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LAUDES Study: impact of digital ulcers on hand functional limitation, work productivity and daily activities, in systemic sclerosis patients

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Abstract

The objective of this study was to evaluate the impact of digital ulcers (DUs) in daily life of systemic sclerosis (SSc) Spanish patients. We developed a multicenter observational study to compare functional disability in SSc patients with active DUs vs. those without DUs. An additional correlation between perception of patients and physicians on disability due to DUs was performed. A total of 199 patients were enrolled, 70 (35%) with DUs. Patients with DUs were younger (48 vs. 58 years; p < 0.001) and had more frequently the diffuse subtype of SSc (45 vs. 24%; p = 0.004) than patients without DUs. Patients with DUs showed significantly higher scores in the Cochin Hand Function Scale overall (p < 0.002) and for each of its five dimensions. They also showed higher scores in the Systemic Sclerosis Health Assessment Questionnaire items related to hand function such as, dress and self-care (p < 0.013), eat (p < 0.013) and grip (p < 0.03), and higher Visual Analogic Scale scores for pain (p < 0.013), trouble related with Raynaud’s Phenomenon (p < 0.001) and sense of severity (p < 0.004). Impact on daily activities was significantly higher in patients with DUs (p = 0.002), with a non-significant trend to experience higher impact on work productivity (p = 0.07). A high correlation was found between DUs patients and physicians opinion on the impact of DUs (daily life: Pearson R = 0.86; work productivity: Pearson R = 0.87). Study findings show an impaired hand function and increased disability for daily life activities and work productivity in SSc patients with DUs compared with patients without DUs in Spanish population.

