title: Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course: Results from the PASSION Study.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  AbbVie.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT01383421.
authors.affiliation: Ghent University Hospital and VIB Center for Inflammation Research, Ghent, Belgium. filip.vandenbosch@ugent.be.
authors.forename: Filip
authors.initials: F
authors.lastname: Van den Bosch
authors.affiliation: Addenbrooke's Hospital, Cambridge, UK.
authors.forename: Andrew J K
authors.initials: AJK
authors.lastname: Ostor
authors.affiliation: Rheumazentrum, Ratingen, Germany.
authors.forename: Siegfried
authors.initials: S
authors.lastname: Wassenberg
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Naijun
authors.initials: N
authors.lastname: Chen
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Chen
authors.initials: C
authors.lastname: Wang
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Vishvas
authors.initials: V
authors.lastname: Garg
authors.affiliation: AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
authors.forename: Jasmina
authors.initials: J
authors.lastname: Kalabic
keywords: Adalimumab; Patient support program; Rheumatoid arthritis