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Impact of participation in the Adalimumab (Humira) patient support program on rheumatoid arthritis treatment course : results from the PASSION study

Filip Van den Bosch UGent, Andrew JK Ostor, Siegfried Wassenberg, Naijun Chen, Chen Wang, Vishvas Garg and Jasmina Kalabic (2017) RHEUMATOLOGY AND THERAPY. 4(1). p.85-96
abstract
Introduction: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care (R)). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. Methods: PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to >= 1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of >= 0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study. Results: Overall, 42.8% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8%) at week 78 (p < 0.001, NRI). Most of the studied clinical outcomes and PROs showed significant improvements (p < 0.05) from baseline to week 78 favoring PSP users over PSP non-users. Conclusions: In patients with moderate-to-severe RA who initiated ADA, improvements in clinical, functional, and PROs were achieved in real-world settings with significantly greater improvements among PSP users in comparison with PSP non-users.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
Adalimumab, Patient support program, Rheumatoid arthritis, LONG-TERM SAFETY, MEDICATION ADHERENCE, MANAGEMENT PROGRAM, SELF-MANAGEMENT, OUTCOMES, QUESTIONNAIRE, VALIDATION, CONSUMERS, DISEASE, CARE
journal title
RHEUMATOLOGY AND THERAPY
Rheumatol. Ther
volume
4
issue
1
pages
85 - 96
ISSN
2198-6576
2198-6584
DOI
10.1007/s40744-017-0061-7
language
English
UGent publication?
yes
classification
A2
additional info
correction published in: Rheumatol. Ther. (2017) 4(1), 97 ; DOI 10.1007/s40744-017-0065-3
copyright statement
Creative Commons Attribution 4.0 International Public License (CC-BY 4.0)
id
8516461
handle
http://hdl.handle.net/1854/LU-8516461
date created
2017-03-31 07:23:58
date last changed
2017-12-13 13:45:45
@article{8516461,
  abstract     = {Introduction: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care (R)). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. 
Methods: PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to {\textrangle}= 1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of {\textrangle}= 0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study. 
Results: Overall, 42.8\% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7\% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8\%) at week 78 (p {\textlangle} 0.001, NRI). Most of the studied clinical outcomes and PROs showed significant improvements (p {\textlangle} 0.05) from baseline to week 78 favoring PSP users over PSP non-users. 
Conclusions: In patients with moderate-to-severe RA who initiated ADA, improvements in clinical, functional, and PROs were achieved in real-world settings with significantly greater improvements among PSP users in comparison with PSP non-users.},
  author       = {Van den Bosch, Filip and Ostor, Andrew JK and Wassenberg, Siegfried and Chen, Naijun and Wang, Chen and Garg, Vishvas and Kalabic, Jasmina},
  issn         = {2198-6576},
  journal      = {RHEUMATOLOGY AND THERAPY},
  keyword      = {Adalimumab,Patient support program,Rheumatoid arthritis,LONG-TERM SAFETY,MEDICATION ADHERENCE,MANAGEMENT PROGRAM,SELF-MANAGEMENT,OUTCOMES,QUESTIONNAIRE,VALIDATION,CONSUMERS,DISEASE,CARE},
  language     = {eng},
  number       = {1},
  pages        = {85--96},
  title        = {Impact of participation in the Adalimumab (Humira) patient support program on rheumatoid arthritis treatment course : results from the PASSION study},
  url          = {http://dx.doi.org/10.1007/s40744-017-0061-7},
  volume       = {4},
  year         = {2017},
}

Chicago
Van den Bosch, Filip, Andrew JK Ostor, Siegfried Wassenberg, Naijun Chen, Chen Wang, Vishvas Garg, and Jasmina Kalabic. 2017. “Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course : Results from the PASSION Study.” Rheumatology and Therapy 4 (1): 85–96.
APA
Van den Bosch, Filip, Ostor, A. J., Wassenberg, S., Chen, N., Wang, C., Garg, V., & Kalabic, J. (2017). Impact of participation in the Adalimumab (Humira) patient support program on rheumatoid arthritis treatment course : results from the PASSION study. RHEUMATOLOGY AND THERAPY, 4(1), 85–96.
Vancouver
1.
Van den Bosch F, Ostor AJ, Wassenberg S, Chen N, Wang C, Garg V, et al. Impact of participation in the Adalimumab (Humira) patient support program on rheumatoid arthritis treatment course : results from the PASSION study. RHEUMATOLOGY AND THERAPY. 2017;4(1):85–96.
MLA
Van den Bosch, Filip, Andrew JK Ostor, Siegfried Wassenberg, et al. “Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course : Results from the PASSION Study.” RHEUMATOLOGY AND THERAPY 4.1 (2017): 85–96. Print.