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Acknowledgements

The authors gratefully thank all contributing investigators and research teams of LAUDES study group: Dr. Aspe de la Iglesia, Bruno (Hospital de Meixoeiro, Vigo); Dra. Barbado Ajo, Julia (Hospital Clínico Universitario de Valladolid, Valladolid); Dr. Batista Perdomo, Daniel (Hospital Insular, Las Palmas de Gran Canaria); Dra. Beltrán Catalán, Emma (Hospital General Universitario de Valencia, Valencia); Dr. Belzunegui Otano, Joaquin (Hospital de Donostia, Donostia); Dr. Blanco Rodríguez, Jorge Santiago (Complejo Hospitalario Universitario de Santiago, Santiago de Compostela); Dr. Caamaño Freire, Manuel (Complejo Hospitalario Universitario de Santiago, Santiago de Compostela); Dr. Cantabrana Alútiz, Alberto (Hospital La Candelaria, Santa Cruz de Tenerife); Dra. Carrio Montes, Isabel (Hospital San Agustín, Avilés); Dra. Cia Lecumberri, Maite (Complejo Hospitalario de Navarra, Pamplona); Dra. Del Castillo Monsalvo, Rosa (Hospital de Guadalajara, Guadalajara); Dra. Diez Alvarez, Elvira (Hospital de León, León); Dr. Egües Dubuc, César Antonio (Hospital de Donostia, Donostia); Dra. Egurbide Arberas, Maria Victoria (Hospital de Cruces, Barakaldo); Dra. Fanlo Mateo, Patricia (Complejo Hospitalario de Navarra, Pamplona); Dra. Freire Dapena, Maria Del Carmen (Hospital Xeral Cies, Vigo); Dra. Freire González, Mercedes (Complejo Hospitalario Universitario de A Coruña, A Coruña); Dr. García Aparicio, Ángel (Hospital Virgen de la Salud, Toledo); Dr. García Hernández, Francisco José (Hospital Virgen del Rocío, Sevilla); Dr. Gómez de Salazar, José (Hospital La Vila, La Vila Joiosa); Dr. González Nieto, José Antonio (Hospital Can Misses, Eivissa); Dr. Graña Gil, Jenaro (Complejo Hospitalario Universitario de A Coruña, A Coruña); Dr. Guillén-Del-Castillo, Alfredo (Hospital Universitari Vall d’Hebron, Barcelona); Dr. Izquierdo Hidalgo, José (Hospital Santa Cristina, Madrid); Dr. Juan Mas, Toni (Hospital Son Llatzer, Palma); Dra. Laiño Piñeiro, Maria Cruz (Clínica Universitaria de Navarra, Pamplona); Dr. López Longo, Francisco Javier (Hospital Gregorio Marañón, Madrid); Dra. Lopez Núñez, Lilian Maria (Hospital del Mar, Barcelona); Dra. Marín Ballvé, Adela (Hospital Clínico Lozano Blesa, Zaragoza); Dr. Marras Fernandez-Cid, Carlos (Hospital Virgen de La Arrixaca, Murcia); Dr. Miguelez, Roberto (Hospital de Móstoles, Móstoles); Dr. Moran Rodriguez, Miguel Ángel (Hospital Universitario de Burgos, Burgos); Dr. Moreno Morales, Juan (Hospital Santa Lucía, Cartagena); Dra. Morlà, Rosa Maria (Hospital del Vendrell, El Vendrell); Dra. Ojeda Bruno, Soledad (Hospital Dr. Negrín, Las Palmas de Gran Canaria); Dr. Olivé Marqués, Alejandro (Hospital Germans Trias i Pujol, Badalona); Dr. Ornilla Laraundogoitia, Enrique (Clínica Universitaria de Navarra, Pamplona); Dr. Ortego, Noberto (Hospital San Cecilio, Granada); Dra. Ortiz Santamaria, Vera (Hospital General de Granollers, Granollers); Dra. Pérez Conesa, Mercedes Pilar (Hospital Miguel Servet, Zaragoza); Dra. Pérez Sandoval, Trinidad (Hospital de León, León); Dra. Pros Simon, Ana (Hospital del Mar, Barcelona); Dra. Rodríguez Lozano, Beatriz (Hospital Universitario de Canarias, Santa Cruz de Tenerife); Dra. Rueda Cid, Amalia (Hospital General de Valencia, Valencia); Dr. Sáez Comet, Luis (Hospital Miguel Servet, Zaragoza); Dr. Salvatierra Osorio, Juan (Hospital San Cecilio, Granada); Dr. Sanmartín López, Alejandro (Hospital de Elda, Elda); Dr. Santos Soler, Gregorio (Hospital La Vila, La Vila Joiosa); Dra. Sarmiento Guevara, Mónica (Hospital de la Santa Creu i Sant Pau, Barcelona); Dr. Todoli Parra, José Antonio (Hospital La Fe, Valencia); Dr. Tornero Ramos, Carmelo (Hospital Morales Meseguer, Murcia); Dr. Tovar Beltrán, Juan (Hospital Morales Meseguer, Murcia); Dra. Uceda Montañez, Julia Maria (Hospital de Valme, Sevilla); Dra. Vicente Rabaneda, Esther (Hospital La Princesa, Madrid). The authors also appreciate the collaboration of the participating patients and their families. Medical Writing support: TFS S.L.: Neus Valveny, PhD and Nerea Gallastegui, PhD.

Funding

This study was supported by Actelion Pharmaceuticals España, S.L. Medical writing assistance was provided by TFS S.L., with funding from Actelion Pharmaceuticals. Actelion did not have any role in the collection, analysis, and interpretation of data or writing the report. The views expressed are, therefore, based on author’s opinions and do not represent the views of Actelion or the journal.

