TY - JOUR
T1 - Unmet needs in ankylosing spondylitis patients receiving tumour necrosis factor inhibitor therapy; results from a large multinational real-world study
AU - Deodhar, A.
AU - Strand, V.
AU - Conaghan, P. G.
AU - Sullivan, E.
AU - Blackburn, S.
AU - Tian, H.
AU - Gandhi, K.
AU - Jugl, S. M.
AU - Alten, R.
N1 - Funding Information:
Medical writing support was provided by Kate Revill of Adelphi Real World Ltd., funded by Novartis Pharma AG. Additional writing support was provided by Elizabeth Holdsworth, Nicola Booth and Katerina Doslikova, employees of Adelphi Real World Ltd. PGC is supported in part by the UK NIHR Leeds Biomedical Research Centre. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. The authors and Novartis would like to thank all patients and physicians who participated in this study.
Funding Information:
This study was supported by Novartis Pharma AG, Switzerland. HT, KG and SMJ, Novartis authors, contributed to the conception, design, analysis and interpretation of the data, and read and approved the final manuscript to be published after critically revising it for important intellectual content.
Funding Information:
AD has received grants or research support from AbbVie, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB Pharma, and consulting fees from Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. VS has received grants and/or consulting fees from AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, Corrona LLC, Crescendo Bioscience, EMD Serono, F. Hoffmann-La Roche Ltd./Genentech, Inc., GSK, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi and UCB, and has served on advisory boards for AbbVie, Amgen, AstraZeneca, BMS, Cell-trion, Crescendo/Myriad Genetics, EMDSerono, Genentech/Roche, GSK, Jans-sen, Lilly, Novartis, Pfizer, Regeneron, Sandoz, Sanofi and UCB. PGC has received speakers’ bureau or consulting fees from Bristol-Myers Squibb, Pfizer and Novartis. RA has received grants or research support from Bristol-Myers Squibb, consulting fees from Bristol-Myers Squibb, Novartis, Pfizer Roche and Eli Lilly. ES & SB are employees of Adelphi Real World; HT and KG are shareholders and employees of Novartis; SJ is a shareholder and employee of Novartis Pharma AG.
Publisher Copyright:
© 2020 The Author(s).
PY - 2020/3/2
Y1 - 2020/3/2
N2 - Background: Symptoms and comorbidities of ankylosing spondylitis (AS) considerably reduce health-related quality of life (HRQoL) and ability to work. This real-world study assessed rates of tumour necrosis factor inhibitor (TNFi) use and switching, treatment failure, and associations between failing TNFi and HRQoL, work productivity and activity impairment (WPAI). Methods: AS patients and their treating physicians completed questionnaires capturing patient demographics, clinical status, TNFi treatment history, reasons for switching TNFi, HRQoL and WPAI. Current TNFi was determined as "failing" if, after ≥3 months, physician-rated disease severity had worsened, remained severe, was "unstable/deteriorating", physicians were dissatisfied with disease control and/or did not consider treatment a "success". Results: The analysis included 2866 AS patients from 18 countries. Of 2795 patients with complete treatment data, 916 (32.8%) patients had never received TNFi therapy, 1623 (58.1%) patients were receiving their 1st TNFi and 200 (7.2%) patients had ever received ≥2 TNFi (treatment switch). Primary or secondary lack of efficacy were the commonest reasons for switching, and the mean delay in switching after primary lack of efficacy was 11.1 months. 232 (15.4%) patients on TNFi were currently "failing" who, compared to those with treatment success, reported poorer HRQoL: 5-dimension EuroQoL (EQ-5D-3 L): 0.63 vs. 0.78; Medical Outcomes Study Short-Form Health Survey version 2 (SF-36v2) mental component summary (MCS): 41.8 vs. 46.3; physical component summary (PCS): 40.2 vs. 45.1; impaired work productivity: 46.4% vs. 25.0%; and activity: 44.5% vs. 29.6%; all P < 0.001. Conclusions: Among AS patients, switching TNFi is uncommon and delayed by nearly 1 year despite primary lack of efficacy. Patients currently failing TNFi experience worse physical function, HRQoL and work productivity.
AB - Background: Symptoms and comorbidities of ankylosing spondylitis (AS) considerably reduce health-related quality of life (HRQoL) and ability to work. This real-world study assessed rates of tumour necrosis factor inhibitor (TNFi) use and switching, treatment failure, and associations between failing TNFi and HRQoL, work productivity and activity impairment (WPAI). Methods: AS patients and their treating physicians completed questionnaires capturing patient demographics, clinical status, TNFi treatment history, reasons for switching TNFi, HRQoL and WPAI. Current TNFi was determined as "failing" if, after ≥3 months, physician-rated disease severity had worsened, remained severe, was "unstable/deteriorating", physicians were dissatisfied with disease control and/or did not consider treatment a "success". Results: The analysis included 2866 AS patients from 18 countries. Of 2795 patients with complete treatment data, 916 (32.8%) patients had never received TNFi therapy, 1623 (58.1%) patients were receiving their 1st TNFi and 200 (7.2%) patients had ever received ≥2 TNFi (treatment switch). Primary or secondary lack of efficacy were the commonest reasons for switching, and the mean delay in switching after primary lack of efficacy was 11.1 months. 232 (15.4%) patients on TNFi were currently "failing" who, compared to those with treatment success, reported poorer HRQoL: 5-dimension EuroQoL (EQ-5D-3 L): 0.63 vs. 0.78; Medical Outcomes Study Short-Form Health Survey version 2 (SF-36v2) mental component summary (MCS): 41.8 vs. 46.3; physical component summary (PCS): 40.2 vs. 45.1; impaired work productivity: 46.4% vs. 25.0%; and activity: 44.5% vs. 29.6%; all P < 0.001. Conclusions: Among AS patients, switching TNFi is uncommon and delayed by nearly 1 year despite primary lack of efficacy. Patients currently failing TNFi experience worse physical function, HRQoL and work productivity.
KW - Ankylosing spondylitis
KW - DMARD
KW - Quality of life
KW - Treatment failure
KW - Tumour necrosis factor-alpha
UR - http://www.scopus.com/inward/record.url?scp=85080921013&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85080921013&partnerID=8YFLogxK
U2 - 10.1186/s41927-020-0118-z
DO - 10.1186/s41927-020-0118-z
M3 - Article
AN - SCOPUS:85080921013
SN - 2520-1026
VL - 4
JO - BMC Rheumatology
JF - BMC Rheumatology
IS - 1
M1 - 19
ER -