N/A
Completed N=412
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)
Source: ClinicalTrials.gov NCT02750800 ↗Enrolled (actual)
412
Serious AEs
4.6%
Results posted
Nov 2019
Primary outcomePrimary: Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months — 11.02; 7.63; 4.38; 12.26 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months |
11.02; 7.63; 4.38; 12.26; 11.81; 9.02 | — |
| SECONDARY Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at 12 Months |
9.63; 10.60; 6.61; 8.54; 5.99; 11.50 | — |
| SECONDARY Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score at 12 Months |
0.185; 0.169; 0.084; 0.203; 0.152; 0.123 | — |
| SECONDARY Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score at 12 Months |
18.5; 22.2; 11.4; 29.7; 22.6; 25.1 | — |
| SECONDARY Mean Change From Baseline in Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at 12 Months in Participants With Crohn's Disease and Ulcerative Colitis |
11.6; 16.1 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at 12 Months in Participants With Psoriasis and Psoriatic Arthritis |
-8.6; -5.5 | — |
| SECONDARY Mean Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at 12 Months in Participants With Ankylosing Spondylitis and Participants With Psoriatic Arthritis With Axial Symptoms |
-6.7; -6.4 | — |
| SECONDARY Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (TSQM) Version 1.4 Score at 12 Months |
7.1; 7.5; 4.8; 6.0; 3.9; 15.2 | — |
| SECONDARY Mean Change From Baseline in Total Satisfaction With Information About Medicines Scale (SIMS) Score at 12 Months |
-0.3; 2.3; 1.4; -0.1; 0.4; 0.9 | — |
| SECONDARY Mean Change From Baseline in Total Morisky Medication Adherence Scale, 4 Questions (MMAS-4) Score at 12 Months |
0.12; -0.02; 0.14; -0.02; 0.04; 0.32 | — |
| SECONDARY Mean Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Score at 12 Months |
-30.6; -20.7; -19.7; -35.0; -33.2; -13.2 | — |
| SECONDARY Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospital Inpatient Days and Number of Sick Leave Days |
-2.56; -5.00; -1.25; -3.75; -3.68; -2.91 | — |
| SECONDARY Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospitalizations and Number of Sick Leaves |
-0.28; -1.06; -0.18; -0.15; -0.35; -0.45 | — |
| SECONDARY Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Outpatient Visits |
-4.32; -4.35; -2.97; -3.41; -5.06; -3.68 | — |
| SECONDARY Mean Change From Baseline in Disease Activity Score 28 (DAS28) at 12 Months |
-3.4; -2.8 | — |
| SECONDARY Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS ESR) at 12 Months |
-1.6; -2.0 | — |
| SECONDARY Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Score at 12 Months |
-174.9 | — |
| SECONDARY Mean Change From Baseline in Partial Mayo (pMayo) Score at 12 Months |
-4.8 | — |
| SECONDARY Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 12 Months |
-16.6 | — |
| SECONDARY Participants' Rating of the AbbVie Care 2.0 Program at 12 Months |
39; 20; 28; 33; 31; 28 | — |
| SECONDARY Correlation Between Disease Activity Scores and Disease-specific Quality of Life Scores |
-0.213; 0.132; -0.138; 0.323; -0.453 | — |
| SECONDARY Correlation Between the Length of AbbVie Care 2.0 Duration and Participant Outcomes |
— | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) by the treating physician
- Age ≥ 18 years at the time of enrollment
- RA, AS, PsA, Ps, UC or CD patients for whom adalimumab treatment was indicated as per local Summary of Product Characteristics (SmPC) and professional/reimbursement guidelines
- Participants assigned to adalimumab treatment not more than 1 month prior to inclusion
- Participants to whom participation in AbbVie Care 2.0 Patient Support Program (PSP) program was offered and participant decided to join and had started the PSP
- Participants willing to be involved in the study and to sign patient informed consent form (ICF) and subject information form (SIF) in order to allow use and disclosure of his/her personal health information
Exclusion Criteria
- Participants who could not be treated with adalimumab according to the local adalimumab SmPC and local professional and reimbursement guidelines
- Participants treated with > 1 prior biologic disease modifying anti rheumatic drug (DMARD) for RA, AS, PsA, Ps, UC or CD
- Prior treatment with adalimumab for more than 1 month
- Participants currently participating in other clinical research studies
- Participants who were unwilling or unable to complete the quality of life and other patient-reported questionnaires
Data sourced from ClinicalTrials.gov (NCT02750800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.