Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)
Condition: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Psoriasis; Crohn's Disease; Ulcerative Colitis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Psoriasis
Study type: Observational

Summary: 
      The objective of this post-marketing observational study (PMOS) was to evaluate the
      effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants
      with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA),
      psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) in the routine clinical
      setting in Hungary.
    

Detailed description: 
      This was a prospective, open label, multicenter, observational cohort study. Adalimumab was
      prescribed in the usual manner in accordance with the terms of the local marketing
      authorization and professional and reimbursement guidelines with regards to dose, population
      and indication. AbbVie offered an array of services as part of a patient support program,
      called AbbVie Care 2.0, to study participants. The purpose of the AbbVie Care 2.0 program was
      to provide educational resources that aimed to help participants understand their health
      condition and disease management (e.g., lifestyle - exercise or diet), but also help to them
      understand how to administer the product safely and be empowered to stay on track with their
      prescribed treatment plan, all with the goal of maximizing patient outcomes. There were five
      target visits: a baseline visit at enrollment and follow-up visits at 3, 6, 9 and 12 months.
    

Intervention name(s): Adalimumab; AbbVie Care 2.0
Intervention type(s): Biological; Behavioral
Intervention description(s): Pre-filled syringe or pen, administered by subcutaneous injection; Supportive services provided to participants included reminder calls, emails, text messages, nursing services, dietician, and psychological support. An adalimumab starter pack, injection guide, digital and print educational materials were also provided.
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic
        arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC)
      
Keywords: Rheumatoid arthritis; Ankylosing spondylitis; Psoriatic arthritis; Psoriasis; Crohn's disease; Ulcerative colitis; Patient support program; Quality of life; Patient related outcomes; Observational study; Adalimumab; Humira; Adherence; Health-related quality of life; Healthcare resource utilization; Disease activity; Treatment satisfaction; Workability