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Review
. 2020 Oct;13(10):18-22.
Epub 2020 Oct 1.

Early Treatment Targets for Predicting Long-term Dermatology Life Quality Index Response in Patients with Moderate-to-Severe Plaque Psoriasis: A Post-hoc Analysis from a Long-term Clinical Study

Luis Puig  1   2   3   4 , Baojin Zhu  1   2   3   4 , Russel Burge  1   2   3   4 , David Shrom  1   2   3   4 , Yan Dong  1   2   3   4 , Wei Shen  1   2   3   4 , Lotus Mallbris  1   2   3   4 , Kristian Reich  1   2   3   4
Affiliations
Review

Early Treatment Targets for Predicting Long-term Dermatology Life Quality Index Response in Patients with Moderate-to-Severe Plaque Psoriasis: A Post-hoc Analysis from a Long-term Clinical Study

Luis Puig et al. J Clin Aesthet Dermatol. 2020 Oct.

Abstract

BACKGROUND: Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody. OBJECTIVE: We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]). METHODS: The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient's skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden's Index. RESULTS: Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher. CONCLUSION: Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment.

Keywords: Dermatology Life Quality Index; Psoriasis Area and Severity Index; ixekizumab; psoriasis.

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Conflict of interest statement

FUNDING:The study was sponsored by Eli Lilly and Company. DISCLOSURES:Professor Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Covagen, Eli Lilly and Company, Forward Pharma, Fresenius Medical Care, Galapagos NV, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, Leo, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, and Xenoport. Dr. Puig has received grants/research supports or participation in clinical trials (paid to Institution). Drs. Zhu, Burge, Shrom, Dong, Shen, and Mallbris are employees and minor stockholders of Eli Lilly and Company.

Figures

FIGURE 1a.
FIGURE 1a.
Proportion of patients reaching PASI 50, PASI 75, PASI 90, and PASI 100 at Weeks 4, 12, and 24 (NRI) *p≤0.05; **p<0.001; ***p≤0.0001 IXE: ixekizumab; NRI: non-responder imputation; PASI: Psoriasis Area and Severity Index; UST: ustekinumab
FIGURE 1b.
FIGURE 1b.
Predictability of DLQI (0,1) responses by early PASI improvement: An example using IXE-treated patients to calculate Se, Sp, PPV, and NPV DLQI: Dermatology Life Quality Index; IXE: ixekizumab; NPV: negative predictor value; NRI: nonresponder imputation; PASI: Psoriasis Area and Severity Index; PPV: positive predictive value; Se: sensitivity; Sp: specificity; UST: ustekinumab; YI: Youden’s Index
FIGURE 2a.
FIGURE 2a.
ROC curve for the pooled intent-to-treat patients on PASI improvement at Weeks 4, 12, and 24 for predicting DLQI (0,1) responders at Week 52 AUC: area under the curve; DLQI: Dermatology Life Quality Index; PASI: Psoriasis Area and Severity Index; ROC: Receiver Operator Characteristic
FIGURE 2b.
FIGURE 2b.
Impact of reaching different PASI response threshold at Weeks 4, 12, and 24 on DLQI (0,1) (mBOCF) at Week 52 for IXE (a) and UST (b) LQI: Dermatology Life Quality Index; IXE: ixekizumab; mBOCF: modified baseline observation carried forward; PASI: Psoriasis Area and Severity Index; UST: ustekinumab
FIGURE 3.
FIGURE 3.
The optimum threshold of PASI improvement at Weeks 4 and 12 for predicting DLQI (0,1) responders at Week 52 DLQI: Dermatology Life Quality Index; IXE: ixekizumab; PASI: Psoriasis Area and Severity Index; UST: ustekinumab; YI: Youden’s Index
FIGURE 3b.
FIGURE 3b.
ROC curve for (a) IXE and (b) UST on PASI improvement at Weeks 4 and 12 for predicting DLQI (0,1) responders at Week 52. AUC: area under the curve; DLQI: Dermatology Life Quality Index; IXE: ixekizumab; PASI: Psoriasis Area and Severity Index; ROC: receiver operating characteristic; UST: ustekinumab
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