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Authors and Affiliations

  1. Unitat de Reumatologia, Hospital de la Santa Creu i Sant Pau, Carrer de Sant Quintí, 89, 08026, Barcelona, Spain

    Ivan Castellví, Bruno Aspe de la Iglesia, Julia Barbado Ajo, Daniel Batista Perdomo, Emma Beltrán Catalán, Joaquin Belzunegui Otano, Jorge Santiago Blanco Rodríguez, Manuel Caamaño Freire, Alberto Cantabrana Alútiz, Isabel Carrio Montes, Maite Cia Lecumberri, Rosa Del Castillo Monsalvo, Elvira Diez Alvarez, César Antonio Egües Dubuc, Maria Victoria Egurbide Arberas, Patricia Fanlo Mateo, Maria Del Carmen Freire Dapena, Mercedes Freire González, Ángel García Aparicio, Francisco José García Hernández, José Gómez de Salazar, José Antonio González Nieto, Jenaro Graña Gil, Alfredo Guillén-Del-Castillo, José Izquierdo Hidalgo, Toni Juan Mas, Maria Cruz Laiño Piñeiro, Francisco Javier López Longo, Lilian Maria López Núñez, Adela Marín Ballvé, Carlos Marras Fernandez-Cid, Roberto Miguelez, Miguel Ángel Moran Rodriguez, Juan Moreno Morales, Rosa Maria Morlà, Soledad Ojeda Bruno, Alejandro Olivé Marqués, Enrique Ornilla Laraundogoitia, Noberto Ortego, Vera Ortiz Santamaria, Mercedes Pilar Pérez Conesa, Trinidad Pérez Sandoval, Ana Pros Simon, Beatriz Rodríguez Lozano, Amalia Rueda Cid, Luis Sáez Comet, Juan Salvatierra Osorio, Alejandro Sanmartín López, Gregorio Santos Soler, Mónica Sarmiento Guevara, José Antonio Todolí Parra, Carmelo Tornero Ramos, Juan Tovar Beltrán, Julia Maria Uceda Montañez, Esther Vicente Rabaneda, Neus Valveny & Nerea Gallastegui

  2. Servicio de Medicina Interna, Hospital Universitario de Cruces, Barakaldo, Spain

    Saioa Eguiluz

  3. Unidad de Gestión Clínica de Reumatología, Hospital Universitario Reina Sofía, Córdoba, Spain

    Alejandro Escudero-Contreras

  4. Servicio de Medicina Interna, Hospital Universitario La Paz, Madrid, Spain

    Juan José Ríos

  5. Servicio de Reumatología, Hospital Universitario Araba, Vitoria, Spain

    Jaime Calvo-Alén

  6. Unidad de Enfermedades Autoinmunes Sistémicas, Hospital Universitario San Cecilio, Granada, Spain

    José Luis Callejas-Rubio

  7. Servicio de Reumatología, Hospital Universitario Ramón y Cajal, Madrid, Spain

    Carlos De la Puente

  8. Unitat de Malalties Autoimmunes Sistèmicas, Servei de Medicina Interna, Hospital Universitari Vall d’Hebron, Barcelona, Spain

    Carmen Pilar Simeón, Alfredo Guillén-Del-Castillo & Vicent Fonollosa

  9. Servei de Reumatologia, Hospital Universitari de Bellvitge, Barcelona, Spain

    Francisco Javier Narváez

  10. Servei de Medicina Interna, Hospital Clínic de Barcelona, Barcelona, Spain

    Gerard Espinosa

  11. Servicio de Reumatología, Hospital Universitario 12 de Octubre, Madrid, Spain

    Patricia E. Carreira

  12. Unitat de Malalties Autoimmunes, Servei de Medicina Interna, Hospital Universitari de Bellvitge, Barcelona, Spain

    Manuel Rubio-Rivas

  13. Servei de Reumatologia, Hospital Universitari Dr. Peset, València, Spain

    Juan José Alegre

  14. Servei de Reumatologia, Hospital Universitari i Politècnic la Fe, Universitat Catòlica de València, València, Spain

    Jose Andrés Román-Ivorra

Authors
  1. Ivan Castellví
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  2. Saioa Eguiluz
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  3. Alejandro Escudero-Contreras
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  4. Juan José Ríos
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  5. Jaime Calvo-Alén
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  6. José Luis Callejas-Rubio
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  7. Carlos De la Puente
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  8. Carmen Pilar Simeón
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  9. Francisco Javier Narváez
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  10. Gerard Espinosa
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  11. Patricia E. Carreira
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  12. Manuel Rubio-Rivas
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  13. Juan José Alegre
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  14. Alfredo Guillén-Del-Castillo
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  15. Jose Andrés Román-Ivorra
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  16. Vicent Fonollosa
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Consortia

