Minimal clinically important difference (MCID) for work productivity and activity impairment (WPAI) questionnaire in psoriasis patients.
J Eur Acad Dermatol Venereol
; 33(2): 318-324, 2019 Feb.
Article
in En
| MEDLINE
| ID: mdl-29846976
ABSTRACT
BACKGROUND:
The clinical meaningfulness of improvements in the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-PsO) reported by patients with psoriasis in response to treatment is unknown due to the lack of any publications that report minimal clinically importance differences (MCID) for WPAI-PsO outcomes.OBJECTIVE:
To determine the MCIDs for the work productivity loss and activity impairment domains of the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-PsO) using results from three Phase 3 trials of ixekizumab.METHODS:
MCIDs for WPAI-PsO domains were derived using treatment agnostic data from patients participating in UNCOVER-1/-2/-3. The analysis included patients randomized to placebo and two ixekizumab treatment groups (ixekizumab either every 2 weeks or 4 weeks) from the trials. WPAI-PsO was administered at baseline and Week 12 for UNCOVER-1/-2/-3 and at Weeks 24, 36, 52 and 60 in UNCOVER-1/-2. MCIDs for the WPAI-PsO domains through Week 12 were derived using an anchor-based method supplemented with the distribution-based method. Anchors included 75%/90%/100% improvement in Psoriasis Area and Severity Index, Static Physicians Global Assessment (sPGA[0] and sPGA[0,1]) and Dermatology Life Quality Index MCID). MCIDs were triangulated using receiver operating characteristics (ROC) and distribution-based methods.RESULTS:
The analyses included 3126 patients (Placebo 792, Ixekizumab 2334). All anchors were shown to be valid. Significant differences in the domains of WPAI-PsO were observed between patients achieving clinically meaningful improvement in the validated anchors (all P-values < 0.001). ROC analyses suggested a 20% improvement in the work productivity loss or activity impairment components best represented the benefit of meeting a clinical meaningful improvement in the validated anchors. The distribution-based method supported the results of the anchor-based method.CONCLUSION:
The MCIDs for both the work productivity loss and the activity impairment domains of WPAI-PsO were estimated to be 20% in patients with PsO.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Psoriasis
/
Surveys and Questionnaires
/
Antibodies, Monoclonal, Humanized
/
Work Performance
/
Minimal Clinically Important Difference
Type of study:
Clinical_trials
/
Prognostic_studies
Aspects:
Patient_preference
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Eur Acad Dermatol Venereol
Journal subject:
DERMATOLOGIA
/
DOENCAS SEXUALMENTE TRANSMISSIVEIS
Year:
2019
Document type:
Article
Affiliation country:
Estados Unidos
Publication country:
ENGLAND
/
ESCOCIA
/
GB
/
GREAT BRITAIN
/
INGLATERRA
/
REINO UNIDO
/
SCOTLAND
/
UK
/
UNITED KINGDOM