Marie Hudson1,2, Sophie Dell'Aniello1, Sophie Shen3, Teresa A Simon3, Pierre Ernst1,4, Samy Suissa1,5. 1. Centre for Clinical Epidemiology, Lady Davis Institute-Jewish General Hospital, Canada. 2. Division of Rheumatology, Jewish General Hospital, Montreal, Québec, Canada. 3. Global Pharmacovigilance and Epidemiology, Bristol Myers Squibb, Hopewell, NJ, USA, Canada. 4. Division of Respiratory Medicine, Jewish General Hospital, Canada. 5. Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Québec, Canada.
Abstract
OBJECTIVES: Abatacept, a biologic DMARD, was associated with respiratory adverse events in a small subgroup of RA patients with chronic obstructive pulmonary disease (COPD) in a trial. Whether this potential risk is specific to abatacept or extends to all biologics and targeted synthetic DMARDs (tsDMARDs) is unclear. We assessed the risk of adverse respiratory events associated with biologic and tsDMARDs compared with conventional synthetic DMARDs (csDMARDs) among RA patients with concomitant COPD in a large, real-world cohort. METHODS: We used a prevalent new-user design to study RA patients with COPD in the US-based MarketScan databases. New users of biologic DMARDs and/or tsDMARDs were matched on time-conditional propensity scores to new users of csDMARDs. Adverse respiratory events were estimated using Cox models comparing current use of biologic/tsDMARDs with csDMARDs. RESULTS: The cohort included 7424 patients initiating biologic/tsDMARDs and 7424 matched patients initiating csDMARDs. The adjusted hazard ratio of hospitalized COPD exacerbation comparing biologic/tsDMARD vs csDMARD was 0.76 (95% CI: 0.55, 1.06), while it was 1.02 (95% CI: 0.82, 1.27) for bronchitis, 1.21 (95% CI: 0.92, 1.58) for hospitalized pneumonia or influenza and 0.99 (95% CI: 0.87, 1.12) for outpatient pneumonia or influenza. The hazard ratio of the combined end point of COPD exacerbation, bronchitis and hospitalized pneumonia or influenza was 1.04 (95% CI: 0.89, 1.21). CONCLUSION: In this large, real-world comparative safety study, biologic and tsDMARDs, including abatacept, were not associated with an increased risk of adverse respiratory events when compared with csDMARDs in patients with RA and COPD.
OBJECTIVES: Abatacept, a biologic DMARD, was associated with respiratory adverse events in a small subgroup of RApatients with chronic obstructive pulmonary disease (COPD) in a trial. Whether this potential risk is specific to abatacept or extends to all biologics and targeted synthetic DMARDs (tsDMARDs) is unclear. We assessed the risk of adverse respiratory events associated with biologic and tsDMARDs compared with conventional synthetic DMARDs (csDMARDs) among RApatients with concomitant COPD in a large, real-world cohort. METHODS: We used a prevalent new-user design to study RApatients with COPD in the US-based MarketScan databases. New users of biologic DMARDs and/or tsDMARDs were matched on time-conditional propensity scores to new users of csDMARDs. Adverse respiratory events were estimated using Cox models comparing current use of biologic/tsDMARDs with csDMARDs. RESULTS: The cohort included 7424 patients initiating biologic/tsDMARDs and 7424 matched patients initiating csDMARDs. The adjusted hazard ratio of hospitalized COPD exacerbation comparing biologic/tsDMARD vs csDMARD was 0.76 (95% CI: 0.55, 1.06), while it was 1.02 (95% CI: 0.82, 1.27) for bronchitis, 1.21 (95% CI: 0.92, 1.58) for hospitalized pneumonia or influenza and 0.99 (95% CI: 0.87, 1.12) for outpatientpneumonia or influenza. The hazard ratio of the combined end point of COPD exacerbation, bronchitis and hospitalized pneumonia or influenza was 1.04 (95% CI: 0.89, 1.21). CONCLUSION: In this large, real-world comparative safety study, biologic and tsDMARDs, including abatacept, were not associated with an increased risk of adverse respiratory events when compared with csDMARDs in patients with RA and COPD.