LAUDES Study Group

  • Bruno Aspe de la Iglesia
  • , Julia Barbado Ajo
  • , Daniel Batista Perdomo
  • , Emma Beltrán Catalán
  • , Joaquin Belzunegui Otano
  • , Jorge Santiago Blanco Rodríguez
  • , Manuel Caamaño Freire
  • , Alberto Cantabrana Alútiz
  • , Isabel Carrio Montes
  • , Maite Cia Lecumberri
  • , Rosa Del Castillo Monsalvo
  • , Elvira Diez Alvarez
  • , César Antonio Egües Dubuc
  • , Maria Victoria Egurbide Arberas
  • , Patricia Fanlo Mateo
  • , Maria Del Carmen Freire Dapena
  • , Mercedes Freire González
  • , Ángel García Aparicio
  • , Francisco José García Hernández
  • , José Gómez de Salazar
  • , José Antonio González Nieto
  • , Jenaro Graña Gil
  • , Alfredo Guillén-Del-Castillo
  • , José Izquierdo Hidalgo
  • , Toni Juan Mas
  • , Maria Cruz Laiño Piñeiro
  • , Francisco Javier López Longo
  • , Lilian Maria López Núñez
  • , Adela Marín Ballvé
  • , Carlos Marras Fernandez-Cid
  • , Roberto Miguelez
  • , Miguel Ángel Moran Rodriguez
  • , Juan Moreno Morales
  • , Rosa Maria Morlà
  • , Soledad Ojeda Bruno
  • , Alejandro Olivé Marqués
  • , Enrique Ornilla Laraundogoitia
  • , Noberto Ortego
  • , Vera Ortiz Santamaria
  • , Mercedes Pilar Pérez Conesa
  • , Trinidad Pérez Sandoval
  • , Ana Pros Simon
  • , Beatriz Rodríguez Lozano
  • , Amalia Rueda Cid
  • , Luis Sáez Comet
  • , Juan Salvatierra Osorio
  • , Alejandro Sanmartín López
  • , Gregorio Santos Soler
  • , Mónica Sarmiento Guevara
  • , José Antonio Todolí Parra
  • , Carmelo Tornero Ramos
  • , Juan Tovar Beltrán
  • , Julia Maria Uceda Montañez
  • , Esther Vicente Rabaneda
  • , Neus Valveny
  •  & Nerea Gallastegui

Contributions

IC contributed in desing, recruitting, statistical analysis, interpretation of results, discussion and final manuscript preparation. SE contributed to desing, recruiting, interpretation and final manuscript preparation. AE-C, JJR, JC-A, JLCR, CdlP, CPS, FJN, GE, PEC, MR-R, JJA, AG, JAR and VF contributed in recruitting, interpretation of results, discussion and final manuscript preparation. All co-authors take full responsibility for all parts of the final manuscript.

Corresponding author

Correspondence to Ivan Castellví.

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Conflict of interest

IC have received speaker fees from Actelion, Roche, BMS and Pfizer. JJR and JJA have received educational grants from Actelion outside the submitted work. JJA has also received speaker fees from Actelion. SE has received a grant from Actelion for the work under consideration, and personal fees from Actelion and an educational grant from GlaxoSmithKline outside the submitted work. JAR has been board member for Roche, Actelion, Lilly, Gebro and MSD, and has received speaker fees from Roche, Abbvie, Lilly, BMS, UCB, Novartis, Pfizer, Celgene, FER and SVR, and travel grants from Janssen, Pfizer and Gebro. AE-C, JC-A, JLCR, CdlP, CPS, FJN, GE, PEC, MR-R, AGdC, and VF declare that they have no conflict of interest.

Ethical approval

All procedures performed were in accordance with the ethical standards of the national research committees of the participant institutions and with the 1964 Helsinki declaration and its later amendments.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Castellví, I., Eguiluz, S., Escudero-Contreras, A. et al. LAUDES Study: impact of digital ulcers on hand functional limitation, work productivity and daily activities, in systemic sclerosis patients. Rheumatol Int 39, 1875–1882 (2019). https://doi.org/10.1007/s00296-019-04436-z

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