View in EDS

Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries.

Saved in:
Bibliographic Details
Title: Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries.
Authors: Reyes, J.M.1 (AUTHOR) JuanManuel.Reyes@pfizer.com, Gutierrez, M.V.2 (AUTHOR), Madariaga, H.3 (AUTHOR), Otero, W.4 (AUTHOR), Guzman, R.5 (AUTHOR), Izquierdo, J.6 (AUTHOR), Abello, M.7 (AUTHOR), Velez, P.8 (AUTHOR), Castillo, D.6 (AUTHOR), Ponce de Leon, D.9 (AUTHOR), Lukic, T.10 (AUTHOR), Amador, L.1 (AUTHOR)
Source: Reumatología Clínica. Jun2023, Vol. 19 Issue 6, p319-327. 9p.
Subjects: PATIENT reported outcome measures, ANTIRHEUMATIC agents, RHEUMATOID arthritis
Geographic Terms: COLOMBIA, PERU
Abstract (English): To describe efficacy, safety, and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions. A noninterventional study was performed between March 2017 and September 2019 at 13 sites in Colombia and Peru. Outcomes measured at baseline and at the 6-month follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed as the least squares mean difference (LSMD). Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the patients' mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 years (SD 7.01). The change from baseline at month 6 was not statistically significant different in the adjusted LSMD [SD] for tofacitinib vs. bDMARDs for RAPID3 score (−2.55[.30] vs. −2.52[.26]), HAQ-DI score (−.56[.07] vs. −.50[.08]), EQ-5D-3L score (.39[.04] vs..37[.04]) and DAS28-ESR (−2.37[.22] vs. −2.77[.20]). Patients from both groups presented similar proportions of nonserious and serious AEs. No deaths were reported. Changes from baseline were not statistically significantly different between tofacitinib and bDMARDs in terms of RAPID3 scores and secondary outcomes. Patients from both groups presented similar proportions of nonserious and serious AEs. NCT03073109. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Describir la eficacia, la seguridad y los desenlaces reportados por los pacientes (PRO) en pacientes con artritis reumatoide (RA) con una respuesta inadecuada a los fármacos antirreumáticos modificadores de la enfermedad sintéticos convencionales (csFARME) tratados con tofacitinib o FARME biológico (bFARME) en condiciones de la vida real. Estudio no intervencional realizado entre marzo de 2017 y septiembre de 2019 en 13 centros de Colombia y Perú. Los desenlaces evaluados al inicio y a los seis meses de seguimiento fueron la actividad de la enfermedad (puntaje Routine Assessment of Patients Index Data [RAPID3]), el estado funcional (puntaje Health Assessment Questionnaire [HAQ-DI]) y la calidad de vida (EuroQol Questionnaire [EQ-5D-3L]). El puntaje de actividad de la enfermedad-28 (DAS28-ESR) y la frecuencia de eventos adversos (EA). Se estimaron las diferencias no ajustadas y ajustadas con respecto a los valores basales y se expresaron como diferencia de medias por mínimos cuadrados (LMD). Se recolectó información de 100 pacientes tratados con tofacitinib y 70 pacientes con bFARME. Al inicio del estudio, la edad media de los pacientes era de 53,53 años (DE 13,77) y la duración media de la enfermedad de 6,31 años (DE 7,01). El cambio con respecto al valor basal en el mes 6 no fue estadísticamente significativo en la LMD ajustada (SE) para tofacitinib vs. los bFARME para RAPID3 (−2,55 [0,30] vs. −2,52 [0,26]), puntuación HAQ-DI (−0,56 [0,07] vs. −0,50 [0,08]), puntuación EQ-5D-3L (0,39 [0,04] vs. 0,37 [0,04]) y DAS28-ESR (−2,37 [0,22] vs. −2,77 [0,20]). Los pacientes de ambos grupos presentaron proporciones similares de EA no graves y graves. Ninguna muerte fue reportada. Los cambios desde el inicio no fueron estadísticamente significativos entre tofacitinib y los bFARME en RAPID3 y en los desenlaces secundarios. Los pacientes de ambos grupos presentaron proporciones similares de EA no graves y graves. NCT03073109. [ABSTRACT FROM AUTHOR]
Copyright of Reumatología Clínica is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: MedicLatina
FullText Text:
  Availability: 0
Header DbId: lth
DbLabel: MedicLatina
An: 163851546
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Reyes%2C+J%2EM%2E%22">Reyes, J.M.</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> JuanManuel.Reyes@pfizer.com</i><br /><searchLink fieldCode="AR" term="%22Gutierrez%2C+M%2EV%2E%22">Gutierrez, M.V.</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Madariaga%2C+H%2E%22">Madariaga, H.</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Otero%2C+W%2E%22">Otero, W.</searchLink><relatesTo>4</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Guzman%2C+R%2E%22">Guzman, R.</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Izquierdo%2C+J%2E%22">Izquierdo, J.</searchLink><relatesTo>6</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Abello%2C+M%2E%22">Abello, M.</searchLink><relatesTo>7</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Velez%2C+P%2E%22">Velez, P.</searchLink><relatesTo>8</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Castillo%2C+D%2E%22">Castillo, D.</searchLink><relatesTo>6</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ponce+de+Leon%2C+D%2E%22">Ponce de Leon, D.</searchLink><relatesTo>9</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lukic%2C+T%2E%22">Lukic, T.</searchLink><relatesTo>10</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Amador%2C+L%2E%22">Amador, L.</searchLink><relatesTo>1</relatesTo> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Reumatología+Clínica%22">Reumatología Clínica</searchLink>. Jun2023, Vol. 19 Issue 6, p319-327. 9p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22PATIENT+reported+outcome+measures%22">PATIENT reported outcome measures</searchLink><br /><searchLink fieldCode="DE" term="%22ANTIRHEUMATIC+agents%22">ANTIRHEUMATIC agents</searchLink><br /><searchLink fieldCode="DE" term="%22RHEUMATOID+arthritis%22">RHEUMATOID arthritis</searchLink>
