PMID- 29846976
OWN - NLM
STAT- MEDLINE
DCOM- 20190606
LR  - 20190606
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 33
IP  - 2
DP  - 2019 Feb
TI  - Minimal clinically important difference (MCID) for work productivity and activity 
      impairment (WPAI) questionnaire in psoriasis patients.
PG  - 318-324
LID - 10.1111/jdv.15098 [doi]
AB  - 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.
CI  - (c) 2018 European Academy of Dermatology and Venereology.
FAU - Wu, J J
AU  - Wu JJ
AD  - Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, USA.
FAU - Lin, C
AU  - Lin C
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Sun, L
AU  - Sun L
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Goldblum, O
AU  - Goldblum O
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Zbrozek, A
AU  - Zbrozek A
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Burge, R
AU  - Burge R
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
AD  - College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
FAU - Augustin, M
AU  - Augustin M
AD  - Institute for Health Services Research in Dermatology and Nursing (IVDP), 
      University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
FAU - Feldman, S R
AU  - Feldman SR
AD  - Department of Dermatology, Wake Forest University, Winston-Salem, NC, USA.
LA  - eng
GR  - Eli Lilly and Company/
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20180626
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Biological Products)
RN  - 0 (Dermatologic Agents)
RN  - BTY153760O (ixekizumab)
SB  - IM
CIN - J Eur Acad Dermatol Venereol. 2019 Feb;33(2):257-258. PMID: 30746799
MH  - Absenteeism
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Biological Products/pharmacology/therapeutic use
MH  - Dermatologic Agents/therapeutic use
MH  - Disability Evaluation
MH  - Efficiency/drug effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Minimal Clinically Important Difference
MH  - Psoriasis/*drug therapy/physiopathology
MH  - ROC Curve
MH  - Severity of Illness Index
MH  - Sickness Impact Profile
MH  - *Surveys and Questionnaires
MH  - Treatment Outcome
MH  - *Work Performance
EDAT- 2018/05/31 06:00
MHDA- 2019/06/07 06:00
CRDT- 2018/05/31 06:00
PHST- 2018/03/01 00:00 [received]
PHST- 2018/05/16 00:00 [accepted]
PHST- 2018/05/31 06:00 [pubmed]
PHST- 2019/06/07 06:00 [medline]
PHST- 2018/05/31 06:00 [entrez]
AID - 10.1111/jdv.15098 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2019 Feb;33(2):318-324. doi: 10.1111/jdv.15098. 
      Epub 2018 Jun 26.