we herein present long-term data on selexipag safety and efficacy in the treatment of SSc digital vasculopathy.

METHODS:

Selexipag was administered to patients with SSc with severe digital vasculopathy refractory or with contraindication to all other vasoactive therapies. Each subject was assessed at baseline and after 3, 6, and 12 months. Clinical outcomes related to RP and DUs were evaluated along with modified Rodnan skin score of the fingers. Digital perfusion was assessed by laser speckle contrast analysis (LASCA). Nailfold videocapillaroscopy (NVC) was also performed.

RESULTS:

Eight patients with SSc (63% female, mean age 50.1 years) received selexipag. After 12 months of treatment, RP was reported to significantly decrease in the number of daily episodes and mean duration (P < 0.001 and P = 0.01, respectively). All patients achieved a complete healing of their DUs (P = 0.03) within 6 months. A progressive reduction of fingers skin score was observed (P = 0.03). No structural changes of capillaries were noted on NVC. Conversely, LASCA revealed an important increase in total digital perfusion (P = 0.004) despite seasonal variability. The safety profile was consistent with that reported in the literature.

CONCLUSION:

We observed a sustained efficacy of selexipag on SSc digital vasculopathy during 1 year of administration. Our promising results encourage the design of a new randomized controlled trial to evaluate the effect of selexipag on SSc digital vasculopathy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirazinas / Enfermedad de Raynaud / Esclerodermia Sistémica / Dedos / Acetamidas Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Rheumatol Año: 2024 Tipo del documento: Article Pais de publicación: Canadá
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirazinas / Enfermedad de Raynaud / Esclerodermia Sistémica / Dedos / Acetamidas Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Rheumatol Año: 2024 Tipo del documento: Article Pais de publicación: Canadá