Efficacy of belimumab in Primary Sjögren's syndrome: A systematic review / Eficacia del belimumab en el síndrome de Sjögren primario: una revisión sistemática

Objective: To evaluate the efficacy and safety of belimumab in patients with Primary Sjögren's syndrome (pSS). Methods: The search included manuscripts assessing the efficacy or safety of belimumab in patients with pSS (American-European Consensus Criteria 2002) published between 2004 and 2017 in MEDLINE, EMBASE or Cochrane databases. Two reviewers independently selected the articles, extracted data and evaluated the quality of the evidence following Scottish Intercollegiate Guidelines Network (SIGN) recommendation grades. Results: Out of 135 citations, only 3 articles were included. All of them publishing results from the same study at different time points including 28 patients. At week 28 improvement was reported for visual analogue scale (VAS) dryness score and glandular manifestations in 37% and 77% of patients, respectively, which persisted at week 52 (W52). Belimumab was well tolerated and safely administered. Conclusion: Published evidence to determine the efficacy of belimumab in pSS is limited. Belimumab seems to be effective to reduce systemic activity, parotid enlargement, lymphadenopathies, articular manifestation and B cell biomarkers.(AU)

Objetivo: Evaluar la eficacia y la seguridad de belimumab en pacientes con síndrome de Sjögren primario (SSp). Métodos: La búsqueda incluyó manuscritos que evaluaban la eficacia o seguridad de belimumab en pacientes con SSp (Criterios Europeo-Americanos del 2002) publicados entre 2004 y 2007 en MEDLINE, EMBASE o Cochrane database. Dos revisores independientes seleccionaron los artículos, extrajeron los datos y evaluaron la calidad de la evidencia según los grados de recomendación de la Scottish Intercollegiate Guidelines Network (SIGN). Resultados: De 135 artículos se incluyeron 3. Todos publicaban resultados del mismo estudio en diferentes momentos, incluyéndose 28 pacientes. En la semana 28 presentaban una mejoría en la puntuación de sequedad en la escala analógica visual (VAS) y en las manifestaciones glandulares un 37 y 77% de los pacientes, respectivamente, que persistieron en la 52. La administración de belimumab fue segura y bien tolerada. Conclusión: Belimumab parece ser efectivo para reducir la actividad sistémica, el aumento parotídeo, las linfadenopatías, las manifestaciones articulares y los biomarcadores de células B, aunque con evidencia limitada.(AU)

Efficacy of belimumab in Primary Sjögren's syndrome: A systematic review.

OBJECTIVE: To evaluate the efficacy and safety of belimumab in patients with Primary Sjögren's syndrome (pSS). METHODS: The search included manuscripts assessing the efficacy or safety of belimumab in patients with pSS (American-European Consensus Criteria 2002) published between 2004 and 2017 in MEDLINE, EMBASE or Cochrane databases. Two reviewers independently selected the articles, extracted data and evaluated the quality of the evidence following Scottish Intercollegiate Guidelines Network (SIGN) recommendation grades. RESULTS: Out of 135 citations, only 3 articles were included. All of them publishing results from the same study at different time points including 28 patients. At week 28 improvement was reported for visual analogue scale (VAS) dryness score and glandular manifestations in 37% and 77% of patients, respectively, which persisted at week 52 (W52). Belimumab was well tolerated and safely administered. CONCLUSION: Published evidence to determine the efficacy of belimumab in pSS is limited. Belimumab seems to be effective to reduce systemic activity, parotid enlargement, lymphadenopathies, articular manifestation and B cell biomarkers.