Minimal clinically important difference (MCID) for work productivity and activity impairment (WPAI) questionnaire in psoriasis patients.

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.

• Authors: J J Wu, C Lin, L Sun, O Goldblum, A Zbrozek, R Burge, M Augustin, S R Feldman
• Journal: Journal of the European Academy of Dermatology and Venereology : JEADV (J Eur Acad Dermatol Venereol) Vol. 33 Issue 2 Pg. 318-324 (Feb 2019) ISSN: 1468-3083 [Electronic] England
• PMID: 29846976 (Publication Type: Clinical Trial, Phase III, Journal Article)
• Copyright: © 2018 European Academy of Dermatology and Venereology.

Chemical References

• Antibodies, Monoclonal, Humanized
• Biological Products
• Dermatologic Agents
• ixekizumab

Topics

• Absenteeism
• Adult
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Biological Products (pharmacology, therapeutic use)
• Dermatologic Agents (therapeutic use)
• Disability Evaluation
• Efficiency (drug effects)
• Female
• Humans
• Male
• Middle Aged
• Minimal Clinically Important Difference
• Psoriasis (drug therapy, physiopathology)
• ROC Curve
• Severity of Illness Index
• Sickness Impact Profile
• Surveys and Questionnaires
• Treatment Outcome
• Work Performance