– Name: SubjectGeographic
  Label: Geographic Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22COLOMBIA%22">COLOMBIA</searchLink><br /><searchLink fieldCode="DE" term="%22PERU%22">PERU</searchLink>
– Name: Abstract
  Label: Abstract (English)
  Group: Ab
  Data: To describe efficacy, safety, and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions. A noninterventional study was performed between March 2017 and September 2019 at 13 sites in Colombia and Peru. Outcomes measured at baseline and at the 6-month follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed as the least squares mean difference (LSMD). Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the patients' mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 years (SD 7.01). The change from baseline at month 6 was not statistically significant different in the adjusted LSMD [SD] for tofacitinib vs. bDMARDs for RAPID3 score (−2.55[.30] vs. −2.52[.26]), HAQ-DI score (−.56[.07] vs. −.50[.08]), EQ-5D-3L score (.39[.04] vs..37[.04]) and DAS28-ESR (−2.37[.22] vs. −2.77[.20]). Patients from both groups presented similar proportions of nonserious and serious AEs. No deaths were reported. Changes from baseline were not statistically significantly different between tofacitinib and bDMARDs in terms of RAPID3 scores and secondary outcomes. Patients from both groups presented similar proportions of nonserious and serious AEs. NCT03073109. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: Describir la eficacia, la seguridad y los desenlaces reportados por los pacientes (PRO) en pacientes con artritis reumatoide (RA) con una respuesta inadecuada a los fármacos antirreumáticos modificadores de la enfermedad sintéticos convencionales (csFARME) tratados con tofacitinib o FARME biológico (bFARME) en condiciones de la vida real. Estudio no intervencional realizado entre marzo de 2017 y septiembre de 2019 en 13 centros de Colombia y Perú. Los desenlaces evaluados al inicio y a los seis meses de seguimiento fueron la actividad de la enfermedad (puntaje Routine Assessment of Patients Index Data [RAPID3]), el estado funcional (puntaje Health Assessment Questionnaire [HAQ-DI]) y la calidad de vida (EuroQol Questionnaire [EQ-5D-3L]). El puntaje de actividad de la enfermedad-28 (DAS28-ESR) y la frecuencia de eventos adversos (EA). Se estimaron las diferencias no ajustadas y ajustadas con respecto a los valores basales y se expresaron como diferencia de medias por mínimos cuadrados (LMD). Se recolectó información de 100 pacientes tratados con tofacitinib y 70 pacientes con bFARME. Al inicio del estudio, la edad media de los pacientes era de 53,53 años (DE 13,77) y la duración media de la enfermedad de 6,31 años (DE 7,01). El cambio con respecto al valor basal en el mes 6 no fue estadísticamente significativo en la LMD ajustada (SE) para tofacitinib vs. los bFARME para RAPID3 (−2,55 [0,30] vs. −2,52 [0,26]), puntuación HAQ-DI (−0,56 [0,07] vs. −0,50 [0,08]), puntuación EQ-5D-3L (0,39 [0,04] vs. 0,37 [0,04]) y DAS28-ESR (−2,37 [0,22] vs. −2,77 [0,20]). Los pacientes de ambos grupos presentaron proporciones similares de EA no graves y graves. Ninguna muerte fue reportada. Los cambios desde el inicio no fueron estadísticamente significativos entre tofacitinib y los bFARME en RAPID3 y en los desenlaces secundarios. Los pacientes de ambos grupos presentaron proporciones similares de EA no graves y graves. NCT03073109. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Reumatología Clínica is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=lth&AN=163851546
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/j.reuma.2023.02.005
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 9
        StartPage: 319
    Subjects:
      – SubjectFull: PATIENT reported outcome measures
        Type: general
      – SubjectFull: ANTIRHEUMATIC agents
        Type: general
      – SubjectFull: RHEUMATOID arthritis
        Type: general
      – SubjectFull: COLOMBIA
        Type: general
      – SubjectFull: PERU
        Type: general
    Titles:
      – TitleFull: Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Reyes, J.M.
      – PersonEntity:
          Name:
            NameFull: Gutierrez, M.V.
      – PersonEntity:
          Name:
            NameFull: Madariaga, H.
      – PersonEntity:
          Name:
            NameFull: Otero, W.
      – PersonEntity:
          Name:
            NameFull: Guzman, R.
      – PersonEntity:
          Name:
            NameFull: Izquierdo, J.
      – PersonEntity:
          Name:
            NameFull: Abello, M.
      – PersonEntity:
          Name:
            NameFull: Velez, P.
      – PersonEntity:
          Name:
            NameFull: Castillo, D.
      – PersonEntity:
          Name:
            NameFull: Ponce de Leon, D.
      – PersonEntity:
          Name:
            NameFull: Lukic, T.
      – PersonEntity:
          Name:
            NameFull: Amador, L.
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 06
              Text: Jun2023
              Type: published
              Y: 2023
          Identifiers:
            – Type: issn-print
              Value: 1699258X
          Numbering:
            – Type: volume
              Value: 19
            – Type: issue
              Value: 6
          Titles:
            – TitleFull: Reumatología Clínica
              Type: main
ResultId 1