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. 2016 Dec;17(6):691-699.
doi: 10.1007/s40257-016-0229-x.

Body Region Involvement and Quality of Life in Psoriasis: Analysis of a Randomized Controlled Trial of Adalimumab

April W Armstrong  1 , Delfina Guadalupe Villanueva Quintero  2 , Cristina M Echeverría  3 , Yihua Gu  4 , Mahinda Karunaratne  4 , Ofelia Reyes Servín  4
Affiliations

Body Region Involvement and Quality of Life in Psoriasis: Analysis of a Randomized Controlled Trial of Adalimumab

April W Armstrong et al. Am J Clin Dermatol. 2016 Dec.

Abstract

Background: Psoriasis severity and treatment responsiveness vary by body region, which differentially impacts quality of life (QoL).

Objective: The objective of the study was to examine adalimumab efficacy by body region and regional response and QoL relationship.

Methods: Patients (n = 1212) with moderate-to-severe psoriasis were randomized 2:1 to 80 mg at week 0, followed by adalimumab 40 mg or placebo every other week for 16 weeks in the double-blind REVEAL study. Psoriasis Area and Severity Index (PASI) responses and Dermatology Life Quality Index outcomes were analyzed.

Results: Week 16 regional mean PASI improvements were significantly greater with adalimumab (83.1 ± 1.57, 81.3 ± 1.58, 75.7 ± 1.34, and 73.9 ± 1.26% in the trunk, head, upper extremities, and lower extremities, respectively; all p < 0.001 vs. placebo). Likewise, percentages of patients with regional PASI ≥75/≥90/100% reduction from baseline were significantly higher with adalimumab (all p < 0.001); adalimumab responses were greater for the trunk (77.9/65.0/59.1%) and head (74.6/66.1/62.8%; all p ≤ 0.0001 vs. lower) than upper (67.7/45.1/39.6%; p = 0.4, p = 0.04, p = 0.0005, respectively, vs. lower) and lower extremities (65.7/40.0/31.3%). Adalimumab significantly improved Dermatology Life Quality Index scores vs. placebo (8.2- vs 1.7-point decrease from baseline; p < 0.001).

Limitations: The study was a post hoc analysis.

Conclusions: Adalimumab treatment resulted in statistically significant and clinically meaningful improvements in disease severity and QoL. QoL improvements were associated with PASI responses in all body regions.

Trial registration: ClinicalTrials.gov identifier NCT00237887.

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Conflict of interest statement

Compliance with Ethical StandardsFundingAbbVie Inc. funded the study (NCT00237887), contributed to its design, and was involved in the collection, analysis, and interpretation of the data, and in the writing, review, and approval of the publication.Conflict of interestApril W. Armstrong serves as an investigator and/or consultant for AbbVie Inc., Amgen, Janssen, Merck, Lilly, Celgene, Novartis, Pfizer, and Modernizing Medicine. Delfina Guadalupe Villanueva Quintero has served as a consultant and speaker for UCB Pharma, Leo Pharma, Pfizer, and AbbVie Inc. Cristina M. Echeverría has served as a consultant and speaker for AbbVie Inc. and UCB Pharma. Yihua Gu, Mahinda Karunaratne, and Ofelia Reyes Servín are employees of AbbVie Inc. and may own AbbVie Inc. stock and/or stock options.Ethics approval and consent to participateThis is a post hoc analysis of a previously published study (Menter et al. Adalimumab therapy for moderate-to-severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58:106-115). The original study was conducted in accordance with the protocol, International Conference on Harmonisation guidelines, applicable regulations and guidelines governing clinical study conduct, and the ethical principles that have their origin in the 1964 Helsinki Declaration and its later amendments.Written informed consent for the original study was obtained from all individual participants.

Figures

Fig. 1
Fig. 1
a Mean percentage improvement from baseline in PASI scores through week 16 overall and by region (head, trunk, upper extremities, and lower extremities) for the ITT population (LOCF). b Proportion of patients achieving PASI 75, 90, and 100 responses through week 16 overall and by region (head, trunk, upper extremities, and lower extremities) in the ITT population (nonresponder imputation). ADA adalimumab, ITT intent-to-treat, LOCF last observation carried forward, PASI Psoriasis Area and Severity Index, PBO placebo, ***p < 0.001, *p < 0.05, adalimumab vs. placebo group
Fig. 1
Fig. 1
a Mean percentage improvement from baseline in PASI scores through week 16 overall and by region (head, trunk, upper extremities, and lower extremities) for the ITT population (LOCF). b Proportion of patients achieving PASI 75, 90, and 100 responses through week 16 overall and by region (head, trunk, upper extremities, and lower extremities) in the ITT population (nonresponder imputation). ADA adalimumab, ITT intent-to-treat, LOCF last observation carried forward, PASI Psoriasis Area and Severity Index, PBO placebo, ***p < 0.001, *p < 0.05, adalimumab vs. placebo group
Fig. 2
Fig. 2
Proportion of patients achieving PASI 75 and 100 responses at week 16 by baseline PASI scores in a overall, b head, c trunk, d upper extremities, and e lower extremities (ITT population; nonresponder imputation). Baseline PASI categories correspond to the overall PASI score (a) or the regional PASI score (b–e); includes patients with non-zero baseline PASI scores in the respective region. ADA adalimumab, ITT intent-to-treat, PASI Psoriasis Area and Severity Index, PBO placebo, ***p ≤ 0.001; *p < 0.05, adalimumab vs. placebo group
Fig. 3
Fig. 3
Mean ± SE change from baseline in DLQI at weeks 4 and 16 in the ITT population (LOCF). Scores range from 0 to 30, with higher scores indicating increasing impact on quality of life. DLQI Dermatology Life Quality Index, ITT intent-to-treat, LOCF last observation carried forward, SE standard error, ***p < 0.001 adalimumab vs. placebo group
Fig. 4
Fig. 4
a Mean percentage improvements from baseline in DLQI scores. b Proportion of patients with a DLQI score of 0 or 1 at week 16 by regional PASI response in the ITT population (LOCF). DLQI Dermatology Life Quality Index, ITT intent-to-treat, LOCF last observation carried forward, PASI Psoriasis Area and Severity Index
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References

    1. Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Investig Dermatol. 2013;133(2):377–385. doi: 10.1038/jid.2012.339. - DOI - PubMed
    1. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3 Pt 1):401–407. doi: 10.1016/S0190-9622(99)70112-X. - DOI - PubMed
    1. van de Kerkhof PC, Murphy GM, Austad J, et al. Psoriasis of the face and flexures. J Dermatol Treat. 2007;18(6):351–360. doi: 10.1080/09546630701341949. - DOI - PubMed
    1. Kragballe K, Menter A, Lebwohl M, et al. Long-term management of scalp psoriasis: perspectives from the International Psoriasis Council. J Dermatol Treat. 2013;24(3):188–192. doi: 10.3109/09546634.2012.681017. - DOI - PubMed
    1. Wozel G. Psoriasis treatment in difficult locations: scalp, nails, and intertriginous areas. Clin Dermatol. 2008;26(5):448–459. doi: 10.1016/j.clindermatol.2007.10.026. - DOI - PubMed

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