Gastrointestinal adverse drug reaction profile of etanercept: real world data from patients and healthcare professionals

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl

Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, NL; Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam, NL; Department of Pharmacy, Sint Maartenskliniek, Nijmegen NL; Department of Pharmacy, Radboud University Medical Center, Nijmegen, NL; Amsterdam Rheumatology & immunology Center (ARC) | Reade, Amsterdam, NL; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, NL; Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, NL; Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam UMC, Location Academic Medical Center, Amsterdam, NL; Department of Rheumatology, Maastricht University Medical Center, Maastricht, NL; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, NL; Transparency in Healthcare B.V., Hengelo, NL; Department of Psychology, Health & Technology, University of Twente, Enschede, NL; Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, NL; Department of Gastroenterology, Radboud University Medical Center, Nijmegen, NL; Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, NL. The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. Corresponding author: Jette A. van Lint,Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch. E-mail: j.vanlint@lareb.nl