Impact of adalimumab on clinical outcomes, healthcare resource utilization, and sick leave in patients with ankylosing spondylitis: an observational study from five Central and Eastern European countries

Article Details

Authors
Daniela Opris-Belinski MD, PhD, Shandor F Erdes MD, PhD, Simeon Grazio MD, PhD, Ladislav Šenolt MD, PhD, Maja Hojnik MD, PhD, Orsolya Nagy MD, PhD, Diana Marina BSc, Sándor Szántó MD, PhD, DSc

Article Type
Original Research

DOI
10.7573/dic.212556

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Abstract

Background: Patients with ankylosing spondylitis (AS) are substantial users of healthcare resources due to chronic and potentially disabling disease. This study assessed the impact of adalimumab on clinical outcomes, healthcare resource utilization, and sick leave in patients with AS in five Central and Eastern Europe (CEE) countries.

Methods: This was an observational study in the routine clinical setting. Patients diagnosed with AS and starting treatment with originator adalimumab were followed for 12 months by assessing disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] and Ankylosing Spondylitis Disease Activity Score [ASDAS]) and physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]). Data on healthcare resource utilization and sick leave were collected prospectively and compared with historical data before adalimumab initiation, as well as between treatment responders and non-responders defined by BASDAI-50.

Results: The total effectiveness population comprised 450 patients with on average long-standing AS, high disease activity, and functional impairment. At 12 months of adalimumab therapy, mean ASDAS and BASFI scores were in the range of low disease activity and normal physical function, respectively. The mean number of hospital admissions, hospital inpatient days, and healthcare provider visits were decreased by 67.9, 83.0, and 46.3%, respectively. The number and length of sick leaves were decreased by 65.6 and 81.4%, respectively. Reductions were higher in treatment responders than non-responders.

Conclusion: Originator adalimumab in routine clinical practice in five CEE countries produced clinically meaningful improvements in disease activity and physical function, and it was associated with reductions in healthcare resource utilization and sick leave.

Keywords: adalimumab, ankylosing spondylitis, disease activity, healthcare resource utilization, physical function, work outcomes.

Citation: Opris-Belinski D, Erdes SF, Grazio S, Šenolt L, Hojnik M, Nagy O, Marina D, Szántó S. Impact of adalimumab on clinical outcomes, healthcare resource utilization, and sick leave in patients with ankylosing spondylitis: an observational study from five Central and Eastern European countries. Drugs in Context 2018; 7: 212556. DOI: 10.7573/dic.212556

Contributions: The design and study conduct for the clinical trial were provided by AbbVie. DOB, MH, and ON contributed substantially to the conception and design of the work. DOB, SFE, SG, LS, MH, ON, and SS contributed substantially to the acquisition, analysis, and interpretation of data for the work. DOB, SFE, SG, LS, MH, ON, DM, and SS contributed substantially to drafting of the manuscript and revising it critically for important intellectual content. DOB, SFE, SG, LS, MH, ON, DM, and SS provided final approval of the version to be published.

Disclosure and potential conflicts of interest: Dr Opris-Belinski has received speaker fees from AbbVie, BMS, Pfizer, Roche, and Teva; and has received consulting fees from AbbVie, BMS, Pfizer, Roche, and Teva. Dr Erdes has received honoraria for lectures from AbbVie, Biocad, Dr Reddy’s, Gedeon Richter, MSD, Novartis, Pfizer, and USB; and has received support for clinical trials and scientific projects from AbbVie, Biocad, MSD, Novartis, and UCB. Dr Grazio has received speaker fees from AbbVie/Abbott Laboratories, Belupo, Berlin-Chemie, Boehringer Ingelheim, Eli Lilly, Ewopharma, Grünenthal, Krka, Medis, MSD, Novartis, Pfizer, PharmaSwiss, Pliva/Teva, Roche, Sanofi-Aventis, and Stada; has received consulting fees from AbbVie/Abbott Laboratories, Eli Lilly, Grünenthal, MSD, Novartis, Pfizer, and Roche; and has received support for clinical trials and scientific projects from AbbVie/Abbott Laboratories, Krka, MSD, and SetPoint Medical. Dr Šenolt has received speaker fees, consulting fees, and support for clinical trials and scientific projects from AbbVie, Bristol-Myers Squibb, Celgene Corporation, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi Genzyme, Takeda, and UCB. Dr Szántó has received speaker fees from AbbVie, Bristol-Myers Squibb, Novartis, Pfizer, and Roche; has received consulting fees from AbbVie, Pfizer, and Teva; and has received support for clinical trials and projects from AbbVie, Pfizer, and Roche. Dr Hojnik, Dr Marina, and Dr Nagy are employees of AbbVie Ltd and may own AbbVie stock. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors are available for download at https://www.drugsincontext.com/wp-content/uploads/2018/10/dic.212556-COI.pdf

Acknowledgments: Medical writing assistance was provided by Robert Furlong and Kerry Dechant of Content Ed Net. The study was previously presented as a poster (THU0363) at the Annual European Congress of Rheumatology, Madrid, Spain, 14–17 June 2017.

Funding declaration: Financial support for the clinical trial and for medical writing assistance was provided by AbbVie.

Copyright: Copyright © 2018 Opris-Belinski D, Erdes SF, Grazio S, Šenolt L, Hojnik M, Nagy O, Marina D, Szántó S. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2018 Opris-Belinski D, Erdes SF, Grazio S, Šenolt L, Hojnik M, Nagy O, Marina D, Szántó S. https://doi.org/10.7573/dic.212556. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/impact-of-adalimumab-on-clinical-outcomes-healthcare-resource-utilization-and-sick-leave-in-patients-with-ankylosing-spondylitis-an-observational-study-from-five-central-and-eastern-european-countries

Correspondence: Daniela Opris-Belinski, Spitalul Clinic Sfanta Maria, Bd Ion Mihalache 37-39, S1, Bucharest, Romania. danaopris0103@yahoo.com

Provenance: submitted; externally peer reviewed.

Submitted: 5 September 2018; Peer review comments to author: 12 October 2018; Revised manuscript received: 25 October 2018; Accepted: 26 October 2018; Publication date: 21 November 2018.

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