AI Article Synopsis

  • - The study aimed to evaluate the effectiveness of adalimumab (ADA) in treating rheumatoid arthritis (RA) over 78 weeks, particularly focusing on patients utilizing a proprietary support program (PSP) called AbbVie Care.
  • - Results showed that 42.8% of PSP users achieved significant improvements in their health status, with PSP users outperforming non-users in multiple clinical outcomes and patient-reported outcomes.
  • - Overall, patients with moderate-to-severe RA using the PSP experienced better clinical and functional improvements compared to those who did not participate in the program.

Article Abstract

Introduction: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care). 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.

Funding: AbbVie.

Trial Registration: ClinicalTrials.gov identifier, NCT01383421.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443730PMC
http://dx.doi.org/10.1007/s40744-017-0061-7DOI Listing

Publication Analysis

Top Keywords

psp users
16
psp
9
patient support
8
support program
8
rheumatoid arthritis
8
treatment course
8
percentage patients
8
patients achieving
8
compared baseline
8
haq-di week
8

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!