PMID- 28361468
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210421
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 4
IP  - 1
DP  - 2017 Jun
TI  - Impact of Participation in the Adalimumab (Humira) Patient Support Program on 
      Rheumatoid Arthritis Treatment Course: Results from the PASSION Study.
PG  - 85-96
LID - 10.1007/s40744-017-0061-7 [doi]
AB  - 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. FUNDING: AbbVie. TRIAL REGISTRATION: ClinicalTrials.gov 
      identifier, NCT01383421.
FAU - Van den Bosch, Filip
AU  - Van den Bosch F
AD  - Ghent University Hospital and VIB Center for Inflammation Research, Ghent, 
      Belgium. filip.vandenbosch@ugent.be.
FAU - Ostor, Andrew J K
AU  - Ostor AJK
AD  - Addenbrooke's Hospital, Cambridge, UK.
FAU - Wassenberg, Siegfried
AU  - Wassenberg S
AD  - Rheumazentrum, Ratingen, Germany.
FAU - Chen, Naijun
AU  - Chen N
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Wang, Chen
AU  - Wang C
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Garg, Vishvas
AU  - Garg V
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Kalabic, Jasmina
AU  - Kalabic J
AD  - AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01383421
PT  - Journal Article
DEP - 20170330
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
EIN - Rheumatol Ther. 2017 Jun;4(1):97. PMID: 28474206
PMC - PMC5443730
OTO - NOTNLM
OT  - Adalimumab
OT  - Patient support program
OT  - Rheumatoid arthritis
EDAT- 2017/04/01 06:00
MHDA- 2017/04/01 06:01
PMCR- 2017/03/30
CRDT- 2017/04/01 06:00
PHST- 2017/02/13 00:00 [received]
PHST- 2017/04/01 06:00 [pubmed]
PHST- 2017/04/01 06:01 [medline]
PHST- 2017/04/01 06:00 [entrez]
PHST- 2017/03/30 00:00 [pmc-release]
AID - 10.1007/s40744-017-0061-7 [pii]
AID - 61 [pii]
AID - 10.1007/s40744-017-0061-7 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2017 Jun;4(1):85-96. doi: 10.1007/s40744-017-0061-7. Epub 2017 
      Mar 30.