Authors: Allison L Smitten; Hyon K Choi; Marc C Hochberg; Samy Suissa; Teresa A Simon; Marcia A Testa; K Arnold Chan Journal: J Rheumatol Date: 2008-02-01 Impact factor: 4.666
Authors: Sofia Ramiro; Alexandre Sepriano; Katerina Chatzidionysiou; Jackie L Nam; Josef S Smolen; Désirée van der Heijde; Maxime Dougados; Ronald van Vollenhoven; Johannes W Bijlsma; Gerd R Burmester; Marieke Scholte-Voshaar; Louise Falzon; Robert B M Landewé Journal: Ann Rheum Dis Date: 2017-03-15 Impact factor: 19.103
Authors: Teresa A Simon; Johan Askling; Diane Lacaille; Jarrod Franklin; Frederick Wolfe; Allison Covucci; Samy Suissa; Marc C Hochberg Journal: Arthritis Res Ther Date: 2010-04-14 Impact factor: 5.156
Authors: Christopher J L Murray; Charles Atkinson; Kavi Bhalla; Gretchen Birbeck; Roy Burstein; David Chou; Robert Dellavalle; Goodarz Danaei; Majid Ezzati; A Fahimi; D Flaxman; Sherine Gabriel; Emmanuela Gakidou; Nicholas Kassebaum; Shahab Khatibzadeh; Stephen Lim; Steven E Lipshultz; Stephanie London; Michael F MacIntyre; A H Mokdad; A Moran; Andrew E Moran; Dariush Mozaffarian; Tasha Murphy; Moshen Naghavi; C Pope; Thomas Roberts; Joshua Salomon; David C Schwebel; Saeid Shahraz; David A Sleet; Jerry Abraham; Mohammed K Ali; Charles Atkinson; David H Bartels; Kavi Bhalla; Gretchen Birbeck; Roy Burstein; Honglei Chen; Michael H Criqui; Eric L Ding; E Ray Dorsey; Beth E Ebel; Majid Ezzati; S Flaxman; A D Flaxman; Diego Gonzalez-Medina; Bridget Grant; Holly Hagan; Howard Hoffman; Nicholas Kassebaum; Shahab Khatibzadeh; Janet L Leasher; John Lin; Steven E Lipshultz; Rafael Lozano; Yuan Lu; Leslie Mallinger; Mary M McDermott; Renata Micha; Ted R Miller; A A Mokdad; A H Mokdad; Dariush Mozaffarian; Mohsen Naghavi; K M Venkat Narayan; Saad B Omer; Pamela M Pelizzari; David Phillips; Dharani Ranganathan; Frederick P Rivara; Thomas Roberts; Uchechukwu Sampson; Ella Sanman; Amir Sapkota; David C Schwebel; Saeid Sharaz; Rupak Shivakoti; Gitanjali M Singh; David Singh; Mohammad Tavakkoli; Jeffrey A Towbin; James D Wilkinson; Azadeh Zabetian; Jerry Abraham; Mohammad K Ali; Miriam Alvardo; Charles Atkinson; Larry M Baddour; Emelia J Benjamin; Kavi Bhalla; Gretchen Birbeck; Ian Bolliger; Roy Burstein; Emily Carnahan; David Chou; Sumeet S Chugh; Aaron Cohen; K Ellicott Colson; Leslie T Cooper; William Couser; Michael H Criqui; Kaustubh C Dabhadkar; Robert P Dellavalle; Daniel Dicker; E Ray Dorsey; Herbert Duber; Beth E Ebel; Rebecca E Engell; Majid Ezzati; David T Felson; Mariel M Finucane; Seth Flaxman; A D Flaxman; Thomas Fleming; Mohammad H Forouzanfar; Greg Freedman; Michael K Freeman; Emmanuela Gakidou; Richard F Gillum; Diego Gonzalez-Medina; Richard Gosselin; Hialy R Gutierrez; Holly Hagan; Rasmus Havmoeller; Howard Hoffman; Kathryn H Jacobsen; Spencer L James; Rashmi Jasrasaria; Sudha Jayarman; Nicole Johns; Nicholas Kassebaum; Shahab Khatibzadeh; Qing Lan; Janet L Leasher; Stephen Lim; Steven E Lipshultz; Stephanie London; Rafael Lozano; Yuan Lu; Leslie Mallinger; Michele Meltzer; George A Mensah; Catherine Michaud; Ted R Miller; Charles Mock; Terrie E Moffitt; A A Mokdad; A H Mokdad; A Moran; Mohsen Naghavi; K M Venkat Narayan; Robert G Nelson; Casey Olives; Saad B Omer; Katrina Ortblad; Bart Ostro; Pamela M Pelizzari; David Phillips; Murugesan Raju; Homie Razavi; Beate Ritz; Thomas Roberts; Ralph L Sacco; Joshua Salomon; Uchechukwu Sampson; David C Schwebel; Saeid Shahraz; Kenji Shibuya; Donald Silberberg; Jasvinder A Singh; Kyle Steenland; Jennifer A Taylor; George D Thurston; Monica S Vavilala; Theo Vos; Gregory R Wagner; Martin A Weinstock; Marc G Weisskopf; Sarah Wulf Journal: JAMA Date: 2013-08-14 Impact factor: 56.272