Your browser doesn't support javascript.
loading
Real-world Effectiveness of Sarilumab in RA: Results from the Open-label, Prospective, Single-arm Observational PROFILE Study.
Kivitz, Alan; Gottenberg, Jacques Eric; Bergman, Martin; Qiu, Chunfu; van Hoogstraten, Hubert; de Nijs, Ron; Bessette, Louis.
Afiliación
  • Kivitz A; Altoona Centre for Clinical Research, 175 Meadowbrook Lane, Duncansville, PA, 16635-8445, USA. ajkivitz@yahoo.com.
  • Gottenberg JE; Department of Rheumatology, Hôpitaux de Hautepierre, Strasbourg, France.
  • Bergman M; Department of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA.
  • Qiu C; Sanofi, Bridgewater, NJ, USA.
  • van Hoogstraten H; Sanofi, Bridgewater, NJ, USA.
  • de Nijs R; Department of Rheumatology, Elkerliek Hospital, Helmond, The Netherlands.
  • Bessette L; Department of Medicine, Université Laval, Québec, Québec, Canada.
Rheumatol Ther ; 2024 Sep 16.
Article en En | MEDLINE | ID: mdl-39287897
ABSTRACT

INTRODUCTION:

The 1-year PROspective sarilumab (preFILled syringe/pen) multinational, obsErvational (PROFILE) study evaluated the real-world effectiveness and safety of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA).

METHODS:

Safety endpoints included adverse events (AEs) and lab abnormalities. Effectiveness endpoints included the ACR core set. The primary endpoint was the change from baseline in Clinical Disease Activity Index (CDAI). All statistics are descriptive and p values were nominal.

RESULTS:

In total, 595 patients were treated, of whom 223 (37.5%) received sarilumab monotherapy and 372 (62.5%) received combination therapy. Upon initiation of sarilumab, an improvement in the mean (SD) CDAI score was observed at week 24 [11.4 (10.3)] and was maintained through week 52 [10.0 (10.5)], resulting in a mean [SD] reduction of -14.9 (12.7) and -14.4 (12.9), respectively. There were consistent improvements in disease activity that were similar for patients on monotherapy vs. combination therapy. An increase in the proportion of patients achieving remission and low disease activity was reported. By week 52, both groups had improved physical function and quality of life. There were no new safety signals. The proportions of any patients reporting a treatment-emergent adverse event (TEAE) or serious treatment-emergent AE (SAE) was 66.2% and 5.9%, respectively, and were similar between both treatment groups. Overall, 15.6% of patients discontinued sarilumab treatment due to TEAEs. The most commonly reported TEAE of interest was neutropenia (14.1%).

CONCLUSIONS:

In this 1-year, observational real-world study, sarilumab therapy resulted in improved clinical outcomes. The safety profile was consistent with that observed in sarilumab randomized clinical trials. This study was entered on the German website (Paul Ehrlich Institute) on January 11, 2018, with NIS No. 423.
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Rheumatol Ther Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Rheumatol Ther Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido